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Imcivree FDA Approval History

Last updated by Judith Stewart, BPharm on June 16, 2022.

FDA Approved: Yes (First approved November 25, 2020)
Brand name: Imcivree
Generic name: setmelanotide
Dosage form: Injection
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.

  • Imcivree is indicated for chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic 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).
    • Bardet-Biedl syndrome (BBS).
  • Imcivree is administered subcutaneously once daily.
  • Imcivree warnings and precautions include disturbance in sexual arousal, depression and suicidal ideation, and skin pigmentation and darkening of pre-existing nevi.
  • Common adverse reactions include skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

Development timeline for Imcivree

DateArticle
Jun 16, 2022Approval Rhythm Pharmaceuticals Announces FDA Approval of Imcivree (setmelanotide) for Use in Patients with Bardet-Biedl Syndrome
Nov 27, 2020Approval FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
Jul  1, 2020Rhythm Pharmaceuticals Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Setmelanotide for Treatment of POMC and LEPR Deficiency Obesities
May 13, 2020Rhythm Pharmaceuticals Announces FDA Acceptance of New Drug Application for Setmelanotide for the Treatment of POMC and LEPR Deficiency Obesities
Mar 30, 2020Rhythm Pharmaceuticals Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Setmelanotide in POMC and LEPR Deficiency Obesities
Mar 18, 2020Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome
Dec 13, 2018Rhythm Pharmaceuticals Announces First Patient Enrolled in Pivotal Phase 3 Clinical Trial Evaluating Setmelanotide in Bardet-Biedl and Alström Syndromes
Jun 14, 2018Rhythm Pharmaceuticals Completes Pivotal Enrollment in Two Ongoing Phase 3 Clinical Trials Evaluating Setmelanotide in Rare Genetic Disorders of Obesity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.