8 completed. 6 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 6 |
| Phase 1 | 3 | Completed 3 |
Follow setanaxib: new trials by email Literature Review of setanaxib trials Research Report on setanaxib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate Setanaxib in Patients With Alport Syndrome Setanaxib, Placebo - Alport Syndrome | Phase 1 / Phase 2 | Completed | Calliditas Therapeutics AB | 20 | 2023-11-27 | 2026-04-13 |
| A Study of Setanaxib Co-Administered With Pembrolizumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) Setanaxib, Pembrolizumab, Placebo - Squamous Cell Carcinoma of Head and Neck | Phase 2 | Completed | Calliditas Therapeutics Suisse SA | 55 | 2022-04-06 | 2025-09-02 |
| A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness Setanaxib, Placebo - Primary Biliary Cholangitis, Liver Stiffness | Phase 2 | Completed | Calliditas Therapeutics Suisse SA | 76 | 2022-02-14 | 2025-04-24 |
| GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Placebo Oral Tablet, GKT137831 - Idiopathic Pulmonary Fibrosis | Phase 2 | Completed | University of Alabama at Birmingham | 58 | 2020-09-07 | 2026-05-11 |
| Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects Setanaxib - Phase 1 | Phase 1 | Completed | Calliditas Therapeutics AB | 64 | 2020-06-24 | 2022-06-30 |
| Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets GKT137831 - Phase 1 | Phase 1 | Completed | Calliditas Therapeutics AB | 15 | 2018-12-19 | 2022-06-30 |
| Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol. GKT137831, Placebo oral capsule - Primary Biliary Cirrhosis | Phase 2 | Completed | Calliditas Therapeutics AB | 111 | 2017-06-26 | 2022-06-29 |
| Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria GKT137831, Placebo - Type 2 Diabetes Mellitus With Diabetic Nephropathy | Phase 2 | Completed | Calliditas Therapeutics AB | 136 | 2013-10-01 | 2025-02-28 |
Liver Cirrhosis, Biliary (2) · Albuminuria (1) · Diabetes Mellitus, Type 2 (1) · Idiopathic Pulmonary Fibrosis (1) · Nephritis, Hereditary (1) · Proteinuria (1) · Squamous Cell Carcinoma of Head and Neck (1)
Calliditas Therapeutics AB (5) · Calliditas Therapeutics Suisse SA (2) · University of Alabama at Birmingham (1)
France (5) · United States (5) · Germany (4) · Spain (4) · United Kingdom (4) · Canada (3) · Czechia (3) · Italy (3) · Poland (3) · Australia (2) · Austria (2) · Belgium (2) · Greece (2) · Israel (2) · Hungary (1)
Philippe Wiesel, MD (2) · Steven R Duncan, MD (1)
PMID 33515429, PMID 36809195, PMID 37183520, PMID 40938675, PMID 41805697
2016 (1)