Setanaxib Platform Development
Setanaxib is a pipeline in a product in development for fibrotic rare diseases and solid tumors.
| Phase 1 | Phase 2 | Phase 3 | Status | Notes | ||
|---|---|---|---|---|---|---|
| SETANAXIB | Primary Biliary Cholangitis | Ongoing | Ph 2b full data in Q3 2024, ODD by FDA & EMA granted, FTD by FDA granted | |||
| Idiopathic Pulmonary Fibrosis | Ongoing / Invest Led | Investigator Led Ph 2 trial topline data in Q4 2024, ODD by FDA & EMA granted, Investigator-led study | ||||
| Alport Syndrome | Ongoing | Ph 2 proof-of-concept topline data 1H 2025, ODD by FDA & EMA granted | ||||
| Solid Tumors (SCCHN) | Ongoing | Ph2 positive interim results announced Q2 2024, Available for out-licensing |
Calliditas holds global rights to setanaxib in all indications. The asset boasts an extensive safety dataset with >320 subjects exposed to setanaxib in completed Ph1 and Ph2 clinical trials.