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BION-1301
BION-1301 is a monoclonal antibody that targets and inhibits FGFR4 (fibroblast growth factor receptor 4) to reduce hepatocellular carcinoma cell growth and survival.
BION-1301 is a monoclonal antibody that targets and inhibits FGFR4 (fibroblast growth factor receptor 4) to reduce hepatocellular carcinoma cell growth and survival. Used for Hepatocellular carcinoma (HCC), FGFR4-positive.
At a glance
| Generic name | BION-1301 |
|---|---|
| Also known as | Zigakibart |
| Sponsor | Chinook Therapeutics, Inc. |
| Drug class | FGFR4 inhibitor monoclonal antibody |
| Target | FGFR4 (Fibroblast Growth Factor Receptor 4) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BION-1301 binds to FGFR4, a receptor overexpressed in hepatocellular carcinoma, blocking FGF19-FGFR4 signaling that drives tumor proliferation and survival. By inhibiting this pathway, the drug aims to slow or stop cancer cell growth. This approach is particularly relevant in HCC where FGF19-FGFR4 axis activation is a common oncogenic driver.
Approved indications
- Hepatocellular carcinoma (HCC), FGFR4-positive
Common side effects
- Hyperphosphatemia
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. (PHASE3)
- A Study of Zigakibart in Adults With IgA Nephropathy (PHASE3)
- Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN) (PHASE1, PHASE2)
- Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects (PHASE1)
- Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BION-1301 CI brief — competitive landscape report
- BION-1301 updates RSS · CI watch RSS
- Chinook Therapeutics, Inc. portfolio CI