Narcolepsy
Sleep 2 original drugsSleep indication. Narcolepsy has 2 FDA-approved novel treatments, led by HARMONY, with 19 active industry clinical trials across 4 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.
Narcolepsy Market Leaders
Companies with the most FDA-approved novel Narcolepsy drugs.
Phase 3 Readouts Pro
8 active Phase 3 trials with confidence-graded completion dates.
Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Narcolepsy Treatments by Mechanism
Top 2 mechanisms across 4 industry trials with a known mechanism of action.
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Narcolepsy Clinical Pipeline by Phase
70 industry-sponsored trials across 25 sponsors
Novel Narcolepsy Drugs by Company (New molecular entities)
2 companies have an FDA-approved novel drug for Narcolepsy.
Reformulations (18 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Narcolepsy Drug Targets
Molecular targets of approved and investigational Narcolepsy drugs — 4 targets tracked.
Generic Drugs (4 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs