Developer · ALKS · Ireland

Alkermes plc

Alkermes plc is a biopharmaceutical company that develops and commercializes medicines for central nervous system (CNS) disorders, including neurological and psychiatric conditions. Its commercial portfolio includes proprietary CNS products such as VIVITROL, ARISTADA, LYBALVI and (following the 2026 Avadel acquisition) LUMRYZ, alongside a pipeline led by the orexin 2 receptor agonist alixorexton.

alkermes.com ↗

3compounds
4programs
3indications
Phase 3lead asset

Phase distribution

  • Phase 33
  • Phase 21

Modality

  • Small molecule 3

Mechanism focus

Pipeline (3)

Deals & partnerships

  • Feb 12, 2026AcquisitionAlkermes completes acquisition of Avadel Pharmaceuticals, adding LUMRYZAlkermes plc completed its acquisition of Avadel Pharmaceuticals plc on February 12, 2026, after the Irish High Court sanctioned the scheme of arrangement, delisting Avadel (Nasdaq: AVDL). Avadel shareholders received $21.00 per share in cash plus a contingent value right of up to $1.50 per share (total ~$2.1 billion), financed with ~$775 million of cash and $1.525 billion in term loans. The deal, originally announced on October 22, 2025, adds Avadel's FDA-approved product LUMRYZ (sodium oxybate extended-release), a once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in narcolepsy, to Alkermes' commercial portfolio and accelerates its entry into the sleep medicine market.LUMRYZ (sodium oxybate extended-release)source ↗

Catalysts · 4 upcoming · 3 reported

Recently reported

  • 2026-05-12met

    LUMRYZ (sodium oxybate extended-release)forIdiopathic HypersomniaTopline data

    REVITALYZ Phase 3 positive topline: LUMRYZ met the primary ESS endpoint and all key secondary endpoints (PGI-C, IHSS, ESS worsening on placebo), each p<0.0001, in adults with idiopathic hypersomnia; sNDA planned by end of 2026.

    source ↗

  • 2025-11-12met

    AlixorextonforNarcolepsyTopline data

    Vibrance-2 Phase 2 study in narcolepsy type 2 met the primary MWT endpoint at 14 mg and 18 mg, with ESS significant at 18 mg (p<0.05 adjusted).

    source ↗

  • 2025-07-09met

    AlixorextonforNarcolepsyTopline data

    Vibrance-1 Phase 2 study in narcolepsy type 1 met the primary MWT endpoint across all doses (4, 6, 8 mg) with statistically significant, dose-dependent improvements in wakefulness vs placebo.

    source ↗

Recent activity

  • Jun 15, 2026Phase changeAlixorexton·Idiopathic HypersomniaPhase 2U.S. FDA granted orphan drug designation to alixorexton for the treatment of idiopathic hypersomnia (the European Commission separately granted orphan designation for narcolepsy).source ↗
  • May 12, 2026ReadoutLUMRYZ (sodium oxybate extended-release)·Idiopathic HypersomniametREVITALYZ Phase 3 positive topline: LUMRYZ met the primary ESS endpoint and all key secondary endpoints (PGI-C, IHSS, ESS worsening on placebo), each p<0.0001, in adults with idiopathic hypersomnia; sNDA planned by end of 2026.source ↗
  • Apr 6, 2026Phase changeAlixorexton·NarcolepsyPhase 3Alkermes initiated the Phase 3 Brilliance program evaluating alixorexton in narcolepsy type 1 and type 2: three 12-week, randomized, double-blind, placebo-controlled studies (Brilliance NT1 Study 302 NCT07455383 and Study 304 NCT07540897; Brilliance NT2 Study 303 NCT07502443).source ↗
  • Mar 25, 2026Phase changeLUMRYZ (sodium oxybate extended-release)·Idiopathic HypersomniaPhase 3REVITALYZ Phase 3 study reached primary completion / completion (registry actual date).source ↗
  • Jan 6, 2026Phase changeAlixorexton·NarcolepsyPhase 2FDA granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1, based on Phase 1 and Phase 2 data including the positive Vibrance-1 study.source ↗
  • Nov 12, 2025ReadoutAlixorexton·NarcolepsymetVibrance-2 Phase 2 study in narcolepsy type 2 met the primary MWT endpoint at 14 mg and 18 mg, with ESS significant at 18 mg (p<0.05 adjusted).source ↗
  • Jul 9, 2025ReadoutAlixorexton·NarcolepsymetVibrance-1 Phase 2 study in narcolepsy type 1 met the primary MWT endpoint across all doses (4, 6, 8 mg) with statistically significant, dose-dependent improvements in wakefulness vs placebo.source ↗
  • May 22, 2025Phase changeAlixorexton·Idiopathic HypersomniaPhase 2Vibrance-3 Phase 2 study in idiopathic hypersomnia (NCT06843590) initiated (study start 22 May 2025): a randomized, double-blind, parallel-group, dose-range-finding study of once-daily alixorexton (10, 14, 18 mg) vs placebo over 8 weeks, primary endpoint change in ESS at Week 8.source ↗
  • Aug 1, 2024Phase changeLUMRYZ (sodium oxybate extended-release)·Idiopathic HypersomniaPhase 3REVITALYZ Phase 3 study (NCT06525077) in idiopathic hypersomnia initiated (registry start date); sponsored by Avadel Pharmaceuticals.source ↗
  • Jun 30, 2022Phase changeLYBALVI (olanzapine/samidorphan)·SchizophreniaPhase 3ENLIGHTEN-Youth (NCT05303064), the pivotal Phase 3, randomized, double-blind, 52-week study of OLZ/SAM vs olanzapine in pediatric subjects with schizophrenia (13-17) or bipolar I disorder (10-17), began; primary endpoint change in BMI Z-score at week 12. Trial is recruiting.source ↗
  • Aug 3, 2021Phase changeLYBALVI (olanzapine/samidorphan)·SchizophreniaPhase 1ALKS 3831-A311 (NCT04987658), a Phase 1 open-label study of OLZ/SAM safety, tolerability and pharmacokinetics in pediatric subjects (ages 10-12) with bipolar I disorder, initiated; subsequently completed with n=7. Establishes pediatric PK/safety supporting the pediatric program.source ↗

Trials recruiting · 3 recruiting of 8 sponsored

  • Phase 3Alixorextonn=15017 sites · United States, Canada

    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 302)

    Narcolepsy Type 1NCT07455383 ↗

  • Phase 3LYBALVI (olanzapine/samidorphan)n=22047 sites · United States, Brazil, Argentina

    A Phase 3, Randomized, Double-Blind, 52-Week Study of OLZ/SAM vs Olanzapine to Evaluate Weight Gain as Assessed by Change in BMI Z-Score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (ENLIGHTEN-Youth)

    SchizophreniaBipolar I DisorderNCT05303064 ↗

  • Phase 2Alixorextonn=12650 sites · United States, Italy, Australia

    A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

    Idiopathic HypersomniaNCT06843590 ↗

Competitive landscape

Other companies developing against Alkermes plc's targets or indications.

Leadership & advisors (13)