Clinical Trials

Numerous clinical trials across early to late phases evaluate enarodustat for erythropoietic indications, including chronic kidney disease-associated anemia in dialysis-dependent and non-dialysis patients, transfusion-dependent non-severe aplastic anemia, and chemotherapy-induced anemia. Sponsored by academic medical centers and commercial pharmaceutical developers, these studies span multiple recruitment stages, ranging from completed evaluations to actively recruiting, withdrawn, or upcoming investigations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06725810 RECRUITING
Chronic Kidney Disease Associated Anemia
Shanghai Zhongshan Hospital
 2025-03-27 PHASE4
NCT07522996 WITHDRAWN
Transfusion-dependent Non-severe Aplastic Anemia
Peking Union Medical College Hospital
 2026-06 PHASE3
NCT07548671 NOT_YET_RECRUITING
Transfusion-dependent Non-severe Aplastic Anemia
Peking Union Medical College Hospital
 2026-04 PHASE3
NCT07079579 NOT_YET_RECRUITING
Renal Anemia in Non-dialysis Chronic Kidney Disease
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2025-08 PHASE4
NCT06737081 RECRUITING
Anemia
Shenzhen Salubris Pharmaceuticals Co., Ltd.
 2024-09-14 PHASE2
NCT04027517 COMPLETED
Anemia of Chronic Kidney Disease
JW Pharmaceutical
 2019-01-15 PHASE3
NCT02805244 COMPLETED
Anemia of Chronic Kidney Disease
Akros Pharma Inc.
 2016-06 PHASE1
NCT02805244 Completed
Anemia of Chronic Kidney Disease
Akros Pharma Inc.
 2016-06 Phase 1
NCT02581124 COMPLETED
Anemia of Chronic Kidney Disease
Akros Pharma Inc.
 2015-10 PHASE1
NCT01971164 COMPLETED
Anemia of Chronic Kidney Disease
Akros Pharma Inc.
 2013-05 PHASE1
NCT01978587 COMPLETED
Anemia in Chronic Kidney Disease
Akros Pharma Inc.
 2013-10 PHASE1
NCT01978587 Completed
Anemia in Chronic Kidney Disease
Akros Pharma Inc.
 2013-10 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-07-28)

Check the Enarodustat (JTZ-951) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enarodustat functions as a potent hypoxia-inducible factor prolyl hydroxylase inhibitor that targets PHD2, thereby preventing the enzymatic degradation of HIF-alpha subunits. This stabilization triggers the transcriptional activation of downstream target genes to stimulate endogenous erythropoietin expression and iron utilization, ultimately promoting red blood cell production in patients with chronic kidney disease-associated anemia.

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>).

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Note: Technical data last updated: Sep 1, 2026.