FDA & Government News

FDA Clears Setmelanotide for Hypothalamic Obesity

First and only FDA-approved therapy showed an 18.4% placebo-adjusted BMI reduction at 52 weeks

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The FDA has approved setmelanotide (IMCIVREE) as the first treatment for acquired hypothalamic obesity, a condition caused by damage to the hypothalamus affecting weight regulation. This therapy is effective for adults and children aged 4 and older, demonstrating an 18.4% placebo-adjusted reduction in BMI over 52 weeks, according to data from the TRANSCEND trial. Common side effects include skin hyperpigmentation and nausea, with serious warnings related to adrenal insufficiency. The drug is now available in the U.S. and is supported by a patient program from Rhythm Pharmaceuticals.

Original Source(s)

FDA Clears Setmelanotide for Hypothalamic Obesity

  • by Kerri Miller

  • March 20, 2026

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