isotretinoin
Trade name: Accutane
Small moleculeapproved
Approved
May 7, 1982
Isotretinoin, also known as 13-cis-retinoic acid and sold under the brand name Accutane among others, is a medication used to treat skin diseases like harlequin-type ichthyosis, and lamellar ichthyosis, and severe cystic acne or moderate acne that is unresponsive to antibiotics. Isotretinoin is used off-label to treat basal cell carcinoma and squamous cell carcinoma, although clinical evidence suggests it is not effective in this setting. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug. — Wikipedia
Clinical trial activity
144 trials · 125 clinical orgs · 12 marketing orgs
Phase 1
38
Phase 2
81
Phase 3
27
Phase 4
18
Earliest trial started May 1, 1990 (NCT00038376)
Timeline
1990s
2000s
- Nov 8, 2002
Mylan — Marketing Organization
- Dec 24, 2002
Sun Pharmaceuticals — Marketing Organization
- Apr 11, 2003
Teva — Marketing Organization
2010s
- Jan 19, 2012
Douglas Pharmaceuticals — Marketing Organization
- May 25, 2012
Sun Pharmaceuticals — NDA Secondary Org
- Mar 25, 2013
Dr. Reddy's Laboratories — Marketing Organization
- Sep 29, 2017
Amneal Pharmaceuticals — Marketing Organization
2020s
- Mar 31, 2021
Actavis — Marketing Organization
- Mar 31, 2021
AbbVie — Marketing Organization
- Apr 12, 2021
Upsher-Smith Laboratories — Marketing Organization
- Aug 29, 2023
Zydus Discovery DMCC — Marketing Organization
- Jan 29, 2024
Aurobindo Pharma — Marketing Organization
Indications
Approved for
Studied for
- Acneiform Eruptions · Phase 4
- Alzheimer Disease · Phase 1/Phase 2
- Anus Neoplasms · Phase 1
- Astrocytoma · Phase 1
- Brain Neoplasms · Phase 3
- Breast Neoplasms · Phase 3
- Burkitt Lymphoma · Phase 1
- Carcinoma, Renal Cell · Phase 1/Phase 2
- Central Nervous System Neoplasms · Phase 3
- Chromosome Aberrations · Phase 2
- COVID-19 · Phase 4
- COVID-19 Vaccines · Phase 1/Phase 2
- Cytochrome P-450 CYP2D6 · Phase 4
- Dermatitis, Phototoxic · Phase 2
- Dermatitis, Seborrheic · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Epidermolysis Bullosa · Phase 1
- Esophageal Neoplasms · Phase 2
- Ganglioneuroblastoma · Phase 3
- Glioblastoma · Phase 2
- Glioma · Phase 1/Phase 2
- Gliosarcoma · Phase 1
- Head and Neck Neoplasms · Phase 3
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 2
- HIV Infections · Phase 3
- Hodgkin Disease · Phase 1
- Ichthyosis · Phase 3
- Infertility · Phase 4
- Infertility, Male · Phase 2
- Intraocular Lymphoma · Phase 1
- Keratosis, Actinic · Phase 2
- Kidney Neoplasms · Phase 3
- Klinefelter Syndrome · Phase 2
- Leukemia · Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 1
- Leukemia-Lymphoma, Adult T-Cell · Phase 1
- Leukemia, Myeloid, Acute · Phase 1
- Leukemia, Myeloid, Chronic-Phase · Phase 1
- Leukemia, Myelomonocytic, Juvenile · Phase 2
- Leukoplakia, Oral · Phase 1
- Lung Neoplasms · Phase 3
- Lymphoma · Phase 1
- Lymphoma, B-Cell, Marginal Zone · Phase 1
- Lymphoma, Follicular · Phase 1
- Lymphoma, Large B-Cell, Diffuse · Phase 1
- Lymphoma, Large-Cell, Anaplastic · Phase 1
- Lymphoma, Large-Cell, Immunoblastic · Phase 1
- Lymphoma, Mantle-Cell · Phase 1
- Lymphoma, Non-Hodgkin · Phase 1
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1
- Lymphoma, T-Cell · Phase 2
- Lymphomatoid Granulomatosis · Phase 1
- Medulloblastoma · Phase 3
- Melanoma · Phase 2
- Melanosis · Phase 1
- Multiple Myeloma · Phase 2
- Mycosis Fungoides · Phase 2
- Myelodysplastic Syndromes · Phase 1/Phase 2
- Myeloproliferative Disorders · Phase 1/Phase 2
- Neoplasms · Phase 1
- Neoplasms, Germ Cell and Embryonal · Early Phase 1
- Neoplasms, Second Primary · Phase 4
- Nerve Sheath Neoplasms · Phase 2
- Neuroblastoma · Phase 3
- Neuroectodermal Tumors · Phase 1
- Neuroectodermal Tumors, Primitive · Early Phase 1
- Oligodendroglioma · Phase 1
- Onychomycosis · Phase 1
- Penile Neoplasms · Phase 2
- Pharmacokinetics · Phase 4
- Pinealoma · Early Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1
- Prostatic Neoplasms · Phase 2
- Quality of Life · Phase 4
- Rhabdoid Tumor · Phase 1
- Rosacea · Phase 4
- Sezary Syndrome · Phase 1
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Thrombocytopenia · Phase 1/Phase 2
- Tinea · Phase 2
- Tuberculosis · Phase 2
- Tumor Suppressor Protein p53 · Phase 2
- Uterine Cervical Dysplasia · Phase 3
- Uterine Cervical Neoplasms · Phase 2
- Vitreoretinopathy, Proliferative · Phase 4
- Waldenstrom Macroglobulinemia · Phase 1
- Warts · Phase 3
Mechanism of action
- Retinoic acid receptorAGONIST
Retinoic acid receptor agonist
Prodrug. RARG/RXRA are predominant forms in skin
Approval history
- approvedPriority reviewMay 7, 1982
Chemistry & pharmacology
Loading structure…
SMILES
CC1=C(/C=C/C(C)=C/C=C/C(C)=C\C(=O)O)C(C)(C)CCC1- Mol. weight
- 300.44 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Black box warning
Sources
- WikipediaIsotretinoin ↗
- ChEMBLCHEMBL547 ↗
Also known as
- 13 cis-retinoic acid
- 13 cis-retinoic acid
- 13-cis-retinoic acid
- 13-cis-retinoic acid
- 13-cis-retinoic acid
- 13-cis-retinoic acid
- 13-cis-vitamin a acid
- 13-cis-vitamin a acid
- 13-cis-vitamin a acid
- 13-ra
- 13-ra
- (7e,9e,11e,13z)-retinoic acid
- (7e,9e,11e,13z)-retinoic acid
- (7e,9z,11e,13e)-retinoic acid
- (7e,9z,11e,13e)-retinoic acid
- absorica
- absorica
- accure
- accutane
- accutane
- accutane
- accutane
- amnesteem
- amnesteem
- cip-isotretinoin
- cip-isotretinoin
- cis-ra
- cis-ra
- cis-retinoic acid
- cis-retinoic acid
- claravis
- claravis
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoin
- isotretinoina
- isotretinoina
- isotretinoine
- isotretinoine
- isotretinoino
- isotretinoino
- isotretinoinum
- isotretinoinum
- isotrex
- isotrex
- isotrex
- myorisan
- myorisan
- neovitamin a acid
- neovitamin a acid
- neovitamin a acid
- ro-43780
- ro-43780
- roaccutan
- roaccutane
- roaccutane
- roaccutane
- sotret
- sotret
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06942039 | Early Phase 1 (Phase 1) | Sep 30, 2025 | C17 Council |
| NCT07142070 | N/A | Sep 1, 2025 | Istanbul Medipol University |
| NCT07309341 | N/A | Jun 1, 2025 | The Scientific and Technological Research Council of Turkey, Uşak University |
| NCT06698263 | Phase 4 | Mar 1, 2025 | University of Strasbourg |
| NCT06225570 | Early Phase 1 (Phase 1) | Jan 31, 2025 | Medical University of South Carolina |
| NCT07054398 | N/A | Jan 10, 2025 | Aswan University |
| NCT06447480 | Phase 3 | Dec 1, 2024 | University of Nice Sophia Antipolis |
| NCT06485505 | Phase 1 | Jul 31, 2024 | Zagazig University |
| NCT06172296 | Phase 3 | Feb 14, 2024 | National Cancer Institute (NCI) |
| NCT06242288 | Phase 3 | Jan 30, 2024 | Tanta University |
| NCT06873087 | Phase 4 | Sep 1, 2023 | Istanbul University, SB Istanbul Education and Research Hospital |
| NCT05869188 | N/A | Jun 1, 2023 | South Valley University |
| NCT06201624 | Phase 1 | Mar 1, 2023 | Zagazig University |
| NCT05666765 | Phase 4 | Jan 1, 2023 | Tanta University |
| NCT05316675 | Phase 4 | Dec 31, 2022 | Assiut University |
| NCT06378983 | N/A | Sep 1, 2022 | Sun Yat-Sen University |
| NCT05295732 | Phase 3 | Jun 21, 2022 | Timber Pharmaceuticals LLC |
| NCT05373901 | Phase 1 | Jun 7, 2022 | BeOne Medicines |
| NCT05622253 | N/A | Mar 1, 2022 | Zagazig University |
| NCT05684861 | Phase 2 | Jan 1, 2022 | South Valley University |
Showing 20 of 144 trials
Page 1 / 8
Organizations
Research & Development (125)
125 organizations
Page 1 / 7
Marketing (14)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AbbVie | For profit | MKTG | Mar 31, 2021 |
| Actavis | For profit | MKTG | Mar 31, 2021 |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 29, 2017 |
| Aurobindo Pharma | For profit | MKTG | Jan 29, 2024 |
| Douglas Pharmaceuticals | For profit | MKTG | Jan 19, 2012 |
| Dr. Reddy's Laboratories | For profit | MKTG | Mar 25, 2013 |
| Mylan | For profit | MKTG | Nov 8, 2002 |
| Roche | For profit | NDA | May 7, 1982 |
| Sun Pharmaceuticals | For profit | NDA2 | May 25, 2012 |
| Sun Pharmaceuticals | For profit | MKTG | Dec 24, 2002 |
| Sun Pharmaceuticals | For profit | SYN | Nov 5, 2019 |
| Teva | For profit | MKTG | Apr 11, 2003 |
| Upsher-Smith Laboratories | For profit | MKTG | Apr 12, 2021 |
| Zydus Discovery DMCC | For profit | MKTG | Aug 29, 2023 |