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Trifarotene
Aklief (trifarotene) is a small molecule pharmaceutical. Trifarotene was first approved as Aklief on 2019-10-04. It is used to treat acne vulgaris in the USA. The pharmaceutical is active against retinoic acid receptor gamma. In addition, it is known to target retinoic acid receptor beta and retinoic acid receptor alpha.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Aklief
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Trifarotene
Tradename
Company
Number
Date
Products
AKLIEFGaldermaN-211527 RX2019-10-04
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
akliefNew Drug Application2020-05-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acne vulgarisEFO_0003894D000152L70
Agency Specific
FDA
EMA
Expiration
Code
TRIFAROTENE, AKLIEF, GALDERMA LABS LP
2024-10-04NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Trifarotene, Aklief, Galderma Labs Lp
90847782033-05-30DPU-134
94984652033-05-30DPU-1033
78077082031-07-19DS, DP
82275072025-12-21U-818
84708712025-12-21U-2639
ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AD: Retinoids for topical use in acne
— D10AD06: Trifarotene
HCPCS
No data
Clinical
Clinical Trials
11 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acne vulgarisD000152EFO_0003894L70—153—9
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lamellar ichthyosisD017490Q80—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTRIFAROTENE
INNtrifarotene
Description
Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris. It is a retinoid; more specifically, it is a fourth generation selective retinoic acid receptor (RAR)-γ agonist.
Classification
Small molecule
Drug classarotinoid derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)c1cc(-c2cc(-c3ccc(C(=O)O)cc3)ccc2OCCO)ccc1N1CCCC1
Identifiers
PDB—
CAS-ID895542-09-3
RxCUI2205637
ChEMBL IDCHEMBL3707313
ChEBI ID—
PubChem CID11518241
DrugBankDB12808
UNII ID0J8RN2W0HK (ChemIDplus, GSRS)
Target
Agency Approved
RARG
RARG
Organism
Homo sapiens
Gene name
RARG
Gene synonyms
NR1B3
NCBI Gene ID
5916
Protein name
retinoic acid receptor gamma
Protein synonyms
Nuclear receptor subfamily 1 group B member 3, RAR-gamma
Uniprot ID
Q9UJ38
Mouse ortholog
Rarg (19411)
retinoic acid receptor gamma (P18911)
Alternate
RARB
RARB
RARA
RARA
Organism
Homo sapiens
Gene name
RARB
Gene synonyms
HAP, NR1B2
NCBI Gene ID
5915
Protein name
retinoic acid receptor beta
Protein synonyms
HBV-activated protein, hepatitis B virus activated protein, Nuclear receptor subfamily 1 group B member 2, RAR-beta, RAR-epsilon, retinoic acid receptor, beta polypeptide
Uniprot ID
P10826
Mouse ortholog
Rarb (218772)
retinoic acid receptor beta (P22605)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 74 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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