New FDA Approvals: FDA Approves Cycle’s Harliku

Jul 17
Jul 17, 2025

June 10: The FDA approved Cycle Pharmaceuticals Ltd.’s Harliku (nitisinone) for the reduction of urine homogentisic acid in adults with alkaptonuria (AKU), an ultra-rare hereditary disorder also known as black urine disease. It is the first FDA-approved treatment for AKU. The agency first approved the hydroxyphenyl-pyruvate dioxygenase inhibitor as Nityr on July 26, 2017, for a different indication. Recommended dosing of the tablet is 2 mg once daily. The drug is launching in July.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.