A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy

Summary

This study is of an investigational drug called SUVN-G3031 (Samelisant) as a possible treatment for narcolepsy with cataplexy or narcolepsy without cataplexy. The main purpose of this study is to learn how well the study drug works and how safe the study drug is compared to placebo.

Timeline

Start

2019-09-21

Primary completion

2023-06-07

Completion

2023-06-13

Outcome

Met primary endpoint

paper A statistically significant treatment effect of Samelisant was observed on the primary endpoint, indicating improvements in EDS. PMID 39504585 ↗

registry p = 0.024; Mixed Models Analysis NCT04072380 ↗

Publications

• Results Nirogi R, Shinde A, Goyal VK, Ravula J, Benade V, Jetta S, Pandey SK, Subramanian R, Chowdary Palacharla VR, Mohammed AR, Abraham R, Dogiparti DK, Kalaikadhiban I, Jayarajan P, Jasti V, Bogan RK. Samelisant (SUVN-G3031), a histamine 3 receptor inverse agonist: Results from the phase 2 double-blind randomized placebo-controlled study for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Sleep Med. 2024 Dec;124:618-626. doi: 10.1016/j.sleep.2024.10.037. Epub 2024 Oct 30.
• Nirogi R, Mudigonda K, Bhyrapuneni G, Muddana NR, Shinde A, Goyal VK, Pandey SK, Mohammed AR, Ravula J, Jetta S, Palacharla VRC. Safety, Tolerability, and Pharmacokinetics of SUVN-G3031, a Novel Histamine-3 Receptor Inverse Agonist for the Treatment of Narcolepsy, in Healthy Human Subjects Following Single and Multiple Oral Doses. Clin Drug Investig. 2020 Jul;40(7):603-615. doi: 10.1007/s40261-020-00920-8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SUVN-G3031	Unknown	2 mg	Oral
Subject	SUVN-G3031	Unknown	4 mg	Oral

Indications