varenicline
varenicline: developed by 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
What to watch
Prepared research question
How could varenicline → RDY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 3 study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| DR REDDYS LABORATORIES LTD (RDY) | Approved |
Clinical Trials (8)
Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness
Primary endpoint: Number of participants whose self-report of prolonged smoking abstinence is bioverified
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)
Primary endpoint: Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation
Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation
Primary endpoint: Smoking Abstinence (26 weeks post-quit)
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
Primary endpoint: Change in cigarettes smoked per day (CPD)
Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
Primary endpoint: 7-day point prevalence tobacco abstinence at 52 weeks
A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination
Primary endpoint: Smoking Cessation
Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy
Primary endpoint: Smoking Abstinence Rate
Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease: a Pilot Randomized Trial
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).
FDA Decisions1 records
Frequently asked questions
Who is developing varenicline?
varenicline is being developed by 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 for 1 INDICATIONS AND USAGE Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 ), dated October 1, 2024.