TYRA-300 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Tyra Biosciences, Inc. are currently evaluating TYRA-300 for conditions such as advanced urothelial carcinoma, low-grade non-muscle-invasive bladder cancer, upper tract urothelial carcinoma, solid tumors with FGFR3 alterations, and pediatric achondroplasia, alongside pharmacokinetic evaluations in healthy volunteers. Recruitment across the portfolio includes both actively recruiting protocols and active, non-recruiting cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07265947	RECRUITING	Low Grade Upper Tract Urothelial Carcinoma	Tyra Biosciences, Inc	2025-12-22	PHASE2
NCT06842355	RECRUITING	Achondroplasia	Tyra Biosciences, Inc	2025-03-04	PHASE2
NCT06995677	RECRUITING	Low-grade NMIBC; FGFR Gene Amplification; FGFR Gene Alterations; FGFR3 Gene Alteration; FGFR3 Gene Mutation; FGFR3 Gene Fusions	Tyra Biosciences, Inc	2025-06-27	PHASE2
NCT05544552	ACTIVE_NOT_RECRUITING	Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Solid Tumor; Urothelial Carcinoma; Solid Tumor, Adult; Bladder Cancer; Non-muscle-invasive Bladder Cancer; FGFR3 Gene Mutation; FGFR3 Gene Alteration; Advanced Solid Tumor; Advanced Urothelial Carcinoma; Urinary Tract Cancer; Urinary Tract Tumor; Urinary Tract Carcinoma	Tyra Biosciences, Inc	2022-11-22	PHASE1; PHASE2
NCT06006702	ACTIVE_NOT_RECRUITING	Healthy	Tyra Biosciences, Inc	2023-10-16	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the TYRA-300 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TYRA-300 acts as a potent, selective, and reversible inhibitor of fibroblast growth factor receptor 3 (FGFR3), blocking downstream kinase activity and intracellular signaling pathways. This biochemical inhibition suppresses abnormal cellular proliferation in FGFR3-altered models, mediating tumor growth suppression in urothelial carcinomas and addressing growth plate dysregulation in conditions like achondroplasia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).