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 melanocortin receptor 4, melanocyte-stimulating hormone receptor, melanocortin receptor 3, and melanocortin receptor 5.
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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 | 2024-08-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| erythropoietic protoporphyria | — | D046351 | E80.0 |
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
23 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 protoporphyria | D046351 | — | E80.0 | 1 | 2 | 4 | — | — | 6 |
| Vitiligo | D014820 | EFO_0004208 | L80 | 1 | 3 | 1 | — | — | 5 |
| Contact dermatitis | D003877 | — | L25 | — | — | 1 | — | 1 | 2 |
| Exanthema | D005076 | — | — | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Xeroderma pigmentosum | D014983 | — | Q82.1 | — | 2 | — | — | — | 2 |
| Ichthyosis | D007057 | — | E50.8 | — | 2 | — | — | — | 2 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | — | — | 1 |
| Solar urticaria | D000092130 | — | L56.3 | — | 1 | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | — | 1 | — | — | — | 1 |
| Squamous cell neoplasms | D018307 | — | — | — | 1 | — | — | — | 1 |
| Organ transplantation | D016377 | — | — | — | 1 | — | — | — | 1 |
| Actinic keratosis | D055623 | — | L57.0 | — | 1 | — | — | — | 1 |
| Keratosis | D007642 | — | — | — | 1 | — | — | — | 1 |
| Ischemic stroke | D000083242 | — | — | — | 1 | — | — | — | 1 |
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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 is a polypeptide comprising of 13 amino acids which is an analogue of alpha-melanocyte stimulating hormone. It is approved as a dermatologic drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria. It has a role as a dermatologic drug. |
| 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 | 16154396 |
| DrugBank | DB04931 |
| UNII ID | QW68W3J66U (ChemIDplus, GSRS) |
Target
Variants
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Safety
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21 adverse events reported
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