Melanocortin-system peptides
Setmelanotide
Also known as Imcivree · RM-493
A melanocortin-4 receptor agonist approved for rare genetic obesities caused by defects in the leptin–melanocortin pathway.
In 60 seconds
Approved (2020 onward) for POMC, PCSK1 or LEPR deficiency obesity and Bardet–Biedl syndrome; studied in hypothalamic obesity. Trials report injection-site reactions and skin hyperpigmentation (an expected MC1R effect), with nausea early in treatment.
- Summarises setmelanotide’s development and first approval for POMC, PCSK1 or LEPR deficiency obesity.
- Phase 3 trials measured weight and hunger changes with setmelanotide in LEPR or POMC deficiency.
- A phase 3 trial of setmelanotide in Bardet–Biedl and Alström syndromes.
Mechanism
MC4R neurons integrate leptin and POMC signals to regulate hunger and energy expenditure. Setmelanotide restores MC4R signalling when an upstream gene (POMC, PCSK1, LEPR) is defective.
Research status
Approved (2020 onward) for POMC, PCSK1 or LEPR deficiency obesity and Bardet–Biedl syndrome; studied in hypothalamic obesity.
Key studies
Summarises setmelanotide’s development and first approval for POMC, PCSK1 or LEPR deficiency obesity.
Setmelanotide: First Approval — Drugs, 2021 · PMID 33638809
Phase 3 trials measured weight and hunger changes with setmelanotide in LEPR or POMC deficiency.
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 · PMID 33137293
A phase 3 trial of setmelanotide in Bardet–Biedl and Alström syndromes.
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 · PMID 36356613
A phase 2 open-label trial in hypothalamic obesity after hypothalamic damage.
Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial — Lancet Diabetes Endocrinol, 2024 · PMID 38697184
Safety signals in the literature
Trials report injection-site reactions and skin hyperpigmentation (an expected MC1R effect), with nausea early in treatment.
Legal status (South Africa)
Melanocortin-agonist peptides such as melanotan are named in SAHPRA warnings; registered melanocortin medicines are prescription-only. Research use only.
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Comparisons
Questions
What is Setmelanotide?
A melanocortin-4 receptor agonist approved for rare genetic obesities caused by defects in the leptin–melanocortin pathway. MC4R neurons integrate leptin and POMC signals to regulate hunger and energy expenditure. Setmelanotide restores MC4R signalling when an upstream gene (POMC, PCSK1, LEPR) is defective.
What is the research status of Setmelanotide?
Approved (2020 onward) for POMC, PCSK1 or LEPR deficiency obesity and Bardet–Biedl syndrome; studied in hypothalamic obesity.
What safety signals are reported for Setmelanotide?
Trials report injection-site reactions and skin hyperpigmentation (an expected MC1R effect), with nausea early in treatment.
Does Living Water Labs stock Setmelanotide?
Not at present. Setmelanotide is profiled here for reference, with citations to the published literature. You can ask to be notified if we add it. Melanocortin-agonist peptides such as melanotan are named in SAHPRA warnings; registered melanocortin medicines are prescription-only. Research use only.
More in Melanocortin
Research reference only. This page summarises published literature; it is not medical advice and contains no guidance on human use. Products supplied by Living Water Labs are for laboratory research only.
