melanocortin-4 receptor agonist

Setmelanotide companies

Answer

Public registers name 2 licence holders, 1 ingredient maker with a drug master file, 5 bulk ingredient labelers, 1 US labeler and 4 trial sponsors for Setmelanotide.

Each row is what a register states. A company named here is not endorsed or accused by this site.

MARKETING AUTHORISATION HOLDER

2 companies

Holds the licence to sell the medicine in a country (EMA, MHRA, Health Canada).

Rhythm Pharmaceuticals Netherlands B.V.	Imcivree (EMEA/H/C/005089), Authorised Regulator EMA IMCIVREE 10 MG/ML SOLUTION FOR INJECTION, PLGB 55587/0001, Authorised Regulator MHRA
RHYTHM PHARMACEUTICALS, INC.	IMCIVREE (DIN 02537745), Marketed Regulator Health Canada

API MANUFACTURER

1 company

Filed a drug master file with FDA for the active ingredient.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTD	DMF 41490, type II, active, submitted 2025-03-28 Regulator FDA drug master file list

BULK INGREDIENT LABELER

5 companies

Lists the bulk active ingredient with FDA (NDC directory).

Apicore pharmaceuticals private limited	Setmelanotide acetate, BULK INGREDIENT Regulator openFDA
Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd.	Setmelanotide Acetate, BULK INGREDIENT Regulator openFDA
Darmerica, LLC	Setmelanotide (RM-493) Acetate, BULK INGREDIENT Regulator openFDA
POLYPEPTIDE SA	SETMELANOTIDE ACETATE, BULK INGREDIENT Regulator openFDA
Qingdao Biopeptek Co., Ltd.	Setmelanotide Acetate, BULK INGREDIENT Regulator openFDA

US LABELER

1 company

Lists a finished product with FDA (NDC directory); can be a maker, repackager or distributor.

RHYTHM PHARMACEUTICALS, INC.	Imcivree, NDA Regulator openFDA

TRIAL SPONSOR

4 companies

Sponsors registered clinical trials of the peptide.

RHYTHM PHARMACEUTICALS, INC.	1 registered trial Trial register EU CTIS 21 registered trials Trial register ClinicalTrials.gov
Massachusetts General Hospital	1 registered trial Trial register ClinicalTrials.gov
Tom Hühne	1 registered trial Trial register ClinicalTrials.gov
Universitair Medisch Centrum Utrecht	1 registered trial Trial register EU CTIS

Every company across all peptides: companies. Names are matched only when identical apart from case and punctuation, so one group can appear under two spellings. Trade between countries in all polypeptide hormones, Setmelanotide among them: trade.

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