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Diazoxide choline approved in the USA for excessive hunger in Prader-Willi syndrome

Official drug approval

A decision by a medicines regulator (FDA, European Commission, etc.). The regulator has reviewed the clinical studies behind the drug. For accelerated or conditional approvals, the lasting benefit is still being confirmed.

On March 26, 2025, the US Food and Drug Administration (FDA) approved diazoxide choline tablets for excessive hunger in Prader-Willi syndrome. The drug is for children aged 4 years and older and for adults. It is a slow-release tablet taken by mouth once a day. In the approval record, the drug is listed as a medicine for a rare disease. Blood sugar and fluid build-up in the body need to be monitored.

What does it mean for patients and families?

Excessive hunger is one of the hardest problems for families. This drug does not replace diet and close supervision. Access in Türkiye depends on TİTCK (Turkish Medicines and Medical Devices Agency) and SGK (Social Security Institution) processes.

Source

ABD Gıda ve İlaç Dairesi (FDA) – Drugs@FDA: Drugs@FDA: FDA-Approved Drugs — NDA 216665

The source page was opened and read on October 7, 2026. Summary prepared by the Doktorclub editorial team and translated from Turkish; it has not yet been reviewed by a physician (a scientific board is being set up).

This page is translated from the Turkish original.

This page reports a development; it is not a treatment recommendation. Your doctor decides whether a treatment is right for you.

The information on these pages is for general information only and does not replace medical advice. Talk to your doctor about diagnosis and treatment decisions. In an emergency in Türkiye, call 112.

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This page was translated from Turkish by the Doktorclub editorial team.