How many clinical trials are studying Varenicline?

5 recruiting trials in our tracked data involve Varenicline.

What conditions is Varenicline being studied for?

In our tracked recruiting trials, Varenicline is being studied in trials for HIV, Smoking Cessation, Cardiovascular Diseases.

Varenicline: clinical trials recruiting now

Q: Is Varenicline FDA-approved?

Yes. According to the FDA drug label available through openFDA, Varenicline is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Varenicline appears in the FDA drug-label database. Marketed as Varenicline.

FDA-approved use

Varenicline tablets are indicated for use as an aid to smoking cessation treatment. Varenicline tablets are a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment. ( 1 and 2.1 )

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2021-03-15
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit — Pfizer Inc.	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2021-08-13
CGMP Deviations: Intermittent exposure to temperature excursion during storage. — Cardinal Health Inc.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2021-03-15
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit — Pfizer Inc.	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2021-06-09
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit — Pfizer Inc.	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2021-06-09

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 2 Phase 4 1 Not applicable 2

Conditions being studied

Condition	Trials
HIV · Varenicline for HIV	4
Smoking Cessation · Varenicline for Smoking Cessation	3
Cardiovascular Diseases	1
Comorbidities and Coexisting Conditions	1
Human Immunodeficiency Virus	1
Parkinsonism	1
Schizoaffective Disorder	1
Schizophrenia	1
Sleep	1
Smoking, Tobacco	1
Tardive Dyskinesia	1
Tobacco Smoking	1
Tobacco Use	1

Recruiting trials involving Varenicline

Evaluating Smoking Cessation Interventions for PWH in South Africa
NCT05413122 · Phase: Phase 2, Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
NCT03495024 · Phase: Phase 4 · Ages: 18 Years to 75 Years · Sex: All (male and female) · 1 location
Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
NCT05642715 · Phase: Not applicable (e.g. observational or device study) · Ages: 40 Years to 79 Years · Sex: All (male and female) · 1 location
V+PSF-M for Tobacco Cessation in HIV Care in India
NCT05786547 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 2 locations
Wellness Intervention for Smoking and HIV
NCT04725617 · Phase: Not applicable (e.g. observational or device study) · Ages: 18 Years to 75 Years · Sex: All (male and female) · 2 locations

Common questions

Is Varenicline FDA-approved?

Yes, marketed as Varenicline.

How many recruiting trials involve Varenicline?

5 recruiting trials across 13 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.