Varenicline

also known as Chantix · Champix · Varenicline tartrate · CP-526,555 · OC-01 · VAR · OC-01 (varenicline solution) Nasal Spray · TYRVAYA · +13 more

Small molecule targets CHRNA4 via activation

Developed for: nicotine dependence · schizophrenia · dry eye syndrome · alcohol-related disorders · Parkinson disease · schizoaffective disorder · alcohol dependence · cannabis dependence
+23 more
· chronic obstructive pulmonary disease · depressive disorder · bipolar disorder · opiate dependence · substance-related disorder · acute coronary syndrome · cocaine dependence · alcohol abuse · Alzheimer disease · amphetamine abuse · attention deficit-hyperactivity disorder · chronic pain syndrome · coronary artery disorder · drug dependence · Friedreich ataxia · irritable bowel syndrome · Machado-Joseph disease · methamphetamine dependence · schizophreniform disorder · Sjogren syndrome · substance abuse · substance dependence · eye adnexa disorder
Investigated by: Pfizer · National Institute on Drug Abuse (NIDA) · National Cancer Institute (NCI) · Yale University · Medical University of South Carolina · National Institute on Alcohol Abuse and Alcoholism (NIAAA)
+147 more
· Mayo Clinic · University of Pennsylvania · National Institutes of Health (NIH) · University of Wisconsin, Madison · Duke University · M.D. Anderson Cancer Center · Albert Einstein College of Medicine · Centre for Addiction and Mental Health · Massachusetts General Hospital · Oyster Point Pharma, Inc. · VA Office of Research and Development · Brown University · Butler Hospital · Heart and Stroke Foundation of Ontario · Johns Hopkins University · Ottawa Heart Institute Research Corporation · Corxel Pharmaceuticals · Foundation for a Smoke Free World INC · Nathan Kline Institute for Psychiatric Research · National Heart, Lung, and Blood Institute (NHLBI) · Nikki Nollen, PhD, MA · Northwestern University · Queen Mary University of London · Rose Research Center, LLC · Roswell Park Cancer Institute · Shaare Zedek Medical Center · Stanley Medical Research Institute · Thomas Jefferson University · US Department of Veterans Affairs · University Health Network, Toronto · University of California, Los Angeles · University of California, San Diego · University of California, San Francisco · University of Kansas Medical Center · University of Michigan · University of Oklahoma · University of South Florida · Viatris Inc. · AAI Scientific Cultural Services Ltd (AAISCS) · ANRS, Emerging Infectious Diseases · Abramson Cancer Center at Penn Medicine · Alliance for Clinical Trials in Oncology · American University of Beirut Medical Center · Amsterdam UMC, location VUmc · Andalusian Public Foundation for Health Research in Seville · Andaluz Health Service · Aristotle University Of Thessaloniki · Arizona State University · Bob Allison Ataxia Research Center (BAARC) · Brandon Baartman · British Columbia Centre of Excellence for Women's Health · CTC Bio, Inc. · Canadian Institutes of Health Research (CIHR) · Canadian Tobacco Control Research Initiative · Centre for Human Drug Research, Netherlands · Chonbuk National University Hospital · Clínica Galatea · Colorado State University · Corporal Michael J. Crescenz VA Medical Center · European Commission · Friedreich's Ataxia Research Alliance · General Hospital of Kavala · Global Research Awards for Nicotine Dependence (GRAND) · Hospital Sant Rafael · Hospital Universitari Vall d'Hebron Research Institute · Hospital de Sant Pau · Inje University · Intelligent Automation, Inc. · Iowa City VA Health Care System · Iowa City Veterans Affairs Medical Center · Jeil Pharmaceutical Co., Ltd. · Johannes Gutenberg University Mainz · Josep Maria Ramon Torrell, PhD · Joseph Valentino, MD · all 153 on the full record

Regulatory milestones approvals, filings & regulatory actions · 11 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed dry eye syndrome 1 milestone
Filed	US (FDA)	—	dry eye syndrome	2023-06-13	“an applicant submitted an abbreviated new drug application (“ANDA”) seeking FDA approval for a generic to Tyrvaya® (varenicline solution) Nasal Spray” viatris.com ↗
Approved Indication not stated 3 milestones
Label expansions (8)	US (FDA)	CHANTIX	—	2011-07-22 – 2019-02-22	fda.gov ↗
Approved	EU (EMA)	Champix	—	2006-09-25	europa.eu ↗
Approved	US (FDA)	CHANTIX	—	2006-05-10	fda.gov ↗

Trials 206 · started per year

today

US approved 2006

EU approved 2006

200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 04 trials · 1 met primary
Phase 0	NCT06582888	Nov 2024 → Aug 2028 expected	nicotine dependence	University of California, San Diego	Recruiting	No outcome recorded
Phase 0	NCT04317300	Feb 2023	—	Mayo Clinic	Withdrawn	No outcome recorded
Phase 0	NCT03742154	Dec 2018 → Apr 2020	nicotine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 0	NCT03059940	Jun 2017 → Jun 2026 overdue	—	M.D. Anderson Cancer Center	Active not recruiting	Met primary
Phase 119 trials
Phase 1	NCT06854406	Jun → Nov 2025	irritable bowel syndrome	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT05576415	Dec 2022 → Apr 2023	dry eye syndrome	Corxel Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT04225052	Dec 2019 → Jan 2020	—	Yuhan Corporation	Completed	No outcome recorded
Phase 1	NCT04072146	Aug → Nov 2019	—	Oyster Point Pharma, Inc.	Completed	No outcome recorded
Phase 1	NCT04631874	Jul 2019 → May 2020	—	CTC Bio, Inc.	Completed	No outcome recorded
Phase 1	NCT03069768	Apr 2018 → Jan 2019	nicotine dependence	Duke University	Withdrawn	No outcome recorded
Phase 1	NCT03059563	Jan 2018 → Sep 2023	cognitive disorder, substance abuse	University of California, Los Angeles	Terminated	No outcome recorded
Phase 1	NCT03362008	Jul 2017	—	Jeil Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT04018378	Jan → May 2017	—	Korea University Anam Hospital	Completed	No outcome recorded
Phase 1	NCT02048917	Jul 2014 → May 2019	head and neck cancer, lung cancer	University of Kentucky	Completed	No outcome recorded
Phase 1	NCT01436474	Jun 2011 → Sep 2012	chronic pain syndrome, opiate dependence	Mayo Clinic	Completed	No outcome recorded
Phase 1	NCT01309685	Feb 2011 → Nov 2014	drug dependence	National Institute on Drug Abuse (NIDA)	Withdrawn	No outcome recorded
Phase 1	NCT01234142	Nov 2010 → Mar 2011	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01013454	Dec 2009	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00774605	Dec 2008	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00731562	Jul → Sep 2008	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00527150	Oct 2007 → Feb 2008	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00463918	May → Dec 2007	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT00452894	Mar 2007	—	Pfizer	Completed	No outcome recorded

Phase 1/25 trials · 1 met primary
Phase 1/2	NCT04525755	Feb 2021 → Apr 2025	nicotine dependence	Medical University of South Carolina	Completed	Met primary
Phase 1/2	NCT03035708	May 2017 → Jul 2018	alcohol-related disorders	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Completed	No outcome recorded
Phase 1/2	NCT02393547	Sep 2013 → Dec 2015	nicotine dependence	Mayo Clinic	Completed	No outcome recorded
Phase 1/2	NCT00695500	Jun 2008 → Jul 2014	alcohol-related disorders	Vijay Ramchandani, Ph.D.	Completed	No outcome recorded
Phase 1/2	NCT00580398	Jan 2008 → Apr 2012	lung cancer	Massachusetts General Hospital	Completed	No outcome recorded
Phase 247 trials · 6 met primary · 9 missed
Phase 2	NCT07099638	May 2026 → Jun 2029 expected	—	University of Oklahoma	Not yet recruiting	No outcome recorded
Phase 2	NCT07171112	Nov 2025 → Jul 2026	acute pancreatitis, chronic pancreatitis, nicotine dependence, recurrent acute pancreatitis	Mayo Clinic	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT07040566	Oct 2025 → Jul 2030 expected	nicotine dependence	Yale University	Recruiting	No outcome recorded
Phase 2	NCT06006143	Jun 2025 → Aug 2026 overdue	HIV infectious disease, alcohol-related disorders, nicotine dependence	Yale University	Active not recruiting	No outcome recorded
Phase 2	NCT06679374	Apr 2025 → Jan 2029 expected	Parkinson disease	Vikas Kotagal	Recruiting	No outcome recorded
Phase 2	NCT06780215	Feb → Sep 2025	—	Yihan Chen	Completed	Met primary
Phase 2	NCT05294263	Apr 2023 → Jul 2024	cannabis dependence, nicotine dependence	VA Office of Research and Development	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT05541497	Nov 2022 → Sep 2023	—	Yale University	Completed	Missed primary
Phase 2	NCT04634071	Jan 2021 → Jan 2026	cancer-related condition	Joseph Valentino, MD	Completed	No outcome recorded
Phase 2	NCT04198116	Nov 2020 → Apr 2025	—	Yale University	Completed	No outcome recorded
Phase 2	NCT03980561	Jan 2020 → Feb 2023	cannabis dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 2	NCT03722966	Jan 2020 → Feb 2022	—	University of Oklahoma	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04167306	Mar 2019 → Dec 2022	alcohol dependence	Vastra Gotaland Region	Completed	Met primary
Phase 2	NCT04403399	Jun 2017 → Jun 2019	Parkinson disease	University of Michigan	Completed	Missed primary
Phase 2	NCT02501265	Jun 2017 → Jul 2020	nicotine dependence	Duke University	Completed	Met primary
Phase 2	NCT02892110	Feb 2017 → Nov 2018	substance-related disorder	Medical University of South Carolina	Completed	No outcome recorded
Phase 2	NCT02723162	May 2016 → Mar 2020	nicotine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 2	NCT02933372	Oct 2015 → Jun 2019	Parkinson disease	University of Michigan	Completed	No outcome recorded
Phase 2	NCT02683161	Oct 2015 → Jul 2017	obesity disorder	Johns Hopkins University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT01806779	Mar 2013 → Dec 2014	nicotine dependence	Duke University	Completed	Met primary
Phase 2	NCT01680887	Aug 2012 → Jan 2018	cocaine dependence	University of Pennsylvania	Completed	Missed primary
Phase 2	NCT01365819	Feb 2012 → Aug 2014	amphetamine abuse, methamphetamine dependence	University of California, Los Angeles	Completed	Missed primary
Phase 2	NCT01341080	Dec 2010 → Nov 2018	Parkinson disease	Rush University Medical Center	Completed	Missed primary
Phase 2	NCT00741884	Aug 2010 → Aug 2011	—	Pfizer	Withdrawn	No outcome recorded
Phase 2	NCT01093365	Mar 2010 → Aug 2016	schizoaffective disorder, schizophrenia	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 2	NCT01071187	Mar 2010 → Sep 2011	alcohol dependence	Johannes Gutenberg University Mainz	Unknown	No outcome recorded
Phase 2	NCT01111149	Dec 2009 → Aug 2012	schizophrenia	University of Minnesota	Completed	Missed primary
Phase 2	NCT01000987	Oct 2009 → Nov 2016	—	Yale University	Completed	No outcome recorded
Phase 2	NCT00992771	Oct 2009 → Apr 2011	Machado-Joseph disease	University of South Florida	Completed	No outcome recorded
Phase 2	NCT00744978	Jul 2009 → Nov 2010	Alzheimer disease	Pfizer	Completed	Missed primary
Phase 2	NCT00906386	May → Oct 2009	—	Vancouver Coastal Health	Unknown	No outcome recorded
Phase 2	NCT00835900	Mar 2009 → Jul 2010	—	Roswell Park Cancer Institute	Completed	No outcome recorded
Phase 2	NCT00846859	Mar 2009 → Aug 2010	alcohol dependence	Sahlgrenska University Hospital	Completed	No outcome recorded
Phase 2	NCT00937235	Jan 2009 → Dec 2015	nicotine dependence, post-traumatic stress disorder	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT00860028	Oct 2008 → May 2010	alcohol abuse, nicotine dependence	Yale University	Completed	Missed primary
Phase 2	NCT00595868	Mar 2008 → Jan 2010	nicotine dependence	University of Vermont Medical Center	Completed	Missed primary
Phase 2	NCT00731055	Feb 2008 → May 2009	nicotine dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00773422	Jan 2008 → Nov 2016	—	Yale University	Completed	No outcome recorded
Phase 2	NCT00567008	Dec 2007 → Sep 2009	cocaine dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT00664755	Jul 2007 → Dec 2013	nicotine dependence	Medical University of South Carolina	Completed	Met primary
Phase 2	NCT00580645	Apr 2007 → Nov 2016	alcohol-related disorders	Yale University	Completed	No outcome recorded
Phase 2	NCT00580853	Apr 2007 → Oct 2016	—	Yale University	Completed	No outcome recorded
Phase 2	NCT00139750	Dec 2004 → Feb 2006	—	Pfizer	Completed	Met primary
Phase 2	NCT00635401	May → Aug 2004	—	Pfizer	Completed	No outcome recorded
Phase 2	NCT00150228	Dec 2001 → Sep 2002	—	Pfizer	Completed	No outcome recorded
Phase 2	NCT00150254	Sep 2001 → Oct 2002	—	Pfizer	Completed	No outcome recorded
Phase 2	NCT00150241	Feb 2000 → Jan 2002	—	Pfizer	Completed	No outcome recorded

Phase 2/310 trials · 1 met primary
Phase 2/3	NCT05413122	Nov 2023 → Aug 2027 expected	HIV infectious disease	Johns Hopkins University	Recruiting	No outcome recorded
Phase 2/3	NCT04501016	Sep 2020 → Aug 2021 overdue	nicotine dependence	Iowa City Veterans Affairs Medical Center	Not yet recruiting	No outcome recorded
Phase 2/3	NCT04210180	Nov 2019 → Oct 2020	—	Rose Research Center, LLC	Completed	No outcome recorded
Phase 2/3	NCT03521141	May 2018 → Apr 2019	nicotine dependence	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 2/3	NCT02854800	Jul 2016 → Apr 2017	opiate dependence	West Virginia University	Completed	No outcome recorded
Phase 2/3	NCT01531049	May 2012 → Dec 2015	—	Tuula Toljamo	Completed	No outcome recorded
Phase 2/3	NCT00803868	May 2009 → May 2010	Friedreich ataxia	University of South Florida	Terminated	No outcome recorded
Phase 2/3	NCT01141855	May 2008 → Dec 2011	nicotine dependence	The Queen Elizabeth Hospital	Completed	Met primary
Phase 2/3	NCT01092702	Apr → Sep 2008	nicotine dependence	Mayo Clinic	Completed	No outcome recorded
Phase 2/3	NCT00507728	Dec 2005 → Dec 2019	nicotine dependence	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 331 trials · 10 met primary · 7 missed
Phase 3	NCT06883162	May 2025 → Sep 2028 expected	cannabis dependence, nicotine dependence	Medical University of South Carolina	Recruiting	No outcome recorded
Phase 3	NCT05786547	Jan 2024 → Jul 2026 overdue	HIV infectious disease, nicotine dependence	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 3	NCT05703672	Jul 2023 → Dec 2026 expected	—	University of Kansas Medical Center	Recruiting	No outcome recorded
Phase 3	NCT05378945	Jul 2022 → Apr 2023	dry eye syndrome	Corxel Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT05082974	Oct 2021 → Aug 2022	dry eye syndrome	Vance Thompson Vision ND	Completed	No outcome recorded
Phase 3	NCT05045508	Aug 2021 → Aug 2022	dry eye syndrome	Brandon Baartman	Unknown	No outcome recorded
Phase 3	NCT04590404	Nov 2020 → May 2024	—	Vanderbilt-Ingram Cancer Center	Completed	Missed primary
Phase 3	NCT04176172	Feb 2020 → Nov 2026 expected	HIV infectious disease, nicotine dependence	Abramson Cancer Center at Penn Medicine	Active not recruiting	No outcome recorded
Phase 3	NCT03897439	May 2019 → Nov 2021	—	University of Kansas Medical Center	Completed	Missed primary
Phase 3	NCT03262662	Oct 2017 → Apr 2021	nicotine dependence	State University of New York at Buffalo	Completed	Missed primary
Phase 3	NCT02856581	Sep 2017 → May 2021	lung carcinoma	Alliance for Clinical Trials in Oncology	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01756885	Jan 2013 → May 2018	nicotine dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 3	NCT01694732	Aug 2012 → Nov 2015	chronic obstructive pulmonary disease	University Hospital, Brest	Completed	Missed primary
Phase 3	NCT01509547	Aug 2012 → Jan 2018	nicotine dependence	Medical University of South Carolina	Completed	Missed primary
Phase 3	NCT01206010	Jul 2011 → Nov 2012	nicotine dependence	Queen Mary University of London	Completed	No outcome recorded
Phase 3	NCT01169610	Jan 2011 → Jun 2013	alcohol dependence, nicotine dependence	Mayo Clinic	Terminated	No outcome recorded
Phase 3	NCT01162239	May 2010 → Jun 2016	nicotine dependence	University of California, San Francisco	Completed	No outcome recorded
Phase 3	NCT00918307	Oct 2009 → Jan 2014	HIV infectious disease, nicotine dependence	ANRS, Emerging Infectious Diseases	Completed	Met primary
Phase 3	NCT00794573	Sep 2009 → Jun 2015	acute coronary syndrome	Mark Eisenberg	Completed	Met primary
Phase 3	NCT00789074	Jul → Dec 2009	nicotine dependence	Queen Mary University of London	Completed	Missed primary
Phase 3	NCT00523445	Sep 2007 → Jun 2009	schizophrenia	Inje University	Completed	Missed primary
Phase 3	NCT00587769	Jul 2007 → Jul 2008	nicotine dependence	Mayo Clinic	Completed	No outcome recorded
Phase 3	NCT00371813	Sep 2006 → Jun 2007	—	Pfizer	Completed	Met primary
Phase 3	NCT00285012	May 2006 → Jul 2008	—	Pfizer	Completed	Met primary
Phase 3	NCT00282984	Feb 2006 → Nov 2007	—	Pfizer	Completed	Met primary
Phase 3	NCT00141167	Feb 2005 → Jan 2006	—	Pfizer	Completed	Met primary
Phase 3	NCT00143325	Jan 2005 → Jun 2006	—	Pfizer	Completed	Met primary
Phase 3	NCT00143299	Oct 2003 → Mar 2005	—	Pfizer	Completed	No outcome recorded
Phase 3	NCT00143364	Jun 2003 → Mar 2005	—	Pfizer	Completed	Met primary
Phase 3	NCT00141206	May 2003 → Apr 2005	—	Pfizer	Completed	Met primary
Phase 3	NCT00143286	Apr 2003 → Mar 2005	—	Pfizer	Completed	Met primary

Phase 467 trials · 11 met primary · 7 missed
Phase 4	NCT07835555	Sep 2027 → Sep 2030 expected	HIV infectious disease, nicotine dependence	Yale University	Not yet recruiting	No outcome recorded
Phase 4	NCT06966362	Aug 2026 → Jun 2030 expected	nicotine dependence	VA Office of Research and Development	Recruiting	No outcome recorded
Phase 4	NCT07606625	Mar → Dec 2026 expected	dry eye syndrome	University of California, Berkeley	Recruiting	No outcome recorded
Phase 4	NCT06688539	Feb 2025 → Mar 2027 expected	nicotine dependence	Medical University of South Carolina	Recruiting	No outcome recorded
Phase 4	NCT06029907	Jul 2024 → Aug 2025	—	Duke University	Completed	No outcome recorded
Phase 4	NCT06218823	Mar 2024 → Aug 2025	cancer	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT04088942	Jul 2023 → Jan 2026	chronic obstructive pulmonary disease	Pradeesh Sivapalan	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT05700422	May → Aug 2023	Sjogren syndrome, dry eye syndrome	University of Pennsylvania	Completed	No outcome recorded
Phase 4	NCT05514041	Oct 2022 → Dec 2023	dry eye syndrome	Stephenson Eye Associates	Completed	No outcome recorded
Phase 4	NCT05367492	Jun 2022 → Mar 2024	nicotine dependence	Massachusetts General Hospital	Completed	Met primary
Phase 4	NCT05277207	May 2022 → Sep 2023	nicotine dependence	VA Office of Research and Development	Completed	No outcome recorded
Phase 4	NCT04191278	Nov 2021 → Jul 2022	AIDS	Duke University	Withdrawn	No outcome recorded
Phase 4	NCT04602494	Dec 2020 → Jun 2022	nicotine dependence	Massachusetts General Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04604509	Aug 2020 → Dec 2028 expected	—	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 4	NCT04490057	Jul 2020 → Oct 2024	nicotine dependence	Yale University	Completed	Missed primary
Phase 4	NCT04199117	Mar 2020 → Oct 2024	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT04228965	Jan 2020 → Jun 2024	nicotine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 4	NCT04135937	Nov 2019 → Jul 2021	HIV infectious disease	VA Office of Research and Development	Completed	No outcome recorded
Phase 4	NCT02894957	Oct → Dec 2019	—	Shaare Zedek Medical Center	Unknown	Met primary
Phase 4	NCT04011280	Aug 2019 → Mar 2022	bipolar disorder, nicotine dependence, schizoaffective disorder, schizophrenia	University of California, San Diego	Completed	No outcome recorded
Phase 4	NCT04188106	Jun → Dec 2019	sleep disorder	Rose Research Center, LLC	Completed	No outcome recorded
Phase 4	NCT03495024	Jan 2019 → Apr 2020 overdue	nicotine dependence, parkinsonian disorder, schizoaffective disorder, schizophrenia +1	Corporal Michael J. Crescenz VA Medical Center	Recruiting	No outcome recorded
Phase 4	NCT03809897	Jan 2019 → Apr 2020	nicotine dependence	Hospital Universitari Vall d'Hebron Research Institute	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT03365362	Oct 2018 → Nov 2023	nicotine dependence, opiate dependence	Albert Einstein College of Medicine	Completed	No outcome recorded
Phase 4	NCT03557294	May 2018 → Apr 2022	nicotine dependence, substance withdrawal syndrome	Arizona State University	Completed	No outcome recorded
Phase 4	NCT02859142	Mar 2018 → Sep 2020	alcohol-related disorders	University of Chicago	Completed	Met primary
Phase 4	NCT03176784	Nov 2017 → Jul 2020	nicotine dependence	University of Wisconsin, Madison	Completed	Missed primary
Phase 4	NCT02575183	Aug 2016 → Mar 2021	nicotine dependence	American University of Beirut Medical Center	Completed	No outcome recorded
Phase 4	NCT02147132	Mar 2016 → Aug 2017	—	University of Cincinnati	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02681510	Feb → Jun 2016	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT02634281	Feb 2016 → Jun 2018	—	Shaare Zedek Medical Center	Completed	Met primary
Phase 4	NCT02162849	Dec 2015 → Feb 2028 expected	nicotine dependence	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
Phase 4	NCT02562521	Sep 2015 → Dec 2016	—	Yale University	Completed	No outcome recorded
Phase 4	NCT02360631	Jul 2015 → Jul 2018	—	Lisa Sanderson Cox, PhD	Completed	Met primary
Phase 4	NCT02378714	Jul 2015 → Mar 2020	major depressive disorder, nicotine dependence	Northwestern University	Completed	Mixed
Phase 4	NCT02271919	May 2015 → Jun 2025	nicotine dependence	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 4	NCT04595318	Jan → Jul 2015	cannabis dependence, nicotine dependence	Albert Einstein College of Medicine	Completed	No outcome recorded
Phase 4	NCT02473562	May 2013 → Jan 2018	Parkinson disease	Amsterdam UMC, location VUmc	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01836276	Feb 2013 → Apr 2017	—	Nikki Nollen, PhD, MA	Completed	No outcome recorded
Phase 4	NCT01574703	May 2012 → Jul 2015	—	Pfizer	Completed	No outcome recorded
Phase 4	NCT01553084	May 2012 → Nov 2015	nicotine dependence	University of Wisconsin, Madison	Completed	Missed primary
Phase 4	NCT02922387	May 2012 → May 2015	asthma, chronic obstructive pulmonary disease	General Hospital of Kavala	Completed	No outcome recorded
Phase 4	NCT01538394	Jan 2012 → Jun 2013	—	Josep Maria Ramon Torrell, PhD	Completed	Missed primary
Phase 4	NCT01312909	Apr 2011 → Jan 2018	—	Pfizer	Completed	Missed primary
Phase 4	NCT01244061	Dec 2010 → Nov 2012	—	Pfizer	Completed	Met primary
Phase 4	NCT01623505	Jun 2010 → Jun 2014	psychiatric disorder	Ottawa Heart Institute Research Corporation	Completed	Missed primary
Phase 4	NCT01078298	Mar 2010 → Jun 2012	depressive disorder	Pfizer	Completed	Met primary
Phase 4	NCT01010204	Jan 2010 → Mar 2013	bipolar disorder	K.N. Roy Chengappa	Completed	Met primary
Phase 4	NCT00962988	Dec 2009 → Apr 2015	cerebrovascular disorder	Ottawa Heart Institute Research Corporation	Completed	No outcome recorded
Phase 4	NCT00889720	Nov 2009 → Jul 2010	—	Pfizer	Completed	No outcome recorded
Phase 4	NCT01027754	Aug 2009 → Sep 2011	substance-related disorder	Albert Einstein College of Medicine	Completed	Met primary
Phase 4	NCT00879177	Apr 2009 → Aug 2014	hypertensive disorder	UConn Health	Completed	No outcome recorded
Phase 4	NCT00907218	Apr 2009 → May 2010	attention deficit-hyperactivity disorder	Massachusetts General Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00959972	Apr 2009 → Nov 2010	coronary artery disorder	Ottawa Heart Institute Research Corporation	Completed	No outcome recorded
Phase 4	NCT00828113	Jan 2009 → Sep 2010	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT00948155	Jan 2009 → Nov 2010	nicotine dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 4	NCT00944554	Oct 2008 → May 2011	substance-related disorder	Johns Hopkins University	Completed	No outcome recorded
Phase 4	NCT00802919	Sep 2008 → Dec 2013	schizophrenia	Nathan Kline Institute for Psychiatric Research	Completed	No outcome recorded
Phase 4	NCT00691483	Sep 2008 → Sep 2009	—	Pfizer	Completed	Met primary
Phase 4	NCT00749944	Sep 2008 → Jul 2009	—	Pfizer	Completed	Missed primary
Phase 4	NCT00717093	Aug 2008 → Apr 2009	nicotine dependence	Pfizer	Completed	Met primary
Phase 4	NCT00937508	Jun 2008 → Jul 2010	—	University Health Network, Toronto	Unknown	No outcome recorded
Phase 4	NCT00702793	Apr 2008 → May 2012	schizoaffective disorder, schizophrenia	University of British Columbia	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT01170338	Jan 2008 → Jul 2011	acute coronary syndrome	Newark Beth Israel Medical Center	Unknown	No outcome recorded
Phase 4	NCT00548470	Jun 2007 → Sep 2009	nicotine dependence, schizophrenia	Nathan Kline Institute for Psychiatric Research	Completed	No outcome recorded
Phase 4	NCT00492349	May 2007 → May 2010	schizoaffective disorder, schizophrenia, schizophreniform disorder	University of Maryland, Baltimore	Completed	Mixed
Phase 4	NCT00781755	—	nicotine dependence	VA Boston Healthcare System	Withdrawn	No outcome recorded

Phase not applicable23 trials · 2 met primary
—	NCT07705893	Aug → Dec 2026 expected	dry eye syndrome	Ocular Aesthetics, LLC dba Ocular Clinical Trials	Not yet recruiting	No outcome recorded
—	NCT04694846	Aug 2020 → Aug 2024	head and neck squamous cell carcinoma, non-small cell lung carcinoma	Thomas Jefferson University	Completed	No outcome recorded
—	NCT04190966	Jan 2020 → Jul 2021	—	University of Birmingham	Unknown	No outcome recorded
—	NCT02991781	Jan 2017 → Jun 2019	asthma, chronic obstructive pulmonary disease	Aristotle University Of Thessaloniki	Completed	No outcome recorded
—	NCT02994082	Dec 2016 → Sep 2019	nicotine dependence	Mark Vander Weg	Unknown	No outcome recorded
—	NCT03553173	Oct 2016 → Oct 2018	—	Andalusian Public Foundation for Health Research in Seville	Completed	No outcome recorded
—	NCT02146911	May 2014 → Dec 2016	nicotine dependence	Centre for Addiction and Mental Health	Completed	Met primary
—	NCT01926041	Aug 2013 → Dec 2020 overdue	diabetes mellitus, prediabetes syndrome	National Taiwan University Hospital	Active not recruiting	Met primary
—	NCT01511614	May 2013 → Mar 2020	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
—	NCT01898195	Mar 2013 → Dec 2014	nicotine dependence	NYU Langone Health	Completed	No outcome recorded
—	NCT01771627	Oct 2012 → Sep 2014	nicotine dependence	Roswell Park Cancer Institute	Completed	No outcome recorded
—	NCT01632189	Sep 2012 → Aug 2015	nicotine dependence	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT01378858	Jul 2011 → Jul 2015	nicotine dependence	Albert Einstein College of Medicine	Completed	No outcome recorded
—	NCT01320462	Dec 2010 → Apr 2017	—	University Health Network, Toronto	Completed	No outcome recorded
—	NCT01011907	Jan 2010 → Jul 2011	substance dependence	University of California, San Francisco	Completed	No outcome recorded
—	NCT01093937	Nov 2009 → Feb 2011	nicotine dependence	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT00934024	Apr 2009 → Jan 2012	nicotine dependence	Medical University of South Carolina	Completed	No outcome recorded
—	NCT00813800	Jan 2009 → Jan 2011	bipolar disorder, depressive disorder	Mark Frye	Completed	No outcome recorded
—	NCT00781599	Oct 2008 → Mar 2010	—	Nikki Nollen, PhD, MA	Completed	No outcome recorded
—	NCT00790569	Sep 2008 → Oct 2012	cervical cancer, esophageal cancer, gastric cancer, head and neck cancer +7	Butler Hospital	Completed	No outcome recorded
—	NCT00525928	Oct 2007 → Oct 2008	depressive disorder	Butler Hospital	Withdrawn	No outcome recorded
—	NCT00525837	Sep 2007 → Mar 2008	depressive disorder	Butler Hospital	Completed	No outcome recorded
—	NCT00606892	Aug 2007 → Nov 2008	—	Yale University	Completed	No outcome recorded

Comparator or background therapy119 trials
Phase 0	NCT02582008 Comparator	Jan 2016 → Oct 2018	hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, nasopharyngeal carcinoma, oral cavity squamous cell carcinoma +1	Wake Forest University Health Sciences	Terminated	No outcome recorded Stop: Enrollment
Phase 0	NCT02202499 Comparator	Jul 2014 → Dec 2015	nicotine dependence	H. Lee Moffitt Cancer Center and Research Institute	Completed	No outcome recorded
Phase 0	NCT02193256 Comparator	Jul 2014 → Jan 2015	alcohol-related disorders	Yale University	Completed	No outcome recorded
Phase 0	NCT01098955 Background	Mar 2010 → Sep 2027 expected	head and neck cancer	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
Phase 0	NCT00931021 Comparator	Jul 2009 → Dec 2012	—	Yale University	Terminated	No outcome recorded
Show all 119 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 13

Date	Issuer	Release
2023-12-06	Lupin Limited	Regulatory Lupin Receives Approval from U.S. FDA for Varenicline Tablets lupin.com ↗
2023-06-13	Zydus Lifesciences Limited	Regulatory Zydus receives final approval from the USFDA for Varenicline Tablets zyduslife.com ↗ Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg (USRLD: Chantix® Tablets).
2023-06-13	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Regulatory Viatris Statement Regarding Submission of Application Seeking Approval for a Generic to Tyrvaya® viatris.com ↗ Viatris has received notice that an applicant submitted an abbreviated new drug application (“ANDA”) seeking FDA approval for a generic to Tyrvaya® (varenicline solution) Nasal Spray, with Paragraph IV certifications to the six patents currently listed in FDA’s Orange Book.
2023-05-02	Kriya Therapeutics, Inc.	Results Kriya to Present 10 Abstracts at the 2023 American Society of Gene and Cell Therapy Annual Meeting kriyatx.com ↗ AAV Mediated Expression of a Chimeric Ion Channel in Combination with its Ligand Varenicline Demonstrates a Dose Response Improvement in Pain Hypersensitivity in a Rat Model of Trigeminal Pain
2021-03-25	Achieve Life Sciences	Results Achieve Announces Publication of the RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix(R) (varenicline) in Addiction achievelifesciences.com ↗ Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline
2020-09-18	Achieve Life Sciences	Results Achieve Life Sciences Announces Results from Evaluation of Cytisinicline (cytisine) versus Chantix® (varenicline) in 5-HT3 Receptor Binding Assay Study achievelifesciences.com ↗ Using a radioligand antagonist displacement design, the study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.
2020-09-18	Achieve Life Sciences	Results Achieve Announces Presentation of Investigator-Led RAUORA Trial Data Demonstrating Significantly Fewer Side Effects with Higher Quit Rates for Cytisinicline (cytisine) Compared to Chantix® (varenicline) in First Head-to-Head Comparative Study achievelifesciences.com ↗ Specifically, continuous abstinence rates at 6 months, verified by exhaled carbon monoxide, were 12.1% for cytisinicline compared to 7.9% for varenicline.
2020-06-29	Achieve Life Sciences	Results Achieve Announces Successful Results from the Investigator-Initiated RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) as a Treatment to Quit Smoking achievelifesciences.com ↗ The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months.
2018-03-23	Pfizer	Results Pfizer Reports Top-Line Results from a Study of CHANTIX®/CHAMPIX® (varenicline) in Adolescent Smokers pfizer.com ↗ The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 for CHANTIX/CHAMPIX compared to placebo.
2016-12-16	Pfizer	Regulatory FDA Approves Removal Of Boxed Warning Regarding Serious Neuropsychiatric Events From CHANTIX® (varenicline) Labeling pfizer.com ↗ Pfizer announced today that the U.S. Food and Drug Administration (FDA) approved updates to the CHANTIX ® (varenicline) labeling, including removal of the boxed warning regarding serious neuropsychiatric events.
2016-09-14	Pfizer	Regulatory FDA Advisory Committees Recommend to Remove Boxed Warning in Labeling for Pfizer’s Smoking Cessation Therapy, CHANTIX® (varenicline) pfizer.com ↗ The Committees recommended by a majority vote to remove the boxed warning regarding serious neuropsychiatric adverse events from the CHANTIX labeling.
2016-05-23	Pfizer	Regulatory CHAMPIX® (varenicline) European Union Label Updated to Include New Safety and Efficacy Data from the EAGLES Clinical Trial Following Endorsement from CHMP pfizer.com ↗ The CHAMPIX EU label update was implemented following the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
2016-04-22	Pfizer	Results CHANTIX®/CHAMPIX® (varenicline) Results from the Largest Global Clinical Trial of Smoking Cessation Medicines Published in The Lancet pfizer.com ↗ The authors concluded that the trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with CHANTIX/CHAMPIX or bupropion compared to placebo and nicotine patch.

All press releases naming this drug 18 releases

Date	Issuer	Release
2026-10-05	Harrow Inc	Harrow Closes Acquisition of TYRVAYA® harrow.com ↗
2026-08-06	Harrow Inc	Harrow Acquires Global Rights to TYRVAYA®, the First and Only FDA-Approved Nasal Spray for Dry Eye Disease harrow.com ↗
2025-02-05	Alfred E. Tiefenbacher (GmbH & Co. KG)	Tiefenbacher Pharmaceuticals Launch: Varenicline in UK tiefenbacher-pharmaceuticals.com ↗
2024-08-22	Alfred E. Tiefenbacher (GmbH & Co. KG)	Tiefenbacher Pharmaceuticals First to Market Launch: Varenicline in Europe tiefenbacher-pharmaceuticals.com ↗
2024-01-10	Lupin Limited	Lupin Launches Varenicline Tablets in the United States lupin.com ↗
2023-12-06	Lupin Limited	Lupin Receives Approval from U.S. FDA for Varenicline Tablets lupin.com ↗
2023-06-13	Zydus Lifesciences Limited	Zydus receives final approval from the USFDA for Varenicline Tablets zyduslife.com ↗
2023-06-13	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Viatris Statement Regarding Submission of Application Seeking Approval for a Generic to Tyrvaya® viatris.com ↗
2023-05-02	Kriya Therapeutics, Inc.	Kriya to Present 10 Abstracts at the 2023 American Society of Gene and Cell Therapy Annual Meeting kriyatx.com ↗
2021-03-25	Achieve Life Sciences	Achieve Announces Publication of the RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix(R) (varenicline) in Addiction achievelifesciences.com ↗
2020-09-18	Achieve Life Sciences	Achieve Life Sciences Announces Results from Evaluation of Cytisinicline (cytisine) versus Chantix® (varenicline) in 5-HT3 Receptor Binding Assay Study achievelifesciences.com ↗
2020-09-18	Achieve Life Sciences	Achieve Announces Presentation of Investigator-Led RAUORA Trial Data Demonstrating Significantly Fewer Side Effects with Higher Quit Rates for Cytisinicline (cytisine) Compared to Chantix® (varenicline) in First Head-to-Head Comparative Study achievelifesciences.com ↗
2020-06-29	Achieve Life Sciences	Achieve Announces Successful Results from the Investigator-Initiated RAUORA Head-to-Head Non-Inferiority Clinical Trial Comparing Cytisinicline and Chantix® (varenicline) as a Treatment to Quit Smoking achievelifesciences.com ↗
2018-03-23	Pfizer	Pfizer Reports Top-Line Results from a Study of CHANTIX®/CHAMPIX® (varenicline) in Adolescent Smokers pfizer.com ↗
2016-12-16	Pfizer	FDA Approves Removal Of Boxed Warning Regarding Serious Neuropsychiatric Events From CHANTIX® (varenicline) Labeling pfizer.com ↗
2016-09-14	Pfizer	FDA Advisory Committees Recommend to Remove Boxed Warning in Labeling for Pfizer’s Smoking Cessation Therapy, CHANTIX® (varenicline) pfizer.com ↗
2016-05-23	Pfizer	CHAMPIX® (varenicline) European Union Label Updated to Include New Safety and Efficacy Data from the EAGLES Clinical Trial Following Endorsement from CHMP pfizer.com ↗
2016-04-22	Pfizer	CHANTIX®/CHAMPIX® (varenicline) Results from the Largest Global Clinical Trial of Smoking Cessation Medicines Published in The Lancet pfizer.com ↗

Evidence & citations 26 cited values

Every value below carries the sentence it was read from. 333 sources stand behind the page.

Field	Value	Cited text
Known as	Varenicline	“Participants in this group will receive a 12-week supply of varenicline. Treatment will begin 2 weeks before the target quit date and continue for 10 weeks after the target quit date.” NCT01623505 ↗ 314 “Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily).” NCT04501016 ↗ “The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo.” NCT02575183 ↗ “Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes” NCT04190966 ↗ “Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.” NCT03059940 ↗ “Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement” NCT00571805 ↗ “Varenicline prescribed for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.” NCT04088942 ↗ “All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)” NCT01106456 ↗ “Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.” NCT05277207 ↗ “Nicotine Replacement Therapy (nicotine patch), Varenicline, or Bupropion” NCT04035603 ↗ “Those receiving Augmented Treatment will receive varenicline.” NCT02859142 ↗ Show 304 more sources
Known as	Champix	“Our previous smoking cessation trials have established varenicline (Champix) as the "gold standard" for patients with CVD.” NCT05257629 ↗ 12 “Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg).” PMID 30522992 ↗ Dec 2018 “Varenicline tartrate (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks.” NCT02146911 ↗ “Varenicline, Champix® 0.50 mg tablets Posology of vareniclin follows varenicline's monograph.” NCT03630614 ↗ “Varenicline (Champix)” NCT00832806 ↗ “Varenicline (Champix)” NCT06832085 ↗ “Varenicline (Champix;” NCT01623505 ↗ “Varenicline (Champix)” NCT04015414 ↗ “Champix” NCT07596485 ↗ NCT01141855 ↗ NCT04631874 ↗ Show 2 more sources
Known as	Champix (varenicline)	“Champix (varenicline)” NCT02307045 ↗
Known as	Chantix	“This study will conduct a real-world clinic-based smoking cessation trial examining the augmentation strategy of Chantix (Varenicline Tartrate), nicotine patch, and behavioral...” NCT02859142 ↗ 26 “The Study to Evaluate the Relative Bioavailability of Varenicline Administered as OC-01 (Varenicline) Nasal Spray as Compared to Varenicline Administered Orally as Chantix (ZEN...” PMID 34456060 ↗ Aug 2021 “This is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who...” NCT00781755 ↗ “The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of...” NCT06883162 ↗ “The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch.” NCT02501265 ↗ “Varenicline (Chantix) is an FDA-approved partial agonist at α4β2 and α6β2 nAChRs with documented efficacy in the management of chronic pain associated with opioid withdrawal” NCT06854406 ↗ “The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo.” NCT02575183 ↗ “The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.” NCT03557294 ↗ “This study will examine cocaine-derived reinforcement under week-long sub-chronic varenicline (Chantix) dosing, and under placebo conditions.” NCT01143857 ↗ “Safety and Efficacy of the Novel Selective Nicotinic Receptor Partial Agonist, CHANTIX (Varenicline) in Patients With Acute Coronary Syndrome” NCT01170338 ↗ “Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA) to help people stop smoking.” NCT01309685 ↗ Show 16 more sources
Known as	CP-526, 555-18	“varenicline tartrate (CP-526, 555-18)” NCT00594204 ↗
Known as	CP-526,555	“A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal...” NCT00774605 ↗ 10 “A Phase 1, Open-Label, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Delivery System Applied To The Skin Of Adult Smokers” NCT01013454 ↗ “A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation” NCT00143299 ↗ “Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation” NCT00143364 ↗ “varenicline (CP-526,555)” NCT00143286 ↗ “CP-526,555 (varenicline)” NCT00150254 ↗ “varenicline (CP-526,555)” NCT00143325 ↗ “varenicline (CP-526,555)” NCT00141206 ↗ NCT00139750 ↗ NCT00150241 ↗ NCT00150228 ↗
Known as	HGP1604	“varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.” NCT04018378 ↗
Known as	HIP1502	“varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.” NCT04018378 ↗
Known as	OC-01	“Varenicline is a small-molecule nicotinic acetylcholine receptor agonist recently approved for use as a preservative-free nasal spray (OC-01 [varenicline solution] nasal spray...” PMID 35653029 ↗ Jun 2022 7 “PURPOSE: To estimate the systemic bioavailability of OC-01 (varenicline) nasal spray, an investigational treatment for dry eye disease, relative to oral varenicline approved...” PMID 34456060 ↗ Aug 2021 “OC-01 (varenicline 0.6mg/ml) nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of Drye Eye Disease.” NCT05082974 ↗ “OC-01 (varenicline solution) 0.03 mg nasal spray” NCT05700422 ↗ “OC-01 (varenicline solution) nasal spray 0.03 mg” NCT05514041 ↗ “OC-01 (varenicline) nasal spray” NCT03920215 ↗ “OC-01 (varenicline) nasal spray” NCT04036292 ↗ “OC-01 (varenicline) nasal spray” NCT03636061 ↗
Known as	OC-01 (varenicline solution) Nasal Spray	“OC-01 (varenicline solution) Nasal Spray” NCT05576415 ↗ 1 “OC-01 (varenicline solution) Nasal Spray” NCT05378945 ↗
Known as	OC-01 VNS	“Varenicline is a small-molecule nicotinic acetylcholine receptor agonist recently approved for use as a preservative-free nasal spray (OC-01 [varenicline solution] nasal spray...” PMID 35653029 ↗ Jun 2022
Known as	TYRVAYA	“Varenicline solution nasal spray (TYRVAYA®; Oyster Point Pharmaceuticals, Princeton, NJ) is FDA approved for the treatment of signs and symptoms of dry eye disease.” PMID 37096956 ↗ Apr 2023 1 NCT07705893 ↗
Known as	VAR	“Participants will be randomly assigned to a varenicline (VAR) treatment or placebo group by the Semel Institute Statistic Unit.” NCT03059563 ↗ 2 “Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows.” NCT00756275 ↗ “Varenicline (VAR)” NCT07099638 ↗
Known as	varencline	“Drug: varencline” NCT00571805 ↗
Known as	Varenicline (Champix)	“Varenicline (Champix)” NCT01926041 ↗
Known as	Varenicline (Chantix)	“Varenicline (Chantix®)” NCT00944554 ↗
Known as	varenicline free base	“Drug: varenicline free base” NCT00661765 ↗ 1 “varenicline free base patch” NCT01234142 ↗
Known as	varenicline oxalate	“varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.” NCT04018378 ↗
Known as	Varenicline tartrate	“In a randomized 1:1 allocation varenicline tartrate 1 mg twice daily, given in an incremental dosage for the first week before target quit date (TQD), will be compared to...” NCT01444131 ↗ 12 “The goal of this study is to evaluate if KRIYA-748 (RP-008) is safe, tolerable, and preliminary effective in treating trigeminal neuralgia (TN) when used in combination with...” NCT07596485 ↗ “Varenicline tartrate, a novel, selective, nicotinic acetylcholine receptor partial agonist, has been developed specifically as a smoking cessation drug.” PMID 19192221 ↗ Feb 2009 “varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.” NCT04018378 ↗ “the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation” NCT01387425 ↗ “CDFF0318: Varenicline salt changed Champix: Varenicline tartrate” NCT04631874 ↗ “varenicline tartrate (CP-526, 555-18)” NCT00594204 ↗ “Varenicline Tartrate Nasal Spray” NCT05378945 ↗ “Drug: Varenicline Tartrate” NCT03235505 ↗ “Drug: Varenicline Tartrate” NCT00717093 ↗ “Drug: varenicline tartrate” NCT00661765 ↗ Show 2 more sources
Known as	VCN	“Varying oral doses of Varenicline (VCN), starting with very low doses, will be administered to participants” NCT02933372 ↗
Known as	VNS	“PURPOSE: We evaluated the efficacy of varenicline solution nasal spray (VNS) in treating dry eye disease (DED) associated with moderate to severe Sjogren's disease and analyzed...” PMID 40166690 ↗ Mar 2025 1 “varenicline solution nasal spray (VNS) within the context of clinical trial discontinuation” PMID 37096956 ↗ Apr 2023
Known as	VRN	“Varenicline (VRN)” NCT02723162 ↗
Action	Activate	“a novel alpha4beta2 nicotinic acetylcholine receptor partial agonist” PMID 17692719 ↗ Jun 2007
Modality	Small molecule	“Varenicline is a small-molecule nicotinic acetylcholine receptor agonist” PMID 35653029 ↗ Jun 2022
Route	Oral	“orally for 12 weeks” PMID 16820546 ↗ Jul 2006
Target	CHRNA4	“The gene CHRNA4 is an important gene for anti-smoking pharmacogenetics studies because they encode the alpha 4 beta 2 subunits of acetylcholine- nicotinic receptors ( which is...” NCT03362099 ↗