Phase 2 Trial of XH-02 for Hypoparathyroidism
Summary
NIH has registered a Phase 2 clinical trial (NCT07540286) for XH-02, an mRNA nucleic acid drug designed to express parathyroid hormone (PTH) in the body following subcutaneous injection for the treatment of hypoparathyroidism. The study will further validate the safety and efficacy of subcutaneously administered XH-02 in an expanded patient cohort. Prior clinical studies demonstrated preliminary safety and efficacy results for subcutaneous XH-02 administration.
“This study aims to further validate the safety and efficacy of subcutaneously injected XH-02 in the treatment of hypoparathyroidism in a expanded cohort.”
What changed
NIH has registered a Phase 2 clinical trial for XH-02, an investigational mRNA nucleic acid drug intended to provide PTH replacement therapy through gene expression following subcutaneous injection. The study will evaluate both single and multiple subcutaneous injection regimens in patients with hypoparathyroidism.
Affected parties include clinical investigators conducting hypoparathyroidism research and pharmaceutical companies developing novel PTH replacement therapies. The trial represents standard clinical development progression following preliminary safety and efficacy data from prior studies.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
An Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
Phase 2 NCT07540286 Kind: PHASE2 Apr 20, 2026
Abstract
XH-02 is an mRNA nucleic acid drug that expresses PTH in the body following intravenous or subcutaneous injection, providing PTH replacement therapy for patients with hypoparathyroidism. Previous clinical studies have demonstrated the safety of subcutaneously administered XH-02 in several patients with hypoparathyroidism and have yielded clear efficacy results. This study aims to further validate the safety and efficacy of subcutaneously injected XH-02 in the treatment of hypoparathyroidism in a expanded cohort.
Conditions: Hypoparathyroidism
Interventions: Single subcutaneous injection, Multiple subcutaneous injection
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