Desidustat Clinical Trials

Size	Price	Qty
5mg	USD 370

Clinical Trials

Desidustat has been evaluated in a completed Phase I clinical trial sponsored by Zydus Lifesciences Limited to assess its safety, tolerability, and pharmacokinetic characteristics following single-dose administration. The study targeted conditions including anemia associated with chronic kidney disease and chemotherapy-induced anemia. Findings from this trial established foundational safety and pharmacokinetic profiles to support further clinical evaluation of Desidustat for erythropoiesis stimulation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04667533	Completed	Anemia of Chronic Kidney Disease\|Chemotherapy Effect	Zydus Lifesciences Limited	2020-11-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desidustat functions as an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that blocks PHD-mediated degradation of HIF-alpha, leading to HIF accumulation, nuclear translocation, and downstream activation of erythropoietin gene transcription. This elevation in endogenously produced erythropoietin promotes erythropoiesis and increases hemoglobin levels, providing a biological rationale for its clinical evaluation in treating anemia associated with chronic kidney disease and chemotherapy.

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>).