Weight LossFDA ApprovedFDA Approved

Setmelanotide

Also known as Imcivree, RM-493

An MC4R agonist for rare genetic obesity disorders. FDA approved for specific gene mutations causing obesity.

FDA Approved - Specific genetic obesities (POMC, PCSK1, LEPR deficiency)

Regulatory Pathway

Preclinical
Phase I
Phase II
Phase III
Phase IV
Approved

Dosing Protocol

Typical Dose

2-3 mg daily

Frequency

Once daily

Duration

Long-term / chronic use

Community-reported dosing. Individual results vary. Not a medical recommendation.
Typical community protocol: 2-3 mg daily via Subcutaneous injection daily, Once daily. Dose range: 1-3 mg daily. Duration: Long-term / chronic use.

Timing & Administration

Administer via Subcutaneous injection daily. Frequency: Once daily.

Mechanism of Action

Activates melanocortin-4 receptors (MC4R) in the hypothalamus, restoring the satiety signaling pathway that is disrupted in certain genetic obesity syndromes. Works downstream of leptin signaling.

Research Summary

Evidence level: fda approved. Clinical status: FDA Approved - Specific genetic obesities (POMC, PCSK1, LEPR deficiency).

Side Effects & Safety

Important Warnings

  • Prescription only; intended for specific genetic obesity conditions
Skin hyperpigmentation (67-83%)
injection site reactions
nausea
spontaneous erections in males
priapism risk
depression risk

References

No references available.