JS1-1-01 / Tasly - LARVOL DELTA

Translational pharmacokinetic-pharmacodynamic modeling of preclinical and clinical data of the triple reuptake inhibitor JS1-1-01 to determine the recommended phase II dose (CINP-AsCNP 2025) - P1, P2 | "A daily dose of 75~200 mg JS1-1-01 might achieve the target effect in patients with depression (>90%)."

Clinical data • P2 data • PK/PD data • Preclinical • CNS Disorders • Depression • Psychiatry

A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression (clinicaltrials.gov) - P2 | N=267 | Completed | Sponsor: Tasly Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed | Trial completion date: Apr 2025 ➔ Oct 2024 | Trial primary completion date: Apr 2025 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Mood Disorders • Psychiatry

A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects. (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Tasly Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed | Phase classification: P1b ➔ P1

Phase classification • Trial completion • BDNF

A Study of the Effectiveness and Safety of JS1-1-01 in Patients With Moderate to Severe Depression (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: Tasly Pharmaceutical Group Co., Ltd

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

A Study of the Safety,Tolerability,and Pharmacokinetics of Multiple-Ascending Dose JS1-1-01 in Healty Subjects. (clinicaltrials.gov) - P1b | N=48 | Recruiting | Sponsor: Tasly Pharmaceutical Group Co., Ltd

New P1 trial

Tasly (600535.SH): JS1-1-01 tablet was approved by the US FDA for clinical trials [Google translation] (Sina Pharmaceutical News) - "A few days ago, Tasly (North America) Pharmaceutical Co., Ltd....received the U.S. Food and Drug Administration ('FDA') approval of chemical drugs notification of clinical trials of new drug JS1-1-01 tablets for the treatment of moderate to severe depression (IND number: 153206). It is reported that JS1-1-01 is a brand-new structure of serotonin-norepinephrine-dopamine triple reuptake inhibitors (SNDRIs) independently developed by the company, which can also promote the secretion of brain-derived neurotrophic factor (BDNF), So as to play an anti-depressant effect."

IND • CNS Disorders • Depression • Major Depressive Disorder