Molidustat (BAY 85-3934) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 337

Clinical Trials

Numerous clinical trials sponsored by Bayer evaluate the therapeutic profile of oral molidustat across Phase 1, Phase 2, and Phase 3 studies. These investigations primarily target renal anemia, anemia secondary to chronic renal insufficiency, and chronic kidney disease, evaluating pharmacokinetics, pharmacodynamics, safety, and efficacy. Recruitment statuses across these studies are predominantly recorded as completed or active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03543657	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2018-06-23	PHASE3
NCT03418168	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2018-02-22	PHASE3
NCT03350347	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2017-12-13	PHASE3
NCT03350321	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2017-12-12	PHASE3
NCT03351166	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2018-01-22	PHASE3
NCT03418168	Completed	Anemia\|Renal Insufficiency Chronic	Bayer	2018-02-22	Phase 3
NCT03351166	Completed	Anemia\|Renal Insufficiency Chronic	Bayer	2018-01-22	Phase 3
NCT03350347	Completed	Anemia\|Renal Insufficiency Chronic	Bayer	2017-12-13	Phase 3
NCT02055482	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2014-06-24	PHASE2
NCT02064426	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2014-03-13	PHASE2
NCT02312973	COMPLETED	Renal Insufficiency, Chronic	Bayer	2015-01-14	PHASE1
NCT01975818	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2013-10-28	PHASE2
NCT02021409	COMPLETED	Anemia; Renal Insufficiency, Chronic	Bayer	2014-01-28	PHASE2
NCT02312973	Completed	Renal Insufficiency Chronic	Bayer	2015-01-14	Phase 1
NCT01318551	COMPLETED	Anemia	Bayer	2011-03-16	PHASE1
NCT01332942	COMPLETED	Anemia	Bayer	2011-04	PHASE1
NCT01679587	COMPLETED	Kidney Diseases	Bayer	2012-09	PHASE1
NCT01458028	Completed	Anemia	Bayer	2011-09	Phase 1
NCT01332942	Completed	Anemia	Bayer	2011-04	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-01-29)

Check the Molidustat (BAY 85-3934) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Molidustat reversibly inhibits hypoxia-inducible factor prolyl hydroxylase enzymes PHD1, PHD2, and PHD3, thereby preventing the prolyl hydroxylation and subsequent ubiquitin-proteasomal degradation of hypoxia-inducible factor-alpha subunits. The resulting accumulation and nuclear translocation of hypoxia-inducible factor activate the transcription of erythropoietin, effectively promoting red blood cell production to treat renal anemia in patients with chronic kidney disease.

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>).