Wednesday, July 8, 2026

Drug profile · INN

isotretinoin

isotretinoin (APO-ISOTRETINOIN) is a retinoic acid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 5
Pipeline programs 2
News articles 0
Drug details — isotretinoin
US status
approved
Class
Route
ORAL
Patents
5
Programs
2
Data quality
0.89

Quick answer

isotretinoin (APO-ISOTRETINOIN) is a retinoic acid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN isotretinoin
Brand APO-ISOTRETINOIN
Mechanism Retinoic acid receptor agonist
Target Retinoic acid receptor
Route ORAL
Formulation CAPSULE
Originator Apotex Pty Ltd

Mechanism of action

Retinoic acid receptor agonist

Primary target: Retinoic acid receptor

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment Phase 3 · United Therapeutics Europe · COVID19
  2. Isotretinoin Approved · VYNE Therapeutics · Acne Vulgaris

Related & competitor drugs

  1. tazarotene Retinoic acid receptor agonist
  2. tretinoin Retinoic acid receptor agonist
  3. adapalene Retinoic acid receptor agonist
  4. palovarotene Musculo-skeletal system (M09)
  5. trifarotene Retinoic acid receptor gamma agonist
  1. US 12005123

    Conjugate of isotretinoin and peptide

    Expires Mon Jun 06 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11351266

    Conjugate of isotretinoin and peptide

    Expires Mon Jun 02 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11219631

    Foamable compositions, breakable foams and their uses

    Expires Mon Jan 06 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11103454

    Wax foamable vehicle and pharmaceutical compositions thereof

    Expires Mon Aug 26 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 11033491

    Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof

    Expires Mon Jun 10 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is isotretinoin?

isotretinoin (APO-ISOTRETINOIN) is a retinoic acid receptor agonist. Associated with Apotex Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for isotretinoin?

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

What is the US approval status of isotretinoin?

isotretinoin 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.