Last reviewed · How we verify
BION-1301
BION-1301 is a FGFR4 inhibitor monoclonal antibody Biologic drug developed by Chinook Therapeutics, Inc.. It is currently in Phase 3 development for Hepatocellular carcinoma (HCC), FGFR4-positive. Also known as: Zigakibart.
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.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about BION-1301
What is BION-1301?
How does BION-1301 work?
What is BION-1301 used for?
Who makes BION-1301?
Is BION-1301 also known as anything else?
What drug class is BION-1301 in?
What development phase is BION-1301 in?
What are the side effects of BION-1301?
What does BION-1301 target?
Related
- Drug class: All FGFR4 inhibitor monoclonal antibody drugs
- Target: All drugs targeting FGFR4 (Fibroblast Growth Factor Receptor 4)
- Manufacturer: Chinook Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Hepatocellular carcinoma (HCC), FGFR4-positive
- Also known as: Zigakibart
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing