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Cycle-length evidence

Setmelanotide cycle length: what human studies ran

Short answer: Setmelanotide has no "cycle". As an approved drug it is used as its label and a prescriber direct.

Treatment and follow-up in human studies

No human study durations are recorded.

What has not been tested

  • On-and-off schedules or breaks between courses.
  • Repeated courses and long-term exposure beyond the periods listed.
  • Setmelanotide combined with other compounds, unless a study above says so.

Frequently asked questions

Is there an established Setmelanotide cycle length?
No cycle is defined. Setmelanotide is an approved drug whose label describes treatment under a prescriber's care; the label, not a cycle, governs duration.
What is the longest human study of Setmelanotide?
None is recorded.
Do study durations tell me how long to use something?
No. A study duration is how long investigators administered a compound to selected participants under monitoring. It is not a recommended course, and a break between courses has not been tested for any compound on this site that is not approved.

References

  1. IMCIVREE (setmelanotide) injection, prescribing information (DailyMed SPL version 14, published Apr 02, 2026) FDA label (DailyMed). 2026
  2. Drugs@FDA application NDA 213793 (IMCIVREE, Rhythm; original approval 2020-11-25) via openFDA FDA (openFDA Drugs@FDA). 2026
  3. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials Lancet Diabetes Endocrinol. 2020
  4. Efficacy and safety of setmelanotide, a melanocortin-4 receptor agonist, in patients with Bardet-Biedl syndrome and Alström syndrome: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial with an open-label period Lancet Diabetes Endocrinol. 2022
  5. Setmelanotide for the Treatment of Acquired Hypothalamic Obesity N Engl J Med. 2026
  6. Tractatenblad 2026 Nr. 25: Anti-doping convention (ETS No. 135), amendment to the appendix - The 2026 Prohibited List, World Anti-Doping Code (English text; entry into force 1 January 2026) Tractatenblad van het Koninkrijk der Nederlanden (official government publication). 2026
  7. PubChem compound record for setmelanotide (CID 11993702) PubChem. 2026