At a glance
| Known as | alixorexton · ALKS 2680 |
|---|---|
| Sponsor | Alkermes |
| Mechanism | Oral orexin receptor 2 (OX2R) agonist |
| Stage | Phase 3 |
| Indications | NT1 · NT2 · IH |
| Registered trials | 7 · 5 recruiting |
| Last verified | 4 Aug 2026 |
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 ID | Study | Phase | Status | Primary 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.
Source
This entry was last checked against its primary source on 4 Aug 2026: https://investor.alkermes.com/news-releases/news-release-details/alkermes-announces-initiation-phase-3-brilliance-studies
Found something out of date? Send a correction with a primary source and it will be fixed.
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