Setanaxib
Sponsors
Calliditas Therapeutics Suisse S.A., Calliditas Therapeutics AB, Calliditas Therapeutics Suisse SA
Conditions
Alport SyndromeAlport syndromeLiver StiffnessPhase 1Primary Biliary CholangitisRecurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)Squamous Cell Carcinoma of Head and Neck
Phase 1
Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects
CompletedNCT04327089
Start: 2020-06-24End: 2021-03-23Updated: 2022-06-30
A Study to Evaluate Setanaxib in Patients With Alport Syndrome
CompletedNCT06274489
Start: 2023-11-27End: 2025-06-25Updated: 2026-04-13
Phase 2
A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness
CompletedNCT05014672
Start: 2022-02-14End: 2024-07-02Updated: 2025-04-24
A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
CompletedNCT05323656
Start: 2022-04-06End: 2025-08-21Updated: 2025-09-02
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the NOX1/4 Inhibitor Setanaxib in Patients with Alport Syndrome
CompletedCTIS2023-505292-73-00
Start: 2024-01-10End: 2025-06-25Target: 28Updated: 2025-03-14
A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability, and Effects on Tumour Biomarkers of the NOX1/4 Inhibitor Setanaxib, when Administered with the PD-1 Inhibitor Pembrolizumab, in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
CompletedCTIS2023-509917-35-00
Start: 2022-03-21End: 2025-08-21Target: 48Updated: 2025-03-14