Wednesday, July 8, 2026

Drug profile · INN

baclofen

baclofen (APO-BACLOFEN) is a gaba-b receptor agonist. Associated with Alphapharm Pty Ltd. Route of administration: intrathecal. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 17
Pipeline programs 12
News articles 0
Congress events 1
Drug details — baclofen
US status
approved
Class
Route
INTRATHECAL
Patents
17
Programs
12
Data quality
0.89

Quick answer

baclofen (APO-BACLOFEN) is a gaba-b receptor agonist. Associated with Alphapharm Pty Ltd. Route of administration: intrathecal. Current US regulatory status: approved.

Key facts

INN baclofen
Brand APO-BACLOFEN
Mechanism GABA-B receptor agonist
Target GABA-B receptor
Route INTRATHECAL
Formulation TABLET, ORALLY DISINTEGRATING

Mechanism of action

GABA-B receptor agonist

Primary target: GABA-B receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Congress & event coverage

  • Presentation
    ScopeX

    1 presentation · general

Pipeline programs

  1. Ralinepag Phase 3 · United Therapeutics Europe · PAH
  2. Arbaclofen Placarbil Phase 2 · Indivior Pty · Alcohol Use Disorder
  3. Baclofen Phase 2 · BRIGHT MINDS BIOSCIENCES · Marijuana Dependence
  4. Baclofen Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine-Related Disorders
  5. Ommaya 02 Phase 2 · First People's Hospital · Leptomeningeal Metastasis of HER2-positive Breast Cancer
  6. oral treprostinil Phase 2 · United Therapeutics Europe · PAH
  7. Arbaclofen Placarbil SR Phase 1 · Indivior Pty · Healthy Volunteers
  8. HS135-002 Phase 1 · Anaxis Pharma · Pulmonary arterial hypertension

Related & competitor drugs

  1. calcium oxybate GABA-B receptor agonist
  2. sodium oxybate Nervous system (N07)
  1. US 12383522

    Baclofen formulations and methods of minimizing patient exposure to metabolite variations

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12350245

    Stable oral suspensions of baclofen

    Expires Mon Jul 03 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12295929

    Intravenous baclofen formulations and treatment methods

    Expires Mon May 08 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12011502

    Compositions and methods of administering baclofen

    Expires Mon Jun 13 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11931328

    Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives

    Expires Mon Mar 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 11857524

    Stable oral suspensions of baclofen

    Expires Mon Dec 28 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 11850225

    Baclofen formulations and methods of minimizing patient exposure to metabolite variations

    Expires Mon Dec 21 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 11654124

    Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives

    Expires Mon May 18 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 11523984

    Compositions and methods of administering baclofen

    Expires Mon Dec 08 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 11491125

    Baclofen formulations and methods of minimizing patient exposure to metabolite variations

    Expires Mon Nov 03 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 10933042

    Intravenous baclofen formulations and treatment methods

    Expires Mon Feb 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 10350183

    Intravenous baclofen formulations and treatment methods

    Expires Mon Jul 11 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 9289408

    High concentration baclofen preparations

    Expires Mon Mar 17 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 8529916

    High concentration baclofen preparations

    Expires Mon Sep 05 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 8357379

    High concentration baclofen preparations

    Expires Mon Jan 17 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 8062647

    High concentration baclofen preparations

    Expires Mon Nov 17 2031 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 7824697

    High concentration baclofen preparations

    Expires Mon Oct 28 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is baclofen?

baclofen (APO-BACLOFEN) is a gaba-b receptor agonist. Associated with Alphapharm Pty Ltd. Route of administration: intrathecal. Current US regulatory status: approved.

What is the brand name for baclofen?

APO-BACLOFEN is a marketed brand name for baclofen. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of baclofen?

baclofen 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.