HARLIKU (nitisinone)
Harliku helps adult patients with alkaptonuria by lowering the levels of homogentisic acid found in their urine. This medication is used to manage the metabolic buildup associated with the condition. It is prescribed specifically for adults to address the accumulation of this acid within the tyrosine breakdown process.
How HARLIKU Works
This drug works by blocking an enzyme called hydroxyphenyl-pyruvate dioxygenase, which is located upstream in the tyrosine catabolic pathway. By inhibiting this enzyme, the medication prevents the production of homogentisic acid that would otherwise accumulate in patients.
Details
- Status
- Prescription
- First Approved
- 2017-07-26
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- TABLET
HARLIKU Approval History
What HARLIKU Treats
1 indicationsHARLIKU is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alkaptonuria
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01390077 results posted | WLN02 | Ph 2, Ph 3 | completed | Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria |
| NCT01838655 results posted | 130124 13-EI-0124 | Ph 1, Ph 2 | completed | Nitisinone for Type 1B Oculocutaneous Albinism |
| NCT02750345 results posted | CT-003 PXL227430 | Ph 1 | completed | Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1) |
| NCT02750709 results posted | CT-001 PXL225418 | Ph 1 | completed | Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin |
| NCT02750332 results posted | CT-002 PXL225421 | Ph 1 | completed | Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1) |
| NCT02323529 HT-1 | Sobi.NTBC-003 | Ph 3 | completed | Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1 |
| NCT01734889 results posted | Sobi.NTBC-002 | Ph 1 | completed | Taste and Palatability of Orfadin Suspension |
| NCT01828463 SONIA1 | UoL000928 | Ph 2 | completed | Dose Response Study of Nitisinone in Alkaptonuria |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HARLIKU FDA Label Details
Indications & Usage
FDA Label (PDF)HARLIKU is indicated for the treatment of Alkaptonuria.
HARLIKU Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for HARLIKU
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.