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Isotretinoin
Absorica (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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COVID-19
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Absorica, Absorica ld (generic drugs available since 2002-11-08, discontinued: 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 LDsparcN-211913 RX2019-11-05
4 products, RLD, RS
ABSORICASun Pharmaceutical IndustriesN-021951 RX2012-05-25
6 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
absorica absorica ldNew Drug Application2020-06-19
accutaneANDA2022-08-09
amnesteemANDA2019-08-07
claravisANDA2018-05-30
isotretinoinANDA2023-05-23
myorisanANDA2020-11-23
sotret2006-11-07
zenataneANDA2019-01-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
leukemia—D007938C95
neuroblastomaEFO_0000621D009447—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Isotretinoin, Absorica Ld, Sun Pharm
97005352035-08-04DP
97507112035-05-29DP
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
141 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 vulgarisD000152EFO_0003894L705317520
Covid-19D000086382U07.11421—8
Proliferative vitreoretinopathyD018630EFO_1001129———1—1
Seborrheic dermatitisD012628L21———1—1
Second primary neoplasmsD016609———1—1
Acneiform eruptionsD017486EFO_1000662———1—1
Olfaction disordersD000857R43.0———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_000062111208—440
RetinoblastomaD0121753—2——5
Lung neoplasmsD008175C34.90—31—15
GanglioneuroblastomaD018305121——4
Central nervous system neoplasmsD016543—12——3
Hiv infectionsD015658EFO_0000764B20111——3
Brain neoplasmsD001932EFO_0003833C71111——3
MedulloblastomaD0085272—1——3
Head and neck neoplasmsD006258—11——2
Kidney neoplasmsD007680EFO_0003865C64111——2
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_000051532———4
Myelomonocytic leukemia juvenileD054429C93.321———3
LeukemiaD007938C9523———3
Prostatic neoplasmsD011471C61—2———2
Myelodysplastic syndromesD009190D4621———2
Drug-related side effects and adverse reactionsD064420T88.7—1——12
Lamellar ichthyosisD017490Q80—2———2
Uterine cervical neoplasmsD002583—2———2
Plasma cell neoplasmsD054219—1———1
TineaD014005EFO_0007510B35.4—1———1
Show 20 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—5————5
NeoplasmsD009369C803————3
Myeloid leukemia acuteD015470C92.02————2
Breast neoplasmsD001943EFO_0003869C501———12
Non-hodgkin lymphomaD008228C85.92————2
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.02————2
Burkitt lymphomaD002051C83.72————2
Lymphomatoid granulomatosisD008230C83.82————2
GliomaD005910EFO_00005201————1
GliosarcomaD0183161————1
Show 20 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Malformed nailsD009264Q84.5————11
Vitamin d deficiencyD014808EFO_0003762E55————11
Musculoskeletal diseasesD009140————11
Stevens-johnson syndromeD013262EFO_0004276L51.1————11
Hepatic insufficiencyD048550————11
MelanomaD008545————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameISOTRETINOIN
INNisotretinoin
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 classretinol 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-ID4759-48-2
RxCUI6064
ChEMBL IDCHEMBL547
ChEBI ID6067
PubChem CID5282379
DrugBankDB00982
UNII IDEH28UP18IF (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Accutane - Fortress Biotech, Inc.
$
€
£
₣
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Accutane - Journey Medical
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,012 documents
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Safety
Black-box Warning
Black-box warning for: Absorica absorica ld, Accutane, Amnesteem, Isotretinoin, Sotret, Zenatane
Adverse Events
Top Adverse Reactions
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891 adverse events reported
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