Overview

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Indication

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Research Report

Published: May 23, 2025

TYRA-430: A Novel FGFR4/3-Biased Inhibitor for FGF/FGFR Pathway-Aberrant Cancers

1. Introduction to TYRA-430 and the FGF/FGFR Pathway in Cancer

1.1. Overview of TYRA-430

TYRA-430 is an investigational, orally administered, reversible, small-molecule inhibitor with a biased specificity for Fibroblast Growth Factor Receptor 4 (FGFR4) and Fibroblast Growth Factor Receptor 3 (FGFR3).[1] Developed by Tyra Biosciences, Inc., TYRA-430 is engineered as a next-generation precision medicine aimed at addressing cancers driven by aberrations in the FGF/FGFR signaling pathway, particularly advanced hepatocellular carcinoma (HCC) and other solid tumors.[4] Its development leverages the company's proprietary SNÅP (Structure-based NÅnobodies and Panel) platform, which facilitates rapid and precise drug design to overcome challenges such as acquired drug resistance.[1] The key characteristics of TYRA-430 are summarized in Table 1.

Table 1: TYRA-430 - Key Drug Characteristics

Characteristic	Description	Source(s)
Drug Name (Synonyms)	TYRA-430	General
Developer	Tyra Biosciences, Inc.	4
Drug Type	Small molecule, oral, reversible, FGFR4/3-biased inhibitor	1
Primary Targets	Fibroblast Growth Factor Receptor 4 (FGFR4), Fibroblast Growth Factor Receptor 3 (FGFR3)	2
Key Mechanism of Action	Inhibition of FGFR4 and FGFR3 kinase activity, particularly in the context of FGF19-driven signaling	2
Therapeutic Areas	Oncology (Neoplasms), Digestive System Disorders (specifically HCC)	5
Lead Indications	Advanced Hepatocellular Carcinoma (HCC) with FGF19 overexpression or other activating FGF/FGFR pathway aberrations; other advanced solid tumors with similar activating FGF/FGFR pathway aberrations	1

1.2. The FGF/FGFR Signaling Pathway in Oncology

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations	2025/04/08	NCT06915753	Phase 1	Recruiting	Tyra Biosciences, Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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Tyra Biosciences' TYRA-300 Shows Promise in Metastatic Urothelial Cancer

10 months ago

• TYRA Biosciences reported positive interim results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study, demonstrating notable anti-tumor activity. • The company's IND was cleared for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), with plans to initiate the study in Q1 2025. • TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development. • Doug Warner, MD, was appointed as Chief Medical Officer, bringing extensive experience in oncology and skeletal disease drug development to Tyra Biosciences.

Tyra Biosciences Advances FGFR Inhibitor Pipeline with Multiple Clinical Trials

11 years ago

Tyra Biosciences is developing TYRA-300, a selective FGFR3 inhibitor, for bladder cancer and skeletal dysplasia, with Phase 2 trials for achondroplasia expected to begin in Q1 2025.

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