Isotretinoin
Approved · FDAAlso known as 13 cis retinoic acid, 13-RA, 13-cRA, 13-cis retinoic acid+16 more
13 cis retinoic acid, 13-RA, 13-cRA, 13-cis retinoic acid, 13-cis-Retinoic acid, 13-cis-Vitamin A acid, Absorica, Accutane, Amnesteem, Claravis, Myorisan, Neovitamin A acid, Sotret, Zenatane, cis-RA, Isotretinoino, Isotretinoína, Isotrétinoine, (7E,9E,11E,13Z)-retinoic acid, Isotretinoinum.
Recent clinical, regulatory, research and industry developments relating to this drug.
Effects of Isotretinoin on Nasal Mucociliary Clearance and Olfactory Function
Label change: ISOTRETINOIN (ANDA213571)
Label change: ISOTRETINOIN (NDA021951)
Label change: ISOTRETINOIN (NDA211913)
Supplemental approval: ISOTRETINOIN (ANDA213571)
Guidelines of care for the management of acne vulgaris.
Risk of Suicide and Psychiatric Disorders Among Isotretinoin Users: A Meta-Analysis.
Effect of isotretinoin on CYP2D6 and CYP3A activity in patients with severe acne.
Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
13-cis Retinoic Acid (Isotretinoin) and Sperm Production
Recent completions
Trials that read out recently, adding to the completed evidence base.
Neuroblastoma Protocol 2012: Therapy for Children With Advanced Stage High-Risk Neuroblastoma
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- The New England journal of medicine2
- British journal of clinical pharmacology1
- JAMA dermatology1
- Journal of the American Academy of Dermatology1
- The Journal of investigative dermatology1
- Matthay KK2
- Reynolds CP2
- Shimada H2
- Villablanca JG2
- Anderson B1
- Barbieri JS1
- Black CT1
- Brodeur GM1
- American Academy of Dermatology1
- Beth Israel Deaconess Medical Center1
- Brigham and Women's Hospital1
- Emory University School of Medicine1
- Massachusetts General Hospital1
- Mayo Clinic1
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
Studied across the same disease area as Isotretinoin in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.