The Food and Drug Administration has approved Harliku (nitisinone) for the reduction of urine homogentisic acid in adult patients with alkaptonuria.

The FDA approved nitisinone (Harliku) for the reduction of urine homogentisic acid (HGA) in adults with alkaptonuria, Cycle ...

Harliku becomes the first FDA-approved treatment for alkaptonuria, indicated to reduce homogentisic acid levels in affected ...

Privately-held UK firm Cycle Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved Harliku ...

Cycle Pharmaceuticals’ Harliku ™ (nitisinone) tablets receive first FDA-approval as treatment for alkaptonuria (AKU). News release. Cycle Pharmaceuticals. June 19, 2025.

Cycle Pharmaceuticals announced that the FDA has approved HARLIKU (nitisinone) Tablets for the reduction of urine ...

Harliku is the only FDA-approved drug for alkaptonuria, a rare condition characterized by skin discoloration, arthritis and ...

Spears KR, Rossignol F, Perry MB, et al. 2024 Patient-reported outcomes and functional assessments of patients with Alkaptonuria in a 3-year Nitisinone treatment trial. Mol Genet Metab . 143(1-2 ...