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setmelanotide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 5416 | 920014-72-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Setmelanotide is an 8 amino acid cyclic peptide analog of endogenous melanocortin peptide alpha-MSH (alpha-melanocyte stimulating hormone). It is a melanocortin 4 (MC4) receptor agonist, with 20-fold less activity at the melanocortin 3 (MC3) and melanocortin 1 (MC1) receptors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -0.732 | High | 0.84 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.871 | High | 0.84 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.514 | 10^-6 cm/s | High | 0.84 |
| dh-clint | Dog hepatocyte intrinsic clearance | 1.528 | uL/min/10^6 cells | High | 0.84 |
| dppb | Dog plasma protein binding (% unbound) | 82.420 | % | High | 0.84 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 45.640 | % | High | 0.84 |
| herg | hERG pIC50 | 4.507 | pIC50 | High | 0.84 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.009 | uL/min/10^6 cells | High | 0.84 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.540 | uL/min/mg protein | High | 0.84 |
| hppb | Human plasma protein binding (% unbound) | 78.250 | % | High | 0.84 |
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK | 18 | |||
| kinase-selectivity-class | GRK2 | 1 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.384 | High | 0.84 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 19.724 | High | 0.84 | |
| mppb | Mouse plasma protein binding (% unbound) | 75.930 | High | 0.84 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 1.871 | High | 0.84 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 80.330 | % | High | 0.84 |
| rh-clint | Rat hepatocyte intrinsic clearance | 5.164 | uL/min/10^6 cells | High | 0.84 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 80.510 | % | High | 0.84 |
| rppb | Rat plasma protein binding (% unbound) | 67.830 | % | High | 0.84 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 891.251 | uM | High | 0.84 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 25, 2020 | FDA | RHYTHM PHARMACEUTICALS INC | |
| Nov. 19, 2018 | EMA | Rhythm Pharmaceuticals Limited |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Skin hyperpigmentation | 92.68 | 47.37 | 15 | 144 | 6836 | 90621452 |
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Skin hyperpigmentation | 90.87 | 51.10 | 16 | 248 | 8680 | 110580355 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | A08AA12 | ALIMENTARY TRACT AND METABOLISM ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Centrally acting antiobesity products |
| FDA EPC | N0000193940 | Melanocortin 4 Receptor Agonist |
| FDA MoA | N0000193941 | Melanocortin 4 Receptor Agonists |
| CHEBI has role | CHEBI:74518 | anti-obesity agent |
Related Drugs by ATC class:
A08AA Centrally acting antiobesity products 15 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| BardetBiedl syndrome | indication | 5619004 | DOID:1935 |
| Obesity | indication | 414916001 | DOID:9970 |
| Pro-opiomelanocortin (POMC) deficiency | indication | 702949005 | |
| Leptin receptor (LEPR) deficiency | indication | 785722006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | Nov. 25, 2027 | INDICATED FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH OBESITY DUE TO PROOPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR LEPTIN RECEPTOR (LEPR) DEFICIENCY CONFIRMED BY GENETIC TESTING DEMONSTRATING VARIANTS IN POMC, PCSK1, OR LEPR GENES THAT ARE INTERPRETED AS PATHOGENIC, LIKELY PATHOGENIC, OR OF UNCERTAIN SIGNIFICANCE (VUS) |
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | Dec. 20, 2027 | NEW PATIENT POPULATION |
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | March 19, 2029 | TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN ADULTS AND PEDIATRIC PATIENTS AGED 4 YEARS AND OLDER WITH ACQUIRED HYPOTHALAMIC OBESITY |
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | June 16, 2029 | FOR CHRONIC WEIGHT MANAGEMENT IN ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH MONOGENIC OR SYNDROMIC OBESITY DUE TO BARDET-BIEDL SYNDROME (BBS) |
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | Dec. 20, 2031 | TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN PEDIATRIC PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WITH SYNDROMIC OR MONOGENIC OBESITY DUE TO BARDET-BIEDL SYNDROME (BBS) |
| EQ 10MG BASE/ML (EQ 10MG BASE/ML) | IMCIVREE | RHYTHM | N213793 | Nov. 25, 2020 | RX | SOLUTION | SUBCUTANEOUS | Dec. 20, 2031 | TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN PEDIATRIC PATIENTS AGED 2 YEARS TO LESS THAN 6 YEARS WITH SYNDROMIC OR MONOGENIC OBESITY DUE TO PRO-OPIOMELANOCORTIN (POMC), PROPROTEIN CONVERTASE SUBTILISIN/KEXIN TYPE 1 (PCSK1), OR LEPTIN RECEPTOR (LEPR) DEFICIENCY AS DETERMINED BY AN FDA-APPROVED TEST DEMONSTRATING VARIANTS IN POMC, PCSK1, OR LEPR GENES THAT ARE INTERPRETED AS PATHOGENIC, LIKELY PATHOGENIC, OR OF UNCERTAIN SIGNIFICANCE (VUS) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Melanocortin receptor 4 | GPCR | AGONIST | Kd | 8.68 | DRUG LABEL | DRUG LABEL | |||
| Melanocortin receptor 5 | GPCR | AGONIST | Ki | 6.37 | IUPHAR | ||||
| Melanocortin receptor 3 | GPCR | AGONIST | Ki | 8 | IUPHAR | ||||
| Melanocyte-stimulating hormone receptor | GPCR | AGONIST | Ki | 8.41 | IUPHAR | ||||
| Melanocortin receptor 4 | GPCR | AGONIST | Ki | 8.57 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| D11927 | KEGG_DRUG |
| N7T15V1FUY | UNII |
| 2324799-41-7 | SECONDARY_CAS_RN |
| 1504602-49-6 | SECONDARY_CAS_RN |
| C4279595 | UMLSCUI |
| CHEBI:755301 | CHEBI |
| CHEMBL3301624 | ChEMBL_ID |
| 11993702 | PUBCHEM_CID |
| DB11700 | DRUGBANK_ID |
| CHEMBL4594386 | ChEMBL_ID |
| CHEMBL4650273 | ChEMBL_ID |
| 10011 | INN_ID |
| C579663 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9272 | IUPHAR_LIGAND_ID |
| 1137634006 | SNOMEDCT_US |
| 1137658005 | SNOMEDCT_US |
| 1137662004 | SNOMEDCT_US |
| 4042518 | VANDF |
| 341288 | MMSL |
| 39054 | MMSL |
| d09689 | MMSL |
| 018576 | NDDF |
| 018577 | NDDF |
| 2469247 | RXNORM |
| N7T15V1FUY | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Imcivree | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72829-010 | SOLUTION | 10 mg | SUBCUTANEOUS | NDA | 28 sections |