SHR6508 / Jiangsu Hengrui Pharma - LARVOL DELTA

A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2025 ➔ Apr 2025

Enrollment closed • Trial primary completion date • Endocrine Disorders • Secondary Hyperparathyroidism

A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P1 trial • Endocrine Disorders • Secondary Hyperparathyroidism

The pharmacokinetics, pharmacodynamics and tolerability of SHR6508 in chinese healthy subjects: a randomized, placebo-controlled, double-blind, single-dose and dose-escalation phase I trial. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Twenty-one TEAEs occurred in 12 subjects (54.5%), and no serious or severe TEAEs occurred. The overall safety and tolerability of a single intravenous dose of 0.5-5 mg SHR6508 in healthy subjects was favorable, exhibiting dose-dependent PK and PD properties."

Journal • P1 data • PK/PD data • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

SHR6508, a Calcium-Sensing Receptor Agonist, in Patients on Hemodialysis Who Have Secondary Hyperparathyroidism: A Phase 2 Trial (KIDNEY WEEK 2024) - "SHR6508 showed greater efficacy in iPTH reduction and similar safety profiles compared to cinacalcet in HD patients with SHPT."

Clinical • P2 data • Endocrine Disorders • Secondary Hyperparathyroidism

SHR6508-202: Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial (clinicaltrials.gov) - P2 | N=303 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

SHR6508-301: The Trial of SHR6508 in Secondary Hyperparathyroidism (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism

SHR6508-301: The Trial of SHR6508 in Secondary Hyperparathyroidism (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

New P3 trial • Endocrine Disorders • Renal Disease • Secondary Hyperparathyroidism