HRS-9057 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Aug 2026 ➔ Dec 2026

Enrollment closed • Trial completion date • Cardiovascular • Heart Failure

Phase Ib study of intravenous HRS-9057, an arginine vasopressin V2 receptor antagonist, versus oral tolvaptan in congestive heart failure with volume overload despite prior diuretic therapy (ESC 2026) - "Both HRS-9057 groups maintained a negative fluid balance throughout the 7-day treatment, whereas the tolvaptan group exhibited a negative balance only on Day 1 (Figure 2). Comparable elevations in serum sodium were observed across all groups, with values remaining within the normal range.ConclusionIn CHF patients with persistent volume overload, intravenous HRS-9057 showed a trend toward greater body weight reduction and decongestive effects compared with oral tolvaptan, with no new safety concerns."

P1 data • Cardiovascular • Congestive Heart Failure • Heart Failure

A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Cardiovascular • Heart Failure

Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention (clinicaltrials.gov) - P2 | N=118 | Recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

Phase II Clinical Study of HRS-9057 Injection in Patients With Heart Failure-induced Fluid Retention (clinicaltrials.gov) - P2 | N=118 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P2 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of HRS-9057 in Patients With Heart Failure and Volume Overload (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Sep 2024 ➔ Oct 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure

A Study of HRS-9057 in Patients With Heart Failure and Volume Overload (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure