TS-142 / Taisho - LARVOL DELTA

Efficacy and safety of vornorexant in Japanese patients with insomnia: a randomized, placebo-controlled phase 3 pivotal study. (PubMed, Sleep) - "Treatment with 5 and 10 mg of vornorexant significantly improved sleep onset latency and sleep efficiency compared with placebo without relevant safety concerns."

Journal • P3 data • Cataplexy • CNS Disorders • Excessive Daytime Sleepiness • Insomnia • Sleep Disorder

Preclinical pharmacological profiles of vornorexant, a novel potent dual orexin receptor antagonist. (PubMed, J Pharmacol Exp Ther) - "Here, we report the pharmacological profiles of [(2S)-2-{[3-(5-Fluoropyridin-2-yl)-1H-pyrazol-1-yl]methyl}-1,3-oxazinan-3-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone (vornorexant), also known as ORN0829...Moreover, vornorexant promoted sleep even after switching treatment from zolpidem or when administered in combination with zolpidem in rats. These results suggest that vornorexant possesses properties that are desirable for insomnia drugs."

Journal • Preclinical • CNS Disorders • Insomnia • Sleep Disorder

Preclinical metabolism and the disposition of vornorexant/TS-142, a novel dual orexin 1/2 receptor antagonist for the treatment of insomnia. (PubMed, Pharmacol Res Perspect) - "These findings demonstrate that vornorexant is absorbed immediately after administration, and vornorexant and its metabolites are rapidly and completely eliminated in rats and dogs. Thus, vornorexant may have favorable pharmacokinetic profiles as a hypnotic drug to provide rapid onset of action and minimal next-day residual effects in humans."

Journal • Preclinical • CNS Disorders • Insomnia • Sleep Disorder

Long-Term Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=401 | Completed | Sponsor: Taisho Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Insomnia • Sleep Disorder

Phase III Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=1155 | Completed | Sponsor: Taisho Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=540 ➔ 1155

Enrollment change • Trial completion • CNS Disorders • Insomnia • Sleep Disorder

A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Taisho Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=24 ➔ 84

Enrollment change • Trial completion • Hepatology

A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Taisho Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | N=16 ➔ 43

Enrollment change • Trial completion

Pharmacokinetics, pharmacodynamics, and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: randomized, double-blind, placebo-controlled phase-1 studies. (PubMed, Basic Clin Pharmacol Toxicol) - "Exposure in elderly individuals was generally comparable to that in non-elderly individuals. Altogether, vornorexant may have a favorable profile for insomnia treatment, including rapid onset of action and minimal next-day residual effects."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Insomnia • Sleep Disorder

Long-Term Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=401 | Active, not recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=300 ➔ 401

Enrollment change • Enrollment closed • CNS Disorders • Insomnia • Sleep Disorder

A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Next-day Residual Effects of TS-142 in Healthy Elderly Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd.

New P1 trial

A Food Effect Study of TS-142 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Taisho Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Food Effect Study of TS-142 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

A Food Effect Study of TS-142 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd.

New P1 trial

A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Pharmacokinetic Study of TS-142 in Patients With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd.

New P1 trial • Hepatology

Long-Term Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Phase III Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=540 | Recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Insomnia • Sleep Disorder

Long-Term Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Insomnia • Sleep Disorder

Phase III Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P3 | N=540 | Not yet recruiting | Sponsor: Taisho Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Insomnia • Sleep Disorder

Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. (PubMed, Psychopharmacology (Berl)) - P2 | "Single-dose TS-142 was well tolerated and had clinically relevant effects on objective and subjective sleep parameters in patients with insomnia."

Clinical • Journal • P2 data • CNS Disorders • Insomnia • Sleep Disorder

A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects (clinicaltrials.gov) - P1; N=61; Completed; Sponsor: Taisho Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

Late Phase II Study of TS-142 in Patients With Insomnia (clinicaltrials.gov) - P2; N=179; Completed; Sponsor: Taisho Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Insomnia • Sleep Disorder

A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea. (clinicaltrials.gov) - P1; N=46; Completed; Sponsor: Taisho Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A QT/QTc Evaluation Study of TS-142 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=59; Completed; Sponsor: Taisho Pharmaceutical Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion