Wednesday, July 8, 2026
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Drug profile · INN

setmelanotide acetate

IMCIVREE

setmelanotide acetate (IMCIVREE) is a melanocortin receptor 4 agonist. Associated with Rhythm Pharmaceuticals Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 11
Pipeline programs 14
News articles 1
Drug details — setmelanotide acetate
US status
approved
Class
—
Route
SUBCUTANEOUS
Patents
11
Programs
14
Data quality
0.89
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Quick answer

setmelanotide acetate (IMCIVREE) is a melanocortin receptor 4 agonist. Associated with Rhythm Pharmaceuticals Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

Key facts

INN setmelanotide acetate
Brand IMCIVREE
Mechanism Melanocortin receptor 4 agonist
Target Melanocortin receptor 4
Route SUBCUTANEOUS
Formulation SOLUTION
Originator Rhythm Pharmaceuticals Netherlands B.V.

Mechanism of action

Melanocortin receptor 4 agonist

Primary target: Melanocortin receptor 4

Approval history

Authority Status Date
FDA approved —

Recent coverage

View all news
Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity
High impact NewsRare neuroendocrine diseases / ObesityMay 2, 2026

Rhythm Pharmaceuticals' IMCIVREE Receives European Commission Approval for Acquired Hypothalamic Obesity

Rare neuroendocrine diseases / Obesity · 3 min

IMCIVREE becomes first therapy approved in both US and Europe for acquired hypothalamic obesity, targeting adults and children 4+ with hypothalamic injury.

Dr. Emily Carter

Pipeline programs

Search pipeline Sponsor programs
  1. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Pro-opiomelanocortin (POMC) Deficiency Obesity
  2. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Bardet Biedl Syndrome (BBS)
  3. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Hypothalamic Obesity
  4. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Leptin Receptor Deficiency Obesity
  5. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Obesity
  6. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Obesity Associated With Defects in Leptin-melanocortin Pathw
  7. Setmelanotide Phase 3 · Rhythm Pharmaceuticals Netherlands · Bardet-Biedl Syndrome
  8. Setmelanotide Phase 2 · Rhythm Pharmaceuticals Netherlands · Genetic Obesity

Related & competitor drugs

Browse all drugs
  1. setmelanotide Alimentary tract and metabolism (A08)
  2. bremelanotide acetate Melanocortin receptor 4 agonist

Related patents

Browse patents Rhythm Pharmaceuticals Netherlands B.V. patent hub

  1. US 12285460

    Pharmaceutical compositions

    Expires Mon Apr 24 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 12263202

    Method of treating melanocortin-4 receptor pathway-associated disorders

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 12077612

    Peptide compositions

    Expires Mon Aug 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 11702448

    Method of treating melanocortin-4 receptor-associated disorders in heterozygous carriers

    Expires Mon Jul 13 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 11129869

    Pharmaceutical compositions

    Expires Mon Sep 23 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 10960046

    Method of treating melanocortin-4 receptor pathway-associated disorders

    Expires Mon Mar 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 10954268

    Method of treating melanocortin-4 receptor-associated disorders in heterozygous carriers

    Expires Mon Mar 18 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 10858399

    Peptide compositions

    Expires Mon Dec 03 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 10196425

    Peptide compositions

    Expires Mon Jan 31 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 10167312

    Method of treating melanocortin-4 receptor-associated disorders in heterozygous carriers

    Expires Mon Dec 27 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 9845339

    Method of treating melanocortin-4 receptor-associated disorders in heterozygous carriers

    Expires Mon Dec 14 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is setmelanotide acetate?

setmelanotide acetate (IMCIVREE) is a melanocortin receptor 4 agonist. Associated with Rhythm Pharmaceuticals Netherlands B.V.. Route of administration: subcutaneous. Current US regulatory status: approved.

What is the brand name for setmelanotide acetate?

IMCIVREE is a marketed brand name for setmelanotide acetate. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of setmelanotide acetate?

setmelanotide acetate has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.

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