Isotretinoin
Absorica, Amnesteem, Claravis, Isotretinoin, Myorisan, Zenatane (isotretinoin) is a small molecule pharmaceutical. Isotretinoin was first approved as Accutane on 1982-05-07. It is used to treat acne vulgaris, leukemia, and neuroblastoma in the USA.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Absorica, Absorica ld, Amnesteem, Claravis, Isotretinoin, Myorisan, Zenatane (discontinued: Absorica ld, Accutane, Sotret)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Isotretinoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ABSORICA LD | Sun Pharmaceutical Industries | N-211913 RX | 2019-11-05 | 4 products, RLD, RS |
| ABSORICA | Sun Pharmaceutical Industries | N-021951 RX | 2012-05-25 | 6 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| absorica | New Drug Application | 2018-11-02 |
| absorica absorica ld | New Drug Application | 2023-06-12 |
| accutane | ANDA | 2023-12-20 |
| amnesteem | ANDA | 2022-08-22 |
| claravis | ANDA | 2022-08-31 |
| epuris | Export only | 2024-12-06 |
| isotretinoin | ANDA | 2024-11-30 |
| myorisan | ANDA | 2022-12-19 |
| sotret | 2006-11-07 | |
| zenatane | ANDA | 2024-05-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| leukemia | — | D007938 | C95 |
| acne vulgaris | EFO_0003894 | D000152 | L70 |
| neuroblastoma | EFO_0000621 | D009447 | — |
Agency Specific
FDA
EMA
No data
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AD: Retinoids for topical use in acne
— D10AD04: Isotretinoin
— D10AD54: Isotretinoin, combinations
— D10B: Anti-acne preparations for systemic use
— D10BA: Retinoids for treatment of acne
— D10BA01: Isotretinoin
HCPCS
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Clinical
Clinical Trials
197 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Isotretinoin |
| INN | isotretinoin |
| Description | Isotretinoin is a retinoic acid that is all-trans-retinoic acid in which the double bond which is alpha,beta- to the carboxy group is isomerised to Z configuration. A synthetic retinoid, it is used for the treatment of severe cases of acne and other skin diseases. It has a role as a keratolytic drug, an antineoplastic agent and a teratogenic agent. It is a conjugate acid of a 13-cis-retinoate. |
| Classification | Small molecule |
| Drug class | retinol derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1=C(/C=C/C(C)=C/C=C/C(C)=C\C(=O)O)C(C)(C)CCC1 |
Identifiers
| PDB | — |
| CAS-ID | 4759-48-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL547 |
| ChEBI ID | 6067 |
| PubChem CID | 5282379 |
| DrugBank | DB00982 |
| UNII ID | EH28UP18IF (ChemIDplus, GSRS) |
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Accutane – Fortress Biotech
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Accutane – Journey Medical
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Estimated US medical usage
Isotretinoin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 8,650 documents
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Safety
Black-box Warning
Black-box warning for: Absorica, Absorica absorica ld, Accutane, Amnesteem, Sotret, Zenatane
Adverse Events
Top Adverse Reactions
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65,415 adverse events reported
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