Cycle Pharmaceuticals’ Harliku (nitisinone) tablets receive first FDA approval as treatment for alkaptonuria

Cycle Pharmaceuticals

19 June 2025 - Cycle Pharmaceuticals announced that the FDA has approved Harliku (nitisinone) tablets for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

The approval of Harliku is based on data from a randomised, no-treatment controlled study of 40 patients with alkaptonuria.

Read Cycle Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration