Last reviewed 2026-04-22 · How we verify

BPI-16350

BPI-16350 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells.

BPI-16350 is a selective inhibitor of fibroblast growth factor receptor (FGFR) that blocks aberrant FGFR signaling in cancer cells. Used for Cholangiocarcinoma with FGFR2 fusion or rearrangement, Other FGFR-altered solid tumors.

At a glance

Mechanism of action

BPI-16350 targets FGFR mutations and fusions that drive proliferation in certain solid tumors. By inhibiting FGFR kinase activity, the drug suppresses downstream signaling pathways critical for tumor cell survival and growth. This mechanism is particularly relevant in cancers with FGFR alterations, including cholangiocarcinoma and other FGFR-driven malignancies.

Approved indications

• Cholangiocarcinoma with FGFR2 fusion or rearrangement
• Other FGFR-altered solid tumors

Common side effects

• Hyperphosphatemia
• Diarrhea
• Fatigue
• Nausea
• Stomatitis

Key clinical trials

• A Phase I Study of BPI-16350 in Patients with Advanced Solid Tumor (PHASE1)
• A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer (PHASE3)
• A Food-Effect Study of BPI-16350 in Healthy Subjects (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• BPI-16350 CI brief — competitive landscape report
• BPI-16350 updates RSS · CI watch RSS
• Betta Pharmaceuticals Co., Ltd. portfolio CI