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
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 |
---|---|---|---|---|
SCENESSE | Clinuvel Pharmaceuticals | N-210797 RX | 2019-10-08 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
scenesse | New Drug Application | 2023-01-12 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
AFAMELANOTIDE, SCENESSE, CLIVUNEL INC | |||
2026-10-08 | ODE-270 | ||
2024-10-08 | NCE |
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 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | AFAMELANOTIDE |
INN | afamelanotide |
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 class | peptides: 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-ID | 75921-69-6 |
RxCUI | — |
ChEMBL ID | CHEMBL441738 |
ChEBI ID | — |
PubChem CID | 16197727 |
DrugBank | DB04931 |
UNII ID | QW68W3J66U (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:
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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
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4,888 adverse events reported
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