Product Description
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. Orexin neuropeptides are important regulators of the sleep/wake cycle through OX2R activation, and loss of orexinergic neurons in the brain is associated with excessive daytime sleepiness and cataplexy in narcolepsy.1 ALKS 2680 was designed to address the underlying pathology of narcolepsy with the goal of improving duration of wakefulness and providing cataplexy control. Once-daily oral administration of ALKS 2680 is currently being evaluated in a phase 1 study in healthy volunteers and people living with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia. (Sourced from: https://www.benzinga.com/pressreleases/23/10/n35157874/alkermes-to-present-first-clinical-data-for-orexin-2-receptor-agonist-alks-2680-at-world-sleep-con)
Mechanisms of Action: OX2R Agonist
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Alkermes
Company Location: Europe
Company Founding Year: 1987
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, Czech Republic, France, Italy, Netherlands, Spain, United States
Active Clinical Trial Count: 11
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Alkermes presented P2 Narcolepsy results on 2026-05-28 for Alixorexton
- Clinical Outcomes Reported - Alkermes presented P2 Narcolepsy results on 2026-04-20 for Alixorexton
- Clinical Outcomes Reported - Alkermes presented P2 Narcolepsy results on 2025-11-12 for Alixorexton
Highest Development Phases
Phase 3: Cataplexy|Disorders of Excessive Somnolence|Narcolepsy
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07502443 |
Brilliance NT2 | P3 |
Recruiting |
Narcolepsy|Disorders of Excessive Somnolence |
2027-05-01 |
12% |
2026-04-23 |
Primary Endpoints|Treatments|Trial Status |
NCT07455383 |
Brilliance NT1 | P3 |
Recruiting |
Cataplexy|Disorders of Excessive Somnolence|Narcolepsy |
2027-05-01 |
12% |
2026-04-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06843590 |
Vibrance-3 | P2 |
Recruiting |
Disorders of Excessive Somnolence |
2026-06-01 |
12% |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Start Date|Treatments |
2024-511112-24-00 |
ALKS 2680-201 | P2 |
Recruiting |
Narcolepsy |
2025-09-30 |
2025-05-02 |
Treatments |
|
2024-515452-20-00 |
ALKS 2680-202 | P2 |
Recruiting |
Narcolepsy |
2025-08-15 |
2025-05-02 |
Treatments |
|
NCT06358950 |
Vibrance-1 | P2 |
Completed |
Narcolepsy |
2025-06-19 |
12% |
2025-08-16 |
Primary Endpoints |
NCT06767683 |
ALKS 2680-301 | P3 |
Recruiting |
Disorders of Excessive Somnolence|Narcolepsy |
2028-06-01 |
19% |
2025-07-03 |
|
2024-519822-18-00 |
ALKS 2680-301 | P3 |
Not yet recruiting |
Narcolepsy |
2027-12-31 |
2025-05-01 |
Treatments |
|
NCT07540897 |
Brilliance NT1 - 304 | P3 |
Recruiting |
Disorders of Excessive Somnolence|Narcolepsy |
2027-06-01 |
12% |
2026-05-16 |
Primary Endpoints|Treatments|Trial Status |
2025-520981-23-00 |
ALKS 2680-203 | P2 |
Not yet recruiting |
Unknown |
2026-12-31 |
|||
NCT06555783 |
Vibrance-2 | P2 |
Completed |
Narcolepsy|Disorders of Excessive Somnolence |
2025-11-11 |
2% |
2026-02-28 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |