This section highlights FDA-related milestones and regulatory updates for drugs developed by Alkermes (ALKS).
Over the past two years, Alkermes has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
alixorexton, LYBALVI, and ALKS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Alixorexton FDA Regulatory Timeline and Events
Alixorexton is a drug developed by Alkermes for the following indication: Treatment of Narcolepsy Type 1.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- alixorexton
- Announced Date:
- April 16, 2026
- Indication:
- Treatment of Narcolepsy Type 1
Announcement
Alkermes plc announced plans to present new data from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at the American Academy of Neurology (AAN) 2026 Annual Meeting, taking place April 18-22, 2026 in Chicago.
AI Summary
Alkermes plc will present new data from the Vibrance-1 phase 2 study of alixorexton in patients with narcolepsy type 1 at the American Academy of Neurology (AAN) 2026 Annual Meeting in Chicago, April 18–22, 2026. Results from the seven-week open-label extension showed sustained improvements in patient-reported disease severity, cognitive functioning, and fatigue. Across the six-week randomized double-blind period and the seven-week extension, alixorexton was generally well tolerated at all doses tested. No serious treatment-emergent adverse events were reported, and most adverse events were mild to moderate.
The data will be presented as Poster 14-002, titled “Improvement in Patient-Reported Disease Severity, Cognitive Functioning, and Fatigue in Patients With Narcolepsy Type 1 Treated With Alixorexton, an Orexin 2 Receptor Agonist, in the Vibrance-1 Phase 2 Study.” Presenter: Giuseppe Plazzi, M.D., Ph.D. Presentation: Monday, April 20, 2026, 5:00–6:00 p.m. CT during Poster Session 6. The ongoing Phase 3 Brilliance NT1 study of alixorexton is also underway.
Read Announcement- Drug:
- alixorexton
- Announced Date:
- April 1, 2026
- Indication:
- Treatment of Narcolepsy Type 1
Announcement
Alkermes plc announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company's novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (IH).
AI Summary
Alkermes plc has initiated the Brilliance Studies, a phase 3 program evaluating alixorexton in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). The program comprises three 12-week, randomized, double-blind, placebo-controlled trials that compare once-daily and split-dose regimens. Brilliance NT1 includes Study 302 and Study 304, and Brilliance NT2 is Study 303. Each study will assess the safety and efficacy of alixorexton versus placebo in adult patients.
Alixorexton is the company’s investigational, oral, selective orexin 2 receptor (OX2R) agonist being developed for NT1, NT2 and idiopathic hypersomnia (IH). By testing different dosing schedules in rigorous phase 3 trials, the Brilliance Studies aim to determine whether alixorexton can offer symptom relief and an acceptable safety profile for adults with these sleep‑wake disorders, and to guide future clinical and regulatory decisions.
Read Announcement- Drug:
- alixorexton
- Announced Date:
- January 6, 2026
- Indication:
- Treatment of Narcolepsy Type 1
Announcement
Alkermes plc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1), based on phase 1 and phase 2 clinical data, including positive results from Vibrance-1, a large (n=92) phase 2 study evaluating alixorexton in patients with NT1.
AI Summary
Alkermes announced the FDA granted Breakthrough Therapy designation to alixorexton for treating narcolepsy type 1 (NT1), based on phase 1 and phase 2 clinical data, including positive results from Vibrance‑1 (n=92). The designation is intended to speed development and review of drugs for serious conditions when early evidence suggests they may offer substantial improvement over current therapies.
Alixorexton is an investigational, oral selective orexin‑2 receptor (OX2R) agonist. In Vibrance‑1, the drug met its primary endpoint across all doses, showing statistically significant, clinically meaningful, dose‑dependent improvements in wakefulness on the Maintenance of Wakefulness Test versus placebo. It was generally well tolerated. The company said the designation underscores the strength of the initial data and supports advancing alixorexton into phase 3 development, with plans to begin a global phase 3 program in the first quarter of 2026.
Read Announcement
LYBALVI (olanzapine and samidorphan) FDA Regulatory Events
LYBALVI (olanzapine and samidorphan) is a drug developed by Alkermes for the following indication: Early in Illness.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYBALVI (olanzapine and samidorphan)
- Announced Date:
- April 14, 2026
- Indication:
- Early in Illness
Announcement
Alkermes plc announced the publication of a 56-week post hoc analysis of the effects of LYBALVI® (olanzapine and samidorphan) on negative symptoms in adults living with schizophrenia in the peer-reviewed publication The Journal of Clinical Psychiatry.
AI Summary
Alkermes plc announced publication in The Journal of Clinical Psychiatry of a 56‑week post hoc analysis examining LYBALVI® (olanzapine and samidorphan) for negative symptoms in adults living with schizophrenia. The analysis pooled data from the ENLIGHTEN‑1 study and its open‑label extension to look specifically at hard‑to‑treat negative symptoms, a core part of schizophrenia that includes blunted emotions, social withdrawal, and low motivation.
Results showed a decrease in negative symptoms during the first four weeks in a pooled comparison of LYBALVI, olanzapine, and placebo in ENLIGHTEN‑1, with continued improvement over 52 weeks of open‑label LYBALVI treatment. The analysis also examined subgroups defined by a Marder Negative Factor score ≥24 and, for predominant negative symptoms with low positive symptoms, additional PANSS criteria. Overall, the findings suggest sustained reductions in difficult‑to‑treat negative symptoms with LYBALVI over the 56‑week period.
Read Announcement
ALKS 2680 FDA Regulatory Timeline and Events
ALKS 2680 is a drug developed by Alkermes for the following indication: For the treatment of narcolepsy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALKS 2680
- Announced Date:
- November 12, 2025
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced positive topline results from the Vibrance-2 dose-ranging phase 2 study evaluating alixorexton in patients with narcolepsy type 2 (NT2).
AI Summary
Alkermes announced positive topline results from Vibrance-2, a dose-ranging phase 2 study of alixorexton in adults with narcolepsy type 2 (NT2). Alixorexton is an oral, selective orexin 2 receptor (OX2R) agonist and is the first of its kind to show efficacy in a large randomized phase 2 NT2 trial. Once-daily dosing for eight weeks produced clinically meaningful improvements in wakefulness and daytime sleepiness versus placebo.
The study randomized 93 NT2 patients to 10 mg, 14 mg, 18 mg or placebo. Dual primary endpoints were mean sleep latency on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week eight. The 14 mg and 18 mg doses were statistically significant versus placebo on the MWT; the 18 mg dose was statistically significant on the ESS. Alixorexton was generally well tolerated; most adverse events were mild to moderate and no serious treatment-emergent events were reported.
About 95% of participants completed the double-blind period and entered an optional open-label extension. Alkermes plans to move alixorexton into global phase 3 development.Read Announcement
- Drug:
- ALKS 2680
- Announced Date:
- September 8, 2025
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1). Alixorexton, formerly ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).
AI Summary
Alkermes plc reported positive phase 2 results from the Vibrance-1 study of alixorexton, a once-daily oral orexin 2 receptor agonist for narcolepsy type 1 (NT1). In this randomized, placebo-controlled trial of 92 patients over six weeks, alixorexton doses of 4 mg, 6 mg and 8 mg led to significant, dose-dependent improvements in wakefulness, measured by mean sleep latency on the Maintenance of Wakefulness Test, and in daytime sleepiness on the Epworth Sleepiness Scale.
Alixorexton also showed meaningful benefits for cataplexy, cognition and fatigue. More than 40% of patients at the higher doses had no cataplexy episodes in week six. Patient-reported outcomes indicated most treated patients achieved normal fatigue levels and minimal cognitive impairment by week six.
The drug was generally well tolerated. No serious adverse events were reported, and most side effects were mild to moderate, including temporary insomnia and blurred vision. Alkermes plans to start global phase 3 trials in early 2026.
Read Announcement- Drug:
- ALKS 2680
- Announced Date:
- August 25, 2025
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced plans to present detailed results from its Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at World Sleep Congress, taking place Sept. 5-10, 2025 in Singapore, and in an investor webcast presentation hosted by the company.
AI Summary
Alkermes plc announced plans to share detailed results from its Vibrance-1 phase 2 study of alixorexton in narcolepsy type 1 (NT1) at the World Sleep Congress in Singapore (Sept. 5–10, 2025). Three oral presentations will cover primary and secondary efficacy and safety measures, plus exploratory patient-reported outcomes on disease severity, fatigue and cognition.
Presentations will occur on Sept. 8 during the “Targeting the orexin pathway” session. In addition, the company will host an investor webcast on Monday, Sept. 8 at 8:00 a.m. ET to review these data with slides and a live Q&A. The webcast will be available on the Investors section of Alkermes’ website, with a 30-day replay.
Alixorexton is Alkermes’ oral, selective orexin 2 receptor agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 and idiopathic hypersomnia. Positive topline results from Vibrance-1 support further research in this class.
Read Announcement- Drug:
- ALKS 2680
- Announced Date:
- July 21, 2025
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced positive topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1).
AI Summary
Alkermes plc announced positive topline results from the randomized, double-blind Vibrance-1 phase 2 study of alixorexton in narcolepsy type 1 (NT1). Alixorexton, a once-daily oral orexin 2 receptor agonist, met its primary endpoint at all doses tested, showing statistically significant, dose-dependent improvements in wakefulness versus placebo on the Maintenance of Wakefulness Test (MWT).
Participants taking alixorexton achieved normative wakefulness (mean sleep latency >20 minutes) and reported meaningful benefits on the Epworth Sleepiness Scale (ESS), narcolepsy severity, fatigue (PROMIS-Fatigue), and cognitive complaints (BC-CCI). The treatment was generally well tolerated; most adverse events were mild to moderate, with no serious treatment-emergent safety signals observed.
These data support the rapid advancement of alixorexton into a global phase 3 program for NT1. Detailed efficacy and safety results will be presented at the World Sleep Congress in September, underscoring the potential of orexin 2 receptor agonists to address multiple facets of narcolepsy.
Read Announcement- Drug:
- ALKS 2680
- Announced Date:
- April 1, 2025
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced the initiation of Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with idiopathic hypersomnia (IH).
AI Summary
Alkermes plc announced the start of Vibrance-3, a phase 2 clinical study aimed at evaluating the safety and efficacy of ALKS 2680 in adults with idiopathic hypersomnia (IH). This randomized, double-blind, placebo-controlled trial will have participants take one of three daily doses—10 mg, 14 mg, or 18 mg—of ALKS 2680 over an eight-week period. The investigational oral drug is a selective orexin 2 receptor agonist, which may help improve wakefulness and reduce excessive daytime sleepiness, a major issue for those with IH.
The study will assess changes in sleepiness using the Epworth Sleepiness Scale and other measures to determine if ALKS 2680 can offer significant improvements over placebo. Vibrance-3 builds on promising earlier data and seeks to address an important unmet need in the IH community.
Read Announcement- Drug:
- ALKS 2680
- Announced Date:
- September 23, 2024
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced plans to present clinical data from its phase 1b study of ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at the European Sleep Research Society's (ESRS) 27th Congress, Sleep Europe 2024, taking place Sept. 24-27, 2024 in Seville, Spain.
AI Summary
Alkermes plc announced it will present clinical data from its phase 1b study on ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at the European Sleep Research Society’s 27th Congress, Sleep Europe 2024. The event will be held from September 24-27, 2024, in Seville, Spain. The company will share data from the NT2 cohort, which involved nine patients, during an oral presentation on September 25, 2024. Additionally, a poster presentation featuring results from the IH cohort of eight patients will be shown on September 26, 2024. The data indicate that ALKS 2680, a novel investigational, oral, selective orexin 2 receptor agonist, was generally well tolerated and showed improved wakefulness compared to placebo. Alkermes looks forward to engaging with clinicians and researchers at this important meeting to further discuss these promising findings.
Read Announcement- Drug:
- ALKS 2680
- Announced Date:
- August 22, 2024
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with narcolepsy type 2 (NT2).
AI Summary
Alkermes plc has initiated the Vibrance-2 study, a phase 2 clinical trial testing its investigational drug ALKS 2680 in adults with narcolepsy type 2 (NT2). This new oral treatment is a selective orexin 2 receptor (OX2R) agonist developed for once-daily use to help manage excessive daytime sleepiness, a key symptom of narcolepsy.
The trial is randomized, double-blind, placebo-controlled, and will enroll about 80 patients from the United States, Australia, and Europe. Participants will be assigned to one of three dose groups—10 mg, 14 mg, or 18 mg of ALKS 2680—or a placebo for eight weeks. The main goal is to determine if ALKS 2680 provides a greater reduction in sleepiness compared to placebo, measured by the change in mean sleep latency. Safety, efficacy, and additional sleepiness assessments will also be evaluated during the study.
Read Announcement
