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alixorexton

Alkermes

Phase 3 Brilliance program opened 1 Apr 2026: Study 302 and Study 304 in NT1, Study 303 in NT2. Vibrance-3 continues in idiopathic hypersomnia at Phase 2.

Breakthrough TherapyEnrolling

At a glance

Known asalixorexton · ALKS 2680
SponsorAlkermes
MechanismOral orexin receptor 2 (OX2R) agonist
StagePhase 3
IndicationsNT1 · NT2 · IH
Registered trials7 · 5 recruiting
Last verified4 Aug 2026
Phase 3
NT1 · NT2 · IH

Where it stands

Alixorexton is Alkermes' oral OX2R agonist and the second programme in the class to reach Phase 3. The Brilliance programme opened on 1 April 2026 and runs three registrational studies: Study 302 and Study 304 in narcolepsy type 1, and Study 303 in narcolepsy type 2.

The result that made this programme interesting is in narcolepsy type 2. Patients with NT2 are not orexin-deficient in the way NT1 patients are, so there was a live question about whether adding orexin signalling would help them at all. Alixorexton was the first oral OX2R agonist to show efficacy in a large Phase 2 study in that population.

A separate study, Vibrance-3, continues at Phase 2 in idiopathic hypersomnia. Alkermes holds Breakthrough Therapy designation for the programme.

First oral OX2R agonist to show efficacy in a large Phase 2 study in NT2, where patients are not orexin-deficient.

Registered trials

All 7 studies on ClinicalTrials.gov that name alixorexton or its development code, pulled from the registry on 4 Aug 2026.

Registry IDStudyPhaseStatusPrimary completion
NCT07540897 A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)150 participants Phase 3 Recruiting 1 Jun 2027
NCT07502443 A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2176 participants Phase 3 Recruiting 1 May 2027
NCT07455383 A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1150 participants Phase 3 Recruiting 1 May 2027
NCT06843590 A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia126 participants Phase 2 Recruiting 1 Nov 2026
NCT06767683 A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia256 participants Phase 2/Phase 3 Recruiting 1 Jun 2028
NCT06555783 A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 293 participants Phase 2 Completed 11 Nov 2025
NCT06358950 A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)92 participants Phase 2 Completed 19 Jun 2025

Trial records are maintained by the sponsor and change without notice. Follow each link for current recruitment status and eligibility.

alixorexton — common questions

What phase is alixorexton in?

Phase 3 for narcolepsy. The Brilliance programme opened on 1 April 2026 with Study 302 and Study 304 in narcolepsy type 1 and Study 303 in narcolepsy type 2. Its idiopathic hypersomnia study, Vibrance-3, is still at Phase 2.

Does alixorexton work in narcolepsy type 2?

It was the first oral OX2R agonist to show efficacy in a large Phase 2 study in narcolepsy type 2, a population that is not orexin-deficient. Phase 3 Study 303 is now testing that result in a registrational setting.

Is alixorexton recruiting patients?

Yes. The Phase 3 Brilliance studies opened on 1 April 2026 and the programme is flagged as enrolling. Recruiting sites and eligibility criteria are listed on ClinicalTrials.gov.

What is ALKS 2680?

ALKS 2680 is the development code for alixorexton. The two names refer to the same Alkermes compound.

The rest of the class

Compounds sharing at least one indication with alixorexton come first.

oveporexton

Takeda Pharmaceutical Company · Approved · NT1

cleminorexton

Centessa Pharmaceuticals · Phase 3 · NT1 / NT2 / IH

E2086

Eisai Co. · Phase 2 · NT1

TAK-360

Takeda Pharmaceutical Company · Phase 2 · NT1 / NT2 / IH

ALKS 4510

Alkermes plc · Phase 1 · Fatigue in MS / Fatigue in Parkinson's

ALKS 7290

Alkermes plc · Phase 1 · ADHD

BP-205

Harmony Biosciences Holdings · Phase 1 · Not yet specified

ORX142

Centessa Pharmaceuticals · Phase 1 · Neurological / Neurodegenerative

ORX489

Centessa Pharmaceuticals · Phase 1 · Neuropsychiatric

Published evidence

Peer-reviewed papers reporting data on alixorexton. A sponsor announcement says what a company decided; a paper says what the data showed, and can be read by anyone. Papers about the orexin system as a whole rather than this compound are under research.

  1. Targeting orexin 2 receptors in idiopathic hypersomnia and narcolepsy: a randomised phase 1b proof-of-concept study of alixorexton

    Grunstein RR, Yee BJ, Chapman JL, Tai JE, Sivam S, Hopkinson C, Smith DG, Lovett A, Liu S, Yagoda S, Rege B · Journal of Sleep Research · 4 Aug 2026 · PMID 42551881

    The first peer-reviewed publication of human data on alixorexton. A four-way crossover in 27 patients: 8 with idiopathic hypersomnia, 9 with narcolepsy type 2 and 10 with narcolepsy type 1, each given three single doses and a placebo. The narcolepsy type 1 group received lower doses than the other two, because people who have lost their orexin neurons respond to less drug. The primary endpoint was safety and tolerability; wakefulness was measured by the maintenance of wakefulness test. This is a proof-of-concept study, not a trial built to establish efficacy.

Source

This entry was last checked against its primary source on 4 Aug 2026 by Simon Stawski: https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-initiation-phase-3-brilliance-studies

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