First-In-Human Study of Safety, Tolerability, Efficacy, and Pharmacokinetics of CPNE7-Derived Peptide (Selcopintide) for Dentin Hypersensitivity.

ABSTRACT: Dentin hypersensitivity is characterized by transient, sharp pain resulting from dentin exposure due to enamel or cementum loss. Current treatments, which primarily focus on superficial tubule occlusion or nerve desensitization, provide only temporary relief. Copine7 (CPNE7) induces odontoblast differentiation and physiologic dentin regeneration, enabling biological dentin sealing and presenting a novel therapeutic approach. This study reports the first-in-human results of a randomized, double-blind, dose-escalation phase 1/2a clinical trial evaluating the safety, tolerability, preliminary efficacy, and pharmacokinetics of the CPNE7-derived functional peptide (selcopintide) in patients with dentin hypersensitivity. In Part A (Single Ascending Dose, SAD), 24 participants received a single t

SUBMITTER: Lee MJ 

PROVIDER: S-EPMC12361636 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature