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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2022-08-22 |
| claravis | ANDA | 2022-08-31 |
| epuris | Export only | 2023-10-04 |
| isotretinoin | ANDA | 2024-11-02 |
| 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
No data
Clinical
Clinical Trials
195 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 13 | 26 | 11 | 1 | 4 | 52 |
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 6 | 3 | 6 | 9 | 16 | 39 |
| Covid-19 | D000086382 | — | — | 2 | 5 | 2 | 2 | 1 | 11 |
| Recurrence | D012008 | — | — | 6 | 1 | — | 1 | 1 | 9 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | 1 | — | 1 | 2 | 4 |
| Pseudotumor cerebri | D011559 | EFO_1001132 | G93.2 | — | — | — | 1 | — | 1 |
| Papilledema | D010211 | EFO_1001074 | H35.81 | — | — | — | 1 | — | 1 |
| Intracranial hypertension | D019586 | EFO_1000992 | — | — | — | — | 1 | — | 1 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | — | 1 | — | 1 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | 1 | — | 1 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | 2 | — | — | 5 |
| Ganglioneuroblastoma | D018305 | — | — | 1 | 2 | 2 | — | — | 5 |
| Retinoblastoma | D012175 | — | — | 3 | — | 2 | — | — | 5 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 3 | 1 | — | 1 | 5 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | 1 | — | 1 | 4 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | 1 | — | — | 4 |
| Nervous system neoplasms | D009423 | — | — | — | 2 | 2 | — | — | 4 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 1 | 1 | — | — | 4 |
| Syndrome | D013577 | — | — | 3 | 1 | 1 | — | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | 1 | — | — | 3 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 5 | 4 | — | — | — | 7 |
| Glioblastoma | D005909 | EFO_0000515 | — | 3 | 3 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 3 | 1 | — | — | — | 4 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 3 | 2 | — | — | — | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 3 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 1 | — | — | — | 3 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | — | 3 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | — | — | 2 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | 1 | — | — | — | 2 |
Show 44 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Papillomavirus infections | D030361 | — | — | 1 | — | — | — | 1 | 2 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 2 | — | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 2 | — | — | — | — | 2 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | — | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | — | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | 2 | — | — | — | — | 2 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 2 | — | — | — | — | 2 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 2 | — | — | — | — | 2 |
Show 38 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 1 | 1 |
| Papillomaviridae | D027383 | — | — | — | — | — | — | 1 | 1 |
| Papilloma | D010212 | — | — | — | — | — | — | 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 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Accutane – Fortress Biotech
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Accutane – Journey Medical
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Isotretinoin
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 8,454 documents
View more details
Safety
Black-box Warning
Black-box warning for: Absorica, Absorica absorica ld, Accutane, Amnesteem, Isotretinoin, Sotret, Zenatane
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
63,022 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use