NDAORALTABLETPriority Review
Approved
Aug 2019
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WAKIX (pitolisant hydrochloride) is an oral tablet approved by the FDA in August 2019 for the treatment of narcolepsy. As a histamine H3-receptor antagonist/inverse agonist, it works by increasing histamine levels in the brain to promote wakefulness. WAKIX is currently in its peak lifecycle stage and represents an important therapeutic option in the narcolepsy treatment landscape, addressing excessive daytime sleepiness and cataplexy in patients.
$0.1BPart D
3.8 years to LOEMechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
WAKIX® (Pitolisant) Pregnancy Registry
Started Aug 2021
1,329 enrolled
Pregnancy RelatedNarcolepsy
Why This Matters for Your Career
LOE in ~4 years — strategic planning for patent cliff underway
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.