ALKS 2680 / Alkermes - LARVOL DELTA

Vibrance-3: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Alkermes, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Sleep Disorder

ALKS 2680-301: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia (clinicaltrials.gov) - P2/3 | N=256 | Recruiting | Sponsor: Alkermes, Inc. | N=160 ➔ 256

Enrollment change • Narcolepsy • Sleep Disorder

The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Narcolepsy Type 1: An Initial Proof of Concept Phase 1b Study (AAN 2025) - "ALKS 2680 was generally well-tolerated. Single doses up to 8 mg led to statistically significant, clinically meaningful improvements in sleep latency and patient-reported alertness and support further clinical evaluation of ALKS 2680 in phase 2."

Clinical • P1 data • CNS Disorders • Insomnia • Narcolepsy • Sleep Disorder

Vibrance-3: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects with Idiopathic Hypersomnia (clinicaltrials.gov) - P2 | N=96 | Not yet recruiting | Sponsor: Alkermes, Inc.

New P2 trial • Sleep Disorder

Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2024 and Provides Financial Expectations for 2025 (PRNewswire) - "'This year, we have clear objectives for our pipeline as we complete the phase 2 studies for ALKS 2680 in narcolepsy, with data expected in the second half of the year, and prepare to initiate the ALKS 2680 phase 2 study in idiopathic hypersomnia...LYBALVI: Revenues for the fourth quarter were $77.0 million. Fourth quarter revenues and total prescriptions grew 37% and 30%, respectively, compared to the fourth quarter of 2023...ARISTADA: Revenues for the fourth quarter were $96.6 million. Fourth quarter revenues grew 16% compared to the fourth quarter of 2023...VIVITROL: Revenues for the fourth quarter were $134.1 million. Fourth quarter revenues grew 31% compared to the fourth quarter of 2023."

Commercial • New P2 trial • P2 data • Bipolar Disorder • CNS Disorders • Narcolepsy • Schizophrenia • Sleep Disorder

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy (clinicaltrials.gov) - P2/3 | N=160 | Recruiting | Sponsor: Alkermes, Inc.

New P2/3 trial • Narcolepsy • Sleep Disorder

Vibrance-2: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Alkermes, Inc.

New P2 trial • Narcolepsy • Sleep Disorder

Vibrance-1: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Alkermes, Inc.

New P2 trial • Narcolepsy • Sleep Disorder

Preliminary results from a phase 1 study of ALKS 2680, an Orexin-2 receptor agonist, in healthy participants and patients with narcolepsy or idiopathic hypersomnia (WSS 2023) - "The orexin-2 receptor agonist ALKS 2680 is orally bioavailable and, based on preliminary data from healthy participants in a phase 1 study, appears to be centrally active and generally well-tolerated with a pharmacokinetic profile suitable for once-daily administration to promote daytime wakefulness in the treatment of narcolepsy and other disorders characterized by excessive daytime sleepiness. The effects of ALKS 2680 in patients with NT1, NT2, and IH will be evaluated, and an update of available data will be presented.Acknowledgements: This study is sponsored by Alkermes."

Clinical • P1 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Narcolepsy • Pain • Sleep Disorder

Evaluation of a novel, orally available orexin 2 receptor agonist, on wakefulness and cataplexy in a mouse model of Type 1 narcolepsy (WSS 2023) - "Activation of orexin 2 receptors via oral administration of RDC-264177 significantly improved narcolepsy-like symptomatology in orexin-DTA mice that included both decreased cataplexy and increased waking during the active phase. These preclinical data provide strong support for further investigation of RDC-264177 as a therapeutic intervention for the treatment of narcolepsy.Acknowledgements: : We wish to thank our collaborators and all past and present members of the Project Team."

Preclinical • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Narcolepsy • Sleep Disorder

Alkermes plc (ALKS) Q3 2021 Earnings Call Transcript (The Motley Fool) - "Data from a preclinical model which serves as a predictor disease model of narcolepsy in humans demonstrate a dose dependent increases in wakefulness and dose dependent decreases in cataplexy with ALKS 2680....'We have are excited about this program and currently expect to enter the clinic in late 2022 or early 2023 following the completion of IND-enabling activities.'"

New P1 trial • Preclinical • Cataplexy • CNS Disorders • Narcolepsy • Sleep Disorder