ledasorexton (E2086) / Eisai - LARVOL DELTA

A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Eisai Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2026 ➔ Jun 2026 | Trial primary completion date: Feb 2026 ➔ Jun 2026

Trial completion • Trial completion date • Trial primary completion date

A Study to Assess Potential Drug-Drug Interactions of E2086 in Healthy Participants (clinicaltrials.gov) - P1 | N=93 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial

A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy (clinicaltrials.gov) - P2 | N=64 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Narcolepsy • Sleep Disorder

E2086, a Selective Orexin Receptor Two Agonist: Study for Promoting Wakefulness in Patients With Narcolepsy Type One (AAN 2026) - "Design/Methods E2086-A001-101, a multicenter, randomized, double-blind, double-dummy, single-dose, N-of-1, 5-period crossover study, evaluated the efficacy, safety, and tolerability of E2086 (5 mg, 10 mg, 25 mg) compared with placebo (PBO) and modafinil 200 mg in adult participants with NT1. Conclusions These data demonstrate that E2086 has the potential to improve daytime wakefulness in patients with NT1. The efficacy/safety profile supports continued investigation of E2086 in the narcolepsy patient population."

Clinical • Cataplexy • Narcolepsy • Sleep Disorder

A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy (clinicaltrials.gov) - P2 | N=64 | Not yet recruiting | Sponsor: Eisai Inc.

New P2 trial • Narcolepsy • Sleep Disorder

A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, 'Eisai') announced today that it has received an orphan drug designation for its in-house discovered and developed novel selective orexin 2 receptor agonist E2086, with prospective indication for narcolepsy, from the Ministry of Health, Labour and Welfare (MHLW). (Eisai Press Release) - "Eisai presented data from a Phase Ib clinical study in patients with narcolepsy type 1, which suggests that E2086 has the potential to improve daytime wakefulness, at the World Sleep 2025 congress. "

Orphan drug • Narcolepsy

A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial

E2086, a Selective Orexin Receptor-2 Agonist, Study for Promoting Wakefulness in Patients With Narcolepsy Type-1 (WSS 2025) - "Materials and E2086-A001-101 was a multicenter, randomized, double-blind, double-dummy, single-dose, 5-period crossover study evaluating the efficacy, safety, and tolerability of three dose strengths of E2086 compared with placebo (PBO) and modafinil in adult subjects with NT1. These data demonstrate that E2086 has the potential to improve daytime wakefulness in patients with NT1. The efficacy/safety profile supports continued investigation of E2086 in the narcolepsy patient population."

Clinical • Cataplexy • Narcolepsy • Sleep Disorder

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Eisai Inc. | Active, not recruiting ➔ Completed | N=40 ➔ 22

Enrollment change • Trial completion • Narcolepsy • Sleep Disorder

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Eisai Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Narcolepsy • Sleep Disorder

A Study of E2086 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Eisai Inc. | Recruiting ➔ Completed

Trial completion

A Study of E2086 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Narcolepsy • Sleep Disorder

A Study of E2086 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial

A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1 (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial • Narcolepsy • Sleep Disorder

A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants (clinicaltrials.gov) - P1 | N=53 | Completed | Sponsor: Eisai Inc. | Recruiting ➔ Completed

Trial completion

E2086, a novel selective Orexin-2 receptor agonist (WSS 2023) - No abstract available

A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Eisai Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2086 in Healthy Adult and Elderly Participants (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Eisai Inc.

New P1 trial