HS-10506 / Jiangsu Hansoh Pharma - LARVOL DELTA

A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Insomnia • Sleep Disorder

A Study of HS-10506 in Chinese Patients With Insomnia Disorder (clinicaltrials.gov) - P3 | N=732 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P3 trial • CNS Disorders • Insomnia • Sleep Disorder

Safety, Efficacy and Pharmacokinetics of HS-10506 in the Insomnia Patients: A Randomized, Double-Blind, Placebo-Controlled, Phase 1b/2 Study (AAN 2026) - P1/2, P1a | "Its favorable pharmacokinetic profile facilitated prompt sleep initiation with minimal residual daytime effect. These findings support advancing HS-10506 to a phase 3 study."

Clinical • P1/2 data • PK/PD data • CNS Disorders • Infectious Disease • Insomnia • Nephrology • Sleep Disorder

A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial

Study on the Pharmacokinetic Effect of Omeprazole Magnesium Enteric-coated Tablets on HS-10506 Tablets (ChiCTR) - P1 | N=18 | Completed | Sponsor: The Third Xiangya Hospital Central South University; The Third Xiangya Hospital Central South University

New P1 trial • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

A randomised, double-blinded, placebo-controlled, single ascending dose study of HS-10506 in healthy subjects (ECNP 2024) - "Overall, HS-10506 was safe and well-tolerated ranging from dose 2.5 mg to 60 mg. PK profile, particularly the relatively short Tmax and half-life, and dose-related somnolence indicate the therapeutic potential of HS-10506 for insomnia."

Clinical • CNS Disorders • Insomnia • Sleep Disorder

Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder (clinicaltrials.gov) - P1/2 | N=312 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1/2 trial • CNS Disorders • Insomnia • Sleep Disorder

Phase 1a Study in Healthy Participants (clinicaltrials.gov) - P1a | N=52 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial