FDA has approved HARLIKU (nitisinone) Tablets
BOSTON, Massachusetts and Cambridge, UK – June 19, 2025 – Cycle Pharmaceuticals announced that the FDA has approved HARLIKU (nitisinone) Tablets for the reduction of urine homogentisic acid (HGA) in adult patients with AKU.1
HARLIKU™ (nitisinone) Tablets are the first and only FDA-approved treatment available in the U.S. for people living with alkaptonuria (AKU).
You can learn more about how HARLIKU works, the support available for patients and families, and how to enroll by visiting: HARLIKU™ (nitisinone) Tablets | Patients
Warnings & Precautions: Ocular symptoms including keratitis (inflammation of the cornea, eye irritation, eye pain, photophobia) and hyperkeratotic plaques (thick, rough skin) due to elevated plasma tyrosine levels, leukopenia (low number of white blood cells) and severe thrombocytopenia (low levels of platelets in the blood).
Most common side effects: Elevated tyrosine levels, keratitis and thrombocytopenia. If you have any new or worsening negative side effects while taking HARLIKU™ you should immediately call your healthcare provider.
Please refer to the full Prescribing Information at: harliku.com/pi/