Which narcolepsy drugs are in Phase 3?

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

What are the next narcolepsy trial readouts?

Upcoming catalysts include TAK-360 (2H 2026), TAK-360 (FY2026 (by Mar 2027)), Alixorexton (2H 2026) and AXS-12 (reboxetine) (PDUFA May 1, 2027).

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

Phase 21

TAK-360Takeda Pharmaceutical Company LimitedOX2R Agonist

Phase 31

AlixorextonAlkermes plcOX2R Agonist

Filed (NDA)1

AXS-12 (reboxetine)Axsome Therapeutics, Inc.NET Reuptake inhibitor

Approved1

OveporextonTakeda Pharmaceutical Company LimitedOX2R Agonist

Discontinued1

Enerisant (TS-091)OOTEMON Co., Ltd.H3 receptor Inverse agonist

Mechanisms: Small molecule (5)

Pipeline data compiled September 2026 · every fact sourced.

Upcoming readouts & recent results

2H 2026AnticipatedTAK-360Topline dataNCT06812078
Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026 ↗
FY2026 (by Mar 2027)DelayedTAK-360Topline dataNCT06952699
Phase 2b NT2 dose-finding topline (TAK-360-2001, NCT06952699) — Takeda guides FY2026; CT.gov primary completion moved to 30 Nov 2026 ↗
2H 2026AnticipatedAlixorextonTopline dataNCT06843590
Vibrance-3 Phase 2 topline results anticipated in idiopathic hypersomnia (primary endpoint ESS at Week 8). ↗
PDUFA May 1, 2027AnticipatedAXS-12 (reboxetine)Regulatory
FDA PDUFA target action date for the AXS-12 NDA in cataplexy in narcolepsy ↗
May 2027AnticipatedAlixorextonTopline dataNCT07455383
Phase 3 Brilliance NT1 (Study 302) topline anticipated, evaluating the primary MWT endpoint at Week 12 in narcolepsy type 1. ↗
2026-06-15ReportedOveporextonFull resultsmet
SLEEP 2026: FirstLight/RadiantLight secondary and exploratory endpoints (function via FINI, cognition, nighttime sleep/REM) ↗
2026-05-04ReportedAXS-12 (reboxetine)Regulatorymet
AXS-12 NDA for cataplexy in narcolepsy submitted to the FDA (announced May 4, 2026) ↗
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). ↗

See the full catalyst calendar →

Compounds in development (5)

Compound	Company	Phase	Status	Mechanism
OveporextonBTDPriority Review	Takeda Pharmaceutical Company Limited	Approved	Approved	OX2R Agonist
AXS-12 (reboxetine)Orphan	Axsome Therapeutics, Inc.	Filed (NDA)	Active	NET Reuptake inhibitor
AlixorextonBTDOrphan	Alkermes plc	Phase 3	Active	OX2R Agonist
TAK-360Fast Track	Takeda Pharmaceutical Company Limited	Phase 2	Recruiting	OX2R 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 Oveporexton, AXS-12 (reboxetine) and Alixorexton.
What are the next narcolepsy trial readouts?: Upcoming catalysts include TAK-360 (2H 2026), TAK-360 (FY2026 (by Mar 2027)), Alixorexton (2H 2026) and AXS-12 (reboxetine) (PDUFA May 1, 2027).
How many clinical trials are recruiting for narcolepsy?: 1 drug-interventional narcolepsy trial is currently recruiting participants, out of 12 registered interventional trials.