Last reviewed 2026-04-23 · How we verify

Brivanib 400 mg, BID

Zai Lab (Shanghai) Co., Ltd. · Phase 2 active Small molecule

Brivanib 400 mg, BID is a Dual FGFR/VEGFR inhibitor Small molecule drug developed by Zai Lab (Shanghai) Co., Ltd.. It is currently in Phase 2 development for Hepatocellular carcinoma (Phase 2), Advanced solid tumors (Phase 2).

Brivanib is a dual inhibitor of fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) that blocks angiogenesis and tumor cell proliferation.

Brivanib is a dual inhibitor of fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) that blocks angiogenesis and tumor cell proliferation. Used for Hepatocellular carcinoma (Phase 2), Advanced solid tumors (Phase 2).

Likelihood of approval

13.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Brivanib 400 mg, BID
Sponsor	Zai Lab (Shanghai) Co., Ltd.
Drug class	Dual FGFR/VEGFR inhibitor
Target	FGFR, VEGFR
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

Brivanib inhibits both FGFR and VEGFR signaling pathways, which are critical for tumor angiogenesis and growth. By blocking these receptor tyrosine kinases, the drug reduces new blood vessel formation to tumors and directly suppresses cancer cell proliferation. This dual-target approach aims to overcome resistance mechanisms that may develop with single-pathway inhibition.

Approved indications

Hepatocellular carcinoma (Phase 2)
Advanced solid tumors (Phase 2)

Common side effects

Diarrhea
Fatigue
Nausea
Hypertension
Abdominal pain

Key clinical trials

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:

Brivanib 400 mg, BID CI brief — competitive landscape report
Brivanib 400 mg, BID updates RSS · CI watch RSS
Zai Lab (Shanghai) Co., Ltd. portfolio CI

Frequently asked questions about Brivanib 400 mg, BID

What is Brivanib 400 mg, BID?

Brivanib 400 mg, BID is a Dual FGFR/VEGFR inhibitor drug developed by Zai Lab (Shanghai) Co., Ltd., indicated for Hepatocellular carcinoma (Phase 2), Advanced solid tumors (Phase 2).

How does Brivanib 400 mg, BID work?

Brivanib is a dual inhibitor of fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) that blocks angiogenesis and tumor cell proliferation.

What is Brivanib 400 mg, BID used for?

Brivanib 400 mg, BID is indicated for Hepatocellular carcinoma (Phase 2), Advanced solid tumors (Phase 2).

Who makes Brivanib 400 mg, BID?

Brivanib 400 mg, BID is developed by Zai Lab (Shanghai) Co., Ltd. (see full Zai Lab (Shanghai) Co., Ltd. pipeline at /company/zai-lab-shanghai-co-ltd).

What drug class is Brivanib 400 mg, BID in?

Brivanib 400 mg, BID belongs to the Dual FGFR/VEGFR inhibitor class. See all Dual FGFR/VEGFR inhibitor drugs at /class/dual-fgfr-vegfr-inhibitor.

What development phase is Brivanib 400 mg, BID in?

Brivanib 400 mg, BID is in Phase 2.

What are the side effects of Brivanib 400 mg, BID?

Common side effects of Brivanib 400 mg, BID include Diarrhea, Fatigue, Nausea, Hypertension, Abdominal pain.

What does Brivanib 400 mg, BID target?

Brivanib 400 mg, BID targets FGFR, VEGFR and is a Dual FGFR/VEGFR inhibitor.

Drug class: All Dual FGFR/VEGFR inhibitor drugs
Target: All drugs targeting FGFR, VEGFR
Manufacturer: Zai Lab (Shanghai) Co., Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Hepatocellular carcinoma (Phase 2)
Indication: Drugs for Advanced solid tumors (Phase 2)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing