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Research Report
TYRA-300: A Selective FGFR3 Inhibitor in Clinical Development for Oncological and Skeletal Dysplasia Indications – A Comprehensive Review
1. Abstract
TYRA-300 is an investigational, orally bioavailable, selective inhibitor of Fibroblast Growth Factor Receptor 3 (FGFR3) currently under development by Tyra Biosciences. This agent is being evaluated in dual therapeutic pathways: oncology, for the treatment of metastatic urothelial carcinoma (mUC) and non–muscle-invasive bladder cancer (NMIBC) harboring FGFR3 alterations; and for achondroplasia, the most common form of dwarfism, which is predominantly driven by activating FGFR3 mutations. Preclinical studies have demonstrated TYRA-300's potent anti-tumor activity and its ability to promote bone growth in models of achondroplasia by modulating chondrocyte activity. A key design feature of TYRA-300 is its high selectivity for FGFR3 over other FGFR isoforms (FGFR1, FGFR2, FGFR4), which translates to a potentially more favorable tolerability profile compared to pan-FGFR inhibitors. Early clinical data from the SURF301 trial in patients with FGFR3-altered mUC have shown encouraging response rates and a manageable safety profile, with notably fewer off-target toxicities typically associated with broader FGFR inhibition. For achondroplasia, TYRA-300 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA), and the BEACH301 Phase 2 trial in children is underway. The FDA has also cleared Investigational New Drug (IND) applications for Phase 2 studies in NMIBC (SURF302) and pediatric achondroplasia (BEACH301), underscoring its therapeutic potential in addressing significant unmet medical needs in these distinct patient populations.
2. Introduction to TYRA-300
2.1. Overview of Fibroblast Growth Factor Receptors (FGFRs) and FGFR3
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/09/16 | Phase 1 | Recruiting |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Health Canada Drug Approvals
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CIMA AEMPS Drug Approvals
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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