Drugs / ALKS 2680
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT06843590 | May 2025 → Nov 2026 expected | idiopathic hypersomnia | Alkermes, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT06555783 | Jul 2024 → Nov 2025 | narcolepsy without cataplexy | Alkermes, Inc. | Completed | Met primary |
| Phase 2 | NCT06358950 | Mar 2024 → Jun 2025 | narcolepsy 1 | Alkermes, Inc. | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06767683 | Jan 2025 → Jun 2028 expected | idiopathic hypersomnia, narcolepsy 1, narcolepsy without cataplexy | Alkermes, Inc. | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07540897 | Jun 2026 → Jun 2027 expected | narcolepsy 1 | Alkermes, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07502443 | Apr 2026 → May 2027 expected | narcolepsy without cataplexy | Alkermes, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT07455383 | Apr 2026 → May 2027 expected | narcolepsy 1 | Alkermes, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Alkermes, Inc. | Results The Lancet Neurology Publishes Data From Alkermes’ Positive Vibrance-1 Phase 2 Study of Alixorexton in Adults With Narcolepsy Type 1 alkermes.com ↗
As previously announced, treatment with once-daily alixorexton led to statistically significant improvements from baseline versus placebo in both objective and subjective measures of excessive daytime sleepiness, as measured by the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS)1, respectively. |
| 2026-07-13 | Alkermes, Inc. | Results Alkermes’ Alixorexton Demonstrated Sustained Improvement in Wakefulness in Adults With Narcolepsy Type 1 and Type 2 in Long-Term Extension Study Interim Analysis alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced results from a planned interim analysis of the ongoing long-term extension (LTE) study evaluating alixorexton in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). |
| 2026-06-17 | Alkermes, Inc. | Results Alkermes Presents Detailed Positive Results From Vibrance-2 Phase 2 Study of Alixorexton in Adults With Narcolepsy Type 2 at SLEEP 2026 alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-2 phase 2 dose-ranging study evaluating alixorexton in patients with narcolepsy type 2 (NT2). |
| 2026-06-15 | Alkermes, Inc. | Regulatory Alkermes Announces Orphan Drug Designations for Alixorexton in the U.S. and Europe alkermes.com ↗
The U.S. Food and Drug Administration (FDA) has granted ODD to alixorexton for the treatment of IH, and the European Commission has granted ODD to alixorexton for the treatment of narcolepsy. |
| 2026-04-16 | Alkermes, Inc. | Results Alkermes to Present Additional Data From Vibrance-1 Phase 2 Study of Alixorexton in Patients with Narcolepsy Type 1 at the American Academy of Neurology (AAN) 2026 Annual Meeting alkermes.com ↗
The new data demonstrate clinically meaningful improvements from pre-treatment baseline on established measures evaluating excessive daytime sleepiness and cataplexy, as well as participant-reported outcomes, including narcolepsy symptom severity, cognitive functioning and fatigue in patients with NT1 through the seven-week open-label extension. |
| 2026-01-06 | Alkermes, Inc. | Regulatory Alixorexton Granted Breakthrough Therapy Designation by U.S. FDA for the Treatment of Narcolepsy Type 1 alkermes.com ↗
the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1) |
| 2025-11-12 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Vibrance-2 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 2 alkermes.com ↗ |
| 2025-09-08 | Alkermes, Inc. | Results Alkermes Presents Detailed Positive Results from Vibrance-1 Phase 2 Study of Alixorexton in Patients with Narcolepsy Type 1 at World Sleep Congress 2025 alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). |
| 2025-07-21 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Vibrance-1 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1 alkermes.com ↗ |
| 2025-05-29 | Alkermes, Inc. | Results Alkermes to Present New Research Related to ALKS 2680 at SLEEP 2025 alkermes.com ↗
Findings demonstrated a statistically significant, wake-associated qEEG profile with ALKS 2680 compared to placebo. |
| 2024-06-03 | Alkermes, Inc. | Results Alkermes Presents Data From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 1 at SLEEP 2024 alkermes.com ↗ |
| 2024-04-09 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia alkermes.com ↗ |
| 2023-10-23 | Alkermes, Inc. | Results Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress alkermes.com ↗
DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. |
All press releases naming this drug 19 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALKS 2680 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06555783 ↗ |
| Route | Oral | “Oral tablet of ALKS 2680 for once daily administration” NCT06358950 ↗ |