Clinical Trials

Numerous clinical trials evaluate Daprodustat primarily for managing anemia associated with chronic kidney disease, alongside secondary indications including peripheral vascular disease, wound healing, and allergic bronchopulmonary aspergillosis. Spanning Phase 1 pharmacokinetic evaluations through Phase 4 comparative efficacy and safety trials, these studies—sponsored by entities such as GlaxoSmithKline, Qilu Pharmaceutical, and USRC Kidney Research—range in status from recruiting and active to completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07300111 NOT_YET_RECRUITING
Anaemia
Qilu Pharmaceutical Co., Ltd.
 2025-12-31 PHASE3
NCT07755683 NOT_YET_RECRUITING
Chronic Kidney Disease (Stages 3b-5); Anemia Associated With Chronic Kidney Disease
Services Hospital, Lahore
 2026-09-01
NCT05682326 COMPLETED
Anaemia
GlaxoSmithKline
 2023-09-06 PHASE3
NCT05951192 COMPLETED
Anemia; Renal Insufficiency, Chronic; Renal Anemia
USRC Kidney Research
 2023-07-01 PHASE4
NCT05682326 Recruiting
Anaemia
GlaxoSmithKline
 2023-09-06 Phase 3
NCT05951192 Active not recruiting
Anemia|Renal Insufficiency Chronic|Renal Anemia
USRC Kidney Research|GlaxoSmithKline
 2023-07-01 Phase 4
NCT03457701 COMPLETED
Anaemia
GlaxoSmithKline
 2019-07-30 PHASE2
NCT04640311 COMPLETED
Anaemia
GlaxoSmithKline
 2020-12-18 PHASE1
NCT02876835 COMPLETED
Anaemia
GlaxoSmithKline
 2016-09-27 PHASE3
NCT04640311 Completed
Anaemia
GlaxoSmithKline
 2020-12-18 Phase 1
NCT02879305 COMPLETED
Anaemia; Aspergillosis, Allergic Bronchopulmonary
GlaxoSmithKline
 2016-09-28 PHASE3
NCT03409107 COMPLETED
Anaemia
GlaxoSmithKline
 2018-03-05 PHASE3
NCT03029208 COMPLETED
Anaemia
GlaxoSmithKline
 2017-05-11 PHASE3
NCT03029247 COMPLETED
Anaemia
GlaxoSmithKline
 2017-07-27 PHASE2
NCT03400033 COMPLETED
Anaemia
GlaxoSmithKline
 2018-09-05 PHASE3
NCT03446612 TERMINATED
Anaemia
GlaxoSmithKline
 2019-01-10 PHASE2
NCT02791763 COMPLETED
Anaemia
GlaxoSmithKline
 2016-06-06 PHASE3
NCT03223337 COMPLETED
Anaemia
GlaxoSmithKline
 2017-07-24 PHASE1
NCT02969655 COMPLETED
Anaemia
GlaxoSmithKline
 2016-11-21 PHASE3
NCT03493386 COMPLETED
Anaemia
GlaxoSmithKline
 2018-04-24 PHASE1
NCT03239522 COMPLETED
Anaemia
GlaxoSmithKline
 2017-10-10 PHASE1
NCT02829320 COMPLETED
Anaemia
GlaxoSmithKline
 2016-08-08 PHASE3
NCT02243306 COMPLETED
Anaemia
GlaxoSmithKline
 2014-10-24 PHASE1
NCT01831804 COMPLETED
Wound Healing
GlaxoSmithKline
 2013-06-17 PHASE1
NCT02689206 COMPLETED
Anaemia
GlaxoSmithKline
 2016-02-17 PHASE2
NCT02075463 TERMINATED
Anemia; Anaemia
GlaxoSmithKline
 2014-06-11 PHASE2
NCT02371603 COMPLETED
Anaemia
GlaxoSmithKline
 2015-02-11 PHASE1
NCT02231190 COMPLETED
Tendon Injuries
GlaxoSmithKline
 2015-01-15 PHASE1
NCT01977573 COMPLETED
Anaemia
GlaxoSmithKline
 2013-10-31 PHASE2
NCT02293148 COMPLETED
Anaemia
GlaxoSmithKline
 2014-11-17 PHASE1
NCT01977482 COMPLETED
Anaemia
GlaxoSmithKline
 2013-11-01 PHASE2
NCT01920594 COMPLETED
Surgical Procedures
GlaxoSmithKline
 2013-10-31 PHASE2
NCT02019719 COMPLETED
Anaemia
GlaxoSmithKline
 2013-11-05 PHASE2
NCT01406340 TERMINATED
Anaemia
GlaxoSmithKline
 2011-08-30 PHASE1
NCT01587924 COMPLETED
Anaemia
GlaxoSmithKline
 2012-05-23 PHASE2
NCT01587898 COMPLETED
Anaemia
GlaxoSmithKline
 2012-05-17 PHASE2
NCT01673555 COMPLETED
Anaemia
GlaxoSmithKline
 2012-05-15 PHASE1
NCT02135848 COMPLETED
Vascular Disease, Peripheral
GlaxoSmithKline
 2010-10-15 PHASE2
NCT01319006 COMPLETED
Anaemia
GlaxoSmithKline
 2011-02-25 PHASE1
NCT01376232 COMPLETED
Anaemia
GlaxoSmithKline
 2010-11-08 PHASE1
NCT00935831 COMPLETED
Kidney Disease
GlaxoSmithKline
 2009-08-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-23)

Check the Daprodustat (GSK1278863) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daprodustat selectively inhibits hypoxia-inducible factor-prolyl hydroxylase enzymes, preventing the hydroxylation and subsequent ubiquitin-proteasomal degradation of hypoxia-inducible factor alpha subunits. This stabilization allows hypoxia-inducible factor to accumulate and translocate to the nucleus, where it activates transcription of endogenous erythropoietin and stimulates erythropoiesis, providing a targeted therapeutic mechanism for treating 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>).

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