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Imcivree(setmelanotide)
Imcivree (setmelanotide) is a protein pharmaceutical. Setmelanotide was first approved as Imcivree on 2020-11-25. It has been approved in Europe to treat obesity. It is known to target melanocortin receptor 4, melanocortin receptor 3, melanocyte-stimulating hormone receptor, and melanocortin receptor 5.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nutritional and metabolic diseasesD009750
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Imcivree
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Setmelanotide acetate
Tradename
Company
Number
Date
Products
IMCIVREERhythm PharmaceuticalsN-213793 RX2020-11-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
imcivreeNew Drug Application2020-12-11
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
SETMELANOTIDE ACETATE, IMCIVREE, RHYTHM
2029-06-16ODE-402
2027-11-25ODE-336
2025-11-25NCE
2025-06-16I-892
Patent Expiration
Patent
Expires
Flag
FDA Information
Setmelanotide Acetate, Imcivree, Rhythm
111298692034-07-04DP
80394352027-10-13DS, DP
94581952027-10-13DS, DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A08: Antiobesity preparations, excl. diet products
— A08A: Antiobesity preparations, excl. diet products
— A08AA: Centrally acting antiobesity products
— A08AA12: Setmelanotide
HCPCS
No data
Clinical
Clinical Trials
21 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
Healthy volunteers/patients————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9156—110
Bardet-biedl syndromeD020788Orphanet_110Q87.89——3—14
Alstrom syndromeD056769Orphanet_64Q87.8——1——1
Propionic acidemiaD056693E71.121——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OverweightD050177E66.322———3
HypertriglyceridemiaD015228EFO_0004211—1———1
Prader-willi syndromeD011218Orphanet_739Q87.11—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Morbid obesityD009767EFO_00010741————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSETMELANOTIDE
INNsetmelanotide
Description
SETMELANOTIDE
Classification
Protein
Drug classpeptides: melanocortin receptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@H]1CSSC[C@@H](C(N)=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)NC(=O)[C@@H](C)NC1=O
Identifiers
PDB—
CAS-ID920014-72-8
RxCUI—
ChEMBL IDCHEMBL3301624
ChEBI ID—
PubChem CID11993702
DrugBankDB11700
UNII IDN7T15V1FUY (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
MC4R
MC4R
MC3R
MC3R
MC1R
MC1R
MC5R
MC5R
Organism
Homo sapiens
Gene name
MC4R
Gene synonyms
NCBI Gene ID
4160
Protein name
melanocortin receptor 4
Protein synonyms
MC4-R, mutant melanocortin-4 receptor
Uniprot ID
Q3MIJ6
Mouse ortholog
Mc4r (17202)
melanocortin receptor 4 (Q9EQM7)
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 354 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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68,187 adverse events reported
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