HS-10353 / Jiangsu Hansoh Pharma - LARVOL DELTA

Safety, pharmacokinetics, and pharmacodynamics of HS-10353 in healthy adults and patients with major depressive disorder: a phase 1 study (ECNP 2023) - "The results of this trial demonstrated that HS-10353 was generally safe and well tolerated in both healthy subjects and MDD patients. Furthermore, rapid antidepressant effects were observed at day 8 in patients treated with 50 mg of HS-10353, compared with traditional antidepressants, which take several weeks to produce antidepressant effects. These findings support that HS-10353 has the potential to be a promising therapeutic option."

Clinical • P1 data • PK/PD data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of HS-10353 in Chinese Participants. (clinicaltrials.gov) - P1 | N=96 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Enrolling by invitation ➔ Completed | N=72 ➔ 96 | Trial completion date: Jun 2022 ➔ Mar 2023 | Trial primary completion date: Apr 2022 ➔ Mar 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study of HS-10353 in Adult Participants With Major Depressive Disorder (clinicaltrials.gov) - P2 | N=144 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Phase II Study of HS-10353 in Participants With Postpartum Depression (clinicaltrials.gov) - P2 | N=96 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P2 trial • CNS Disorders • Depression • Mood Disorders • Postpartum Depression • Psychiatry