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 12h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
WAKIX (pitolisant hydrochloride) is an oral small-molecule histamine H3-receptor antagonist approved in 2019 for narcolepsy type 1. It works by blocking H3 receptors in the brain to increase histamine signaling, promoting wakefulness. The drug addresses a significant unmet need in a rare neurological disorder with limited treatment options.
$0.101BPart D
Peak3.3 years to LOEWAKIX is in peak commercial phase with strong Part D spending; commercial teams are actively scaling specialty sales and management infrastructure to capture market share.
Mechanism 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.