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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    Setmelanotide is FDA-approved for acquired hypothalamic obesity.

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    Shows a placebo-adjusted BMI reduction of 18.4%.

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    Approved for adults and children aged 4 and older.

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    Common side effects include nausea and skin hyperpigmentation.

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    Serious warnings include acute adrenal insufficiency.

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    Available immediately in the US.

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    Rhythm Pharmaceuticals offers a patient support program.

Original Source(s)

FDA Clears Setmelanotide for Hypothalamic Obesity

  • by Kerri Miller

  • March 20, 2026

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