Which narcolepsy drugs are in Phase 3?

Phase 3 (or later) programs for narcolepsy include AXS-12 (reboxetine), Oveporexton and Alixorexton.

What are the next narcolepsy trial readouts?

Upcoming catalysts include AXS-12 (reboxetine) (January 2026), TAK-360 (2H 2026), TAK-360 (2H 2026) and Alixorexton (2H 2026).

How many clinical trials are recruiting for narcolepsy?

1 drug-interventional narcolepsy trial is currently recruiting participants, out of 12 registered interventional trials.

Sleep-Wake Disorders

Narcolepsy drug pipeline

ICD-11 7A20
MeSH D009290

5 compounds from 4 companies are in active clinical development for narcolepsy, including 3 at Phase 3 or beyond.

5Compounds

4Companies

3Phase 3+

5Upcoming readouts

2Trials recruiting

Filed (NDA) 2
Phase 3 1
Phase 2 1
Discontinued 1

Mechanisms: Small molecule (5)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

January 2026AnticipatedAXS-12 (reboxetine)Regulatory
Axsome guided to completing an NDA submission to the FDA for AXS-12 for cataplexy in narcolepsy in January 2026, after the FDA confirmed via pre-NDA meeting minutes that the regulatory data package would be sufficient. ↗
2H 2026AnticipatedTAK-360Topline dataNCT06812078
Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026 ↗
2H 2026AnticipatedTAK-360Topline dataNCT06952699
Phase 2 NT2 dose-finding topline (TAK-360-2001) — estimated primary completion 20 Aug 2026 ↗
2H 2026AnticipatedAlixorextonTopline dataNCT06843590
Vibrance-3 Phase 2 topline results anticipated in idiopathic hypersomnia (primary endpoint ESS at Week 8). ↗
May 2027AnticipatedAlixorextonTopline dataNCT07455383
Phase 3 Brilliance NT1 (Study 302) topline anticipated, evaluating the primary MWT endpoint at Week 12 in narcolepsy type 1. ↗
2026-02-10ReportedOveporextonRegulatory
FDA accepted the oveporexton NDA for narcolepsy type 1 and granted Priority Review, with a PDUFA target action date in Q3 2026. ↗
2025-11-12ReportedAlixorextonTopline datametNCT06555783
Vibrance-2 Phase 2 study in narcolepsy type 2 met the primary MWT endpoint at 14 mg and 18 mg, with ESS significant at 18 mg (p<0.05 adjusted). ↗
2025-07-14ReportedOveporextonTopline datametNCT06470828
Phase 3 FirstLight and RadiantLight pivotal studies met all primary and key secondary endpoints (p<0.001) at week 12. ↗
2025-07-09ReportedAlixorextonTopline datametNCT06358950
Vibrance-1 Phase 2 study in narcolepsy type 1 met the primary MWT endpoint across all doses (4, 6, 8 mg) with statistically significant, dose-dependent improvements in wakefulness vs placebo. ↗

See the full catalyst calendar →

Compounds in development (5)

Compound	Company	Phase	Status	Mechanism
AXS-12 (reboxetine)Orphan	Axsome Therapeutics, Inc.	Filed (NDA)	Active	NET Reuptake inhibitor
OveporextonBTDPriority Review	Takeda Pharmaceutical Company Limited	Filed (NDA)	Active	OX2R Agonist
AlixorextonBTDOrphan	Alkermes plc	Phase 3	Active	OX2R Agonist
TAK-360Fast Track	Takeda Pharmaceutical Company Limited	Phase 2	Recruiting	OX2 receptor Agonist
Enerisant (TS-091)	OOTEMON Co., Ltd.	Discontinued	Discontinued	H3 receptor Inverse agonist

Trials recruiting now (1)

1 drug-interventional narcolepsy trial recruiting now, of 12 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 3A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 302)
ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo
Alkermes plcn=150Canada, United States · 17 sitesStarted Apr 2026Tracked: Alixorexton NCT07455383

Frequently asked

How many drugs are in development for narcolepsy?: 5 compounds from 4 companies are in active clinical development for narcolepsy, including 3 at Phase 3 or beyond.
Which narcolepsy drugs are in Phase 3?: Phase 3 (or later) programs for narcolepsy include AXS-12 (reboxetine), Oveporexton and Alixorexton.
What are the next narcolepsy trial readouts?: Upcoming catalysts include AXS-12 (reboxetine) (January 2026), TAK-360 (2H 2026), TAK-360 (2H 2026) and Alixorexton (2H 2026).
How many clinical trials are recruiting for narcolepsy?: 1 drug-interventional narcolepsy trial is currently recruiting participants, out of 12 registered interventional trials.