Last reviewed 2026-04-22 · How we verify

BAY2927088

BAY2927088 is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR signaling to inhibit tumor cell proliferation and survival.

BAY2927088 is a fibroblast growth factor receptor (FGFR) inhibitor that blocks FGFR signaling to inhibit tumor cell proliferation and survival. Used for Urothelial carcinoma with FGFR alterations, Other solid tumors with FGFR mutations or fusions.

At a glance

Mechanism of action

BAY2927088 selectively targets fibroblast growth factor receptors, which are frequently dysregulated in various cancers through mutations, amplifications, or fusions. By inhibiting FGFR signaling, the drug suppresses downstream pathways critical for cancer cell growth and survival. This mechanism is particularly relevant in tumors with FGFR alterations, including certain urothelial carcinomas and other solid tumors.

Approved indications

• Urothelial carcinoma with FGFR alterations
• Other solid tumors with FGFR mutations or fusions

Common side effects

• Hyperphosphatemia
• Diarrhea
• Fatigue
• Nausea
• Stomatitis

Key clinical trials

• First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) (PHASE1, PHASE2)
• A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (PHASE2)
• A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) (PHASE3)
• Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation
• A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dose (PHASE1)
• A Study to Learn About How BAY2927088 Affects the Level of Dabigatran or Rosuvastatin in the Blood When These Drugs Are Taken Together in Healthy Participants (PHASE1)
• A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants (PHASE1)
• A Study to Learn About How BAY2927088 Affects the Level of Midazolam in the Blood When Both Drugs Are Taken Together in Healthy Participants (PHASE1)

Primary sources

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