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Scenesse(afamelanotide)
Scenesse (afamelanotide) is a protein pharmaceutical. Afamelanotide was first approved as Scenesse on 2014-12-22. It is used to treat erythropoietic protoporphyria in the USA. It has been approved in Europe to treat erythropoietic protoporphyria. It is known to target melanocyte-stimulating hormone receptor, melanocortin receptor 3, melanocortin receptor 4, and melanocortin receptor 5.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
hereditary congenital and neonatal diseases and abnormalitiesD009358
skin and connective tissue diseasesD017437
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Scenesse
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Afamelanotide
Tradename
Company
Number
Date
Products
SCENESSEClinuvel PharmaceuticalsN-210797 RX2019-10-08
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
scenesseNew Drug Application2023-01-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
erythropoietic protoporphyriaD046351E80.0
Agency Specific
FDA
EMA
Expiration
Code
AFAMELANOTIDE, SCENESSE, CLIVUNEL INC
2026-10-08ODE-270
2024-10-08NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Afamelanotide, Scenesse, Clivunel Inc
83342652029-03-11U-2638
100765552025-02-11U-2638
ATC Codes
D: Dermatologicals
D02: Emollients and protectives
D02B: Protectives against uv-radiation
D02BB: Protectives against uv-radiation for systemic use
D02BB02: Afamelanotide
HCPCS
Code
Description
J7352
Afamelanotide implant, 1 mg
Clinical
Clinical Trials
21 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Erythropoietic protoporphyriaD046351E80.0145
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VitiligoD014820EFO_0004208L80134
Xeroderma pigmentosumD014983Q82.122
Squamous cell neoplasmsD01830711
Actinic keratosisD055623L57.011
Acne vulgarisD000152EFO_0003894L7011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients11
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAFAMELANOTIDE
INNafamelanotide
Description
Afamelanotide, sold under the brand name Scenesse, is a medication used to prevent phototoxicity and to reduce pain from light exposure for people with erythropoietic protoporphyria. It is a melanocortin 1 receptor (MC1-R) agonist and a synthetic peptide and analogue of α-melanocyte stimulating hormone. It is administered as subcutaneous implant.
Classification
Protein
Drug classpeptides: melanocortin receptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCC[C@H](NC(=O)[C@H](CO)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(C)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]cn1)C(=O)N[C@H](Cc1ccccc1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N1CCC[C@H]1C(=O)N[C@H](C(N)=O)C(C)C
Identifiers
PDB
CAS-ID75921-69-6
RxCUI
ChEMBL IDCHEMBL441738
ChEBI ID
PubChem CID16197727
DrugBankDB04931
UNII IDQW68W3J66U (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
MC1R
MC1R
MC3R
MC3R
MC4R
MC4R
MC5R
MC5R
Organism
Homo sapiens
Gene name
MC1R
Gene synonyms
MSHR
NCBI Gene ID
Protein name
melanocyte-stimulating hormone receptor
Protein synonyms
alpha melanocyte stimulating hormone receptor, MC1-R, Melanocortin receptor 1, melanotropin receptor
Uniprot ID
Mouse ortholog
Mc1r (17199)
melanocyte-stimulating hormone receptor (Q75NA3)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 206 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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4,888 adverse events reported
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