Skip to main content

varenicline

Generic: VARENICLINE TARTRATE·Brand: CHANTIX, Chantix, TYRVAYA, Tyrvaya, VARENICLINE TARTRATE

varenicline: sourced relationships with 1 company · 8 clinical trials tracked · 1 FDA decision.

varenicline evidence translation

What we can confirm

1 FDA record · 8 tracked trials

What it means

Source-backed records connect varenicline to RDY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could varenicline → RDY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
DR REDDYS LABORATORIES LTD (RDY)
Reported 2024-10-01 · Current development: unknownSource
Approved
Clinical Trial Registry Records (8)

Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness

NCT07714200Registry updated 2026-07-20·N/A
Not yet recruiting

Primary endpoint: Number of participants whose self-report of prolonged smoking abstinence is bioverified

InterventionalRandomizedopen120 targetStarted 2027-03Completion 2030-091 site · United StatesVA Office of Research and Development

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, and PRELIminary EFficacy of Percutaneous Injection of RP-008 Followed by Daily Oral Varenicline in Patients With Trigeminal Neuralgia (The RELIEF Study)

NCT07596485Registry updated 2026-06-08·Phase 1/Phase 2
Recruiting

Primary endpoint: Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation

Interventionalopen24 targetStarted 2026-08Completion 2029-021 site · CanadaKriya Therapeutics, Inc.

Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation

NCT07099638Registry updated 2026-02-17·Phase 2
Not yet recruiting

Primary endpoint: Smoking Abstinence (26 weeks post-quit)

InterventionalRandomizedopen496 targetStarted 2026-03Completion 2029-061 site · United StatesUniversity of Oklahoma

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

NCT05642715Registry updated 2026-04-21·N/A
Recruiting

Primary endpoint: Change in cigarettes smoked per day (CPD)

InterventionalRandomizedsingle400 targetStarted 2024-04Completion 2027-031 site · United StatesMontefiore Medical Center

Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness

NCT05413122Registry updated 2026-06-09·Phase 2/Phase 3
Recruiting

Primary endpoint: 7-day point prevalence tobacco abstinence at 52 weeks

InterventionalRandomizedopen660 targetStarted 2023-11Completion 2027-081 site · South AfricaJohns Hopkins University

A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination

NCT04525755Registry updated 2026-02-17·Phase 1
Completed

Primary endpoint: Smoking Cessation

InterventionalRandomizedopen652 enrolledStarted 2021-02Completion 2025-041 site · United StatesMedical University of South Carolina

Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy

NCT01098955Registry updated 2026-05-22·Early Phase 1
Active, not recruiting

Primary endpoint: Smoking Abstinence Rate

InterventionalRandomizedopen51 targetStarted 2010-03Completion 2027-091 site · United StatesM.D. Anderson Cancer Center

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial

NCT00959972Registry updated 2026-05-28·Phase 4
Completed

Primary endpoint: The primary outcome will be the self-reported continuous abstinence rate, confirmed by exhaled carbon monoxide levels of 10ppm or below during the last 4 weeks of treatment (Varenicline weeks 9-12 and NRT weeks 8-11).

InterventionalRandomizedopen50 enrolledStarted 2009-04Completion 2010-111 site · CanadaOttawa Heart Institute Research Corporation
FDA Decisions1 records
Approval(RDY)FDA ↗
ANDA215931UNKNOWNStandardOralTablet

Frequently asked questions

Which companies have sourced relationships with varenicline?

varenicline has dated SEC/FDA relationship records for DR REDDYS LABORATORIES LTD.

How many clinical trials involve varenicline?

BioSniper tracks 8 clinical trials involving varenicline.

What is varenicline's latest FDA decision?

The most recent tracked FDA decision for varenicline is Approval, dated October 1, 2024.