Friday, July 10, 2026

Drug profile · INN

varenicline

varenicline (PHARMACOR VARENICLINE) is a neuronal acetylcholine receptor; alpha4/beta2 partial agonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N07) N07BA03
US status approved
Patents linked 2
Pipeline programs 21
News articles 0
Drug details — varenicline
US status
approved
Class
Nervous system (N07)
Route
ORAL
Patents
2
Programs
21
Data quality
0.89

Quick answer

varenicline (PHARMACOR VARENICLINE) is a neuronal acetylcholine receptor; alpha4/beta2 partial agonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN varenicline
Brand PHARMACOR VARENICLINE
Mechanism Neuronal acetylcholine receptor; alpha4/beta2 partial agonist
Target Neuronal acetylcholine receptor; alpha4/beta2
Therapeutic class Nervous system (N07)
Route ORAL
Formulation TABLET
ATC code N07BA03

Mechanism of action

Neuronal acetylcholine receptor; alpha4/beta2 partial agonist

Primary target: Neuronal acetylcholine receptor; alpha4/beta2

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. Champix Phase 3 · Hospital Authority · Tobacco Use Disorder
  2. P150952J Phase 3 · PARItec · Smokers smoking at least 10 cigarettes/day in the past year
  3. Varenicline Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence
  4. Varenicline Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Addiction
  5. Varenicline Phase 2 · BRIGHT MINDS BIOSCIENCES · Alcohol Dependence
  6. Varenicline Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine Dependence
  7. Varenicline Phase 2 · BRIGHT MINDS BIOSCIENCES · Tobacco Use
  8. Varenicline Adaptive Protocol Phase 2 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 8178537

    Solid state forms of varenicline salts and processes for preparation thereof

    Expires Mon May 10 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 8039620

    Varenicline tosylate, an intermediate in the preparation process of varenicline L-tartrate

    Expires Mon Oct 13 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is varenicline?

varenicline (PHARMACOR VARENICLINE) is a neuronal acetylcholine receptor; alpha4/beta2 partial agonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for varenicline?

PHARMACOR VARENICLINE is a marketed brand name for varenicline. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of varenicline?

varenicline has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.