BAY 2402234 (Orludodstat) Clinical Trials

Size	Price	Qty
2mg	USD 337
5mg	USD 557

Clinical Trials

Multiple Phase I and Early Phase I clinical trials have evaluated BAY 2402234 (Orludodstat) in conditions including leukemia, glioma, and malignancies harboring IDH mutations. Sponsored by Bayer alongside academic institutions such as the University of Texas Southwestern Medical Center, these protocols focused on safety, pharmacokinetics, and pharmacodynamics. However, recruitment across these studies has ceased, with the trials currently designated as terminated or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05061251	WITHDRAWN	Glioma; IDH Mutation	University of Texas Southwestern Medical Center	2021-12-01	EARLY_PHASE1
NCT05061251	Withdrawn	Glioma\|IDH Mutation	University of Texas Southwestern Medical Center\|Bayer	2021-12-01	Early Phase 1
NCT03404726	TERMINATED	Leukemia	Bayer	2018-03-29	PHASE1

(data from https://clinicaltrials.gov, updated on 2022-01-11)

Check the BAY 2402234 (Orludodstat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Orludodstat (BAY 2402234) selectively binds to and inhibits dihydroorotate dehydrogenase (DHODH), blocking the de novo pyrimidine biosynthesis pathway and depleting intracellular pyrimidine nucleotide pools. This metabolic disruption impairs essential nucleic acid synthesis and suppresses rapidly proliferating cells, providing a rationale for targeting tumor growth in advanced malignancies such as leukemia and glioma.

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>).