Harliku FDA Approval History
FDA Approved: Yes (First approved June 19, 2025)
Brand name: Harliku
Generic name: nitisinone
Dosage form: Tablets
Company: Cycle Pharmaceuticals
Treatment for: Alkaptonuria
Harliku (nitisinone) is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU).
Development timeline for Harliku
| Date | Article |
|---|---|
| Jun 19, 2025 | Approval FDA Approves Harliku (nitisinone) for the Treatment of Patients with Alkaptonuria |
Further information
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