Safety, Tolerability, and Pharmacokinetics of Single and Multiple Topical Applications of Sodium Taurodeoxycholate, a Treatment for Atopic Dermatitis.

ABSTRACT: Sodium taurodeoxycholate (TDCA) gel is a novel candidate for the treatment of atopic dermatitis and is currently under clinical development. TDCA is a taurine-conjugated bile acid derivative that acts as a G protein-coupled bile acid receptor agonist and modulates immune responses. This phase 1 study aimed to investigate the safety, tolerability, and pharmacokinetic profile of sodium TDCA after single and multiple topical administrations of sodium TDCA gel in healthy male subjects. Subjects were randomized to receive a single topical administration of sodium TDCA 5, 10, 30, and 50 mg (0.05%, 0.1%, 0.3%, and 0.5% of 10 g) gel or placebo in the single-ascending dose (SAD) study (N = 32), and sodium TDCA 10, 30, and 50 mg (0.1%, 0.3%, and 0.5% of 10 g) gel or placebo for 28 days (N = 24) in t

SUBMITTER: Won H 

PROVIDER: S-EPMC12066394 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature