Exenatide

also known as Byetta · Bydureon · AC2993 · Exendin-4 · ITCA 650 · EQW · EXE · - exenatide (Byetta) · +13 more

Peptide targets GLP1R via activation

Developed for: type 2 diabetes mellitus · obesity disorder · diabetes mellitus · glucose intolerance · polycystic ovary syndrome · type 1 diabetes mellitus · NAFLD1 · Parkinson disease
+46 more
· acquired hypothalamic obesity · hyperglycemia · brain injury · coronary artery disorder · diastolic heart failure · gestational diabetes · hypoglycemia · myocardial infarction · Prader-Willi syndrome · prediabetes syndrome · substance-related disorder · alcohol dependence · alcohol-related disorders · Alzheimer disease · aortic valve disorder · cardiac arrest · cardiovascular disorder · cerebrovascular disorder · chronic kidney disease · cocaine dependence · cognitive disorder · cognitive impairment with or without cerebellar ataxia · congestive heart failure · coronary atherosclerosis · coronary restenosis · diabetic kidney disease · diabetic polyneuropathy · glucose metabolism disease · heart failure · HIV infectious disease · hyperinsulinemic hypoglycemia · ischemic stroke · kidney disorder · left ventricular failure · morbid obesity · multiple system atrophy · pseudotumor cerebri · psoriasis · schizoaffective disorder · schizophrenia · short bowel syndrome · Wolfram syndrome · acute myocardial infarction · infectious disease with sepsis · multiple organ dysfunction syndrome · ST-elevation myocardial infarction
Investigated by: AstraZeneca · Eli Lilly and Company · Amylin Pharmaceuticals, LLC. · Intarcia Therapeutics · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · GlaxoSmithKline
+174 more
· Amsterdam UMC, location VUmc · Yale University · Baylor College of Medicine · The University of Texas Health Science Center at San Antonio · The University of Texas Health Science Center, Houston · American Diabetes Association · Beijing Chao Yang Hospital · Carl T. Hayden VA Medical Center · Centre Hospitalier Universitaire de Besancon · Children's Hospitals and Clinics of Minnesota · Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Karolinska Institutet · Mayo Clinic · Peptron, Inc. · RenJi Hospital · Sanofi · The Affiliated Hospital of Xuzhou Medical University · University College, London · University Health Network, Toronto · University at Buffalo · University of Colorado, Denver · University of Florida · University of Minnesota · Air Force Military Medical University, China · Albert Einstein College of Medicine · Antaros Medical · Assistance Publique Hopitaux De Marseille · Astra Zeneca, Bristol-Myers Squibb · Azienda Ospedaliero-Universitaria di Parma · Bayer · Baylor Research Institute · Becton, Dickinson and Company · Beth Israel Deaconess Medical Center · Bing He · Biomedical Research Institute of New Mexico · Boston Medical Center · Bristol-Myers Squibb · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Cambridge University Hospitals NHS Foundation Trust · Camillo Ricordi and Jay Skyler · Canadian Institutes of Health Research (CIHR) · Celerion · Center for Neurology, Stockholm · Chang'An Hospital · Charles University, Czech Republic · Children's Hospital Los Angeles · Chinese Academy of Medical Sciences, Fuwai Hospital · Chinese University of Hong Kong · Christopher D. Verrico · Consano Clinical Research, LLC · Dasman Diabetes Institute · DexCom, Inc. · Diabetes Research Institute Foundation · Dr. Muhammad Abdulghani · EU FP7: SAFEGUARD consortium · Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Filip Krag Knop · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital of Wenzhou Medical University · Fudan University · Fuling Central Hospital of Chongqing City · Garvan Institute of Medical Research · Georgetown University · Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel · Hadassah Medical Organization · Hospital Universitari Vall d'Hebron Research Institute · Huadong Hospital · Huashan Hospital · Huazhong University of Science and Technology · Hvidovre University Hospital · Imperial College London · Indiana University · Ingrid Jazet · Innovative Diabetes Treatment Studies LLC. · all 180 on the full record

Regulatory milestones approvals, filings & regulatory actions · 19 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed type 2 diabetes mellitus 8 milestones
Filed	US (FDA)	BYETTA	type 2 diabetes mellitus	2010-12-22	“a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection” lilly.com ↗
Rejected (CRL)	US (FDA)	BYDUREON	type 2 diabetes mellitus	2010-03-15	“the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON” alkermes.com ↗ “complete response letter issued in October 2010 by FDA regarding Bydureon™, an investigational medication for type 2 diabetes.” lilly.com ↗ “received a complete response letter from the FDA for Bydureon(TM), the proposed brand name for exenatide once weekly.” lilly.com ↗ “In the U.S., the FDA issued a complete response letter for the BYDUREON New Drug Application in late 2010.” lilly.com ↗
Filed	US (FDA)	—	type 2 diabetes mellitus	2009-07-07	“The company and its partners Amylin Pharmaceuticals, Inc., and Alkermes, Inc. submitted a New Drug Application (NDA) to the FDA for exenatide once weekly.” lilly.com ↗ “today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).” alkermes.com ↗
Filed	US (FDA)	—	type 2 diabetes mellitus	2009-05-05	“today announced that a New Drug Application (NDA) for exenatide once weekly has been submitted to the U.S. Food and Drug Administration (FDA).” alkermes.com ↗
Filed	US (FDA)	Byetta	type 2 diabetes mellitus	2008-04-21	“The company, along with its partner, Amylin Pharmaceuticals, Inc., submitted Byetta as a monotherapy treatment for type 2 diabetes to the FDA.” lilly.com ↗
Filed	US (FDA)	BYDUREON	type 2 diabetes mellitus	2004-06-30	“In the U.S., the New Drug Application for BYDUREON (exenatide extended-release for injectable suspension) was submitted to the U.S. Food and Drug Administration (FDA) in 2009.” alkermes.com ↗ “Amylin, Lilly and Alkermes submitted a new drug application (NDA) for exenatide once weekly to the U.S. Food and Drug Administration (FDA) in May 2009;” alkermes.com ↗ “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide.” lilly.com ↗ “The New Drug Application for BYDUREON was submitted to the U.S. Food and Drug Administration (FDA) in 2009.” alkermes.com ↗ “The NDA for exenatide once weekly was submitted in May 2009 and accepted by the FDA in July 2009.” lilly.com ↗ “The NDA for BYDUREON was submitted in May 2009 and accepted by the FDA in July 2009.” alkermes.com ↗ “The New Drug Application (NDA) for BYDUREON was submitted in May 2009.” alkermes.com ↗
Filed	EU (EMA)	Byetta	type 2 diabetes mellitus	—	“Lilly submitted Byetta for the treatment of type 2 diabetes in Europe.” lilly.com ↗
Filed	Japan (PMDA)	Bydureon	type 2 diabetes mellitus	—	“Bydureon was recently submitted for regulatory review in Japan.” lilly.com ↗
Approved Indication not stated 4 milestones
Label expansions (4)	US (FDA)	BYETTA	—	2006-12-22 – 2021-11-04	fda.gov ↗
Label expansions (5)	US (FDA)	BYDUREON PEN	—	2015-09-24 – 2021-07-22	fda.gov ↗
Approved	EU (EMA)	Byetta	—	2006-11-20	europa.eu ↗
Approved	US (FDA)	BYETTA	—	2005-04-28	fda.gov ↗

Trials 217 · started per year

today

US approved 2005

EU approved 2006

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT02690987	Aug 2015 → Aug 2019	alcohol dependence, obesity disorder	Imperial College London	Unknown	No outcome recorded
Phase 124 trials · 1 met primary
Phase 1	NCT06252623	Aug 2024 → Mar 2026	substance-related disorder	Christopher D. Verrico	Withdrawn	No outcome recorded
Phase 1	NCT04001231	Jun 2020 → Jul 2021	type 2 diabetes mellitus	AstraZeneca	Withdrawn	No outcome recorded Stop: Business
Phase 1	NCT03645408	May 2019 → Jul 2021	alcohol-related disorders	Boston Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT03456687	Jun 2018 → Oct 2020	Parkinson disease	University of Florida	Completed	No outcome recorded
Phase 1	NCT03199261	Dec 2016 → Jan 2017	type 2 diabetes mellitus	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT05762744	Jun 2016 → Nov 2018	type 2 diabetes mellitus	University of Maryland, Baltimore	Terminated	No outcome recorded Stop: Enrollment
Phase 1	NCT02650479	Jan → Apr 2016	—	Intarcia Therapeutics	Completed	No outcome recorded
Phase 1	NCT02641990	Dec 2015 → Feb 2016	—	Intarcia Therapeutics	Completed	No outcome recorded
Phase 1	NCT02641899	Dec 2015 → Mar 2016	—	Intarcia Therapeutics	Completed	No outcome recorded
Phase 1	NCT02302976	Nov 2014 → Aug 2018	cocaine dependence	Yale University	Completed	No outcome recorded
Phase 1	NCT02320045	Nov 2014 → Jul 2015	impaired renal function disease	Intarcia Therapeutics	Completed	No outcome recorded
Phase 1	NCT01857895	May → Nov 2013	obesity disorder	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02349802	Feb → Dec 2013	—	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT01855490	Jan 2012 → Jul 2013	type 1 diabetes mellitus	Yale University	Completed	No outcome recorded
Phase 1	NCT01297062	Feb → Apr 2011	—	AstraZeneca	Completed	Met primary
Phase 1	NCT00964262	Aug 2009 → Oct 2010	type 2 diabetes mellitus	Peptron, Inc.	Completed	No outcome recorded
Phase 1	NCT01798264	Feb → May 2009	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	No outcome recorded
Phase 1	NCT00672399	Apr → Jul 2008	—	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT01021527	Feb → Mar 2008	—	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00971659	Jan → Sep 2008	type 2 diabetes mellitus	Profil Institute for Metabolic Research GmbH	Completed	No outcome recorded
Phase 1	NCT00612794	Sep 2007 → May 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT00254800	Nov 2005 → Aug 2006	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 1	NCT00259896	Oct 2005 → ?	type 2 diabetes mellitus	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00517283	Jan → Jun 2005	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded

Phase 1/26 trials · 1 met primary
Phase 1/2	NCT02586831	Jun 2024	hypoglycemia, type 1 diabetes mellitus	Camillo Ricordi and Jay Skyler	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1/2	NCT04941521	Jun → Nov 2021	substance-related disorder	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 1/2	NCT02975297	Jul 2016 → Jan 2020	—	The University of Texas Health Science Center, Houston	Completed	Met primary
Phase 1/2	NCT01061775	Jan 2010 → Jul 2013	acquired hypothalamic obesity	Children's Hospitals and Clinics of Minnesota	Completed	No outcome recorded
Phase 1/2	NCT00894322	Apr → Aug 2009	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 1/2	NCT00882050	Mar 2009 → Apr 2016	hyperglycemia, hypoglycemia	Thomas Jefferson University	Completed	No outcome recorded
Phase 228 trials · 4 met primary · 6 missed
Phase 2	NCT05356104	May 2022 → May 2027 expected	cerebrovascular disorder	Chinese University of Hong Kong	Recruiting	No outcome recorded
Phase 2	NCT04431713	Sep 2020 → Mar 2024	multiple system atrophy	University College, London	Completed	No outcome recorded
Phase 2	NCT04269642	Mar 2020 → Sep 2021	Parkinson disease	Peptron, Inc.	Unknown	No outcome recorded
Phase 2	NCT04305002	Jan 2020 → Oct 2023	Parkinson disease	Center for Neurology, Stockholm	Unknown	No outcome recorded
Phase 2	NCT03287076	Nov 2017 → Oct 2021	ischemic stroke	Neuroscience Trials Australia	Unknown	Missed primary
Phase 2	NCT03017352	Dec 2016 → Jun 2019	type 1 diabetes mellitus	Filip Krag Knop	Completed	Missed primary
Phase 2	NCT02313220	Dec 2014 → Mar 2016	obesity disorder	Uppsala University	Completed	No outcome recorded
Phase 2	NCT01938235	Feb 2014 → Jul 2017	myocardial infarction	University Health Network, Toronto	Unknown	No outcome recorded
Phase 2	NCT01928329	Sep 2013 → Jun 2018	type 1 diabetes mellitus	Yale University	Completed	Missed primary
Phase 2	NCT01484873	Jun 2012 → Mar 2015	craniopharyngioma, obesity disorder	Vanderbilt University Medical Center	Completed	Missed primary
Phase 2	NCT01255163	Nov 2010 → Nov 2016	Alzheimer disease, cognitive impairment with or without cerebellar ataxia	National Institute on Aging (NIA)	Terminated	No outcome recorded
Phase 2	NCT01237197	Oct 2010 → May 2012	obesity disorder	University of Minnesota	Completed	Met primary
Phase 2	NCT01174810	Jul 2010 → Mar 2013	Parkinson disease	University College, London	Unknown	No outcome recorded
Phase 2	NCT00886626	May 2009 → Feb 2011	morbid obesity	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT00701935	Aug 2008 → Jan 2012	type 2 diabetes mellitus	AstraZeneca	Terminated	Missed primary Stop: Enrollment
Phase 2	NCT01154933	Apr 2008 → Nov 2011	type 2 diabetes mellitus	University at Buffalo	Completed	No outcome recorded
Phase 2	NCT00529204	Oct 2007 → Jul 2009	NAFLD1	University of California, Davis	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00500370	Jun 2007 → Feb 2008	obesity disorder	AstraZeneca	Completed	Met primary
Phase 2	NCT00518115	Apr 2007 → May 2008	type 2 diabetes mellitus	GlaxoSmithKline	Completed	Met primary
Phase 2	NCT00456300	Mar 2007 → Mar 2009	type 1 diabetes mellitus	Montefiore Medical Center	Completed	No outcome recorded
Phase 2	NCT00382239	Sep 2006 → May 2007	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 2	NCT00344851	Jun 2006 → Jun 2007	polycystic ovary syndrome	Metabolic Center of Louisiana Research Foundation	Completed	No outcome recorded
Phase 2	NCT00254254	Feb 2006 → Feb 2007	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00241423	Oct 2005 → Jun 2007	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00099333	Feb 2004 → Aug 2005	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00085969	Sep 2003 → Jan 2004	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00064714	Jul 2003 → Mar 2008	diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 2	NCT00044694	Aug 2002 → May 2003	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded

Phase 2/36 trials
Phase 2/3	NCT02584582	Jul → Nov 2015	type 1 diabetes mellitus	Hvidovre University Hospital	Unknown	No outcome recorded
Phase 2/3	NCT02432976	May 2015 → Jan 2017	—	Centre Hospitalier Universitaire de Besancon	Completed	No outcome recorded
Phase 2/3	NCT01969149	Jan → Dec 2015	hyperglycemia	Centre Hospitalier Universitaire de Besancon	Completed	No outcome recorded
Phase 2/3	NCT02157974	Aug 2014 → Dec 2022	fatty liver disease, obesity disorder, polycystic ovary syndrome	University of Colorado, Denver	Completed	No outcome recorded
Phase 2/3	NCT01140893	Nov 2010 → May 2017	type 2 diabetes mellitus	University Hospital, Caen	Unknown	No outcome recorded
Phase 2/3	NCT00650546	Aug 2006 → Aug 2010	NAFLD1	Indiana University	Completed	No outcome recorded
Phase 362 trials · 26 met primary · 4 missed
Phase 3	NCT05347147	Nov 2022 → Sep 2023	pseudotumor cerebri	Invex Therapeutics Ltd.	Terminated	No outcome recorded Stop: Business
Phase 3	NCT03671733	Sep 2018 → Sep 2022	obesity disorder	Xiangya Hospital of Central South University	Unknown	No outcome recorded
Phase 3	NCT03419624	Feb 2018 → Apr 2019	obesity disorder, type 2 diabetes mellitus	University Medical Center Hamburg-Eppendorf	Terminated	No outcome recorded
Phase 3	NCT03060980	Mar 2017 → Jan 2018	type 2 diabetes mellitus	Intarcia Therapeutics	Terminated	No outcome recorded
Phase 3	NCT02860923	Jan 2017 → Jun 2018	acquired hypothalamic obesity, craniopharyngioma	University Hospital, Bordeaux	Completed	Missed primary
Phase 3	NCT02635386	Mar 2016 → Jul 2020	obesity disorder, polycystic ovary syndrome	Woman's	Completed	No outcome recorded
Phase 3	NCT02847403	Feb 2016 → Jul 2019	cognitive disorder, glucose metabolism disease	Azienda Ospedaliero-Universitaria di Parma	Unknown	No outcome recorded
Phase 3	NCT02638805	Dec 2015 → Oct 2017	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	No outcome recorded
Phase 3	NCT02251431	Nov 2015 → Dec 2019	chronic kidney disease, diastolic heart failure, type 2 diabetes mellitus	Baylor Research Institute	Completed	No outcome recorded
Phase 3	NCT02229383	Sep 2014 → Aug 2016	diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT02229396	Sep 2014 → Apr 2016	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT02194595	Sep 2014 → Dec 2021	type 2 diabetes mellitus	Mount Sinai Hospital, Canada	Completed	No outcome recorded
Phase 3	NCT01785771	May 2013 → Jan 2018	type 2 diabetes mellitus	Intarcia Therapeutics	Terminated	No outcome recorded
Phase 3	NCT01455870	May 2013 → Jul 2015	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	No outcome recorded
Phase 3	NCT01455896	Mar 2013 → Mar 2016	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	No outcome recorded
Phase 3	NCT01455857	Mar 2013 → Aug 2014	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	Met primary
Phase 3	NCT01455883	Feb 2013 → Jul 2014	type 2 diabetes mellitus	Intarcia Therapeutics	Withdrawn	No outcome recorded
Phase 3	NCT01455909	Feb 2013 → Jul 2014	type 2 diabetes mellitus	Intarcia Therapeutics	Withdrawn	No outcome recorded
Phase 3	NCT01652729	Feb 2013 → Apr 2014	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT01455922	Feb 2013 → Jul 2014	type 2 diabetes mellitus	Intarcia Therapeutics	Withdrawn	No outcome recorded
Phase 3	NCT01652716	Jan 2013 → Aug 2014	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT01554618	Dec 2011 → May 2020	—	AstraZeneca	Completed	Met primary
Phase 3	NCT01373216	Jun 2011 → May 2014	coronary atherosclerosis, left ventricular failure	Charles University, Czech Republic	Completed	No outcome recorded
Phase 3	NCT02042664	Jan 2011 → Jan 2015	diabetes mellitus, obesity disorder	Assistance Publique Hopitaux De Marseille	Completed	No outcome recorded
Phase 3	NCT01144338	Jun 2010 → Apr 2017	type 2 diabetes mellitus	AstraZeneca	Completed	Mixed
Phase 3	NCT01029886	Jan 2010 → Jan 2011	type 2 diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 3	NCT01003184	Oct 2009 → Jul 2011	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00960661	Sep 2009 → Aug 2012	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00935532	Jul 2009 → Sep 2010	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00917267	Jul 2009 → Sep 2010	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00877890	Mar → Oct 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00676338	Nov 2008 → Jul 2010	type 2 diabetes mellitus	AstraZeneca	Completed	Mixed
Phase 3	NCT00753896	Oct 2008 → Jul 2009	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00765817	Oct 2008 → Jan 2010	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00658021	May 2008 → Apr 2019	type 2 diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 3	NCT00641056	Apr 2008 → May 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00603239	Jan 2008 → Jul 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00577824	Jan → Nov 2008	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00637273	Jan 2008 → Feb 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00516074	Sep 2007 → Apr 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00516048	Aug 2007 → Apr 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00434954	Feb 2007 → Jun 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00381342	Sep 2006 → Sep 2007	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00359762	Sep 2006 → Mar 2011	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00359879	Sep 2006 → Jul 2007	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00375492	Sep 2006 → Feb 2008	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00360334	Jun 2006 → Apr 2008	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00313001	Apr 2006 → Jul 2007	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	No outcome recorded
Phase 3	NCT00324363	Jan 2006 → Apr 2007	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00135330	Oct 2005 → Jul 2008	type 2 diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 3	NCT00099619	Sep 2004 → Aug 2005	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00097500	Sep 2004 → Dec 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00099320	May 2004 → Aug 2005	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT01876849	Dec 2003 → Jul 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00082407	Nov 2003 → Jul 2008	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00082381	Jun 2003 → Jul 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00111540	Nov 2002 → Sep 2006	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT01789957	Sep 2002 → Jun 2004	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00044668	Aug 2002 → Sep 2005	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00035984	May 2002 → Aug 2003	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 3	NCT00039013	Mar 2002 → Jun 2003	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 3	NCT00039026	Feb 2002 → Aug 2003	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary

Phase 470 trials · 8 met primary · 8 missed
Phase 4	NCT05482789	Apr 2023 → Dec 2025 overdue	gestational diabetes	Maisa N. Feghali, MD	Recruiting	No outcome recorded
Phase 4	NCT04307797	Jan → Oct 2022	obesity disorder, type 2 diabetes mellitus	Cambridge University Hospitals NHS Foundation Trust	Completed	No outcome recorded
Phase 4	NCT04897802	Sep 2021 → Apr 2024	central diabetes insipidus, hypothalamic disorder, panhypopituitarism, psychiatric disorder	Sant Pau Research Institute	Completed	No outcome recorded
Phase 4	NCT04969627	Jan 2021 → Jan 2022	polycystic ovary syndrome	Bing He	Completed	No outcome recorded
Phase 4	NCT04135287	Mar 2020 → Mar 2023	type 2 diabetes mellitus	Dasman Diabetes Institute	Unknown	No outcome recorded
Phase 4	NCT04027023	Oct 2019 → Apr 2021	type 2 diabetes mellitus	Sciema UG	Unknown	No outcome recorded
Phase 4	NCT04029272	Jul 2019 → Feb 2020	polycystic ovary syndrome	Peking Union Medical College Hospital	Unknown	Met primary
Phase 4	NCT03970044	Jul 2019 → Jun 2021	type 2 diabetes mellitus	Consano Clinical Research, LLC	Completed	No outcome recorded
Phase 4	NCT03383068	Jan → Dec 2018	glucose intolerance, polycystic ovary syndrome	RenJi Hospital	Unknown	No outcome recorded
Phase 4	NCT03352869	Nov 2017 → Jul 2018	glucose intolerance, polycystic ovary syndrome	RenJi Hospital	Completed	No outcome recorded
Phase 4	NCT03361098	Sep 2017 → Nov 2019	obesity disorder, type 2 diabetes mellitus	Amsterdam UMC, location VUmc	Completed	No outcome recorded
Phase 4	NCT03160261	Sep → Dec 2017	—	University of Tartu	Completed	No outcome recorded
Phase 4	NCT03804411	Aug 2017 → Mar 2020	type 2 diabetes mellitus	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health	Unknown	No outcome recorded
Phase 4	NCT03151005	Jul 2017 → Apr 2021	obesity disorder, polycystic ovary syndrome	Xinqiao Hospital of Chongqing	Completed	No outcome recorded
Phase 4	NCT03018665	Feb 2017 → Dec 2021	type 2 diabetes mellitus	The First Hospital of Jilin University	Unknown	No outcome recorded
Phase 4	NCT03029351	Jan 2017 → Jul 2019	kidney disorder, type 2 diabetes mellitus	University at Buffalo	Terminated	No outcome recorded
Phase 4	NCT02793154	Sep 2016 → Mar 2017	type 2 diabetes mellitus	GlaxoSmithKline	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02802514	Sep 2016 → Aug 2017	diabetes mellitus	GlaxoSmithKline	Terminated	No outcome recorded
Phase 4	NCT03002675	Aug 2016 → Jun 2018	obesity disorder	Ingrid Jazet	Unknown	No outcome recorded
Phase 4	NCT02690883	Apr 2016 → Dec 2019	diabetic kidney disease	Nanfang Hospital, Southern Medical University	Completed	No outcome recorded
Phase 4	NCT02533453	Jan → Dec 2016	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT02621489	Dec 2015 → Aug 2022	atherosclerosis, coronary restenosis, diabetes mellitus	Karolinska Institutet	Completed	Missed primary
Phase 4	NCT02449603	Nov 2015 → Apr 2018	type 2 diabetes mellitus	Xijing Hospital	Completed	No outcome recorded
Phase 4	NCT02584075	Nov 2015 → Nov 2017	coronary artery disorder	Beijing Chao Yang Hospital	Unknown	No outcome recorded
Phase 4	NCT02058940	Aug 2015 → Aug 2017	brain injury	University of North Carolina, Chapel Hill	Completed	No outcome recorded
Phase 4	NCT02467920	Aug 2015 → Dec 2017	type 2 diabetes mellitus	Huazhong University of Science and Technology	Completed	No outcome recorded
Phase 4	NCT02303730	Mar 2015 → Nov 2017	NAFLD1, type 2 diabetes mellitus	Fudan University	Completed	No outcome recorded
Phase 4	NCT02380521	Jan 2015 → Jul 2016	type 2 diabetes mellitus	University of Palermo	Completed	No outcome recorded
Phase 4	NCT02288273	Dec 2014 → Aug 2015	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 4	NCT02501850	Oct 2014 → Jul 2015	type 2 diabetes mellitus	Hospital Universitari Vall d'Hebron Research Institute	Unknown	No outcome recorded
Phase 4	NCT02417142	Sep 2014 → Jul 2019	schizoaffective disorder, schizophrenia	University of Massachusetts, Worcester	Completed	No outcome recorded
Phase 4	NCT02162550	Jun 2014 → Apr 2019	type 2 diabetes mellitus	Phoenix VA Health Care System	Unknown	Missed primary
Phase 4	NCT02160990	Jun 2014 → Mar 2015	obesity disorder	Mayo Clinic	Completed	Met primary
Phase 4	NCT02170324	Jun 2014 → Jul 2015	obesity disorder	Xiang Guang-da	Completed	No outcome recorded
Phase 4	NCT02104739	Apr 2014 → Mar 2017	obesity disorder, prediabetes syndrome	The University of Texas Health Science Center, Houston	Completed	Missed primary
Phase 4	NCT02129985	Feb 2014 → Jun 2015	type 2 diabetes mellitus	xiaolong zhao	Unknown	No outcome recorded
Phase 4	NCT02072096	Feb 2014 → Oct 2015	type 2 diabetes mellitus	Eli Lilly and Company	Terminated	Missed primary
Phase 4	NCT00572689	Aug 2013 → Aug 2015	gestational diabetes	Georgetown University	Withdrawn	No outcome recorded
Phase 4	NCT01744236	Apr 2013 → Aug 2015	type 2 diabetes mellitus	Amsterdam UMC, location VUmc	Completed	Missed primary
Phase 4	NCT01791465	Mar 2013 → Dec 2014	HIV infectious disease, diabetes mellitus	Vanderbilt University	Terminated	No outcome recorded Stop: Business
Phase 4	NCT01818648	Mar 2013 → Jan 2014	short bowel syndrome	Mayo Clinic	Withdrawn	No outcome recorded
Phase 4	NCT03297879	Jan 2013 → Feb 2016	type 2 diabetes mellitus	Beijing Chao Yang Hospital	Completed	No outcome recorded
Phase 4	NCT01524705	Aug 2012 → Jul 2014	type 2 diabetes mellitus	University of Washington	Completed	Met primary
Phase 4	NCT01776788	Aug 2012 → Feb 2015	type 2 diabetes mellitus	The First Affiliated Hospital of Xiamen University	Completed	No outcome recorded
Phase 4	NCT01590433	Mar 2012 → Jan 2019	obesity disorder	Jody Dushay	Completed	Missed primary
Phase 4	NCT01381926	Feb 2011 → Aug 2015	bone remodeling disease, type 2 diabetes mellitus	University of Alabama at Birmingham	Terminated	No outcome recorded
Phase 4	NCT01270191	Nov 2010 → Dec 2014	type 2 diabetes mellitus	Taipei Veterans General Hospital, Taiwan	Unknown	No outcome recorded
Phase 4	NCT01181986	Aug 2010 → Dec 2012	type 2 diabetes mellitus	Carl T. Hayden VA Medical Center	Completed	Met primary
Phase 4	NCT01588418	Jul 2010 → Jul 2015	diabetes mellitus, glucose intolerance	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT01951651	Apr 2010 → Oct 2012	type 2 diabetes mellitus	Baylor College of Medicine	Completed	No outcome recorded
Phase 4	NCT01269047	Aug 2009 → Aug 2016	type 1 diabetes mellitus	Albert Einstein College of Medicine	Completed	No outcome recorded
Phase 4	NCT00799435	Jul 2009 → Apr 2012	diastolic heart failure, type 2 diabetes mellitus	Baylor College of Medicine	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00766857	May 2009 → Dec 2012	congestive heart failure, type 2 diabetes mellitus	Amsterdam UMC, location VUmc	Completed	No outcome recorded
Phase 4	NCT00870194	Mar 2009 → Apr 2010	type 2 diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 4	NCT01107717	Jan 2009 → Feb 2023	type 2 diabetes mellitus	The University of Texas Health Science Center at San Antonio	Completed	Met primary
Phase 4	NCT00845507	Dec 2008 → Jul 2015	—	University of Cincinnati	Completed	No outcome recorded
Phase 4	NCT00845559	Aug 2008 → Mar 2010	cardiovascular disorder, glucose intolerance, obesity disorder	Yale University	Withdrawn	No outcome recorded
Phase 4	NCT00736229	Aug 2008 → Jun 2011	acute coronary syndrome, hyperglycemia, myocardial infarction	Saint Luke's Health System	Completed	Mixed
Phase 4	NCT00729326	Aug 2008 → Oct 2009	type 2 diabetes mellitus	AstraZeneca	Completed	Met primary
Phase 4	NCT00948168	Jul 2008 → Jul 2009	type 2 diabetes mellitus	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Completed	No outcome recorded
Phase 4	NCT01435980	Feb 2008 → Jan 2016	type 2 diabetes mellitus	Wu Qinan	Unknown	No outcome recorded
Phase 4	NCT01006889	Jan 2008 → Dec 2009	NAFLD1, type 2 diabetes mellitus	University of Florida	Completed	No outcome recorded
Phase 4	NCT00623545	Jan 2008 → Apr 2010	—	University of Wisconsin, Madison	Completed	Met primary
Phase 4	NCT00546728	Oct 2007 → Jul 2011	glucose intolerance	St. Paul Heart Clinic	Completed	Missed primary
Phase 4	NCT00845182	Jun 2007 → Jul 2010	glucose intolerance, type 2 diabetes mellitus	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT01432405	Jun 2007 → Jul 2008	type 2 diabetes mellitus	Baylor College of Medicine	Completed	No outcome recorded
Phase 4	NCT00477581	May → Sep 2007	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT00456885	Apr 2007 → Sep 2010	glucose intolerance, obesity disorder	Beth Israel Deaconess Medical Center	Completed	No outcome recorded
Phase 4	NCT00353834	Aug 2006 → Sep 2010	type 2 diabetes mellitus	Joslin Diabetes Center	Completed	No outcome recorded
Phase 4	NCT00974272	Aug 2006 → Nov 2008	glucose intolerance, type 2 diabetes mellitus	Carl T. Hayden VA Medical Center	Completed	No outcome recorded

Phase not applicable20 trials · 2 missed
—	NCT06256419	Jan 2024 → Jan 2028 expected	type 2 diabetes mellitus	The Affiliated Hospital of Xuzhou Medical University	Recruiting	No outcome recorded
—	NCT04909333	Apr 2021 → Apr 2024	hyperinsulinemic hypoglycemia	University Hospital, Basel, Switzerland	Completed	No outcome recorded
—	NCT05037045	Jan 2019 → Oct 2023	type 2 diabetes mellitus	The Affiliated Hospital of Xuzhou Medical University	Completed	No outcome recorded
—	NCT02673931	Feb 2016 → Sep 2024 overdue	aortic valve disorder, brain injury, cardiogenic shock, coronary artery disorder +2	Rigshospitalet, Denmark	Active not recruiting	Missed primary
—	NCT02887625	Feb 2015 → May 2017	type 2 diabetes mellitus	Dr. Muhammad Abdulghani	Unknown	No outcome recorded
—	NCT02344641	Jan 2015 → Dec 2016	heart failure, type 2 diabetes mellitus	Chinese Academy of Medical Sciences, Fuwai Hospital	Unknown	No outcome recorded
—	NCT02118376	Aug → Dec 2014	obesity disorder	Shanghai 10th People's Hospital	Unknown	No outcome recorded
—	NCT02442791	Jun 2014 → Jun 2016	cardiac arrest	Jesper Kjaergaard	Completed	No outcome recorded
—	NCT01783717	Dec 2012 → Jan 2015	acquired hypothalamic obesity, diabetes mellitus	Huashan Hospital	Unknown	No outcome recorded
—	NCT01444898	Mar 2012 → May 2013	Prader-Willi syndrome	Children's Hospital Los Angeles	Completed	Mixed
—	NCT01687582	Jan → Dec 2012	psoriasis, type 2 diabetes mellitus	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Completed	No outcome recorded
—	NCT01281228	Sep 2011 → Oct 2013	obesity disorder, type 2 diabetes mellitus	Amsterdam UMC, location VUmc	Completed	No outcome recorded
—	NCT01302327	Mar 2011 → Mar 2013	Wolfram syndrome, diabetes mellitus	Hadassah Medical Organization	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT01575301	Mar 2011 → Jul 2015	diabetes mellitus	University of Dundee	Completed	No outcome recorded
—	NCT01364584	Oct 2010 → Dec 2014	type 2 diabetes mellitus	University of Colorado, Denver	Completed	No outcome recorded
—	NCT01136798	Jun 2010 → Sep 2016	sleep apnea syndrome, type 2 diabetes mellitus	University of Chicago	Completed	No outcome recorded
—	NCT01056549	Jan 2010 → Sep 2011	hyperlipidemia	University Health Network, Toronto	Completed	No outcome recorded
—	NCT00775684	Oct 2008 → Nov 2012	prediabetes syndrome, type 2 diabetes mellitus	University of Pennsylvania	Completed	No outcome recorded
—	NCT00855439	Jun 2008 → May 2014	diabetic polyneuropathy, type 2 diabetes mellitus	University of Michigan	Completed	Missed primary
—	NCT00551343	Oct 2007 → Sep 2008	Prader-Willi syndrome	Garvan Institute of Medical Research	Completed	No outcome recorded

Comparator or background therapy67 trials
Phase 1	NCT05670379 Comparator	Dec 2024 → Aug 2025	morbid obesity, type 2 diabetes mellitus	Vivani Medical, Inc	Completed	No outcome recorded
Phase 1	NCT03167411 Comparator	May → Jun 2017	type 2 diabetes mellitus	Theracos	Completed	Missed primary
Phase 1	NCT02685852 Comparator	Feb 2016 → Jul 2019	hyperinsulinemic hypoglycemia	University of Minnesota	Completed	No outcome recorded
Phase 1	NCT03059719 Comparator	Apr 2015 → Sep 2016	type 2 diabetes mellitus	PegBio Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT01843127 Comparator	Apr → Sep 2013	type 2 diabetes mellitus	Gilead Sciences	Completed	No outcome recorded
Phase 1	NCT01664624 Comparator	Jul → Nov 2012	type 2 diabetes mellitus	AstraZeneca	Completed	Missed primary
Phase 1	NCT01501084 Comparator	Dec 2011 → Dec 2012	obesity disorder	University of California, Los Angeles	Completed	No outcome recorded
Phase 1	NCT00782418 Comparator	Sep 2008 → Feb 2009	abnormality of glucagon secretion	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT00642538 Comparator	Feb → Sep 2008	type 2 diabetes mellitus	Mannkind Corporation	Completed	No outcome recorded
Phase 1	NCT02084654 Comparator	Nov 2007 → Oct 2012	prediabetes syndrome	Stanford University	Completed	No outcome recorded
Phase 1	NCT00508287 Comparator	Aug → Nov 2007	type 2 diabetes mellitus	Bristol-Myers Squibb	Completed	No outcome recorded
Phase 1/2	NCT01573806 Comparator	Oct 2012 → Oct 2014	glucose metabolism disease, infectious disease with sepsis, multiple organ dysfunction syndrome	Seattle Children's Hospital	Withdrawn	No outcome recorded Stop: Business
Phase 1/2	NCT00566813 Comparator	Nov 2004 → Jul 2010	type 1 diabetes mellitus	University of Illinois at Chicago	Completed	No outcome recorded
Phase 2	NCT05610800 Comparator	Dec 2022 → Nov 2025	—	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 2	NCT03232112 Comparator	Aug 2017 → Mar 2020	alcohol dependence	Anders Fink-Jensen, MD, DMSci	Completed	No outcome recorded
Phase 2	NCT02838589 Comparator	Aug 2016 → Feb 2017	stroke disorder	Christina Kruuse	Completed	No outcome recorded
Phase 2	NCT02829502 Comparator	Aug 2016 → Aug 2023	ischemic stroke	Christina Kruuse	Unknown	No outcome recorded
Phase 2	NCT02496611 Comparator	Dec 2015 → Aug 2020	morbid obesity	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT02794402 Comparator	Sep 2015 → Sep 2016	obesity disorder	Uppsala University	Completed	No outcome recorded
Phase 2	NCT01971242 Comparator	Jun 2014 → May 2016	Parkinson disease	University College, London	Completed	No outcome recorded
Phase 2	NCT01104701 Comparator	May → Dec 2010	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 2	NCT00943917 Comparator	Aug 2009 → Aug 2010	type 2 diabetes mellitus	Intarcia Therapeutics	Completed	No outcome recorded
Phase 2/3	NCT02735031 Comparator	Feb 2017 → Mar 2018	hypoglycemia, type 1 diabetes mellitus	Radboud University Medical Center	Completed	No outcome recorded
Phase 2/3	NCT00747968 Comparator	Feb → Nov 2010	type 2 diabetes mellitus	University of Aarhus	Completed	No outcome recorded
Phase 2/3	NCT00872378 Comparator	Feb 2009 → Dec 2010	morbid obesity	Advanced Specialty Care	Unknown	No outcome recorded
Phase 3	NCT04520490 Comparator	Jan 2021 → Aug 2025 overdue	—	Seattle Children's Hospital	Active not recruiting	No outcome recorded
Phase 3	NCT04232969 Comparator	Jan 2020 → Feb 2024	Parkinson disease	University College, London	Completed	No outcome recorded
Phase 3	NCT02787551 Comparator	Jul 2016 → May 2018	type 2 diabetes mellitus	Sanofi	Completed	Met primary
Phase 3	NCT02664441 Comparator	Mar 2016 → Mar 2020	acquired hypothalamic obesity	Seattle Children's Hospital	Completed	No outcome recorded
Phase 3	NCT02404376 Comparator	Mar 2016 → Aug 2019	ST-elevation myocardial infarction	Hospital Universitari Vall d'Hebron Research Institute	Completed	No outcome recorded
Phase 3	NCT01885208 Comparator	Dec 2013 → Jul 2015	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	Met primary
Phase 3	NCT01794429 Comparator	Feb 2013 → Jun 2015	metabolic syndrome X, obesity disorder, schizophrenia	Bjorn H. Ebdrup	Completed	No outcome recorded
Phase 3	NCT01676116 Comparator	Aug 2012 → Mar 2014	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	Met primary
Phase 3	NCT01064687 Comparator	Feb 2010 → Nov 2011	type 2 diabetes mellitus	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01254123 Comparator	Nov 2009 → ?	acute myocardial infarction	Amsterdam UMC, location VUmc	Unknown	No outcome recorded
Phase 3	NCT00856609 Comparator	Mar 2009 → Sep 2016	obesity disorder	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Completed	No outcome recorded
Phase 3	NCT00717457 Comparator	Jul 2008 → Mar 2011	type 2 diabetes mellitus	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT00707031 Comparator	Jun 2008 → Nov 2010	type 2 diabetes mellitus	Sanofi	Completed	Met primary
Phase 3	NCT00679042 Background	Sep 2007 → Jul 2017 overdue	type 1 diabetes mellitus	CellTrans Inc.	Active not recruiting	No outcome recorded
Phase 3	NCT00518882 Comparator	Aug 2007 → Apr 2008	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	Met primary
Phase 3	NCT00308139 Comparator	Apr 2006 → Jul 2008	type 2 diabetes mellitus	AstraZeneca	Completed	No outcome recorded
Phase 4	NCT06449235 Comparator	Sep 2024 → Apr 2025 overdue	type 2 diabetes mellitus	Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders	Not yet recruiting	No outcome recorded
Phase 4	NCT03331289 Comparator	Feb 2018 → Mar 2022	type 2 diabetes mellitus	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT02981069 Comparator	Dec 2017 → Jul 2022	type 2 diabetes mellitus	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 4	NCT03007329 Comparator	Mar 2017 → Nov 2019	fatty liver disease, type 2 diabetes mellitus	Medical University of Vienna	Completed	No outcome recorded
Phase 4	NCT02455076 Comparator	Sep 2015 → Mar 2018	type 2 diabetes mellitus	Emory University	Completed	No outcome recorded
Phase 4	NCT02325960 Comparator	Jan 2015 → Jul 2016	type 2 diabetes mellitus	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Completed	No outcome recorded
Phase 4	NCT02092597 Comparator	Oct 2013 → Oct 2015	type 2 diabetes mellitus	Charles University, Czech Republic	Completed	No outcome recorded
Phase 4	NCT01269034 Comparator	Dec 2010 → Jan 2017	type 1 diabetes mellitus	Albert Einstein College of Medicine	Completed	No outcome recorded
Phase 4	NCT01235819 Comparator	Nov 2010 → Sep 2011	type 1 diabetes mellitus	Command Hospital, India	Completed	No outcome recorded
Phase 4	NCT01580514 Comparator	Sep 2009 → Aug 2011	myocardial infarction	Kyunghee University Medical Center	Completed	No outcome recorded
Phase 4	NCT00950677 Comparator	Jul 2009 → May 2011	type 2 diabetes mellitus	Baylor College of Medicine	Completed	No outcome recorded
Phase 4	NCT00835848 Comparator	Jan → Dec 2009	myocardial infarction	Rigshospitalet, Denmark	Completed	No outcome recorded
Phase 4	NCT01700075 Comparator	Jan → Dec 2009	atherosclerosis, coronary artery disorder, myocardial infarction, type 2 diabetes mellitus	Nazarbayev University	Completed	No outcome recorded
Phase 4	NCT01208649 Comparator	Jul 2008 → Sep 2010	NAFLD1	Ruhr University of Bochum	Completed	No outcome recorded
Phase 4	NCT01076842 Comparator	Apr 2008 → Apr 2011	type 2 diabetes mellitus	Novo Nordisk A/S	Completed	No outcome recorded
Phase 4	NCT00667732 Comparator	Mar 2007 → Oct 2009	type 2 diabetes mellitus	Oregon Health and Science University	Completed	No outcome recorded
—	NCT03835013 Comparator	Feb 2019 → Nov 2021	cardiovascular disorder	Cambridge University Hospitals NHS Foundation Trust	Completed	No outcome recorded
—	NCT02962492 Comparator	Nov 2016 → Feb 2021	—	University at Buffalo	Completed	No outcome recorded
—	NCT02244164 Comparator	Oct 2014 → Feb 2023	type 2 diabetes mellitus	Erasme University Hospital	Terminated	No outcome recorded Stop: Enrollment
—	NCT01677104 Comparator	Aug 2012 → Jul 2014	obesity disorder, type 2 diabetes mellitus	Katarina Kos	Completed	No outcome recorded
—	NCT01473147 Comparator	Oct 2011 → Jun 2013	type 2 diabetes mellitus	Chang Gung Memorial Hospital	Completed	No outcome recorded
—	NCT01429506 Comparator	Jan 2011 → Aug 2012	diabetes mellitus, obesity disorder	Post Graduate Institute of Medical Education and Research, Chandigarh	Completed	No outcome recorded
—	NCT01147627 Comparator	Aug 2010 → Aug 2012	type 2 diabetes mellitus	Sun Yat-sen University	Completed	No outcome recorded
—	NCT01089569 Comparator	Apr 2010 → May 2013	type 2 diabetes mellitus	HealthPartners Institute	Completed	No outcome recorded
—	NCT01046721 Comparator	Sep 2009 → Dec 2012	type 2 diabetes mellitus	University of Nottingham	Completed	No outcome recorded
—	NCT00744224 Comparator	Feb 2009 → Jan 2010	glucose metabolism disease	Amsterdam UMC, location VUmc	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 148

Date	Issuer	Release
2025-11-03	Invex Therapeutics Ltd.	Results Exenatide shows additional positive benefits in brain model weblink.com.au ↗ New results indicate Exenatide confers a 40% reduction in neurofilament light chain expression, which is a well-accepted measure of neuronal cell damage
2025-01-21	Invex Therapeutics Ltd.	Results Quarterly Activities/Appendix 4C Cash Flow Report weblink.com.au ↗ This was the first time a GLP-1 receptor agonist (GLP-1RA), namely Exenatide has shown evidence of benefit in a three-dimensional human brain model in AD.
2024-12-15	Invex Therapeutics Ltd.	Results Improved Neuronal Cell Survival in 3D Model of Alzheimer's weblink.com.au ↗ Low dose Exenatide shown to increase cell viability by approx. 24% versus controls under similar oxidative stress conditions experienced in AD patients leading to cell death
2024-11-21	Impax Laboratories, LLC	Regulatory Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide, its First Generic Injectable GLP-1 Agonist amneal.com ↗ Second, Amneal has received approval from the FDA for exenatide, which is the Company’s first generic injectable glucagon-like peptide-1 (GLP-1) agonist and reflects its innovation capabilities in peptide development and drug-device combinations.
2024-09-04	Vivani Medical, Inc	Results Vivani Medical Announces Positive Preclinical Liver Fat Results with Miniature, Ultra Long-Acting GLP-1 Implant vivani.com ↗ Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), an innovative biopharmaceutical company developing miniature, ultra long-acting, subdermal drug implants, today reported positive preclinical liver fat results with its exenatide implant.
2024-06-13	Vivani Medical, Inc	Regulatory Vivani Medical Announces FDA Clears Investigational New Drug Application and Lifts Clinical Hold for NPM-119, a Miniature Long-Term Subdermal GLP-1 Drug Implant vivani.com ↗
2024-02-28	Vivani Medical, Inc	Results Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic®/Wegovy® and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio vivani.com ↗ today announced positive preclinical data on weight loss effects for NPM-115, the Company’s miniature, twice-yearly, exenatide implant under development for the treatment of chronic weight management.
2023-06-22	Invex Therapeutics Ltd.	Regulatory Invex Granted European Orphan Drug Designation for TBI weblink.com.au ↗ Invex Receives European Orphan Drug Designation for Exenatide in Traumatic Brain Injury
2023-04-20	Invex Therapeutics Ltd.	Regulatory Invex Receives Regulatory Approval for IIH EVOLVE in France weblink.com.au ↗ This approval from the ANSM/CPP in France completes our competent authority strategy in Europe, where IIH patients across Germany and France will be participating in this important Phase III clinical trial.
2023-04-19	Invex Therapeutics Ltd.	Regulatory Israel Ministry of Health Approval for IIH EVOLVE weblink.com.au ↗ Invex Announces Ministry of Health Approval for IIH EVOLVE Clinical Trial in Israel
2023-03-19	Invex Therapeutics Ltd.	Regulatory German Approval for IIH EVOLVE Phase 3 Clinical Trial weblink.com.au ↗ This approval from the BfArM German competent authority represents our first national regulatory clearance in Europe for our study.
2023-03-13	Invex Therapeutics Ltd.	Results Publication of Invex IIH Phase II Pressure Trial Results weblink.com.au ↗ We are delighted to see that the Phase II trial resulted in our treatment group having lower brain pressure both immediately and after 12 weeks
2022-12-13	Invex Therapeutics Ltd.	Regulatory Invex Receives Approval for Paediatric Plan from the EMA weblink.com.au ↗ today announces the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has accepted the Company’s PIP for the development of Presendin™ for Idiopathic Intracranial Hypertension (IIH) in pubescent boys and girls aged less than 18 years.
2022-11-24	Invex Therapeutics Ltd.	Regulatory MEDSAFE and Ethics Approval for IIH EVOLVE Trial in NZ weblink.com.au ↗ today announces approval to commence the IIH EVOLVE Phase III clinical trial has been received from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for patients with Idiopathic Intracranial Hypertension (IIH).
2022-08-18	Invex Therapeutics Ltd.	Regulatory Invex receives IND approval weblink.com.au ↗ US FDA IND approval received for Presendin™ and for commencement of the IIH EVOLVE Phase III clinical trial in the US
2022-07-03	Invex Therapeutics Ltd.	Regulatory HREC and TGA Approval to Commence Phase 3 in Australia weblink.com.au ↗ We are delighted to receive the approvals from the HREC and TGA to commence this ground-breaking study in IIH.
2022-06-28	Invex Therapeutics Ltd.	Regulatory Invex Receives UK Approval to Commence Phase III Trial weblink.com.au ↗
2021-10-07	Invex Therapeutics Ltd.	Results Presentation at EANS 2021 Congress weblink.com.au ↗ Exenatide reduced ICP acutely and after chronic dosing.
2021-03-30	Invex Therapeutics Ltd.	Regulatory Invex Files Pre-IND/Type B Meeting Request with US FDA weblink.com.au ↗ The filing of this request with the FDA represents an important milestone for the Company.
2020-06-13	Eli Lilly and Company	Results Once-weekly Trulicity® (dulaglutide) demonstrates significantly higher adherence and more persistence compared to once-weekly semaglutide and exenatide injections lilly.com ↗ New real-world data showed Trulicity® (dulaglutide) had significantly higher adherence and longer persistence compared to weekly injections of semaglutide or exenatide (BCise pen) in people with type 2 diabetes new to GLP-1 receptor agonist (RA) treatment.
2020-05-21	Invex Therapeutics Ltd.	Results Phase II Clinical Results and Capital Raising Presentation weblink.com.au ↗ Phase II data strongly supports moving Presendin™ into Phase III clinic
2020-05-19	Invex Therapeutics Ltd.	Results Exenatide Meets Key Endpoints in IIH Clinical Trial weblink.com.au ↗ Invex Therapeutics Ltd (Invex, ASX: IXC, or the Company) today announced the results of the Phase II, double-blind, placebo controlled clinical trial of twice per day Exenatide versus placebo in the treatment of Idiopathic Intracranial Hypertension (IIH).
2019-08-28	Peptron, Inc.	Results 펩트론의 파킨슨병 치료신약, 레보도파 부작용 차단 효과 확인 peptron.co.kr ↗ 펩트론이 개발중인 파킨슨병 신약 PT320 이 기존 표준치료 약물인 레보도파의 한계로 지적받고 있는 부작용을 성공적으로 차단시키는 것으로 나타났다고 22 일 밝혔다 .
2018-09-25	AstraZeneca	Regulatory Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data astrazeneca.com ↗ The prespecified secondary analysis on all-cause mortality has also been accepted for inclusion in the European label.
2018-08-30	AstraZeneca	Regulatory European Commission approves new easy-to-use, once-weekly Bydureon BCise device for patients with type-2 diabetes astrazeneca.com ↗ 30 August 2018 07:00 BST AstraZeneca today announced that the European Commission (EC) has approved Bydureon BCise (exenatide 2mg prolonged-release suspension for injection in pre-filled pen) as a new formulation within the marketing authorisation for Bydureon (exenatide extended release) for the treatment of patients with type-2 diabetes.
2018-07-24	Peptron, Inc.	Results Peptron Announces Published Data Showing a New Sustained-Release Exendin-4 Formulation Prevents Neurodegeneration in a Parkinson’s Disease Model peptron.co.kr ↗
2018-06-29	AstraZeneca	Regulatory Bydureon receives positive EU CHMP opinion for new BCise device for patients with type-2 diabetes astrazeneca.com ↗
2018-06-24	Eli Lilly and Company	Results Real-World Data Show Advantages in People Treated with Lilly's Once-Weekly Trulicity® (dulaglutide) Compared to Those Treated with Liraglutide and Exenatide QW lilly.com ↗ These real-world data show that people starting on once-weekly Trulicity are associated with a higher likelihood of adhering to their treatment regimen and having a lower A1C compared to two other GLP-1 RA options.
2017-10-23	AstraZeneca	Regulatory US FDA approves new easy-to-use, once-weekly Bydureon BCise injectable medicine for patients with type-2 diabetes astrazeneca.com ↗ AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device
2017-09-14	AstraZeneca	Results Bydureon EXSCEL trial demonstrates favourable cardiovascular (CV) safety profile and fewer CV events in patients with type-2 diabetes at wide range of CV risk astrazeneca.com ↗ AstraZeneca today announced full results from the EXSCEL ( EX enatide S tudy of C ardiovascular E vent L owering) trial that showed cardiovascular safety with Bydureon (exenatide extended-release) in patients with type-2 diabetes (T2D) at a wide range of CV risk.
2017-05-23	AstraZeneca	Results Bydureon EXSCEL trial meets primary safety objective in type-2 diabetes patients at wide range of cardiovascular risk astrazeneca.com ↗ The EXSCEL trial met its primary safety objective of non-inferiority for MACE.
2016-09-16	AstraZeneca	Results Phase III combination trial of Bydureon and Forxiga shows significant benefits in patients with type-2 diabetes astrazeneca.com ↗ The trial achieved its primary endpoint with the combination of exenatide and dapagliflozin significantly reducing HbA1c from baseline compared with exenatide or dapagliflozin alone (1.95% versus 1.58% and 1.37% respectively, both P<0.01)1 at 28 weeks.
2015-09-25	Novo Nordisk A/S	Results Novo Nordisk successfully completes second phase 3a trial with semaglutide in people with type 2 diabetes novonordisk.com ↗ Nausea was reported by 22% of people treated with 1.0 mg semaglutide once-weekly compared with 11%*** of people treated with 2.0 mg exenatide once-weekly.
2015-09-15	AstraZeneca	Results AstraZeneca announces new tolerability, long-term efficacy and real-world adherence data for exenatide once weekly in patients with type 2 diabetes astrazeneca.com ↗ In the pooled analysis of three Bydureon clinical trials, ExQW was associated with lower rates of upper GI AEs such as nausea and vomiting (24%) compared to ExBID (37%).
2014-09-19	AstraZeneca	Results Study showed AstraZeneca’s exenatide once-weekly suspension for autoinjection provided superior HbA1c reductions vs. twice-daily exenatide (Byetta®) in adults with type 2 diabetes astrazeneca.com ↗ The study met its primary endpoint of non-inferiority, demonstrating that exenatide once-weekly suspension for autoinjection provided greater mean reductions in HbA1c (blood glucose levels) compared to Byetta at 28 weeks (-1.4% vs. -1.0%, respectively; p-value = 0.007).
2014-03-03	AstraZeneca	Regulatory US FDA approves Bydureon® Pen (exenatide extended-release for injectable suspension) for once-weekly treatment of adults with type 2 diabetes astrazeneca.com ↗ Monday, 3 March 2014 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the BYDUREON® Pen (exenatide extended-release for injectable suspension) 2 mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.
2012-06-09	Alkermes, Inc.	Results Once-Weekly BYDUREON™ Provided Greater Glucose Control, Weight Loss and Lower Risk of Hypoglycemia Compared to Once- or Twice-Daily Levemir® in Type 2 Diabetes alkermes.com ↗ Treatment with BYDUREON also resulted in greater improvement in A1C (-1.3 percentage points) than insulin detemir (-0.88 percentage points).
2012-06-09	Alkermes, Inc.	Results BYDUREON™ Was Associated with Significant and Sustained Glycemic Control at Four Years alkermes.com ↗ In the study, being presented at the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia, patients completing four years of BYDUREON treatment experienced clinically significant improvements in A1C (1.7 percentage points) and fasting plasma glucose (-37 mg/dL) from baseline.
2012-06-09	Alkermes, Inc.	Results BYDUREON™ Improved A1C, Fasting Glucose, Pulse Pressure and Weight Regardless of Baseline Body Weight in Patients with Type 2 Diabetes alkermes.com ↗ Results showed that A1C reduction and weight loss were comparable across all quartiles (A1C: 1.4-1.5 percentage points; weight: 2.5-2.8 percent).
2012-03-23	Eli Lilly and Company	Regulatory BYETTA® Approved for Use with Basal Insulin in Europe lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted marketing authorization to BYETTA® (exenatide twice-daily) as an adjunctive therapy to basal insulin, with or without metformin and/or Actos® (pioglitazone), for the treatment of type 2 diabetes in adults who have not achieved adequate glycemic control with these agents.
2012-02-17	Eli Lilly and Company	Regulatory CHMP Recommends Approval of BYETTA® for Use With Basal Insulin lilly.com ↗
2012-01-27	Alkermes, Inc.	Regulatory FDA Approves BYDUREON™ -- The First and Only Once-Weekly Treatment for Type 2 Diabetes alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved BYDUREON™ (exenatide extended-release for injectable suspension) – the first once-weekly treatment for type 2 diabetes.
2011-10-19	Eli Lilly and Company	Regulatory BYETTA® Approved for Use with Insulin Glargine in the U.S. lilly.com ↗ Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved a new use for BYETTA® (exenatide) injection.
2011-09-13	Alkermes, Inc.	Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON(TM) Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 alkermes.com ↗ The analyses showed that patients receiving BYDUREON for the treatment of type 2 diabetes experienced improvements in composite endpoints related to body weight, abnormal blood pressure and abnormal lipid levels.
2011-09-12	Eli Lilly and Company	Results Analyses Find Type 2 Diabetes Patients Treated with BYDUREON™ Experienced Reduction in Cardiovascular Risk Factors: Results Presented at EASD 2011 lilly.com ↗ Demonstrated statistically significant reduction in body weight (vs. Lantus; treatment difference: 9.8 pounds).
2011-08-10	Eli Lilly and Company	Regulatory BYDUREON™ FDA ACTION DATE SET FOR JANUARY 28, 2012 lilly.com ↗ The FDA has categorized it as a Class 2 resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012.
2011-08-10	Alkermes, Inc.	Regulatory BYDUREON™ FDA Action Date Set For January 28, 2012 alkermes.com ↗ The FDA has categorized it as a Class 2 resubmission requiring up to six months for review and assigned a new Prescription Drug User Fee Act (PDUFA) action date of January 28, 2012.
2011-07-28	Eli Lilly and Company	Regulatory BYDUREON™ Reply Submitted to FDA lilly.com ↗ the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.
2011-07-28	Alkermes, Inc.	Regulatory BYDUREON™ Reply Submitted to FDA alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News), Eli Lilly and Company (NYSE:LLY - News) and Alkermes, Inc. (Nasdaq:ALKS - News) today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.
2011-07-07	Eli Lilly and Company	Results Exenatide tQT Study Showed No Prolongation of QT Interval lilly.com ↗ Using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint, demonstrating that exenatide at and above therapeutic levels did not prolong the corrected QT (QTc) interval in healthy individuals.
2011-07-07	Alkermes, Inc.	Results Exenatide tQT Study Showed No Prolongation of QT Interval alkermes.com ↗ Using multiple heart rate correction methodologies, the study met the pre-specified primary endpoint, demonstrating that exenatide at and above therapeutic levels did not prolong the corrected QT (QTc) interval in healthy individuals.
2011-06-24	Eli Lilly and Company	Results Studies Show Effect of BYDUREON™ on A1C and Weight for Up to Three Years lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced results from long-term extensions of the DURATION-1 and 3 studies evaluating BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.
2011-06-24	Eli Lilly and Company	Results Once-Monthly Exenatide Improved Glucose Control in Patients with Type 2 Diabetes: Phase 2 Study Results Presented at ADA 2011 lilly.com ↗ Fasting plasma glucose was improved with all doses, with reductions of 25 mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL with the 11 mg dose.
2011-06-24	Eli Lilly and Company	Results Analysis Shows BYDUREON™ Was Not Associated with Clinically Relevant QT Prolongation in Patients with Type 2 Diabetes: Results Presented at ADA 2011 lilly.com ↗ The change in QTcF from baseline was small and clinically insignificant at 14 weeks (1.7 milliseconds) and 30 weeks (3.0 milliseconds).
2011-06-24	Eli Lilly and Company	Results Analysis Finds BYETTA® Associated with Lower Likelihood of Heart Failure Compared with Other Diabetes Therapies: Results Presented at ADA 2011 lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a retrospective analysis of more than 778,000 patients that showed the addition of BYETTA® (exenatide) injection to pre-existing diabetes treatment regimens was associated with a reduced likelihood of heart failure, especially among patients receiving insulin.
2011-06-24	Alkermes, Inc.	Results Analysis Shows BYDUREON(TM) Was Not Associated with Clinically Relevant QT Prolongation in Patients with Type 2 Diabetes: Results Presented at ADA 2011 alkermes.com ↗ Data from the DURATION-1 study showed that after three years, patients receiving BYDUREON experienced a significant reduction in A1C (1.6 percentage points), a measure of average blood sugar over three months, and weight (5.1 pounds) compared to baseline.
2011-06-21	Eli Lilly and Company	Regulatory BYDUREON™ RECEIVES MARKETING AUTHORIZATION IN EUROPE lilly.com ↗ Eli Lilly and Company (NYSE: LLY), together with Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq: ALKS), announced today that the European Commission has granted marketing authorization to BYDUREON™ (exenatide 2 mg powder and solvent for prolonged release suspension for injection).
2011-06-21	Alkermes, Inc.	Regulatory BYDUREON™ Receives Marketing Authorization in Europe alkermes.com ↗ Eli Lilly and Company (NYSE: LLY), together with Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq: ALKS), announced today that the European Commission has granted marketing authorization to BYDUREON™ (exenatide 2 mg powder and solvent for prolonged release suspension for injection).
2011-04-15	Eli Lilly and Company	Regulatory BYDUREON™ Recommended for Approval in Europe lilly.com ↗ The CHMP's positive opinion is a pivotal step toward marketing authorization for BYDUREON in Europe.
2011-04-15	Alkermes, Inc.	Regulatory BYDUREON(TM) Recommended for Approval in Europe alkermes.com ↗ The CHMP's positive opinion is a pivotal step toward marketing authorization for BYDUREON in Europe.
2011-03-10	Eli Lilly and Company	Results Exenatide Once Monthly Showed Positive Results in Phase 2 Study lilly.com ↗ After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline.
2011-03-10	Alkermes, Inc.	Results Exenatide Once Monthly Showed Positive Results in Phase 2 Study alkermes.com ↗ After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline.
2011-03-03	Eli Lilly and Company	Results DURATION-6 Top-Line Study Results Announced lilly.com ↗ Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza.
2011-03-03	Alkermes, Inc.	Results DURATION-6 Top-Line Study Results Announced alkermes.com ↗ Results showed that patients receiving BYDUREON experienced a reduction in A1C of 1.3 percentage points from baseline, compared to a reduction of 1.5 percentage points for Victoza.
2010-12-22	Eli Lilly and Company	Regulatory Amylin and Lilly Seek Expanded Use of BYETTA® Along with Basal Insulin lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.
2010-11-17	Eli Lilly and Company	Results Study Highlights Incidence of Cardiovascular Disease-Related Events and All-Cause Hospitalizations Associated with BYETTA® Compared to Insulin, Thiazolidinediones, Sulfonylureas, Metformin and Januvia® lilly.com ↗ In the study, BYETTA was associated with a lower incidence of CVD-related events than insulin, thiazolidinediones (TZDs) and sulfonylureas and a comparable incidence versus metformin and Januvia® (sitagliptin).
2010-10-19	Eli Lilly and Company	Regulatory Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON(TM) lilly.com ↗ In the complete response letter the FDA requested a thorough QT (tQT) study with exposures of exenatide higher than typical therapeutic levels of BYDUREON.
2010-10-19	Alkermes, Inc.	Regulatory Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™ alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).
2010-09-14	Eli Lilly and Company	Results BYETTA(R) and BYDUREON(TM) to be Featured in More Than a Dozen Study Presentations at EASD 2010 lilly.com ↗ Exenatide Added to a Thiazolidinedione with or without Metformin Resulted in Superior Glycaemic Control Versus Placebo after 26 Weeks of Treatment
2010-09-14	Alkermes, Inc.	Results BYETTA® and BYDUREON™ to be Featured in More Than a Dozen Study Presentations at EASD 2010 alkermes.com ↗ Exenatide Added to Insulin Glargine-Treated Patients with Type 2 Diabetes Provided Excellent Fasting and Postprandial Control with Weight Loss and no Increased Risk of Hypoglycaemia
2010-06-26	XOMA (US) LLC	Results Preclinical Results With XOMA 052 in Type 2 Diabetes Presented at American Diabetes Association 70th Scientific Sessions xoma.com ↗ The results also demonstrated no deleterious effects with the two-drug combinations and improved insulin tolerance with a combination of XOMA 052 and sitagliptin.
2010-06-26	Eli Lilly and Company	Results Type 2 Diabetes Patients With Long-Standing Disease Achieved Glycemic Control When BYETTA(R) Was Added to Lantus(R) lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA(R) (exenatide) injection added to Lantus(R) (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia.
2010-06-26	Eli Lilly and Company	Results Study Finds BYETTA(R) Use Was Not Associated With Increased Rate of Acute Pancreatitis Compared to Other Antidiabetic Drugs: Final Results Presented at ADA 2010 lilly.com ↗ today announced final results from a retrospective study including more than 260,000 patients that showed the risk of acute pancreatitis among initiators of BYETTA(R) (exenatide) injection was not increased compared to initiators of other antidiabetic therapies.
2010-06-26	Eli Lilly and Company	Results Improvement in Beta-Cell Function Observed After Three Years of BYETTA(R) Therapy: Data Presented at ADA 2010 lilly.com ↗ Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy.
2010-06-26	Eli Lilly and Company	Results BYDUREON(TM) Safety and Tolerability Pooled Summary Data Presented at ADA 2010 lilly.com ↗ The overall incidence rates of adverse events (AEs), serious AEs and discontinuations due to serious AEs were similar for BYDUREON versus pooled comparators.
2010-06-26	Alkermes, Inc.	Results BYDUREON™ Safety and Tolerability Pooled Summary Data Presented at ADA 2010 alkermes.com ↗ The overall incidence rates of adverse events (AEs), serious AEs and discontinuations due to serious AEs were similar for BYDUREON versus pooled comparators.
2010-06-15	Eli Lilly and Company	Results DURATION-4 Study Results: BYDUREON Efficacy and Tolerability Profile Extended to Monotherapy Treatment lilly.com ↗ After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia.
2010-06-15	Alkermes, Inc.	Results DURATION-4 Study Results: BYDUREON™ Efficacy and Tolerability Profile Extended to Monotherapy Treatment alkermes.com ↗ After 26 weeks of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage points from baseline, which was significantly greater than the reduction of 1.2 percentage points for Januvia.
2010-05-06	Eli Lilly and Company	Regulatory BYDUREON (TM) FDA Review Timeline Set with PDUFA Action Date of October 22, 2010 lilly.com ↗ the U.S. Food and Drug Administration (FDA) has classified the BYDUREON(TM) (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
2010-05-06	Alkermes, Inc.	Regulatory BYDUREON™ FDA Review Timeline Set with PDUFA Action Date of October 22, 2010 alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.
2010-04-22	Eli Lilly and Company	Regulatory Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON(TM) lilly.com ↗ The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes.
2010-04-22	Alkermes, Inc.	Regulatory Amylin, Lilly and Alkermes Submit Reply to FDA Complete Response Letter for BYDUREON™ alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).
2010-03-15	Eli Lilly and Company	Regulatory Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide for extended-release injectable suspension).
2010-03-15	Alkermes, Inc.	Regulatory Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission alkermes.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide for extended-release injectable suspension).
2010-02-25	Eli Lilly and Company	Regulatory Exenatide Once Weekly New Drug Application Review Extended By FDA Due to Weather-Related Closure lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).
2009-12-15	Eli Lilly and Company	Results Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA(R) in DURATION-5 Study lilly.com ↗ Both treatment groups achieved statistically significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients taking exenatide once weekly and 3.0 pounds for patients taking BYETTA.
2009-12-15	Alkermes, Inc.	Results Exenatide Once Weekly Provided Superior Glucose Control Compared to BYETTA® in DURATION-5 Study alkermes.com ↗ Patients treated with exenatide once weekly achieved a mean A1C of 7.1 percent compared with a mean A1C of 7.7 percent in those treated with BYETTA.
2009-11-02	Eli Lilly and Company	Regulatory Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDA's BYETTA(R) (Exenatide) Injection Update lilly.com ↗ On October 30, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.
2009-10-30	Eli Lilly and Company	Regulatory BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes lilly.com ↗ Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA(R) (exenatide) injection.
2009-07-20	Eli Lilly and Company	Results Exenatide Once Weekly Provided Superior Glucose Control Compared To Lantus(R) in Head-to-Head DURATION-3 Study lilly.com ↗ At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8 percent compared with a mean A1C of 7.0 percent in those treated with Lantus.
2009-07-07	Eli Lilly and Company	Regulatory New Drug Application for Exenatide Once Weekly Accepted for Review by FDA lilly.com ↗ today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).
2009-07-07	Alkermes, Inc.	Regulatory New Drug Application for Exenatide Once Weekly Accepted for Review by FDA alkermes.com ↗ Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA).
2009-06-08	ConjuChem	Results ConjuChem Reports Data on PC-DAC(TM):Exendin-4 and PC-Insulin at 2009 American Diabetes Association Meeting conjuchem.com ↗ The first poster detailed previously disclosed results of two randomized, double-blind, placebo controlled phase II trials of PC-DAC(TM):Exendin-4, demonstrating that this long-lasting GLP-1 receptor agonist can significantly and safely reduce HbA1c and body weight.
2009-06-08	Eli Lilly and Company	Results Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009 lilly.com ↗
2009-06-07	Eli Lilly and Company	Results Interim Study Results Presented at ADA 2009: Exenatide Not Associated With Increased Rate of Acute Pancreatitis Compared to Other Antidiabetic Drugs lilly.com ↗
2009-06-07	Eli Lilly and Company	Results Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control with Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009 lilly.com ↗ Significant reductions in A1C of 1.7 percent and fasting plasma glucose (FPG) of 40 mg/dL were maintained after two years of treatment.
2009-06-07	Alkermes, Inc.	Results Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control with Weight Loss Over Two Years: DURATION-1 Interim Long-Term Data Presented at ADA 2009 alkermes.com ↗ Significant reductions in A1C of 1.7 percent and fasting plasma glucose (FPG) of 40 mg/dL were maintained after two years of treatment.
2009-05-05	Eli Lilly and Company	Regulatory Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes lilly.com ↗
2009-05-05	Alkermes, Inc.	Regulatory Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes alkermes.com ↗
2009-03-31	Eli Lilly and Company	Results Exenatide Once Weekly Provided Superior Glucose Control With Weight Loss Compared to Sitagliptin or Pioglitazone in Head-to-Head DURATION-2 Study lilly.com ↗ Treatment with exenatide once weekly also produced statistically significant differences in weight, with weight loss of 6.2 pounds at 26 weeks, compared with a loss of 1.9 pounds for sitagliptin, and a weight gain of 7.4 pounds for pioglitazone.
2009-03-26	Eli Lilly and Company	Results Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events lilly.com ↗ Results of this analysis indicate that the relative risk of cardiovascular events in exenatide-treated patients, compared to controls, was 0.70 with a 95 percent confidence interval of 0.38 - 1.31.
2009-03-26	Alkermes, Inc.	Results Exenatide Clinical Data Analysis Shows No Increased Risk of Cardiovascular Events alkermes.com ↗ Results of this analysis indicate that the relative risk of cardiovascular events in exenatide-treated patients, compared to controls, was 0.70 with a 95 percent confidence interval of 0.38 - 1.31.
2009-02-09	ConjuChem	Results ConjuChem reports final data confirming PC-DAC(TM):Exendin-4 lowers glucose and weight in Phase II diabetes trials conjuchem.com ↗ ConjuChem Biotechnologies, Inc. (TSX:CJB) announced final results today confirming that PC-DAC(TM):Exendin-4 achieved statistically significant glycemic control and weight loss in Phase II clinical trials in Type 2 diabetes.
2008-12-03	ConjuChem	Results ConjuChem’s PC-DAC(TM):Exendin-4 Lowers Glucose and Weight in Phase II Diabetes Trials conjuchem.com ↗ ConjuChem Biotechnologies, Inc. (TSX:CJB) announced preliminary results today showing that its Type 2 diabetes product, PC-DAC(TM):Exendin-4, achieved statistically significant reductions in HbA1c and weight in its two Phase II clinical trials.
2008-09-26	Novo Nordisk A/S	Results Novo Nordisks kapitalmarkedsdag: opdatering på koncernstrategi novonordisk.com ↗ Hovedkonklusionerne fra studiet viste, at patienter, der skiftede over fra exenatide til liraglutide, oplevede følgende fordele - alle statistisk signifikante:
2008-09-09	Eli Lilly and Company	Results First Reported Head-to-Head Study Showed BYETTA(R) (exenatide) Injection Provided Greater Reduction in Post-Meal Glucose Levels Than Januvia(TM) (sitagliptin) in Patients With Type 2 Diabetes lilly.com ↗ Additionally, patients treated with BYETTA reduced post-meal glucagon, showed more efficient use of their body's own insulin and decreased their food intake when compared to Januvia.
2008-06-09	Eli Lilly and Company	Results After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008 lilly.com ↗ This study also showed that patients who switched from BYETTA(R) (exenatide) injection after 30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma glucose.
2008-06-09	Alkermes, Inc.	Results After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008 alkermes.com ↗ Patients taking exenatide once weekly over the course of one year sustained a similar improvement in glucose control [A1C: -2.0%+/-0.08; fasting plasma glucose (FPG) -47+/-3 mg/dL] compared to those receiving treatment for 30 weeks [A1C change from baseline: -1.9%+/-0.08 (LS mean+/-SE)].
2008-06-07	Eli Lilly and Company	Results Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight lilly.com ↗ Type 2 diabetes patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1C (-1.9%+/-0.08 (LS mean+/-SE)) and fasting plasma glucose (FPG -42+/-3 mg/dL) from baseline and compared with BYETTA (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG).
2008-06-07	Eli Lilly and Company	Results Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss lilly.com ↗ Study findings showed that patients treated with monotherapy exenatide showed statistically significant improvement in both A1C and weight loss with a lower incidence of nausea than in previous exenatide studies.
2008-06-07	Alkermes, Inc.	Results Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight alkermes.com ↗ Type 2 diabetes patients treated with exenatide once weekly, an investigational therapy, showed statistically significant improvements in A1C (-1.9%+/-0.08 (LS mean+/-SE)) and fasting plasma glucose (FPG -42+/-3 mg/dL) from baseline and compared with BYETTA (-1.5%+/-0.08, A1C and -25+/-3 mg/dL, FPG).
2008-06-06	Novo Nordisk A/S	Results Klinisk studie viser, at liraglutide giver statistisk signifikant bedre blodsukkerregulering end exenatide novonordisk.com ↗ Patienter, der fik liraglutide, opnåede en reduktion i HbA1c på mere end 1,1 procentpoint, sammenlignet med en reduktion i HbA1c på mindre end 0,8 procentpoint i exenatide-gruppen - en statistisk signifikant forskel.
2008-06-06	Novo Nordisk A/S	Results Clinical study shows liraglutide provides statistically significantly better blood glucose control than exenatide novonordisk.com ↗ Patients treated with liraglutide achieved a reduction in HbA1c of more than 1.1 percentage points, compared to a reduction in HbA1c of less than 0.8 percentage points in the exenatide group, a difference which was statistically significant.
2007-12-06	Eli Lilly and Company	Results Monotherapy BYETTA(R) Showed Significant Improvement in Glucose Control and Weight Loss in Adults with Type 2 Diabetes lilly.com ↗ In addition, approximately 60 percent of study participants on either 5 mcg or 10 mcg of monotherapy BYETTA at the conclusion of the study had an A1C of 7 percent or less, a common target for good glucose control.
2007-10-31	Eli Lilly and Company	Results Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study lilly.com ↗ Once-weekly exenatide, an investigational drug, showed a statistically significant improvement in A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for BYETTA.
2007-10-31	Alkermes, Inc.	Results Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study alkermes.com ↗ Once-weekly exenatide, an investigational drug, showed a statistically significant improvement in A1C of approximately 1.9 percentage points from baseline, compared to an improvement of approximately 1.5 percentage points for BYETTA.
2007-10-17	ConjuChem	Results ConjuChem Reports Final Results of PC-DAC(TM): Exendin-4 Phase I/II Multiple-Dose Study for Type 2 Diabetes Confirming Safety and Efficacy at Once-Weekly Dosing conjuchem.com ↗ Final results demonstrated that the compound was well tolerated and effective in lowering blood glucose when administered once-weekly at each of the dosing levels tested.
2007-09-21	Eli Lilly and Company	Results One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function lilly.com ↗ Study findings showed one year of exenatide therapy, as compared to insulin glargine, markedly improved different indices of beta-cell function, along with similar glycemic improvement.
2007-06-25	Eli Lilly and Company	Results BYETTA(R) Study Showed Sustained Blood Glucose Control Over Three Years in People with Type 2 Diabetes lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced three- year, open-label study results that showed treatment with BYETTA(R) (exenatide) injection was associated with sustained blood sugar control and progressive weight loss in people with type 2 diabetes.
2007-06-24	Eli Lilly and Company	Results BYETTA® Study Showed Comparable Blood Glucose Control to Insulin lilly.com ↗ Study findings showed comparable improvements in blood sugar control with BYETTA and insulin glargine therapies, with weight loss and lower incidence of hypoglycemia associated with BYETTA.
2007-06-23	Eli Lilly and Company	Results BYETTA(R) Treatment for Three and a Half Years Associated with Reductions in Cardiovascular Risk Factors in People with Type 2 Diabetes lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced results from a study that showed BYETTA(R) (exenatide) injection sustained improvements in blood sugar levels and progressive weight loss through three and a half years of therapy.
2007-06-19	ConjuChem	Results ConjuChem Biotechnologies Reports PC-DAC(TM):Exendin-4 Albumin Conjugate Data Presented at American Diabetes Association Annual Meeting conjuchem.com ↗ All three treatment groups experienced reductions in fasting plasma glucose that were statistically significant versus baseline (p less than 0.005) and versus placebo (p less than 0.03) over the 5-week treatment period.
2007-03-26	ConjuChem	Results PC-DAC(TM):Exendin-4 Phase I/II Multiple-Dose Study Preliminary Results Demonstrate Safety and Efficacy at Once-Weekly Dosing conjuchem.com ↗ ConjuChem Biotechnologies Inc. (TSX:CJB) today announced positive preliminary results from its Phase I/II multiple-dose clinical study for the treatment of Type 2 diabetes using the Company’s proprietary PC-DAC(TM):Exendin-4.
2007-02-20	Eli Lilly and Company	Regulatory New Storage Instructions Approved for BYETTA(R) lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved more convenient patient storage instructions for BYETTA(R) (exenatide) injection.
2006-12-22	Eli Lilly and Company	Regulatory FDA Approves BYETTA(R) (exenatide) Injection for Expanded Combination Use lilly.com ↗
2006-11-21	Eli Lilly and Company	Regulatory BYETTA(R) (exenatide) Approved for Treatment of Type 2 Diabetes by European Commission lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the European Commission has granted marketing authorization for BYETTA(R) (exenatide) for the treatment of type 2 diabetes.
2006-09-21	Eli Lilly and Company	Regulatory Exenatide Receives Positive Opinion From the European Committee for Medicinal Products for Human Use for the Treatment of Type 2 Diabetes lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of exenatide for the treatment of type 2 diabetes.
2006-09-14	Eli Lilly and Company	Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Biphasic Insulin Aspart lilly.com ↗ During the one year (52-week) study, patients using exenatide showed improvements in three important measures of blood glucose control: fasting blood glucose, postprandial blood glucose, and hemoglobin A1C (HbA1C).
2006-06-10	Eli Lilly and Company	Results BYETTA(R) Shown to Reduce Blood Glucose Levels When Added to Patients Using a TZD lilly.com ↗ Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced detailed findings from a study that showed BYETTA(R) (exenatide) injection lowered blood glucose levels for people with type 2 diabetes who had not achieved target blood glucose levels despite the use of a thiazolidinedione (TZD) with or without metformin.
2006-06-10	Eli Lilly and Company	Results BYETTA(R) Extension Study Shows Sustained Improvements in Blood Glucose Control and Progressive Weight Loss After Two Years lilly.com ↗ After two years of treatment, patients sustained an average hemoglobin A1C (A1C) reduction of 1.1 percent from baseline.
2006-06-10	Alkermes, Inc.	Results Study Demonstrated Once-Weekly Exenatide LAR Improved Glucose Control in Patients with Type 2 Diabetes alkermes.com ↗ Dose-dependent improvements in A1C and weight loss were observed at 15 weeks.
2006-03-01	Eli Lilly and Company	Regulatory Supplemental New Drug Application for BYETTA Submitted to FDA for Use With TZDs lilly.com ↗
2005-11-15	Eli Lilly and Company	Results BYETTA Shown to Reduce Blood Sugar Levels When Added to Patients Treated With TZDs lilly.com ↗ Compared to placebo, subjects receiving BYETTA experienced an average weight reduction of approximately three pounds at 16 weeks.
2005-09-12	Eli Lilly and Company	Results Study Shows Exenatide Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗ Both treatments were effective in lowering blood sugar, and patients taking exenatide experienced weight reductions while those on insulin glargine gained weight.
2005-09-12	Eli Lilly and Company	Results Long-Term Data on Exenatide Show Sustained Improvements in Glucose Control and Progressive Weight Reduction in People With Type 2 Diabetes lilly.com ↗ Additional data were presented showing improvements in markers associated with cardiovascular risk factors, including lipids and blood pressure through a year-and-a-half of treatment.
2005-08-22	Eli Lilly and Company	Results Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control lilly.com ↗ Dose-dependent improvements in hemoglobin A1C (A1C) and weight were observed.
2005-08-22	Eli Lilly and Company	Results Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control; Preliminary Results From Phase 2 Study Announced lilly.com ↗ A1C, a measure of glucose control, improved approximately 2 percent for subjects receiving the high dose of exenatide LAR, compared to placebo.
2005-08-22	Alkermes, Inc.	Results Once Weekly Exenatide LAR Well Tolerated and Improved Glucose Control; Preliminary Results From Phase 2 Study Announced alkermes.com ↗ After 15 weeks, both doses of exenatide LAR were well tolerated and expected therapeutic blood levels of exenatide were achieved.
2005-06-10	Eli Lilly and Company	Results Study Shows BYETTA(TM) Improves Blood Sugar Levels as Effectively as Insulin Glargine lilly.com ↗ Both treatments were effective in lowering blood sugar, and patients taking BYETTA experienced weight reductions while those on insulin glargine gained weight.
2005-06-10	Eli Lilly and Company	Results Long-Term Data on BYETTA(TM) Show Sustained Improvements in Glucose Control and Progressive Weight Reduction in People with Type 2 Diabetes lilly.com ↗ Additional data was presented showing sustained improvements in blood sugar control and progressive weight reduction in patients who had completed two years of BYETTA therapy.
2005-04-29	Eli Lilly and Company	Regulatory Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide) Injection lilly.com ↗ BYETTA was approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications metformin, a sulfonylurea or both.
2004-09-08	Eli Lilly and Company	Results Scientific Presentations of Exenatide Data Show Significant Improvements in Glucose Control with Associated Weight Loss and Restored Insulin Response in People with Type 2 Diabetes lilly.com ↗ Results from the three pivotal studies showed that exenatide significantly lowered average glucose (blood sugar) levels, measured by A1C, in patients who have failed to achieve adequate glucose control on common oral regimens.
2004-09-01	Eli Lilly and Company	Regulatory Exenatide New Drug Application Accepted for Review by the FDA lilly.com ↗ Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced that the New Drug Application (NDA) for exenatide has been accepted for review by the Food and Drug Administration (FDA).
2004-07-26	Eli Lilly and Company	Results Successful Completion of Study Comparing Exenatide to Insulin Glargine Results in Milestone Payment from Lilly to Amylin lilly.com ↗ Results demonstrate that both exenatide and insulin glargine achieved similar A1C reductions, with endpoint A1Cs of 7.2 percent for both groups at the end of the study.
2004-06-30	Eli Lilly and Company	Regulatory New Drug Application for Exenatide Submitted to FDA for Type 2 Diabetes lilly.com ↗ June 30, 2004 Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for regulatory approval of exenatide.
2004-06-06	Eli Lilly and Company	Results Scientific Presentations of Exenatide Data Show Improvements in Glucose Control and Restored Insulin Response in People with Type 2 Diabetes lilly.com ↗ Results from a separate study will be presented showing that exenatide restored the ability of beta cells to release insulin immediately following an influx of glucose into the bloodstream, an action known as first-phase insulin response.
2004-06-05	Eli Lilly and Company	Results Late-Breaking Presentation of Exenatide Pivotal Studies Show Significant Improvements in Glucose Control with Associated Weight Loss in People with Type 2 Diabetes lilly.com ↗ The studies showed that exenatide significantly lowered average glucose (blood sugar) levels, measured by A1C, in patients who were unable to achieve adequate glucose control on common oral regimens.
2003-03-19	Alkermes, Inc.	Results Amylin, Lilly and Alkermes Announce Preliminary Phase 2 Results and Submission Of IND for Exenatide LAR (Sustained Release) Program in Type 2 Diabetes alkermes.com ↗ Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced preliminary pharmacokinetic results from the first Phase 2 study of exenatide LAR, formerly referred to as AC2993 LAR.

All press releases naming this drug 176 releases

Date	Issuer	Release
Show all 176 releases opens the full record — a long page

Evidence & citations 26 cited values

Every value below carries the sentence it was read from. 298 sources stand behind the page.

Field	Value	Cited text
Known as	exenatide	“Exenatide decreases liver fat content and epicardial adipose tissue in patients with obesity and type 2 diabetes: a prospective randomized clinical trial using magnetic...” PMID 27106272 ↗ May 2016 268 “This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.” NCT05347147 ↗ “Exendin-4 (or Exenatide) is a medication currently used to treat diabetes that has shown promising results in animal and cellular models of Alzheimer's disease.” NCT01255163 ↗ “This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months.” NCT06256419 ↗ “This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months.” NCT05037045 ↗ “exenatide subcutaneously 5 mcg pre-transplant and twice daily for I week, then increased to 10-mcg twice daily for 6 months after the last islet transplant.” NCT00566813 ↗ “Chemical Name: GLP-1 Receptor Agonists (GLP1RA) (e.g., Exenatide, Liraglutide, Dulaglutide, Semaglutide) Class: Glucagon-Like Peptide-1 Receptor Agonists” NCT06449235 ↗ “ITCA 650 osmotic mini pump delivering exenatide 20 mcg/day for 14 days, followed by ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day.” NCT02641899 ↗ “Exenatide (GLP-1) has been approved by the Food and Drug Administration (FDA) to treat patients with Type 2 Diabetes (T2D) and obesity.” NCT04269642 ↗ “Antihyperglycemic drugs: biguanides "Metformin" - 0.5 g two or tree times per day, or "Exenatide" - 5-10 µg per day.” NCT01700075 ↗ “Exenatide for weight-loss maintenance in adolescents with severe obesity: A randomized, placebo-controlled trial.” PMID 35403350 ↗ Apr 2022 Show 258 more sources
Known as	- exenatide (Byetta)	“- exenatide (Byetta®)” NCT02244164 ↗ 2 “Exenatide (Byetta®)” NCT00679042 ↗ “Exenatide (Byetta)” NCT01677104 ↗
Known as	- exenatide extended-release (Bydureon).	“- exenatide extended-release (Bydureon®).” NCT02244164 ↗
Known as	AC2993	“effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes” NCT00035984 ↗ 7 “AC2993 5mcg (0.02 mL) for 4 weeks” NCT00039026 ↗ “AC2993 5 mcg (0.02 mL)” NCT00039013 ↗ “Exenatide (AC2993)” NCT00082381 ↗ NCT00064714 ↗ NCT01789957 ↗ NCT00044694 ↗ NCT00044668 ↗
Known as	Bydureon	“Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks.” NCT04941521 ↗ 15 “Exenatide will be purchased commercially as Bydureon® for subcutaneous injection and administered at 2 mg once a week for 6 weeks.” NCT06252623 ↗ “A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes” NCT01928329 ↗ “Bydureon® (exenatide) is supplied as powder and solvent for prolonged release injection (once-weekly).” NCT03232112 ↗ “Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks” NCT02251431 ↗ “pioglitazone (actos) 30 mg per day and exenatide (bydureon) 2 mg per week” NCT02887625 ↗ “Bydureon (Exenatide once weekly) injections s.c.” NCT02794402 ↗ “Exenatide extended release 2mg (Bydureon)” NCT04232969 ↗ “weekly exenatide (bydureon) 2 mg per week” NCT04135287 ↗ “Exenatide Pen Injector [Bydureon]” NCT04431713 ↗ “Exenatide 2 mg [Bydureon]” NCT03419624 ↗ Show 5 more sources
Known as	Bydureon BCise (exenatide extended release)	“Bydureon BCise (exenatide extended release)” NCT05670379 ↗
Known as	Byetta	“NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) BID and QD vs. Byetta™ Exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in...” NCT00313001 ↗ 21 “Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency:...” NCT04969627 ↗ “A Pilot Study to Determine the Effects of a Single Dose of Exenatide (Byetta ®) on the Acute Metabolic Responses to a Mixed Meal or Intravenous Glucose Tolerance Test in...” NCT01855490 ↗ “A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics.” NCT00344851 ↗ “The incretin mimetic Exenatide (Byetta®) exhibits strong glucoregulatory activities through its multiple biological effects.” NCT01208649 ↗ “They were administered 17.4 μg exenatide (Byetta) or placebo over a 6-hour and 15-minute infusion” PMID 27838646 ↗ Nov 2016 “25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are added to 250 ml isotonic NaCl.” NCT00835848 ↗ “pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD” NCT01676116 ↗ “The medicines are called Symlin (pramlintide) and Byetta (exenatide).” NCT00950677 ↗ “Single dose of subcutaneous injection of 5 μg exenatide (Byetta).” NCT02838589 ↗ “Byetta® (Exenatide), 10 ug, bid, subcutaneous injection” NCT03167411 ↗ Show 11 more sources
Known as	EQW	“OBJECTIVE: We recently reported that after 26 weeks, exenatide once weekly (EQW) resulted in superior A1C reduction, reduced hypoglycemia, and progressive weight loss compared...” PMID 22357185 ↗ Feb 2012 4 “The Diabetes Therapy Utilization: Researching Changes in A1C, Weight, and Other Factors Through Intervention With Exenatide Once Weekly (DURATION) program comprised 6...” PMID 23748506 ↗ May 2013 “The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and coadministered” PMID 34097062 ↗ Sep 2021 “once-weekly exenatide (EQW) in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).” PMID 35761271 ↗ Jun 2022 “The safety and efficacy of exenatide once weekly (EQW) is overall well established.” PMID 32306296 ↗ Apr 2020
Known as	EXE	“AIMS: To investigate the potential synergistic effects of combined exenatide (EXE) and dapagliflozin (DAPA) versus (PLAC) placebo and DAPA on hepatocellular lipid (HCL)...” PMID 33464703 ↗ Feb 2021 3 “treatment with the glucagon-like peptide receptor agonist (GLP-1 RA) exenatide (EXE) could prevent GC-induced glucose intolerance.” PMID 21216851 ↗ Jan 2011 “adjunctive therapy of exenatide (EXE)” PMID 20357372 ↗ Mar 2010 “exenatide (EXE), 5 μg s.c.” PMID 35235659 ↗ Jun 2022
Known as	Exenatide (Byeta)	“Exenatide (Byeta)” NCT00845507 ↗
Known as	Exenatide = BYETTA (R)	“Exenatide = BYETTA (R)” NCT01140893 ↗
Known as	exenatide acetate	“The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent.” NCT05347147 ↗
Known as	exenatide XR	“Those who achieved ≥5% BMI reduction during the run-in were then randomized to 52 weeks of exenatide XR 2.0 mg or placebo weekly.” PMID 35403350 ↗ Apr 2022
Known as	Exendin-4	“Exenatide (Byetta [synthetic Exendin-4]; AstraZeneca, Wilmington DE) is a GLP-1 receptor agonist which reduces appetite and weight and may be an effective treatment in PWS.” NCT01444898 ↗ 5 “In clinical testing in humans a recent randomized clinical study investigated the effect of Exendin-4 (Exenatide) on final infarct size in myocardial infarction.” NCT02673931 ↗ “Exenatide (synthetic exendin-4) is a subcutaneously injected GLP-1 receptor agonist” PMID 20152707 ↗ Mar 2010 “Exenatide is synthetic exendin-4, GLP-1 receptor agonist.” NCT01776788 ↗ “Recombinant Exendin-4 Injection” NCT03199261 ↗ NCT01255163 ↗
Known as	exentide-4	“Exenatide (also known as exentide-4) infused after focal brain ischemia has been shown to reduce infarct volume in mice.” NCT02673931 ↗
Known as	ExQW	“In trials, exenatide once weekly (ExQW), a GLP-1R agonist, improved glycemia, weight, blood pressure (BP), and lipids in patients with T2DM.” PMID 22566747 ↗ Apr 2012 1 “exenatide once weekly extended-release (ExQW, Bydureon®)” NCT04520490 ↗
Known as	ITCA 650	“ITCA 650 (Exenatide in osmotic mini pump)” NCT02320045 ↗ 5 “ITCA 650 is exenatide in DUROS” NCT01455922 ↗ “ITCA 650 is exenatide in DUROS” NCT01455896 ↗ “ITCA 650 is exenatide in DUROS” NCT01455883 ↗ “ITCA 650 is exenatide in DUROS” NCT01455870 ↗ “ITCA 650 is exenatide in DUROS” NCT01455857 ↗
Known as	LY2148568	“exenatide (LY2148568)” NCT00382239 ↗
Known as	Presendin	“This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.” NCT05347147 ↗
Known as	PT302	“SR Exenatide (PT302)” NCT00964262 ↗
Known as	PT320	“Peptron has developed a sustained-release (SR)-Exenatide, (PT320, Q1W and Q2W), which has shown a higher Blood-Brain Barrier (BBB) penetration rate and better patient compliance.” NCT04269642 ↗
Known as	SR Exenatide	“Peptron has developed a sustained-release (SR)-Exenatide, (PT320, Q1W and Q2W), which has shown a higher Blood-Brain Barrier (BBB) penetration rate and better patient compliance.” NCT04269642 ↗ 1 “SR Exenatide (PT302)” NCT00964262 ↗
Action	Activate	“Exenatide, a glucagon-like peptide-1 receptor agonist, is used twice daily (BID)” PMID 22913891 ↗ Jul 2012
Modality	Peptide	“Antibody formation to therapeutic peptides is common. This analysis characterizes the time-course and cross-reactivity of anti-exenatide antibodies and potential effects on...” PMID 22236356 ↗ Feb 2012
Route	Subcutaneous	“All are subcutaneously injected twice daily” NCT00035984 ↗
Target	GLP1R	“glucagon-like peptide-1 receptor agonist” PMID 22913891 ↗ Jul 2012