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Bremelanotide
Vyleesi (bremelanotide) is a protein pharmaceutical. Bremelanotide was first approved as Vyleesi (autoinjector) on 2019-06-21. It is known to target melanocyte-stimulating hormone receptor, melanocortin receptor 5, melanocortin receptor 4, and melanocortin receptor 3.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Vyleesi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bremelanotide acetate
Tradename
Company
Number
Date
Products
VYLEESI (AUTOINJECTOR)Palatin TechnologiesN-210557 RX2019-06-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
vyleesiNew Drug Application2021-02-17
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
BREMELANOTIDE ACETATE, VYLEESI (AUTOINJECTOR), PALATIN TECHNOLOGIES
2024-06-21NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Bremelanotide Acetate, Vyleesi (Autoinjector), Palatin Technologies
115902092041-04-29U-3539
93520132033-11-05U-2568
97005922033-11-05U-2568
102860342033-11-05U-2568
67944892025-06-28DS, DP
ATC Codes
G: Genito urinary system and sex hormones
— G02: Other gynecologicals in atc
— G02C: Other gynecologicals in atc
— G02CX: Other gynecologicals in atc
— G02CX05: Bremelanotide
HCPCS
No data
Clinical
Clinical Trials
8 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
Psychological sexual dysfunctionsD020018F52.0—231—6
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N08—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NauseaD009325HP_0002018R11.01————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBREMELANOTIDE
INNbremelanotide
Description
Bremelanotide is an oligopeptide.
Classification
Protein
Drug classpeptides: melanocortin receptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCCC[C@H](NC(C)=O)C(=O)N[C@H]1CC(=O)NCCCC[C@@H](C(=O)O)NC(=O)[C@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](Cc2ccccc2)NC(=O)[C@H](Cc2c[nH]cn2)NC1=O
Identifiers
PDB—
CAS-ID189691-06-3
RxCUI2176312
ChEMBL IDCHEMBL2070241
ChEBI ID—
PubChem CID9941379
DrugBankDB11653
UNII ID6Y24O4F92S (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
MC1R
MC1R
MC5R
MC5R
MC4R
MC4R
MC3R
MC3R
Organism
Homo sapiens
Gene name
MC1R
Gene synonyms
MSHR
NCBI Gene ID
4157
Protein name
melanocyte-stimulating hormone receptor
Protein synonyms
alpha melanocyte stimulating hormone receptor, MC1-R, Melanocortin receptor 1, melanotropin receptor
Uniprot ID
Q9UN62
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 149 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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