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
ALKS and LYBALVI. 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.
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:
- 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- Drug:
- ALKS 2680
- Announced Date:
- April 9, 2024
- Indication:
- For the treatment of narcolepsy
Announcement
Alkermes plc announced positive topline results from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a phase 1b, proof-of-concept study evaluating ALKS 2680, the company's novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy.
AI Summary
Alkermes announced positive topline data from its phase 1b proof-of-concept study for ALKS 2680, a novel, oral orexin 2 receptor agonist intended as a once-daily treatment for narcolepsy. In this study, both narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts showed significant improvements in wakefulness compared to placebo, as measured by the Maintenance of Wakefulness Test. NT2 patients experienced dose-dependent increases in mean sleep latency improvements of 12 minutes at 5 mg, 19 minutes at 12 mg, and 21 minutes at 25 mg. Similarly, IH patients recorded notable gains of 8, 11, and 18 minutes at the corresponding doses. Overall, ALKS 2680 was well tolerated across all dosages with only mild, transient side effects reported, supporting further evaluation in a planned phase 2 study later this year.
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:
- May 14, 2024
- Indication:
- Early in Illness
Announcement
Alkermes plc announced the presentation of research related to its psychiatry franchise products—LYBALVI® (olanzapine and samidorphan) and ARISTADA® (aripiprazole lauroxil)—at four scientific conferences this spring.
Read Announcement- Drug:
- LYBALVI (olanzapine and samidorphan)
- Announced Date:
- April 8, 2024
- Indication:
- Early in Illness
Announcement
Alkermes plc announced the oral presentation of clinical data at the 2024 Congress of the Schizophrenia International Research Society (SIRS), which took place April 3-7, 2024 in Florence, Italy.
AI Summary
At the 2024 Congress of the Schizophrenia International Research Society in Florence, Italy, Alkermes plc presented new clinical data from a phase 3, open-label extension study. The data focused on the long-term safety, tolerability, and treatment durability of LYBALVI® (a combination of olanzapine and samidorphan), which is approved in the U.S. for adults with schizophrenia and bipolar I disorder. Dr. René Kahn from the Icahn School of Medicine at Mount Sinai delivered the oral presentation during the “New Pharmacological Treatments and Assessments” session. The study provided insights on patients who underwent up to two or four years of treatment, revealing stable symptom control along with minimal changes in weight and metabolic parameters. These findings underline LYBALVI’s potential as a consistent and reliable option for long-term maintenance therapy in these patient populations.
Read Announcement
