YZJ-4729 / Yangzijiang Pharma - LARVOL DELTA

Development and validation of an LC-MS/MS method for quantifying a new G protein selective μ-opioid receptor agonist YZJ-4729 and its major metabolite M10 in human plasma to support a phase I study in healthy subjects. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "The method showed excellent linearity across the ranges of 0.500 to 500 ng/mL for YZJ-4729 and 0.0500 to 50.0 ng/mL for M10. The method was utilized to assess the plasma concentrations of YZJ-4729 and M10 in healthy volunteers after a 30-min intravenous infusion in the phase I clinical study, and the clinical pharmacokinetic profiles of YZJ-4729 and M10 were described."

Journal • P1 data

Efficacy and safety of YZJ-4729 tartrate injection for postoperative analgesia after abdominal surgery: a multicenter, randomized, double-blind, placebo and positive drug parallel controlled phase III clinical trial (ChiCTR) - P3 | N=560 | Not yet recruiting | Sponsor: The Third Xiangya Hospital of Central South University; Third Xiangya Hospital of Central South University

New P3 trial • Pain

A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

New P2 trial • Musculoskeletal Pain • Orthopedics • Pain

A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery (clinicaltrials.gov) - P3 | N=560 | Not yet recruiting | Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

New P3 trial • Pain

A Phase 1 Study of YZJ-4729 Tartrate Injection in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

New P1 trial

A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

New P2 trial • Surgery • Pain

Pharmacokinetics, metabolite profiling, safety and tolerability of YZJ-4729 tartrate, a novel G protein-biased μ-opioid receptor agonist, in healthy Chinese subjects. (PubMed, Front Pharmacol) - " The clinical study results laid a foundation for the further clinical studies of YZJ-4729 in patients. Clinical Trial Registration: http://www.chinadrugtrials.org.cn, identifier CTR20222574."

Clinical • Journal • PK/PD data • Pain