Phase III Study of TS-142 in Patients with Insomnia

Summary

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group confirmatory study in patients with insomnia.

Timeline

Start

2022-08-30

Primary completion

2023-12-05

Completion

2023-12-05

Outcome

Met primary endpoint

paper Subjective sleep latency was significantly improved at week 2 in both groups compared to PBO PMID 41001841 ↗

paper VOR5, -10.6 min [95% CI = -14.2% to -7.0%] p < .001, and VOR10, -10.1 min [-13.8% to -6.5%] p < .001 PMID 41001841 ↗

release “（301試験）では、２週間投与時の主観的睡眠潜時（主要評価項目：sSL*1）ならびに主観的睡眠効率（重要な副次評価項目：sSE*2）は、「ボルズィⓇ」5 mg群、10 mg群のいずれもプラセボ群と比較して有意な改善が認められました” taisho.co.jp ↗

Publications

• Uchiyama M, Kambe D, Hasegawa S, Imadera Y, Yamasaki H, Uchimura N. Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. Sleep. 2026 Mar 11;49(3):zsaf291. doi: 10.1093/sleep/zsaf291.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TS-142	Small molecule	5 mg	Oral
Subject	TS-142	Small molecule	10 mg	Oral

Indications