TRTL-913 / Jiangsu Hansoh Pharma, Tortugas Neuroscience - LARVOL DELTA

A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Tortugas Neuroscience, Inc.

New P2 trial • Otorhinolaryngology

Phase 1 randomized trial of HS-10353, a novel GABA(A) positive allosteric modulator for treatment of major depressive disorder. (PubMed, BMC Med) - P1 | "Single and multiple oral doses of HS-10353 were safe and well tolerated with a favorable PK profile. The findings in this small, short duration study suggest an early signal in patients with MDD that should be further investigated."

Journal • P1 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

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