PITOLISANT · ANNORA PHARMA PRIVATE LIMITED
Development Insights
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- N/A
- Dosage Forms
- TABLET
PITOLISANT Approval History
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07219485 | HBS-101-CL-314 | Ph 3 | enrolling by invitation | A Study of Pitolisant in Participants With Prader-Willi Syndrome |
| NCT05458128 | HBS-101-CL-011 | Ph 3 | completed | A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia |
| NCT05953389 | P21-01 / BF2.649 | Ph 2 | active not recruiting | Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents |
| NCT02611687 results posted | P11-06/BF2.649 2013-001506-29 | Ph 3 | completed | Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period |
| NCT04596267 results posted | H-40959 1R21AA028864-01 | Ph 1 | terminated | Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers |
| NCT05223166 | RSPIT32101 | Ph 3 | completed | A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA |
| NCT04026750 results posted | FPITO-T1D-01.01 | Ph 1 | terminated | Insulin Tolerance Test Study in Patients With Type 1 Diabetes |
| NCT03152123 | P16-02 / BF2.649 | Ph 1 | completed | Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users |
| NCT02929342 | P15-02 / Pitolisant 2016-000748-32 | Ph 1 | completed | Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers |
| NCT01800045 | P11-05 / Pitolisant 2012-003076-39 | Ph 3 | completed | Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP) |
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.
PITOLISANT FDA Label Details
Track PITOLISANT with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment