Clinical Trials
87
54 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
54
62.1%
Completed
26
29.9%
Recruiting
2
2.3%
Terminated
3
3.5%
Withdrawn
2
2.3%
No approval data available
- Japan's Ministry of Health, Labour and Welfare approved WAKIX (pitolisant) for narcolepsy types 1 and 2 and for excessive daytime sleepiness associated with obstructive sleep apnea syndrome. - WAKIX becomes the first histamine H3 receptor antagonist/inverse agonist approved in Japan for these indications and is not classified as a controlled substance. - Approval was supported by positive domestic Phase 3 trial data in Japan plus international studies in narcolepsy and in OSAS patients with residual sleepiness on CPAP. - Viatris holds Japan-only licensing rights to pitolisant, which was discovered by Bioprojet and is already approved in more than 38 countries for narcolepsy.
- Harmony Biosciences reported Phase 1 SAD data for BP-205 showing favorable PK with ~25h half-life and Tmax of 30–75 minutes, supporting once-daily dosing and rapid onset. - BP-205 demonstrated a clean safety profile with no serious TEAEs; most common AEs were headache (~10%), fatigue (~4%), and diarrhea (~3%). - The company will initiate Phase 1b in sleep-deprived volunteers in Q3 2026 and Phase 2 trials across multiple CNS indications in mid-2027. - WAKIX net revenue reached a record $261.3 million in Q2 2026, up 30% year-over-year, with full-year guidance reiterated at $1.0–$1.04 billion.
- Harmony Biosciences reached a settlement agreement with Lupin Limited that prevents generic competition for WAKIX until January 2030, strengthening the company's intellectual property position for its narcolepsy treatment. - The settlement resolves patent infringement litigation related to Lupin's generic application and reinforces the validity of Harmony's patent portfolio protecting pitolisant hydrochloride formulations. - Harmony is advancing next-generation pitolisant formulations with utility patents potentially extending exclusivity to 2044, while continuing to defend against other generic challengers seeking WAKIX approval.
- Harmony Biosciences receives FDA Refusal to File letter for pitolisant's supplemental New Drug Application in adult idiopathic hypersomnia patients with excessive daytime sleepiness. - Phase 3 INTUNE study failed to meet primary endpoint for statistical significance, despite showing clinically meaningful improvements in patient wakefulness during open-label phase. - Company plans to proceed with new Phase 3 registrational trial for Pitolisant HD formulation in Q4 2025, targeting PDUFA date in 2028.
