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: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Alkermes
Company Location: DUBLIN 4 L2 00000
Company CEO: Richard F. Pops
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, Czech Republic, France, Italy, Netherlands, Spain, United States
Active Clinical Trial Count: 6
Highest Development Phases
Phase 3: Narcolepsy
Phase 2: Disorders of Excessive Somnolence
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ALKS 2680-301 | P3 |
Recruiting |
Narcolepsy |
2027-11-01 |
|
| Vibrance-3 | P2 |
Recruiting |
Disorders of Excessive Somnolence |
2026-04-01 |
|
| ALKS 2680-201 | P2 |
Unknown Status |
Narcolepsy |
2025-09-30 |
|
| ALKS 2680-202 | P2 |
Unknown Status |
Narcolepsy |
2025-08-15 |