Wednesday, July 8, 2026

Drug profile · INN

nicotine

nicotine (NICABATE P) is a neuronal acetylcholine receptor; alpha4/beta2 agonist. Associated with HALEON AUSTRALIA PTY LTD. Route of administration: nasal. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 20
Pipeline programs 99
News articles 0
Drug details — nicotine
US status
approved
Class
Route
NASAL
Patents
20
Programs
99
Data quality
0.84

Quick answer

nicotine (NICABATE P) is a neuronal acetylcholine receptor; alpha4/beta2 agonist. Associated with HALEON AUSTRALIA PTY LTD. Route of administration: nasal. Current US regulatory status: approved.

Key facts

INN nicotine
Brand NICABATE P
Mechanism Neuronal acetylcholine receptor; alpha4/beta2 agonist
Target Neuronal acetylcholine receptor; alpha4/beta2
Route NASAL
Formulation INHALANT

Mechanism of action

Neuronal acetylcholine receptor; alpha4/beta2 agonist

Primary target: Neuronal acetylcholine receptor; alpha4/beta2

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. 10-week smoking cessation group therapy combined with NicoDerm CQ Phase 3 · BRIGHT MINDS BIOSCIENCES · Tobacco Use Cessation
  2. Extended treatment Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence
  3. Internet-based smoking treatment Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence
  4. Nicotine Patch Phase 3 · BRIGHT MINDS BIOSCIENCES · Smoking Cessation
  5. Nicotine patch Phase 3 · Jasper Therapeutics · Nicotine Dependence
  6. Nicotine polacrilex, Bupropion Phase 3 · BRIGHT MINDS BIOSCIENCES · Tobacco Use Disorder
  7. Varenicline Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Addiction
  8. Varenicline Phase 3 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence

Related & competitor drugs

  1. nicotine polacrilex Neuronal acetylcholine receptor; alpha4/beta2 agonist
  2. varenicline Nervous system (N07)
  3. varenicline tartrate Neuronal acetylcholine receptor; alpha4/beta2 agonist
  1. US 12274710

    Compound for regulating body weight imbalance, composition thereof and application thereof

    Expires Mon Apr 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12084670

    Regulating alkaloids

    Expires Mon Sep 05 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11865155

    Plant extract obtained from Morus plant leaves which has an IC50 value to inhibit a-glucosidase I at a concentration of less than 90 uG/ml, compositions containing same, method of extraction and uses thereof

    Expires Mon Jan 04 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11712467

    Methods of rational nicotine hapten design and uses thereof

    Expires Mon Jul 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11667924

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Jun 01 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11597916

    Nicotine degrading enzyme variants

    Expires Mon Mar 02 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11572568

    Regulating alkaloids

    Expires Mon Feb 02 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11357848

    Methods of rational nicotine hapten design and uses thereof

    Expires Mon Jun 09 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11090349

    Plant extract obtained from Morus plant leaves, compositions containing same, method of extraction and uses thereof

    Expires Mon Aug 12 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 10907170

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Jan 28 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10829774

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Nov 05 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10731172

    Regulating alkaloids

    Expires Mon Jul 30 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 10287596

    Regulating alkaloids

    Expires Mon May 09 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 10190129

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Jan 24 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 10182994

    Nanoparticulate complex of nicotine and cerium oxide and use thereof

    Expires Mon Jan 17 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 10016474

    Plant extract, compositions containing same, method of extraction and uses thereof

    Expires Mon Jul 05 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 9994860

    Regulating alkaloids

    Expires Mon Jun 07 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 9884114

    Methods of rational nicotine hapten design and uses thereof

    Expires Mon Feb 01 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 9719103

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Jul 27 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 9551003

    Increasing levels of nicotinic alkaloids in plants

    Expires Mon Jan 19 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is nicotine?

nicotine (NICABATE P) is a neuronal acetylcholine receptor; alpha4/beta2 agonist. Associated with HALEON AUSTRALIA PTY LTD. Route of administration: nasal. Current US regulatory status: approved.

What is the brand name for nicotine?

NICABATE P is a marketed brand name for nicotine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of nicotine?

nicotine 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.