Varenicline clinical trials
Also written Chantix, Champix and CP-526555.
Includes 1 study of Varenicline oxalate.
How each study uses Varenicline is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Get an email when these change. Save the Varenicline studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
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Approvals
The first approval found in each region, with its record
- United States
- 10 May 2006 · CHANTIX · NDA 021928 (FDA, Drugs@FDA)
- European Union
- 25 Sept 2006 · Champix · EMEA/H/C/000699 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
253 studies that test it; most in 2008 (29)
| Year | Studies |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2003 | 4 |
| 2004 | 2 |
| 2005 | 4 |
| 2006 | 3 |
| 2007 | 21 |
| 2008 | 29 |
| 2009 | 27 |
| 2010 | 16 |
| 2011 | 22 |
| 2012 | 14 |
| 2013 | 9 |
| 2014 | 3 |
| 2015 | 9 |
| 2016 | 10 |
| 2017 | 11 |
| 2018 | 8 |
| 2019 | 13 |
| 2020 | 9 |
| 2021 | 6 |
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 6 |
| 2025 | 8 |
| 2026 | 6 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 45 · Other 209
Pfizer (32) · Yale University (16) · University of Pennsylvania (14) · Medical University of South Carolina (12) · Mayo Clinic (12) · Centre for Addiction and Mental Health (9) · Duke University (7) · University of Wisconsin, Madison (6)
Often tested with
Tested in the same studies.
Bupropion (20) · Nicotine (19) · Nicotine Patch (10) · Nicotine Replacement (10) · Bupropion Hydrochloride Controlled-release (4) · Naltrexone (3) · Cytisine (3) · Nicotine Chewing Gum (3)
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 7, 2 in phase 3
Studies that test Varenicline, phase 3 first.
- Dec 2026Switching to E-cigarettes in Smokers Not Interested in QuittingPhase 3 · University of Kansas Medical Center
- Aug 2027Evaluating Smoking Cessation Interventions for PWH in South AfricaPhase 2/3 · Johns Hopkins University
- Dec 2026Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mgNot applicable · Ocular Aesthetics, LLC dba Ocular Clinical Trials
- Dec 2026Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye TreatmentPhase 4 · University of California, Berkeley
- Feb 2027Botswana Smoking and Abstinence Reinforcement TrialPhase 4 · University of Maryland, Baltimore
- Mar 2027E-cigarette Cessation in Adults Who Co-use CannabisPhase 4 · Medical University of South Carolina
- Apr 2027Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking CessationPhase 4 · Ottawa Heart Institute Research Corporation
Studies
Open first, then newest update. How each study uses Varenicline is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 254
- RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal NeuralgiaRecruitingPhase 1/2Kriya Therapeutics, Inc.NCT07596485Written as Varenicline tartrate
- Varenicline for Smoking Cessation in PancreatitisNot yet recruitingPhase 4Mayo ClinicNCT07874841Written as Varenicline (VAR)
- Evaluating Smoking Cessation Interventions for PWH in South AfricaRecruitingPhase 2/3Johns Hopkins UniversityNCT05413122Written as Varenicline
- Switching to E-cigarettes in Smokers Not Interested in QuittingRecruitingPhase 3University of Kansas Medical CenterNCT05703672Written as Varenicline Tartrate
- The Avenues Study: Dual Use CessationRecruitingPhase 4University of Wisconsin, MadisonNCT06474299Written as Varenicline
- Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I TrialRecruitingPhase 4M.D. Anderson Cancer CenterNCT04604509Written as Varenicline
- Varenicline for Smoking Reduction in Veterans Not Ready To QuitRecruitingPhase 4VA Office of Research and DevelopmentNCT06966362Written as Motivation-Phase Varenicline
- Varenicline as a Treatment for Cannabis Use DisorderNot yet recruitingPhase 2Medical University of South CarolinaNCT07783555Written as Varenicline (Chantix)
- Treating Contact Lens Discomfort With Varenicline Solution Nasal Spray 0.03mgRecruitingNot applicableOcular Aesthetics, LLC dba Ocular Clinical TrialsNCT07705893Written as Tyrvaya
- E-cigarette Cessation in Adults Who Co-use CannabisRecruitingPhase 4Medical University of South CarolinaNCT06688539Written as Varenicline Pill
- Ocular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye TreatmentRecruitingPhase 4University of California, BerkeleyNCT07606625Written as Varenicline 0.03Mg/Spray Nasal Soln
- Cannabis-Tobacco Co-Use Treatment StudyRecruitingPhase 3Medical University of South CarolinaNCT06883162Written as Varenicline
- Reducing Falls With Varenicline in Hypocholinergic Parkinson DiseaseRecruitingPhase 2Vikas KotagalNCT06679374Written as Varenicline
- Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use DisorderRecruitingEarly Phase 1University of California, San DiegoNCT06582888Written as Varenicline Tartrate
- Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking CessationRecruitingPhase 4Ottawa Heart Institute Research CorporationNCT06832085Written as Varenicline (Champix)
- Botswana Smoking and Abstinence Reinforcement TrialEnrolling by invitationPhase 4University of Maryland, BaltimoreNCT05694637Written as Varenicline
- A Trial of Varenicline for E-cigarette CessationRecruitingPhase 2Yale UniversityNCT07040566Written as Varenicline 1mg BID
- V+PSF-M for Tobacco Cessation in HIV Care in IndiaRecruitingPhase 3University of Colorado, DenverNCT05786547Written as Varenicline
- Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as CorrelatesRecruitingPhase 4Corporal Michael J. Crescenz VA Medical CenterNCT03495024Written as Varenicline
- Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2TerminatedPhase 2Yale UniversityNCT06006143Written as Varenicline
See all 254 studies that test Varenicline →
Given beside what is tested · 41 — Varenicline is usual care or a partner of the new treatment
- Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention for Smoking CessationRecruitingPhase 2University of OklahomaNCT07099638Written as Varenicline (VAR)
- Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation TrialNot yet recruitingPhase 4Yale UniversityNCT07835555Written as nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion
- Varenicline and Accelerated Transcranial Magnetic Stimulation (TMS) for Quitting Nicotine Use (Pilot Study)RecruitingPhase 4Massachusetts General HospitalNCT07145866Written as Varenicline
- Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing HomelessnessNot yet recruitingNot applicableVA Office of Research and DevelopmentNCT07714200Written as Varenicline
- Neural Mechanisms Connecting Deficient Sleep and Smoking RelapseRecruitingPhase 2Yale UniversityNCT06609369Written as Varenicline
- Trial of a Harm Reduction Strategy for People With HIV Who Smoke CigarettesRecruitingNot applicableMontefiore Medical CenterNCT05642715Written as Varenicline
- Wellness Intervention for Smoking and HIVRecruitingNot applicableUniversity of ArizonaNCT04725617Written as Varenicline
- tDCS Plus Varenicline for Smoking CessationRecruitingPhase 4Centre for Addiction and Mental HealthNCT06798324Written as Varenicline 1mg BID
- Optimizing Tobacco Use Treatment for PLWHAActive, not recruitingPhase 3Abramson Cancer Center at Penn MedicineNCT04176172Written as Varenicline
- Smoking Cessation Treatment for Head & Neck Cancer PatientsActive, not recruitingEarly Phase 1M.D. Anderson Cancer CenterNCT01098955Written as Varenicline
- Combining Varenicline and Guanfacine for Smoking CessationCompletedPhase 2Yale UniversityNCT04198116Written as Varenicline
- Metabolism-informed Care for Smoking CessationCompletedNot applicableVanderbilt University Medical CenterNCT03227679Written as Varenicline
- Metabolism Informed Smoking Treatment: The MIST RCTCompletedPhase 3Vanderbilt-Ingram Cancer CenterNCT04590404Written as Varenicline
- Financial Incentives for Homeless Smokers: A Community-based RCTCompletedNot applicableMassachusetts General HospitalNCT04445662Written as Varenicline
- Deep rTMS and Varenicline for Smoking CessationCompletedNot applicableCentre for Addiction and Mental HealthNCT04083144Written as Varenicline
- Nicotine Withdrawal Symptoms and Smoking RelapseCompletedNot applicableNational Institute on Drug Abuse (NIDA)NCT01511614Written as Varenicline Pill
- UW Quitting Using Intensive Treatment Study (QUITS)CompletedPhase 4University of Wisconsin, MadisonNCT03176784Written as Varenicline
- Using Non-invasive Brain Stimulation (tDCS) With Varenicline for Treating Tobacco DependenceCompletedNot applicableCentre for Addiction and Mental HealthNCT03841292Written as Varenicline
- Mobile Health Interventions for Medication Adherence Among PLWHWithdrawnPhase 4Duke UniversityNCT04191278Written as Varenicline
- Addressing Post Cessation Weight GainTerminatedPhase 2/3Mayo ClinicNCT02412631Written as Varenicline
Showing 20 of 41.
As the comparator · 4 — what is tested is compared with Varenicline
- Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy SmokersCompletedPhase 4University of OuluNCT03235505Written as Varenicline Tartrate
- Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without ChemotherapyTerminatedEarly Phase 1Wake Forest University Health SciencesNCT02582008Written as Varenicline
- Cytisine Versus Varenicline for Smoking CessationCompletedPhase 3University of Auckland, New ZealandNCT02957786Written as Varenicline
- Smoking Cessation Using Motivational Therapy and VareniclineCompletedNot applicablePhilip DiazNCT00701896Written as Varenicline tartrate
What changed recently
From the registry's own updates since Oct 16, 2026.
Stopped1
- Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2TerminatedNov 6, 2026NCT06006143
Codes
What other systems call Varenicline · ClinicalTrials.gg INT006521
- MeSH (NLM) D000068580VareniclineConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) W6HS99O8ZOVARENICLINEConfirmed FDA, NLM, Wikidata
- RxNorm 591622One source FDA
- Wikidata Q114826146vareniclineConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C73609VareniclineOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D000068580 | Varenicline | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | W6HS99O8ZO | VARENICLINE | Confirmed FDA, NLM, Wikidata |
| RxNorm | 591622 | — | One source FDA |
| Wikidata | Q114826146 | varenicline | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C73609 | Varenicline | One source FDA |
Also registered as varenicline tartrate (UNII 82269ASB48 · RxNorm 636674).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.