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 |
Show 2 discontinued
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 | 2024-06-23 |
| claravis | ANDA | 2022-08-31 |
| epuris | Export only | 2024-12-06 |
| isotretinoin | ANDA | 2025-07-22 |
| myorisan | ANDA | 2022-12-19 |
| sotret | 2006-11-07 | |
| zenatane | ANDA | 2025-07-11 |
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
200 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 14 | 26 | 11 | 1 | 4 | 53 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 6 | 3 | 6 | 9 | 19 | 42 |
| Covid-19 | D000086382 | — | U07.1 | 2 | 5 | 2 | 1 | 1 | 10 |
| Recurrence | D012008 | — | — | 4 | 2 | — | 1 | — | 7 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 1 | — | 1 | 3 | 5 |
| Infertility | D007246 | EFO_0000545 | — | — | 2 | — | 1 | — | 3 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | 1 | 1 | 2 |
| Rosacea | D012393 | — | L71 | — | — | 1 | 1 | — | 2 |
| Erythema | D004890 | — | L53.9 | — | — | — | 1 | 1 | 2 |
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ganglioneuroblastoma | D018305 | — | — | 1 | 2 | 2 | — | — | 5 |
| Retinoblastoma | D012175 | — | — | 3 | — | 2 | — | — | 5 |
| Lung neoplasms | D008175 | — | C34.90 | — | 3 | 1 | — | 1 | 5 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | 1 | — | — | 4 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | 2 | — | — | 4 |
| Glioma | D005910 | EFO_0000520 | — | 1 | 2 | 1 | — | — | 4 |
| Medulloblastoma | D008527 | — | — | 3 | — | 1 | — | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | 1 | — | — | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 1 | 1 | — | — | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | 2 | 1 | 1 | — | — | 3 |
Show 10 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 4 | 4 | — | — | — | 6 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 3 | — | — | — | 4 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 3 | 2 | — | — | — | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 3 |
| Uterine cervical neoplasms | D002583 | — | — | — | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | — | — | 2 |
| Congenital ichthyosiform erythroderma | D016113 | — | — | — | 2 | — | — | — | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 2 | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 1 | 1 | — | — | 1 | 2 |
| Skin aging | D015595 | EFO_0005422 | — | — | 2 | — | — | — | 2 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 4 | — | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Germ cell and embryonal neoplasms | D009373 | — | — | 2 | — | — | — | — | 2 |
| Pinealoma | D010871 | — | — | 2 | — | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 2 | — | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | — | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | — | — | — | — | 2 |
Show 41 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Papillomaviridae | D027383 | — | — | — | — | — | — | 1 | 1 |
| Malformed nails | D009264 | — | Q84.5 | — | — | — | — | 1 | 1 |
| Muscle strength | D053580 | — | — | — | — | — | — | 1 | 1 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
| Musculoskeletal diseases | D009140 | — | — | — | — | — | — | 1 | 1 |
| Psoriasis | D011565 | EFO_0000676 | L40 | — | — | — | — | 1 | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | — | 1 | 1 |
| Contraception | D003267 | — | — | — | — | — | — | 1 | 1 |
| Drug eruptions | D003875 | — | — | — | — | — | — | 1 | 1 |
| Stevens-johnson syndrome | D013262 | EFO_0004276 | L51.1 | — | — | — | — | 1 | 1 |
Show 11 more
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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,506 documents
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Safety
Black-box Warning
Black-box warning for: Absorica, Absorica absorica ld, Accutane, Amnesteem, Isotretinoin, Sotret, Zenatane
Adverse Events
Top Adverse Reactions
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68,608 adverse events reported
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