Last reviewed 2026-04-22 · How we verify

AZD5335

AZD5335 is a selective inhibitor of fibroblast growth factor receptor 1 (FGFR1) that blocks aberrant FGFR signaling in cancer cells.

AZD5335 is a selective inhibitor of fibroblast growth factor receptor 1 (FGFR1) that blocks aberrant FGFR signaling in cancer cells. Used for FGFR1-amplified or FGFR1-driven solid tumors (in development).

At a glance

Mechanism of action

AZD5335 targets FGFR1, a receptor tyrosine kinase frequently dysregulated in various cancers through gene amplification or activating mutations. By inhibiting FGFR1 phosphorylation and downstream signaling, the drug suppresses tumor cell proliferation and survival in FGFR1-dependent malignancies. This selective approach aims to provide efficacy while potentially reducing off-target toxicities associated with pan-FGFR inhibitors.

Approved indications

• FGFR1-amplified or FGFR1-driven solid tumors (in development)

Common side effects

• Hyperphosphatemia
• Diarrhea
• Nausea
• Fatigue

Key clinical trials

• Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors (PHASE1, PHASE2)
• Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (PHASE1)
• AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (PHASE3)

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:

• AZD5335 CI brief — competitive landscape report
• AZD5335 updates RSS · CI watch RSS
• AstraZeneca portfolio CI