Baricitinib

also known as LY3009104 · Olumiant · BARI · BARICITINIB (INCB028050) · BARICITINIB (LY3009104) · BARICITINIB PHOSPHATE · BARICITINIB PHOSPHATE SALT · INCB-28050 · +1 more

Small molecule targets AAK1, JAK1, JAK2 via inhibition

Developed for: rheumatoid arthritis · COVID-19 · atopic eczema · HIV infectious disease · systemic lupus erythematosus · alopecia areata · pneumonia · Aicardi-Goutieres syndrome
+70 more
· autoimmune thrombocytopenia · depressive disorder · spondyloarthropathy · dermatomyositis · diabetic kidney disease · idiopathic inflammatory myopathy · juvenile dermatomyositis · juvenile idiopathic arthritis · proteosome-associated autoinflammatory syndrome · psoriatic arthritis · Sjogren syndrome · STING-associated vasculopathy with onset in infancy · type 1 diabetes mellitus · uveitis · acute respiratory distress syndrome · allergic contact dermatitis · Alzheimer disease · amyotrophic lateral sclerosis · anterior cerebral artery infarction · antisynthetase syndrome · atypical depressive disorder · autoimmune thrombocytopenic purpura · Behcet disease · cardiac sarcoidosis · central centrifugal cicatricial alopecia · chronic graft versus host disease · chronic kidney disease · cognitive disorder · cognitive impairment with or without cerebellar ataxia · conjunctivitis · dengue disease · diffuse cutaneous systemic sclerosis · frontal fibrosing alopecia · graft versus host disease · granulomatous mastitis · hepatocellular adenoma · hyper-IgE recurrent infection syndrome 4A, autosomal dominant · immunoglobulin G4-related sclerosing disease · infectious disease with sepsis · interstitial lung disease · lichen planus · lichen planus, oral · long COVID-19 · lung disorder · lupus erythematosus · lupus nephritis · major depressive disorder · malignant atrophic papulosis · mucous membrane pemphigoid · nephritis · neuromyelitis optica · nosocomial infection · polymyalgia rheumatica · post-COVID-19 disorder · primary biliary cholangitis · psoriasis · pyoderma gangrenosum · Quinquaud's folliculitis decalvans · severe acute respiratory syndrome · systemic sclerosis · systemic-onset juvenile idiopathic arthritis · Takayasu arteritis · temporal arteritis · thrombocytopenia · thrombocytopenia due to immune destruction · traumatic brain injury · vitiligo · chondrocalcinosis · generalized vitiligo · respiratory failure
Investigated by: Eli Lilly and Company · Incyte Corporation · Assistance Publique - Hôpitaux de Paris · Peking University People's Hospital · Emory University · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
+160 more
· Beijing Friendship Hospital · China-Japan Friendship Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Mental Health (NIMH) · Peking Union Medical College Hospital · Tang-Du Hospital · AbbVie · Assiut University · Beijing Hospital · Beijing Luhe Hospital · Beijing Tsinghua Changgeng Hospital · Chinese PLA General Hospital · Instituto de Investigación Hospital Universitario La Paz · National Cancer Institute (NCI) · Navy General Hospital, Beijing · Peking University First Hospital · Peking University Third Hospital · Tianjin Medical University General Hospital · Tongji Hospital · University Hospital, Bordeaux · University of Alabama at Birmingham · Washington University School of Medicine · 987th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force · ANRS, Emerging Infectious Diseases · ASST Fatebenefratelli Sacco · Aaron R. Mangold · Abu Dhabi Stem Cells Center · Adeline Vanderver, MD · Airlangga University (UNAIR), Indonesia · Australian and New Zealand Intensive Care Research Centre · Azienda Ospedaliero, Universitaria Pisana · Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders · Baoji Fengxiang District Hospital · Berry Consultants · Biogen · Bristol-Myers Squibb · Cambridge University Hospitals NHS Foundation Trust · Centro de Atención y Diagnóstico de Enfermedades Infecciosas, Bucaramanga, Colombia · Chinese University of Hong Kong · Chittagong Medical College Hospital, Chittagong, Bangladesh · Chongqing Hospital of PAP · Chongqing University Central Hospital & Chongqing Emergency Medical Center · Clinical Trials Unit, Manchester · Congressionally Directed Medical Research Programs · Dalhousie University · Dhaka Medical College · Duke University · Epidemiological and Clinical Research Information Network · Fabrizio Cantini · Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Fight AIDS and Infectious Diseases Foundation · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital of Fujian Medical University · First Affiliated Hospital of Zhejiang University · First People's Hospital of Xianyang · Fondazione IRCCS Policlinico San Matteo di Pavia · French National Institute of Health and Medical Research · Fundación Valle del Lili, Cali, Colombia · GEM Flower Xian Changqing Staff Hospital · Galvani Bioelectronics · Germans Trias i Pujol Hospital · Global Coalition for Adaptive Research · Healthcare Pharmaceuticals · Hospital Queen Elizabeth II, Malaysia · Hospital Regional de Loreto, Iquitos, Peru · Hospital Universitario Erasmo Meoz, Cucuta, Colombia · Hospital Universitario de Fuenlabrada · Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam · Hospital of Prato · Iain Bressendorff · Illumination Health · Incepta Pharmaceuticals Ltd · Instituto de Infectologia Emílio Ribas, São Paulo, Brazil · Instituto de Salud Carlos III · all 166 on the full record

Regulatory milestones approvals, filings & regulatory actions · 14 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed alopecia areata 3 milestones
Filed	US (FDA)	—	alopecia areata	2022-02-08	“Regulatory applications for baricitinib as a treatment for alopecia areata have been submitted in the U.S., Europe and Japan.” incyte.com ↗
Filed	Japan (PMDA)	—	alopecia areata	2022-02-08	“Regulatory applications for baricitinib as a treatment for alopecia areata have been submitted in the U.S., Europe and Japan.” incyte.com ↗
Filed	EU (EMA)	—	alopecia areata	2022-02-08	“Regulatory applications for baricitinib as a treatment for alopecia areata have been submitted in the U.S., Europe and Japan.” incyte.com ↗
Filed atopic eczema 2 milestones
Filed	EU (EMA)	—	atopic eczema	—	“In January, Lilly submitted baricitinib for regulatory review in Europe and Japan as a treatment for patients with moderate-to-severe atopic dermatitis” incyte.com ↗ “Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate-to-severe atopic dermatitis” incyte.com ↗ “Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis” incyte.com ↗ “Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe AD” incyte.com ↗
Filed	Japan (PMDA)	—	atopic eczema	—	“In January, Lilly submitted baricitinib for regulatory review in Europe and Japan as a treatment for patients with moderate-to-severe atopic dermatitis” incyte.com ↗
Filed COVID-19 1 milestone
Filed	US (FDA)	—	COVID-19	2022-01-28	“The FDA has granted priority review for the sNDA for baricitinib for the treatment of certain hospitalized patients with COVID-19” incyte.com ↗ “The FDA accepted an sNDA and granted priority review for baricitinib for the treatment of COVID-19.” lilly.com ↗
Filed rheumatoid arthritis 4 milestones
Rejected (CRL)	US (FDA)	Olumiant	rheumatoid arthritis	2017-04-14	“the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) of the investigational medicine baricitinib” incyte.com ↗ “In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib.” incyte.com ↗ “In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib.” incyte.com ↗ “In April 2017, the U.S. Food and Drug Administration issued a Complete Response Letter on the New Drug Application for baricitinib.” lilly.com ↗
Filed	Japan (PMDA)	—	rheumatoid arthritis	—	“Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in 2016.” incyte.com ↗
Filed	US (FDA)	—	rheumatoid arthritis	—	“Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in 2016.” incyte.com ↗ “In December, Lilly announced that it had resubmitted the New Drug Application (NDA) for baricitinib to the U.S. Food & Drug Administration (FDA).” incyte.com ↗ “The NDA for baricitinib was submitted to the FDA in January 2016.” incyte.com ↗
Filed	EU (EMA)	—	rheumatoid arthritis	—	“A New Drug Application (NDA) and a Marketing Authorization Application (MAA) have been submitted by Lilly to the U.S. Food and Drug Administration and the European Medicines...” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., the European Union and Japan in 2016.” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” incyte.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016” lilly.com ↗ “Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in 2016.” incyte.com ↗ “Baricitinib was also submitted to the European Medicines Agency for the treatment of moderately-to-severely active rheumatoid arthritis.” lilly.com ↗
Approved Indication not stated 3 milestones
Label expansions (2)	US (FDA)	OLUMIANT	—	2019-10-08 – 2022-05-10	fda.gov ↗
Approved	US (FDA)	OLUMIANT	—	2018-05-31	fda.gov ↗
Approved	EU (EMA)	Olumiant	—	2017-02-13	europa.eu ↗

Trials 156 · started per year

today

EU approved 2017

US approved 2018

20092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03945760	Sep 2020 → Oct 2023	allergic contact dermatitis	Wright State Physicians	Completed	No outcome recorded
Phase 120 trials
Phase 1	NCT07262983	Oct 2026 → May 2030 expected	atopic eczema, hyper-IgE recurrent infection syndrome 4A, autosomal dominant, lupus erythematosus	National Institute of Allergy and Infectious Diseases (NIAID)	Recruiting	No outcome recorded
Phase 1	NCT07843693	Aug → Dec 2026 expected	—	AbbVie	Recruiting	No outcome recorded
Phase 1	NCT04131738	Apr 2020 → Nov 2021	graft versus host disease	Washington University School of Medicine	Completed	No outcome recorded
Phase 1	NCT03212638	Jun → Jul 2017	—	Eli Lilly and Company	Completed	Mixed
Phase 1	NCT02758613	May → Jul 2016	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT02340104	Jan → Feb 2015	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT02263911	Nov → Dec 2014	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01960140	Oct → Dec 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01968057	Oct → Dec 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01925144	Oct → Nov 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01937026	Sep → Nov 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01924299	Aug → Nov 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01910311	Aug → Oct 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01896726	Jul → Oct 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01870388	Jun → Jul 2013	liver disorder	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01859078	May → Aug 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01536951	Feb 2012 → May 2013	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01398475	Jul → Sep 2011	rheumatoid arthritis	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01299285	Feb → Mar 2011	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT01247350	Nov 2010 → Apr 2011	—	Eli Lilly and Company	Completed	No outcome recorded

Phase 1/26 trials
Phase 1/2	NCT07535645	Mar 2026 → Dec 2027 expected	disease related to hematopoietic stem cell transplant, thrombocytopenia	Peking University People's Hospital	Recruiting	No outcome recorded
Phase 1/2	NCT06548802	Feb 2024 → Jun 2026 overdue	lung disorder	Tianjin Medical University General Hospital	Recruiting	No outcome recorded
Phase 1/2	NCT05792462	Apr 2023 → Dec 2025 overdue	neuromyelitis optica	Tianjin Medical University General Hospital	Recruiting	No outcome recorded
Phase 1/2	NCT05189106	Dec 2022 → Apr 2025	Alzheimer disease, amyotrophic lateral sclerosis, cognitive impairment with or without cerebellar ataxia	Massachusetts General Hospital	Completed	No outcome recorded
Phase 1/2	NCT04916756	Jan → Dec 2020	Sjogren syndrome	Peking Union Medical College Hospital	Completed	No outcome recorded
Phase 1/2	NCT02759731	Nov 2016 → Jun 2022	chronic graft versus host disease	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 252 trials · 6 met primary · 2 missed
Phase 2	NCT07608796	Oct 2026 → Oct 2027 expected	cognitive disorder, depressive disorder	Emory University	Recruiting	No outcome recorded
Phase 2	NCT07209267	Sep 2026 → Jan 2028 expected	HIV infectious disease	Emory University	Not yet recruiting	No outcome recorded
Phase 2	NCT07669675	Jul 2026 → Dec 2027 expected	autoimmune thrombocytopenia	Peking University People's Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT06381661	May 2026 → Jun 2028 expected	infectious disease with sepsis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT07081763	May 2026 → May 2029 expected	HIV infectious disease	ANRS, Emerging Infectious Diseases	Not yet recruiting	No outcome recorded
Phase 2	NCT06868381	Apr 2026 → Jul 2028 expected	cardiac sarcoidosis	Stanford University	Not yet recruiting	No outcome recorded
Phase 2	NCT07268534	Apr 2026 → Nov 2029 expected	Quinquaud's folliculitis decalvans	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT06923072	Feb 2026 → Dec 2030 expected	malignant atrophic papulosis	National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	No outcome recorded
Phase 2	NCT07028385	Sep 2025 → Apr 2026	HIV infectious disease	Fight AIDS and Infectious Diseases Foundation	Completed	No outcome recorded
Phase 2	NCT07003997	Sep 2025 → Feb 2030 expected	major depressive disorder	Emory University	Recruiting	No outcome recorded
Phase 2	NCT06797310	Jan → Dec 2025 overdue	alopecia areata	National Taiwan University Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT06849908	Nov 2024 → Jun 2027 expected	Behcet disease	Peking Union Medical College Hospital	Recruiting	No outcome recorded
Phase 2	NCT07843732	Oct 2024 → Apr 2026	central centrifugal cicatricial alopecia	Raven Clinical Research	Completed	No outcome recorded
Phase 2	NCT06490757	Oct 2024 → Sep 2028 expected	hepatocellular adenoma	Assistance Publique - Hôpitaux de Paris	Recruiting	No outcome recorded
Phase 2	NCT06439615	Aug 2024 → Dec 2026 expected	subarachnoid hemorrhage	Tang-Du Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT06158113	Mar 2024 → Aug 2026 overdue	lichen planus, oral	University of North Carolina, Chapel Hill	Active not recruiting	No outcome recorded
Phase 2	NCT05849038	Dec 2023 → Nov 2027 expected	HIV infectious disease, atypical depressive disorder, depressive disorder	Emory University	Recruiting	No outcome recorded
Phase 2	NCT06065046	Nov 2023 → Jun 2026 overdue	traumatic brain injury	Tang-Du Hospital	Recruiting	No outcome recorded
Phase 2	NCT06114407	Oct 2023 → Jun 2024	spondyloarthropathy	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Unknown	No outcome recorded
Phase 2	NCT04901325	Oct 2023 → Jan 2025	pyoderma gangrenosum, ulcer disease	Oregon Health and Science University	Completed	No outcome recorded
Phase 2	NCT05897372	Aug 2023 → Sep 2024	diabetic kidney disease	Iain Bressendorff	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT05932524	Jul 2023 → Jun 2024	autoimmune thrombocytopenia	Peking University People's Hospital	Unknown	No outcome recorded
Phase 2	NCT05452564	May 2023 → Jan 2028 expected	HIV infectious disease	William Tyor	Recruiting	No outcome recorded
Phase 2	NCT05852847	May 2023 → Nov 2024	autoimmune thrombocytopenia	Peking University People's Hospital	Unknown	No outcome recorded
Phase 2	NCT05852171	May 2023 → Apr 2025	granulomatous mastitis, mastitis	First Affiliated Hospital of Zhejiang University	Unknown	No outcome recorded
Phase 2	NCT05237388	Apr 2023 → Apr 2026	chronic kidney disease	Duke University	Completed	No outcome recorded
Phase 2	NCT06662721	Apr → Dec 2023	Takayasu arteritis	Liu Tian	Completed	No outcome recorded
Phase 2	NCT05524311	Nov 2022 → May 2025	juvenile dermatomyositis	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT05016297	Jul 2022 → Aug 2024	Sjogren syndrome	Peking Union Medical College Hospital	Completed	No outcome recorded
Phase 2	NCT05446831	Jul 2022 → Jun 2023	autoimmune thrombocytopenic purpura, thrombocytopenia due to immune destruction	Peking University People's Hospital	Unknown	No outcome recorded
Phase 2	NCT05400889	Jun 2022 → Mar 2023	idiopathic inflammatory myopathy	Peking University People's Hospital	Unknown	No outcome recorded
Phase 2	NCT05361109	Jun 2022 → Mar 2023	dermatomyositis	University of Washington	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT05263505	Feb 2022 → Sep 2023	conjunctivitis, mucous membrane pemphigoid	Washington University School of Medicine	Terminated	No outcome recorded
Phase 2	NCT05188521	Jan 2022 → May 2023	lichen planus	Aaron R. Mangold	Completed	No outcome recorded
Phase 2	NCT04208464	Oct 2021 → Sep 2023	idiopathic inflammatory myopathy	University of Manchester	Completed	No outcome recorded
Phase 2	NCT04822584	Jul 2021 → Apr 2023	vitiligo	University Hospital, Bordeaux	Completed	Missed primary
Phase 2	NCT04027101	Dec 2020 → Aug 2023	polymyalgia rheumatica	University Hospital, Brest	Completed	Met primary
Phase 2	NCT04393051	May → Jun 2020	COVID-19, severe acute respiratory syndrome	Azienda Ospedaliero, Universitaria Pisana	Unknown	No outcome recorded
Phase 2	NCT04399798	May → Sep 2020	COVID-19	Fondazione IRCCS Policlinico San Matteo di Pavia	Unknown	No outcome recorded
Phase 2	NCT04346147	May 2020 → Jun 2021	pneumonia	Hospital Universitario de Fuenlabrada	Unknown	No outcome recorded
Phase 2	NCT04373044	May 2020 → May 2021	COVID-19	University of Southern California	Terminated	No outcome recorded
Phase 2	NCT04321993	Apr 2020 → Apr 2024	COVID-19	Lisa Barrett	Unknown	No outcome recorded
Phase 2	NCT03921554	Jun 2019 → Jan 2024	Aicardi-Goutieres syndrome	Adeline Vanderver, MD	Completed	Met primary
Phase 2	NCT03742973	Mar → Sep 2019	primary biliary cholangitis	Eli Lilly and Company	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03026504	Mar 2017 → Apr 2021	temporal arteritis	Matthew J Koster	Completed	No outcome recorded
Phase 2	NCT02708095	Mar 2016 → Oct 2017	systemic lupus erythematosus	Eli Lilly and Company	Completed	Met primary
Phase 2	NCT02576938	Feb 2016 → Feb 2017	atopic eczema	Eli Lilly and Company	Completed	Met primary
Phase 2	NCT01683409	Aug 2012 → Sep 2014	diabetic kidney disease	Eli Lilly and Company	Completed	No outcome recorded
Phase 2	NCT01490632	Dec 2011 → Dec 2012	psoriasis	Eli Lilly and Company	Completed	No outcome recorded
Phase 2	NCT01469013	Nov 2011 → Nov 2012	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 2	NCT01185353	Oct 2010 → Dec 2011	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 2	NCT00902486	May 2009 → Jun 2010	rheumatoid arthritis	Incyte Corporation	Completed	Missed primary

Phase 2/310 trials · 1 met primary
Phase 2/3	NCT07449910	Mar 2026 → Aug 2027 expected	anterior cerebral artery infarction	The First Affiliated Hospital of University of Science and Technology of China	Not yet recruiting	No outcome recorded
Phase 2/3	NCT06475820	Dec 2023 → Jul 2024 overdue	acute biphenotypic leukemia, myelodysplastic syndrome	Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Active not recruiting	No outcome recorded
Phase 2/3	NCT05914584	Jul 2023 → Aug 2025	nosocomial infection	Nantes University Hospital	Unknown	No outcome recorded
Phase 2/3	NCT05686746	Jun 2022 → Jun 2023	nephritis, systemic lupus erythematosus	Assiut University	Unknown	No outcome recorded
Phase 2/3	NCT04891133	Jun 2021 → Dec 2022	COVID-19	Oslo University Hospital	Terminated	No outcome recorded
Phase 2/3	NCT04340232	Mar → Aug 2021	COVID-19	University of Colorado, Denver	Withdrawn	No outcome recorded
Phase 2/3	NCT04517253	Oct 2020 → Apr 2023	Aicardi-Goutieres syndrome, STING-associated vasculopathy with onset in infancy, proteosome-associated autoinflammatory syndrome	Eli Lilly and Company	Terminated	No outcome recorded
Phase 2/3	NCT04320277	May → Jun 2020	—	Hospital of Prato	Unknown	No outcome recorded
Phase 2/3	NCT04358614	Mar → Apr 2020	COVID-19, pneumonia	Fabrizio Cantini	Completed	No outcome recorded
Phase 2/3	NCT03570749	Sep 2018 → Feb 2021	alopecia areata	Eli Lilly and Company	Completed	Met primary
Phase 345 trials · 13 met primary · 3 missed
Phase 3	NCT07543458	Oct 2026 → Jul 2030 expected	arbovirus infection, dengue disease, hemorrhagic fever	Oxford University Clinical Research Unit, Vietnam	Not yet recruiting	No outcome recorded
Phase 3	NCT05651880	Jul 2026 → Dec 2029 expected	uveitis	University Hospital, Rouen	Not yet recruiting	No outcome recorded
Phase 3	NCT07222332	Feb 2026 → Jul 2028 expected	type 1 diabetes mellitus	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 3	NCT07222137	Jan 2026 → Jul 2031 expected	type 1 diabetes mellitus	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 3	NCT06631287	Oct 2024 → Nov 2026 expected	COVID-19, long COVID-19	Wes Ely	Recruiting	No outcome recorded
Phase 3	NCT05858515	Oct 2024 → Dec 2027	post-COVID-19 disorder	Vanderbilt University Medical Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT06936215	Jan 2024 → May 2025 overdue	diffuse cutaneous systemic sclerosis	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Recruiting	No outcome recorded
Phase 3	NCT05379322	Mar 2023	rheumatoid arthritis	Abu Dhabi Stem Cells Center	Withdrawn	No outcome recorded
Phase 3	NCT05723198	Feb 2023 → Mar 2028 expected	alopecia areata, hypotrichosis, skin disorder	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 3	NCT04972760	Aug 2022 → Feb 2028 expected	dermatomyositis	Assistance Publique - Hôpitaux de Paris	Recruiting	No outcome recorded
Phase 3	NCT05432531	Jun → Dec 2022	lupus nephritis	Assiut University	Unknown	No outcome recorded
Phase 3	NCT05074420	Dec 2021 → Sep 2024	COVID-19	Eli Lilly and Company	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT05056558	Oct 2021 → Apr 2022	COVID-19	Incepta Pharmaceuticals Ltd	Unknown	No outcome recorded
Phase 3	NCT04870203	Jul 2021 → Mar 2027 expected	rheumatoid arthritis	University Hospital, Bordeaux	Active not recruiting	No outcome recorded
Phase 3	NCT04970719	Jul → Dec 2021	pneumonia	Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders	Withdrawn	No outcome recorded
Phase 3	NCT04832880	Apr 2021 → Mar 2022	COVID-19	ASST Fatebenefratelli Sacco	Unknown	No outcome recorded
Phase 3	NCT04640168	Dec 2020 → May 2021	COVID-19	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 3	NCT04693026	Sep 2020 → Feb 2021	COVID-19, acute respiratory distress syndrome	M Abdur Rahim Medical College and Hospital	Unknown	No outcome recorded
Phase 3	NCT04421027	Jun 2020 → Feb 2021	COVID-19	Eli Lilly and Company	Completed	Missed primary
Phase 3	NCT04401579	May → Jul 2020	COVID-19	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Met primary
Phase 3	NCT04890626	Apr 2020 → Jul 2023	COVID-19	Instituto de Investigación Hospital Universitario La Paz	Completed	No outcome recorded
Phase 3	NCT04088396	Feb 2020 → Oct 2026 expected	systemic-onset juvenile idiopathic arthritis	Eli Lilly and Company	Active not recruiting	No outcome recorded
Phase 3	NCT04088409	Oct 2019 → Jul 2023 overdue	uveitis	Eli Lilly and Company	Active not recruiting	No outcome recorded
Phase 3	NCT03843125	Sep 2019 → Apr 2022	systemic lupus erythematosus	Eli Lilly and Company	Terminated	No outcome recorded
Phase 3	NCT03899259	Jul 2019 → Jan 2021	alopecia areata	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT03952559	May 2019 → Apr 2022 overdue	atopic eczema	Eli Lilly and Company	Active not recruiting	Mixed
Phase 3	NCT03773965	Apr 2019 → Jul 2031 expected	juvenile idiopathic arthritis	Eli Lilly and Company	Recruiting	No outcome recorded
Phase 3	NCT03773978	Dec 2018 → Jan 2022	juvenile idiopathic arthritis	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT03733301	Nov 2018 → Jul 2019	atopic eczema	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT03701789	Sep 2018 → Oct 2021	bone remodeling disease, rheumatoid arthritis	University of Erlangen-Nürnberg Medical School	Unknown	No outcome recorded
Phase 3	NCT03616912	Aug 2018 → Nov 2021	systemic lupus erythematosus	Eli Lilly and Company	Terminated	Met primary
Phase 3	NCT03616964	Aug 2018 → Sep 2021	systemic lupus erythematosus	Eli Lilly and Company	Completed	Missed primary
Phase 3	NCT03559270	Jun 2018 → Oct 2021	atopic eczema	Eli Lilly and Company	Terminated	No outcome recorded
Phase 3	NCT03428100	May 2018 → Nov 2019	atopic eczema	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT03334435	Mar 2018 → Sep 2020	atopic eczema	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT03435081	Feb 2018 → Dec 2019	atopic eczema	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT03334422	Nov 2017 → Dec 2018	atopic eczema	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT03334396	Nov 2017 → Dec 2018	atopic eczema	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT02735707	Apr 2016 → Feb 2026 overdue	pneumonia	UMC Utrecht	Recruiting	Mixed
Phase 3	NCT02265705	Oct 2014 → May 2017	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01885078	Jun 2013 → Nov 2020	rheumatoid arthritis	Eli Lilly and Company	Completed	No outcome recorded
Phase 3	NCT01721044	Jan 2013 → Jun 2014	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01721057	Dec 2012 → Sep 2014	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01711359	Nov 2012 → Feb 2015	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary
Phase 3	NCT01710358	Oct 2012 → Mar 2015	rheumatoid arthritis	Eli Lilly and Company	Completed	Met primary

Phase 414 trials · 1 met primary · 1 missed
Phase 4	NCT07357649	Jan → Apr 2026 overdue	rheumatoid arthritis	Tanta University	Not yet recruiting	No outcome recorded
Phase 4	NCT07160231	Sep 2025 → May 2028 expected	psoriatic arthritis, spondyloarthropathy	Sint Maartenskliniek	Recruiting	No outcome recorded
Phase 4	NCT06240351	Apr 2024 → Oct 2026 expected	frontal fibrosing alopecia	University of Alabama at Birmingham	Active not recruiting	No outcome recorded
Phase 4	NCT05955066	Dec 2023 → Feb 2026 overdue	rheumatoid arthritis	Chinese University of Hong Kong	Recruiting	No outcome recorded
Phase 4	NCT06366932	Sep 2023 → Sep 2025	atopic eczema	Instituto de Investigación Hospital Universitario La Paz	Unknown	No outcome recorded
Phase 4	NCT05827497	Apr 2023 → Mar 2024	rheumatoid arthritis	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Unknown	No outcome recorded
Phase 4	NCT05660655	Oct 2022 → Sep 2023	rheumatoid arthritis	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Completed	Met primary
Phase 4	NCT05238896	Jun 2022 → Feb 2023	rheumatoid arthritis	Assistance Publique - Hôpitaux de Paris	Terminated	No outcome recorded
Phase 4	NCT05300932	Mar 2022 → Aug 2026 overdue	systemic sclerosis	Tongji Hospital	Active not recruiting	No outcome recorded
Phase 4	NCT05080218	Nov 2021 → Apr 2024	psoriatic arthritis, spondyloarthropathy	Jeffrey Curtis	Completed	No outcome recorded
Phase 4	NCT04390464	May 2020 → May 2021	COVID-19	Cambridge University Hospitals NHS Foundation Trust	Unknown	Missed primary
Phase 4	NCT04086745	Feb 2020 → May 2025	rheumatoid arthritis	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT03915964	Apr 2019 → May 2025	rheumatoid arthritis	Eli Lilly and Company	Completed	No outcome recorded
Phase 4	NCT02714634	Mar 2016 → Mar 2029 expected	rheumatoid arthritis	University Hospital, Strasbourg, France	Recruiting	No outcome recorded

Phase not applicable7 trials
—	NCT07406932	May 2026 → Jul 2027 expected	antisynthetase syndrome, interstitial lung disease	China-Japan Friendship Hospital	Recruiting	No outcome recorded
—	NCT05969730	Aug 2023 → Apr 2025	atopic eczema	Mazandaran University of Medical Sciences	Completed	No outcome recorded
—	NCT05305066	Feb 2023 → Dec 2028 expected	rheumatoid arthritis	Marie Hudson, MD	Recruiting	No outcome recorded
—	NCT05781516	Jan 2023 → Jun 2024	immunoglobulin G4-related sclerosing disease	Wen Zhang	Unknown	No outcome recorded
—	NCT05082714	Oct 2021 → Jun 2022	COVID-19	University Hospital of Patras	Completed	No outcome recorded
—	NCT05003310	Oct 2021 → Jul 2027 expected	rheumatoid arthritis	Galvani Bioelectronics	Recruiting	No outcome recorded
—	NCT04378621	Oct 2020 → Sep 2025	depressive disorder, rheumatoid arthritis, subjective cognitive decline	Vastra Gotaland Region	Unknown	No outcome recorded
Phase not stated1 trial
—	NCT01724580	—	Aicardi-Goutieres syndrome, STING-associated vasculopathy with onset in infancy, juvenile dermatomyositis, proteosome-associated autoinflammatory syndrome	Eli Lilly and Company	Approved for marketing	No outcome recorded
Comparator or background therapy16 trials
Phase 1	NCT07554222 Comparator	Apr 2026 → Dec 2027 expected	alopecia areata, vitiligo	Innovent Biologics (Suzhou) Co. Ltd.	Recruiting	No outcome recorded
Phase 1	NCT06545110 Comparator	Sep 2023 → Sep 2024 overdue	alopecia areata	South Valley University	Active not recruiting	No outcome recorded
Phase 2	NCT07779642 Comparator	Sep 2026 → Sep 2029 expected	acute respiratory distress syndrome	University of Colorado, Denver	Not yet recruiting	No outcome recorded
Phase 2	NCT06768294 Comparator	Jan 2025 → Jun 2026 overdue	chondrocalcinosis	I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio	Not yet recruiting	No outcome recorded
Phase 2	NCT04774224 Comparator	Oct 2020 → Jan 2023	type 1 diabetes mellitus	St Vincent's Institute of Medical Research	Completed	No outcome recorded
Phase 2	NCT03755466 Comparator	Nov 2018 → Nov 2023	rheumatoid arthritis	Shinshu University	Unknown	No outcome recorded
Phase 2/3	NCT06768840 Comparator	Oct 2024 → Aug 2025 overdue	generalized vitiligo	South Valley University	Recruiting	No outcome recorded
Phase 2/3	NCT05545020 Comparator	Dec 2022 → Jan 2024	rheumatoid arthritis	Alexandria University	Completed	No outcome recorded
Phase 3	NCT07279688 Comparator	Dec 2025 → Nov 2028 expected	polymyalgia rheumatica	University Hospital, Brest	Recruiting	No outcome recorded
Phase 3	NCT04692493 Comparator	Sep 2021 → May 2029 expected	rheumatoid arthritis	University of Alabama at Birmingham	Recruiting	No outcome recorded
Phase 3	NCT05187793 Background	Jul 2021 → Oct 2022	COVID-19	R-Pharm	Unknown	No outcome recorded
Phase 3	NCT04381936 Comparator	Mar 2020 → Sep 2028 expected	pneumonia	University of Oxford	Recruiting	No outcome recorded
Phase 3	NCT03414502 Comparator	Dec 2007 → Mar 2028 expected	rheumatoid arthritis	University of Nebraska	Recruiting	No outcome recorded
Phase 4	NCT06687551 Comparator	Jan 2025 → Apr 2029 expected	rheumatoid arthritis	University Hospital, Toulouse	Not yet recruiting	No outcome recorded
—	NCT07645430 Comparator	Jan 2023 → Jan 2024	alopecia areata	Benha University	Completed	No outcome recorded
—	NCT05279391 Comparator	Oct 2020 → Nov 2021	respiratory failure	Democritus University of Thrace	Unknown	No outcome recorded

News releases announcing trial results or a regulatory action · 128

Date	Issuer	Release
2026-09-25	Eli Lilly and Company	Regulatory FDA approves Lilly's Olumiant (baricitinib) for pediatric patients 12 years of age and older with severe alopecia areata lilly.com ↗ Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA).
2026-02-27	Eli Lilly and Company	Regulatory Lilly's Olumiant (baricitinib) recommended by CHMP for approval of expanded use in the European Union for adolescents with severe alopecia areata lilly.com ↗
2025-10-24	Eli Lilly and Company	Results Lilly's baricitinib delivered near-complete scalp hair regrowth at one year for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS trial lilly.com ↗ New data show 71% of adolescents with severe disease treated with baricitinib 4 mg achieved successful scalp hair regrowth at one year, with continuous improvements observed throughout those 52 weeks
2025-03-08	Eli Lilly and Company	Results Lilly's baricitinib delivered high rates of hair regrowth for adolescents with severe alopecia areata in Phase 3 BRAVE-AA-PEDS study lilly.com ↗ Late-breaking results presented at AAD show 80% or more scalp hair coverage at Week 36 in 42.4% of adolescents receiving baricitinib 4 mg
2022-06-13	Eli Lilly and Company	Regulatory FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets.
2022-06-13	Incyte Corporation	Regulatory FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) As First and Only Systemic Medicine for Adults with Severe Alopecia Areata incyte.com ↗
2022-05-20	Eli Lilly and Company	Regulatory CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (AA) lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OLUMIANT® (baricitinib) for the treatment of adults with severe alopecia areata (AA).
2022-05-20	Incyte Corporation	Regulatory CHMP Recommends Approval of Lilly and Incyte's OLUMIANT® (baricitinib) as the First and Only Centrally-Authorized Treatment for Adults with Severe Alopecia Areata (AA) incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for OLUMIANT® (baricitinib) for the treatment of adults with severe alopecia areata (AA).
2022-05-11	Eli Lilly and Company	Regulatory FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19 lilly.com ↗ OLUMIANT is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support
2022-05-11	Incyte Corporation	Regulatory FDA Approves Lilly and Incyte's OLUMIANT® (baricitinib) for the Treatment of Certain Hospitalized Patients with COVID-19 incyte.com ↗
2022-03-26	Eli Lilly and Company	Results Nearly 40% of Adults with Alopecia Areata Taking OLUMIANT® 4-mg Saw at Least 80% Scalp Hair Coverage at 52 Weeks in Lilly's Pivotal Phase 3 Studies lilly.com ↗
2022-01-28	Eli Lilly and Company	Results Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis lilly.com ↗ Based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II), Lilly has decided to discontinue the Phase 3 development program for OLUMIANT in lupus.
2022-01-28	Incyte Corporation	Results Updates on OLUMIANT® (baricitinib) Phase 3 lupus program and FDA review for atopic dermatitis incyte.com ↗ The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of SRI-4 response.
2021-11-09	Eli Lilly and Company	Results OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis lilly.com ↗ OLUMIANT® (baricitinib) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA) who received OLUMIANT for 14,744 patient years of exposure, in line with previously published findings.
2021-11-09	Incyte Corporation	Results OLUMIANT® Long-Term Safety Profile Established Up to 9.3 Years in Integrated Analysis of More Than 3,700 Patients with Rheumatoid Arthritis incyte.com ↗ OLUMIANT® (baricitinib) maintained a consistent safety profile in a long-term, integrated safety analysis of patients with rheumatoid arthritis (RA) who received OLUMIANT for 14,744 patient years of exposure, in line with previously published findings.
2021-09-30	Eli Lilly and Company	Results OLUMIANT® Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata lilly.com ↗
2021-09-30	Incyte Corporation	Results OLUMIANT® Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today detailed results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2), which found once-daily OLUMIANT® (baricitinib) 4-mg was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata (AA) as defined by ≥50% scalp hair loss at baseline.
2021-08-03	Eli Lilly and Company	Results Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation lilly.com ↗ INDIANAPOLIS, Aug. 3, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial.
2021-08-03	Incyte Corporation	Results Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation incyte.com ↗ In this sub-study, patients with COVID-19 on mechanical ventilation or extracorporeal membrane oxygenation (ECMO) who received baricitinib plus standard of care were 46 percent less likely to die by Day 28 compared to patients who received placebo plus standard of care (nominal p-value=0.0296; hazard ratio [HR] [95% CI] = 0.54 [0.31, 0.96]; analysis not adjusted for multiplicity).
2021-07-29	Eli Lilly and Company	Regulatory FDA broadens existing emergency use of Lilly and Incyte's baricitinib in patients hospitalized with COVID-19 requiring oxygen lilly.com ↗ The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
2021-07-29	Incyte Corporation	Regulatory FDA broadens existing emergency use of Lilly and Incyte's baricitinib in patients hospitalized with COVID-19 requiring oxygen incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today the U.S. Food and Drug Administration (FDA) has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir, whereas the EUA was previously restricted to use only in combination with remdesivir.
2021-07-16	Eli Lilly and Company	Regulatory Lilly and Incyte provide update on supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) will not meet the Prescription Drug User Fee Act (PDUFA) action date for the supplemental new drug application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).
2021-07-16	Incyte Corporation	Regulatory Lilly and Incyte provide update on supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis incyte.com ↗
2021-06-01	Eli Lilly and Company	Results OLUMIANT® Improved Pain, Physical Function and Morning Joint Stiffness in Rheumatoid Arthritis in Phase 3 Post-Hoc Analyses lilly.com ↗ In this analysis, improvements in fatigue with OLUMIANT 4 mg were greater than with placebo and similar to HUMIRA after 12 weeks of treatment.
2021-06-01	Incyte Corporation	Results OLUMIANT® Improved Pain, Physical Function and Morning Joint Stiffness in Rheumatoid Arthritis in Phase 3 Post-Hoc Analyses incyte.com ↗ In this analysis, improvements in fatigue with OLUMIANT 4 mg were greater than with placebo and similar to HUMIRA after 12 weeks of treatment.
2021-05-04	Eli Lilly and Company	Regulatory Lilly accelerating baricitinib's availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements lilly.com ↗ On Monday, Lilly received permission for restricted emergency use from Central Drugs Standard Control Organization, a division of Ministry of Health, for baricitinib (2 mg and 4 mg) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
2021-04-23	Eli Lilly and Company	Results OLUMIANT® Showed Significant Improvements in the Severity and Extent of Atopic Dermatitis and Other Patient-Reported Outcomes in Phase 3 Study Analyses lilly.com ↗ In one BREEZE-AD5 analysis, OLUMIANT provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by percent change from baseline compared to placebo.
2021-04-23	Incyte Corporation	Results OLUMIANT® Showed Significant Improvements in the Severity and Extent of Atopic Dermatitis and Other Patient-Reported Outcomes in Phase 3 Study Analyses incyte.com ↗ In one BREEZE-AD5 analysis, OLUMIANT provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by percent change from baseline compared to placebo.
2021-04-20	Eli Lilly and Company	Results Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA).
2021-04-20	Incyte Corporation	Results Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study incyte.com ↗ In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo.
2021-04-08	Eli Lilly and Company	Results Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients lilly.com ↗ Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).
2021-04-08	Incyte Corporation	Results Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients incyte.com ↗
2021-04-06	Eli Lilly and Company	Regulatory Lilly and Incyte communicate review extension of supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis lilly.com ↗ The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA.
2021-04-06	Incyte Corporation	Regulatory Lilly and Incyte communicate review extension of supplemental New Drug Application for baricitinib for the treatment of moderate to severe atopic dermatitis incyte.com ↗ The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA.
2021-03-03	Eli Lilly and Company	Results Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial lilly.com ↗ Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo.
2021-03-03	Incyte Corporation	Results Baricitinib is First JAK-Inhibitor to Demonstrate Hair Regrowth in Phase 3 Alopecia Areata (AA) Trial incyte.com ↗ Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo.
2020-12-11	Eli Lilly and Company	Results Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine lilly.com ↗ Results of this study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen.
2020-12-11	Incyte Corporation	Results Data from ACTT-2 Trial of Baricitinib in Hospitalized COVID-19 Patients Supportive of the EUA Published in New England Journal of Medicine incyte.com ↗ Results of this study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen.
2020-11-20	BenevolentAI Bio	Regulatory FDA Grants Emergency Use Authorisation For Baricitinib In Hospitalised COVID-19 Patients Nine Months After Initial Hypothesis Was Published By BenevolentAI benevolent.com ↗ BenevolentAI announced today that baricitinib, a drug it first identified as a potential treatment for COVID-19 by the company has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA).
2020-11-19	Eli Lilly and Company	Regulatory Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 lilly.com ↗
2020-11-19	Incyte Corporation	Regulatory Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19 incyte.com ↗
2020-11-02	Eli Lilly and Company	Results ACR 2020: Lilly and Incyte Highlight Positive Data for Olumiant® in Rheumatoid Arthritis lilly.com ↗ In this analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR patients had Low Disease Activity defined by Simple Disease Activity Index (LDA; SDAI ≤11) after 2.3 years (at week 120) in a Non-responder Imputation analysis.
2020-10-31	Eli Lilly and Company	Results EADV 2020: Lilly and Incyte Showcase New Data for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis lilly.com ↗ These results indicate that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period.
2020-10-31	Incyte Corporation	Results EADV 2020: Lilly and Incyte Showcase New Data for Baricitinib for the Treatment of Moderate to Severe Atopic Dermatitis incyte.com ↗ These results indicate that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period.
2020-10-30	Eli Lilly and Company	Results Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT®) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020.
2020-10-30	Incyte Corporation	Results Fall Clinical Dermatology 2020: Lilly and Incyte Showcase Positive New Data for Baricitinib in Adult Patients with Alopecia Areata incyte.com ↗
2020-10-08	Eli Lilly and Company	Results Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) are sharing additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir.
2020-10-08	Incyte Corporation	Results Baricitinib has Significant Effect on Recovery Time, Most Impactful in COVID-19 Patients Requiring Oxygen incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) are sharing additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir.
2020-09-18	Eli Lilly and Company	Regulatory CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis lilly.com ↗ Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
2020-09-18	Incyte Corporation	Regulatory CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Atopic Dermatitis incyte.com ↗ Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
2020-09-14	Eli Lilly and Company	Results Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial lilly.com ↗ Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
2020-09-14	Incyte Corporation	Results Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial incyte.com ↗ Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
2020-06-03	Eli Lilly and Company	Results EULAR 2020: Lilly Shares New Data for Olumiant® in Rheumatoid Arthritis and Systemic Lupus Erythematosus lilly.com ↗ The study found that among patients with an inadequate response to MTX, 52% of patients initially treated with Olumiant (+MTX) were in a state of SDAI LDA at week 24 and this rate was maintained through week 148.
2020-03-16	Eli Lilly and Company	Regulatory Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA), an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.
2020-03-16	Incyte Corporation	Regulatory Lilly Receives FDA Breakthrough Therapy Designation for Baricitinib for the Treatment of Alopecia Areata incyte.com ↗
2020-01-30	Eli Lilly and Company	Results Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis lilly.com ↗ In this study, the 2-mg dose of baricitinib met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16
2020-01-30	Incyte Corporation	Results Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗ Study met the primary endpoint of at least 75% improvement of skin inflammation and key secondary endpoints
2020-01-27	Eli Lilly and Company	Results Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine lilly.com ↗ In this study, the 4-mg dose of baricitinib plus TCS met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16.
2020-01-27	Incyte Corporation	Results Lilly and Incyte Announce Top-Line Results from Phase 3 Study (BREEZE-AD4) of Oral Selective JAK Inhibitor Baricitinib in Combination with Topical Corticosteroids in Patients with Moderate to Severe Atopic Dermatitis Not Controlled with Cyclosporine incyte.com ↗ Study met primary endpoint of at least 75% improvement of skin inflammation
2019-08-23	Eli Lilly and Company	Results Lilly Announces Top-Line Phase 3 Results for Oral JAK Inhibitor Baricitinib, in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis lilly.com ↗ BREEZE-AD7, an investigational study evaluating the efficacy and safety of baricitinib, an oral JAK inhibitor, to treat moderate to severe atopic dermatitis (AD) in adults met its primary endpoint.
2019-08-23	Incyte Corporation	Results Lilly Announces Top-Line Phase 3 Results for Oral JAK Inhibitor Baricitinib, in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗ INDIANAPOLIS, Aug. 23, 2019 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte Corporation (NASDAQ:INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD7, the third pivotal Phase 3 trial in the BREEZE-AD program to be completed in 2019.
2019-02-04	Eli Lilly and Company	Results Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis (AD).
2019-02-04	Incyte Corporation	Results Lilly Announces Top-Line Phase 3 Results for Baricitinib in Patients with Moderate to Severe Atopic Dermatitis incyte.com ↗
2018-12-13	Eli Lilly and Company	Regulatory FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE) lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE).
2018-12-13	Incyte Corporation	Regulatory FDA Grants Fast Track Designation to the Baricitinib Development Program for the Treatment of Systemic Lupus Erythematosus (SLE) incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE).
2018-10-21	Eli Lilly and Company	Results ACR 2018: Lilly Shares Updated Safety Analysis of OLUMIANT® (baricitinib) in Patients with Moderately-to-Severely Active Rheumatoid Arthritis lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today findings from an updated integrated safety analysis of OLUMIANT® (baricitinib) based on an ongoing long-term extension (LTE) study of rheumatoid arthritis (RA) patients treated up to six years.
2018-10-21	Incyte Corporation	Results ACR 2018: Lilly Shares Updated Safety Analysis of OLUMIANT® (baricitinib) in Patients with Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today findings from an updated integrated safety analysis of OLUMIANT® (baricitinib) based on an ongoing long-term extension (LTE) study of rheumatoid arthritis (RA) patients treated up to six years.
2018-07-19	Eli Lilly and Company	Results Study Published in The Lancet Shows Benefit of Baricitinib 4 mg for the Treatment of Systemic Lupus Erythematosus (SLE) lilly.com ↗ Patients treated with 4 mg of baricitinib experienced improvements compared to placebo on several pre-specified secondary endpoints.
2018-07-19	Incyte Corporation	Results Study Published in The Lancet Shows Benefit of Baricitinib 4 mg for the Treatment of Systemic Lupus Erythematosus (SLE) incyte.com ↗ Patients treated with 4 mg of baricitinib experienced improvements compared to placebo on several pre-specified secondary endpoints.
2018-06-01	Eli Lilly and Company	Regulatory FDA Approves OLUMIANT® (baricitinib) 2-mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis lilly.com ↗
2018-06-01	Incyte Corporation	Regulatory FDA Approves OLUMIANT® (baricitinib) 2-mg Tablets for the Treatment of Adults with Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗
2018-04-23	Eli Lilly and Company	Regulatory FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis lilly.com ↗ For the 2-mg dose, the Advisory Committee voted in favor of the assessment that baricitinib's safety data adequately support its approval.
2018-04-23	Incyte Corporation	Regulatory FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis incyte.com ↗
2017-11-05	Eli Lilly and Company	Results ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
2017-11-05	Incyte Corporation	Results ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
2017-09-14	Eli Lilly and Company	Results Baricitinib Meets Primary Endpoint in Phase 2 Study of Patients with Moderate-to-Severe Atopic Dermatitis lilly.com ↗ The results showed that baricitinib in combination with a mid-potency topical corticosteroid (TCS) significantly improved the signs and symptoms of AD compared to TCS alone.
2017-09-14	Incyte Corporation	Results Baricitinib Meets Primary Endpoint in Phase 2 Study of Patients with Moderate-to-Severe Atopic Dermatitis incyte.com ↗ The results showed that baricitinib in combination with a mid-potency topical corticosteroid (TCS) significantly improved the signs and symptoms of AD compared to TCS alone.
2017-07-25	Eli Lilly and Company	Regulatory Lilly and Incyte Provide Update on Baricitinib lilly.com ↗ The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA.
2017-07-25	Incyte Corporation	Regulatory Lilly and Incyte Provide Update on Baricitinib incyte.com ↗ This request for an additional clinical study does not impact the ongoing clinical trials for baricitinib.
2017-07-03	Eli Lilly and Company	Regulatory Japan Ministry of Health, Labor and Welfare (MHLW) Grants Marketing Approval For Olumiant® (baricitinib) for the Treatment of Rheumatoid Arthritis lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant® (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
2017-07-03	Incyte Corporation	Regulatory Japan Ministry of Health, Labor and Welfare (MHLW) Grants Marketing Approval For Olumiant® (baricitinib) for the Treatment of Rheumatoid Arthritis incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) granted marketing approval for Olumiant® (baricitinib) 2-mg and 4-mg tablets for the treatment of rheumatoid arthritis (RA) (including the prevention of structural injury of joints) in patients with inadequate response to standard-of-care therapies.
2017-06-16	Eli Lilly and Company	Results New Safety and Long-Term Efficacy Data from Baricitinib Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis Presented at EULAR 2017 lilly.com ↗ Additionally, new data from the long-term extension (LTE) of Phase 3 trials showed that two years of baricitinib treatment significantly lowered the rate of joint damage progression and maintained an overall low disease activity (LDA) throughout the treatment period in these patients.
2017-06-16	Incyte Corporation	Results New Safety and Long-Term Efficacy Data from Baricitinib Clinical Trials in Patients with Moderate-to-Severe Rheumatoid Arthritis Presented at EULAR 2017 incyte.com ↗ These results were presented at an oral presentation and two poster presentations at the Annual European Congress of Rheumatology (EULAR 2017) in Madrid.
2017-04-14	Eli Lilly and Company	Regulatory U.S. FDA Issues Complete Response Letter for Baricitinib lilly.com ↗
2017-04-14	Incyte Corporation	Regulatory U.S. FDA Issues Complete Response Letter for Baricitinib incyte.com ↗ The letter indicates that the FDA is unable to approve the application in its current form.
2017-02-15	Eli Lilly and Company	Results Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo lilly.com ↗ At week 52, both ACR50 and ACR70 rates were higher in the baricitinib group compared to adalimumab, although only ACR 50 was statistically significant.
2017-02-15	Incyte Corporation	Results Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo incyte.com ↗ These improvements were statistically significant compared to adalimumab at weeks 12, 20, 28, 32 and 40.
2017-02-13	Eli Lilly and Company	Regulatory European Commission Approves Once-Daily Olumiant Tablets for Treatment of Adults with Moderate-to-Severe Active Rheumatoid Arthritis lilly.com ↗ This is the first regulatory approval around the world for Olumiant -- the first JAK inhibitor approved to treat RA in the European Union -- which may be used as monotherapy or in combination with methotrexate.
2017-02-13	Incyte Corporation	Regulatory European Commission Approves Once-Daily Olumiant Tablets for Treatment of Adults with Moderate-to-Severe Active Rheumatoid Arthritis incyte.com ↗ This is the first regulatory approval around the world for Olumiant -- the first JAK inhibitor approved to treat RA in the European Union -- which may be used as monotherapy or in combination with methotrexate.
2017-01-13	Eli Lilly and Company	Regulatory U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment lilly.com ↗ The FDA extended the action date to allow time to review additional data analyses recently submitted by Lilly in response to the FDA's Information Requests.
2017-01-13	Incyte Corporation	Regulatory U.S. FDA Extends Review Period for Baricitinib, an Investigational Rheumatoid Arthritis Treatment incyte.com ↗
2016-12-16	Eli Lilly and Company	Regulatory CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA) lilly.com ↗ Baricitinib is the first JAK inhibitor to receive a positive CHMP opinion for the treatment of RA in the EU.
2016-12-16	Incyte Corporation	Regulatory CHMP Recommends Approval of Lilly's Baricitinib for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis (RA) incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending the approval of baricitinib - which if approved would be marketed as Olumiant®.
2016-11-14	Eli Lilly and Company	Results New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients lilly.com ↗ What these data showed is that regardless of a patient's age, body mass index or previous experience with conventional synthetic DMARDs, treatment with baricitinib resulted in improvement in rheumatoid arthritis symptoms.
2016-11-14	Eli Lilly and Company	Results Baricitinib Demonstrates Early Response Compared to Placebo and Significant Improvement Compared to Adalimumab in Patient-Reported Outcomes lilly.com ↗
2016-11-14	Incyte Corporation	Results New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients incyte.com ↗ Three post-hoc analyses of two phase 3 studies showed improvements in rheumatoid arthritis symptoms in patients irrespective of age, BMI and number of previously used conventional synthetic DMARDs
2016-11-14	Incyte Corporation	Results Baricitinib Demonstrates Early Response Compared to Placebo and Significant Improvement Compared to Adalimumab in Patient-Reported Outcomes incyte.com ↗ Our study results show that treatment with baricitinib rapidly led to significantly greater symptom improvement compared to adalimumab and placebo.
2016-11-02	Eli Lilly and Company	Results New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo lilly.com ↗ In these patients, treatment with baricitinib through 24 weeks significantly improved most patient-reported outcomes compared with placebo, and patients receiving baricitinib 4 mg showed the most rapid and greatest change.
2016-11-02	Incyte Corporation	Results New data from pivotal RA-BEACON study show significant improvement in patient-reported outcomes in rheumatoid arthritis patients treated with baricitinib compared to placebo incyte.com ↗ In these patients, treatment with baricitinib through 24 weeks significantly improved most patient-reported outcomes compared with placebo, and patients receiving baricitinib 4 mg showed the most rapid and greatest change.
2016-06-09	Eli Lilly and Company	Results Patient-reported outcomes across phase 3 studies of baricitinib demonstrate statistically significant improvements in physical function and quality of life symptoms in patients with rheumatoid arthritis (RA) lilly.com ↗ Pivotal trials show treatment with baricitinib resulted in significant improvements in pain, fatigue and ability to perform daily activities compared to methotrexate - the current standard of care - and adalimumab (Humira®)*
2016-06-09	Eli Lilly and Company	Results Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs lilly.com ↗ The findings demonstrate that baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA).
2016-06-09	Incyte Corporation	Results Patient-reported outcomes across phase 3 studies of baricitinib demonstrate statistically significant improvements in physical function and quality of life symptoms in patients with rheumatoid arthritis (RA) incyte.com ↗ Pivotal trials show treatment with baricitinib resulted in significant improvements in pain, fatigue and ability to perform daily activities compared to methotrexate - the current standard of care - and adalimumab (Humira®)*
2016-06-09	Incyte Corporation	Results Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs incyte.com ↗ The findings demonstrate that baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA).
2016-06-07	Eli Lilly and Company	Results Results of Clinical and Patient-Reported Outcomes Data for Baricitinib in Patients with Rheumatoid Arthritis to be Presented at Annual European Congress of Rheumatology (EULAR 2016) lilly.com ↗ Baricitinib Inhibits Radiographic Progression of Structural Joint Damage at 1 Year in Patients with Rheumatoid Arthritis (RA) and An Adequate Response to csDMARDs
2016-03-31	Eli Lilly and Company	Results Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics lilly.com ↗ The study met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12.
2016-03-31	Incyte Corporation	Results Phase 3 Study Findings Demonstrate Treatment with Baricitinib Results in Significant Improvements for Patients with Rheumatoid Arthritis Who Had Inadequate Response to Biologics incyte.com ↗ The study met its primary endpoint of improved ACR 20 response for baricitinib compared with placebo at week 12.
2016-01-19	Eli Lilly and Company	Regulatory Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis lilly.com ↗
2016-01-19	Incyte Corporation	Regulatory Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis incyte.com ↗
2015-11-08	Eli Lilly and Company	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis lilly.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function.
2015-11-07	Eli Lilly and Company	Results Lilly and Incyte Announce Patients Treated with Baricitinib Demonstrated Significant Improvement in Signs and Symptoms of Rheumatoid Arthritis Compared with Methotrexate lilly.com ↗
2015-11-07	Eli Lilly and Company	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis lilly.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function.
2015-11-07	Incyte Corporation	Results Lilly and Incyte Announce Patients Treated with Baricitinib Demonstrated Significant Improvement in Signs and Symptoms of Rheumatoid Arthritis Compared with Methotrexate incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce detailed data from the pivotal phase 3 RA-BEGIN study, which show investigational baricitinib alone and in combination were superior to methotrexate monotherapy in helping patients achieve clinical remission.
2015-11-07	Incyte Corporation	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis incyte.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients’ pain and improving physical function.
2015-10-14	Eli Lilly and Company	Results Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study lilly.com ↗ The study met its primary objective of demonstrating superiority compared to placebo after 12 weeks of treatment based on ACR20 response - a standard clinical measure that represents at least a 20 percent improvement in RA disease activity.
2015-10-14	Incyte Corporation	Results Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study incyte.com ↗ Baricitinib was also superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment.
2015-09-29	Eli Lilly and Company	Results Baricitinib Superior to Methotrexate in Reducing Signs and Symptoms in Pivotal Phase 3 Study in Patients with Rheumatoid Arthritis lilly.com ↗ The study met its primary objective of demonstrating non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment.
2015-09-29	Incyte Corporation	Results Baricitinib Superior to Methotrexate in Reducing Signs and Symptoms in Pivotal Phase 3 Study in Patients with Rheumatoid Arthritis incyte.com ↗ The study met its primary objective of demonstrating non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment.
2015-02-23	Eli Lilly and Company	Results Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study lilly.com ↗ The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.
2015-02-23	Incyte Corporation	Results Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study incyte.com ↗ The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment.
2014-12-09	Eli Lilly and Company	Results Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis lilly.com ↗
2014-12-09	Incyte Corporation	Results Lilly and Incyte Announce Positive Top-Line Results From Phase 3 Trial of Baricitinib in Moderate to Severe Rheumatoid Arthritis incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announce that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared to placebo after 12 weeks of treatment.
2013-06-13	Eli Lilly and Company	Results Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with Rheumatoid Arthritis lilly.com ↗
2013-06-13	Incyte Corporation	Results Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with Rheumatoid Arthritis incyte.com ↗
2012-11-13	Eli Lilly and Company	Results Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) today announced 24-week results from the continuation of an ongoing Phase IIb study of baricitinib, an orally available janus kinase (JAK) inhibitor, in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to treatment with methotrexate.
2012-11-13	Incyte Corporation	Results Lilly and Incyte Announce Additional Phase IIb Baricitinib Data, Including MRI Results, in Patients with Rheumatoid Arthritis incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (Nasdaq: INCY) today announced 24-week results from the continuation of an ongoing Phase IIb study of baricitinib, an orally available janus kinase (JAK) inhibitor, in patients with moderate-to-severe rheumatoid arthritis (RA) who had an inadequate response to treatment with methotrexate.
2012-06-08	Eli Lilly and Company	Results Lilly and Incyte's Oral JAK1 and JAK2 Inhibitor, Baricitinib, Showed Positive Results in Phase IIb Study in Patients with Active Rheumatoid Arthritis lilly.com ↗ Statistically significant improvement was observed at the first assessment point after two weeks of treatment and was sustained through week 12.
2012-06-08	Incyte Corporation	Results Lilly and Incyte's Oral JAK1 and JAK2 Inhibitor, Baricitinib, Showed Positive Results in Phase IIb Study in Patients with Active Rheumatoid Arthritis incyte.com ↗ A statistically significant difference in response for the ACR20, ACR50 and ACR70 secondary endpoints was observed with the 1 mg, 4 mg and 8 mg dose groups compared with placebo.
2010-11-10	Incyte Corporation	Results Incyte's Selective Oral JAK1 and JAK2 Inhibitor Demonstrates Positive Phase IIa Results in Patients with Active Rheumatoid Arthritis incyte.com ↗ Results from the 125-patient Phase IIa trial demonstrated that all three doses of oral INCB28050 (4 mg QD, 7 mg QD and 10 mg QD) improved on the primary endpoint, the percent of patients achieving American College of Rheumatology (ACR) 20 improvement, over the full 24-week treatment period.

All press releases naming this drug 145 releases

Date	Issuer	Release
Show all 145 releases opens the full record — a long page

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 176 sources stand behind the page.

Field	Value	Cited text
Known as	Baricitinib	“Patients with moderate to severe atopic dermatitis refractory to topical medication, who also have previous experience with cyclosporine and an unsatisfactory response, or in...” NCT06366932 ↗ 165 “Oral JAK inhibitors (tofacitinib 5 mg twice daily, or baricitinib 4 mg once daily, or upadacitinib 15 mg once daily) administered in combination with standard glucocorticoid...” NCT07406932 ↗ “Switching to a targeted synthetic DMARD (choice from targeted synthetic DMARDs; currently available are tofacitinib, baricitinib, upadacitinib) in people with active RA despite...” NCT04692493 ↗ “Baricitinib, a second-generation Janus kinase (JAK) inhibitor has shown potential in preclinical studies to reduce HIV reactivation and modulate immune activation.” NCT07028385 ↗ “Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.” NCT05400889 ↗ “Baricitinib is one of the emerging DMARDs with strong anti-rheumatic effects but has serious side effects.” PMID 39030450 ↗ Jul 2024 “Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor” NCT05432531 ↗ “JAK-inhibitors: Baricitinib (Olumiant), Tofacitinib (Xeljanz)” NCT04378621 ↗ “baricitinib 2 mg po qd (JAK 1/2 inhibitor)” NCT05305066 ↗ “Methotrexate or leflunomide + baricitinib” NCT02714634 ↗ “Tofacitinib, baricitinib, or upadacitinib” NCT05379322 ↗ Show 155 more sources
Known as	BARI	“In this study, we evaluated the effect of JAKi through baricitinib (BARI) on 1) volumetric bone mineral density (vBMD), bone microstructure, biomechanics, and erosion repair...” PMID 37229650 ↗ Sep 2023
Known as	BARICITINIB (INCB028050)	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗
Known as	BARICITINIB (LY3009104)	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗
Known as	BARICITINIB PHOSPHATE	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗
Known as	BARICITINIB PHOSPHATE SALT	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗
Known as	INCB-28050	ChEMBL registry synonym — accepted as the source's own label CHEMBL2105759 ↗
Known as	INCB028050	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00902486 ↗
Known as	LY3009104	“A Study to Investigate the Potential Impact of Organic Anion Transporter 3 Inhibition by Probenecid on the Pharmacokinetics of Baricitinib (LY3009104) in Healthy Subjects” NCT01937026 ↗ 10 “A Drug Drug Interaction (DDI) Study of Baricitinib (LY3009104) and Digoxin in Healthy Participants” NCT01859078 ↗ “Baricitinib (LY3009104) 2 mg” NCT07209267 ↗ “Baricitinib (LY3009104) 4 mg” NCT06687551 ↗ “Baricitinib (LY3009104) 4 mg” NCT06868381 ↗ “Baricitinib (LY3009104) 2 mg” NCT05188521 ↗ NCT01185353 ↗ NCT01398475 ↗ NCT01299285 ↗ NCT01536951 ↗ NCT01247350 ↗
Known as	Olumiant	“Baricitinib Oral Tablet [Olumiant]” NCT05238896 ↗ 3 “Drug: Baricitinib 2 MG [Olumiant]” NCT05263505 ↗ “Baricitinib 2 MG [Olumiant]” NCT05852847 ↗ “"Baricitinib", "olumiant®"” NCT03755466 ↗
Action	Inhibit	“inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014
Modality	Small molecule	“This small molecule” NCT03026504 ↗
Route	Oral	“oral baricitinib administered once daily” PMID 29463520 ↗ Feb 2018
Target	JAK1	“inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014
Target	JAK2	“inhibitor of JAK1/JAK2” PMID 25431052 ↗ Nov 2014