SHR6508 / Jiangsu Hengrui Pharma - LARVOL DELTA

Overcoming Stability Challenge During the Quantification of SHR6508 in Human Plasma by LC-MS/MS. (PubMed, Biomed Chromatogr) - "All validation parameters including selectivity, carryover, precision, accuracy, recovery, and matrix effect fell within the predefined acceptance criteria. The stabilization strategy developed in this work may also offer valuable insights for the collection and analysis of other disulfide bond-containing peptide drugs."

Journal • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

Safety, Pharmacokinetics, and Pharmacodynamics of SHR6508, a Calcium-Sensing Receptor Agonist, in Maintenance Hemodialysis Patients With Secondary Hyperparathyroidism: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. (PubMed, Kidney Med) - "SHR6508 showed promising efficacy and safety in Chinese hemodialysis patients with SHPT. A starting dose of 5 mg for titration was the best dose and will be used in the phase 2 study."

Clinical • Journal • P1 data • PK/PD data • Endocrine Disorders • Renal Disease • 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 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Endocrine Disorders • Nephrology • Renal Disease • Secondary Hyperparathyroidism

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

Trial completion • Endocrine Disorders • Secondary Hyperparathyroidism

SHR6508-301: The Trial of SHR6508 in Secondary Hyperparathyroidism (clinicaltrials.gov) - P3 | N=498 | Completed | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Endocrine Disorders • Secondary Hyperparathyroidism

SHR6508-301: The Trial of SHR6508 in Secondary Hyperparathyroidism (clinicaltrials.gov) - P3 | N=498 | Active, not recruiting | Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Enrollment closed • Trial completion date • 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=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