afamelanotide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 4836 | 75921-69-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
observations suggest that afamelanotide has beneficial effects in patients with erythropoietic protoporphyria, induces epidermal melanin formation
|
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 12, 2014 | EMA | Clinuvel UK Limited | |
| Oct. 8, 2019 | FDA | CLIVUNEL INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D02BB02 | DERMATOLOGICALS EMOLLIENTS AND PROTECTIVES PROTECTIVES AGAINST UV-RADIATION Protectives against UV-radiation for systemic use |
| MeSH PA | D003879 | Dermatologic Agents |
| CHEBI has role | CHEBI:50177 | dermatologic agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Erythropoietic protoporphyria | indication | 51022005 | DOID:13270 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.97 | acidic |
| pKa2 | 9.65 | acidic |
| pKa3 | 12.35 | acidic |
| pKa4 | 12.93 | acidic |
| pKa5 | 13.04 | acidic |
| pKa6 | 13.35 | acidic |
| pKa7 | 13.52 | acidic |
| pKa8 | 13.72 | acidic |
| pKa9 | 11.08 | Basic |
| pKa10 | 10.48 | Basic |
| pKa11 | 6.69 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 16MG | SCENESSE | CLIVUNEL INC | N210797 | Oct. 8, 2019 | RX | IMPLANT | SUBCUTANEOUS | 10076555 | Feb. 11, 2025 | INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) |
| 16MG | SCENESSE | CLIVUNEL INC | N210797 | Oct. 8, 2019 | RX | IMPLANT | SUBCUTANEOUS | 8334265 | March 11, 2029 | INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 16MG | SCENESSE | CLIVUNEL INC | N210797 | Oct. 8, 2019 | RX | IMPLANT | SUBCUTANEOUS | Oct. 8, 2024 | NEW CHEMICAL ENTITY |
| 16MG | SCENESSE | CLIVUNEL INC | N210797 | Oct. 8, 2019 | RX | IMPLANT | SUBCUTANEOUS | Oct. 8, 2026 | INDICATED TO INCREASE PAIN FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Melanocyte-stimulating hormone receptor | GPCR | AGONIST | IC50 | 10 | IUPHAR | DRUG LABEL | |||
| Melanocortin receptor 4 | GPCR | AGONIST | Ki | 8.80 | IUPHAR | ||||
| Melanocortin receptor 5 | GPCR | AGONIST | IC50 | 9 | IUPHAR | ||||
| Melanocortin receptor 3 | GPCR | AGONIST | Ki | 8.90 | IUPHAR | ||||
| Adenosine deaminase | Enzyme | Ki | 7.80 | CHEMBL | |||||
| Melanocortin receptor 5 | GPCR | EC50 | 10.15 | CHEMBL | |||||
| Melanocortin receptor 4 | GPCR | EC50 | 9.92 | CHEMBL | |||||
| Melanocyte-stimulating hormone receptor | GPCR | EC50 | 11 | CHEMBL | |||||
| Melanocortin receptor 3 | GPCR | EC50 | 10.15 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| QW68W3J66U | UNII |
| D10511 | KEGG_DRUG |
| 4039222 | VANDF |
| C2607750 | UMLSCUI |
| CHEBI:136034 | CHEBI |
| CHEMBL441738 | ChEMBL_ID |
| 16197727 | PUBCHEM_CID |
| DB04931 | DRUGBANK_ID |
| CHEMBL4297213 | ChEMBL_ID |
| 9010 | INN_ID |
| C534526 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1324 | IUPHAR_LIGAND_ID |
| 2262250 | RXNORM |
| 324953 | MMSL |
| d09393 | MMSL |
| 018187 | NDDF |
| 819968004 | SNOMEDCT_US |
| 819984003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SCENESSE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73372-0116 | IMPLANT | 16 mg | SUBCUTANEOUS | NDA | 14 sections |
| SCENESSE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73372-0116 | IMPLANT | 16 mg | SUBCUTANEOUS | NDA | 14 sections |
| SCENESSE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73850-0116 | IMPLANT | 16 mg | SUBCUTANEOUS | Unapproved drug for use in drug shortage | 13 sections |