samelisant: Clinical Trials

3 completed, 1 no longer available, 1 recruiting. 2 Phase 1, 1 Phase 2, 1 Phase 3.

By phase and status

Phase	Trials	Status
Phase 1	2	Completed 2
Phase 2	1	Completed 1
Phase 3	1	Recruiting 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) Samelisant, Placebo - Narcolepsy	Phase 3	Recruiting	Suven Life Sciences Limited	240	2026-09-01	2026-09-03
A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy SUVN-G3031, Placebo - Narcolepsy	Phase 2	Completed	Suven Life Sciences Limited	190	2019-09-21	2025-01-13
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects SUVN-G3031 - Cognitive Disorders	Phase 1	Completed	Suven Life Sciences Limited	24	2016-08-01	2017-09-25
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects SUVN-G3031, Placebo - Cognitive Disorders	Phase 1	Completed	Suven Life Sciences Limited	64	2014-09-01	2016-10-14
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy Samelisant - Narcolepsy		No longer available	Suven Life Sciences Limited			2022-09-23

Conditions studied

Narcolepsy (3)  ·  Cataplexy (2)  ·  Cognitive Dysfunction (2)  ·  Disorders of Excessive Somnolence (2)

Sponsors

Suven Life Sciences Limited (5)

Countries

United States (4)  ·  Canada (1)

Top investigators

Murtaugh Thomas, MD (1)

Results publications

PMID 32399853, PMID 39504585