Clinical Trials

Multiple clinical trials evaluate AZD4573 across Phase 1, Phase 1/2, and Phase 2 studies, primarily targeting relapsed or refractory haematological malignancies, including acute myeloid leukemia, acute lymphocytic leukemia, peripheral T-cell lymphoma, classical Hodgkin lymphoma, and multiple myeloma. Industry sponsors, including AstraZeneca and Parexel, spearhead these evaluations assessing AZD4573 both as a monotherapy and in combination regimens. Encompassing completed as well as active, non-recruiting studies, these trials yield critical safety, tolerability, and preliminary efficacy data for hematologic oncology.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04630756 COMPLETED
Advanced Haematological Malignancies
AstraZeneca
2021-02-17 PHASE1; PHASE2
NCT05140382 COMPLETED
Relapsed/Refractory Peripheral T-cell Lymphoma; Relapsed/Refractory Classical Hodgkins Lymphoma
AstraZeneca
2021-12-15 PHASE2
NCT05140382 Completed
Relapsed/Refractory Peripheral T-cell Lymphoma|Relapsed/Refractory Classical Hodgkins Lymphoma
AstraZeneca
2021-12-15 Phase 2
NCT03263637 COMPLETED
Relapsed or Refractory Haematological Malignancies Including; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; High Risk Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Richter's Syndrome; B-cell Non-Hodgkin Lymphoma; T-cell Non-Hodgkin Lymphoma; Small Lymphocytic Lymphoma; Multiple Myeloma
AstraZeneca
2017-10-24 PHASE1
NCT04630756 Active not recruiting
Advanced Haematological Malignancies
AstraZeneca|Parexel
2021-02-17 Phase 1|Phase 2
NCT03263637 Completed
Relapsed or Refractory Haematological Malignancies Including|Acute Myeloid Leukemia|Acute Lymphocytic Leukemia|Chronic Lymphocytic Leukemia|High Risk Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia|Richter''s Syndrome|B-cell Non-Hodgkin Lymphoma|T-cell Non-Hodgkin Lymphoma|Small Lymphocytic Lymphoma|Multiple Myeloma
AstraZeneca
2017-10-24 Phase 1

(data from https://clinicaltrials.gov, updated on 2025-04-09)

Check the AZD4573 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD4573 is a potent and highly selective inhibitor of cyclin-dependent kinase 9 (CDK9) with an IC50 of less than 0.004 μM, which blocks CDK9 activity and suppresses downstream phosphorylation of RNA polymerase II. This selective kinase inhibition rapidly downregulates short-lived oncogenic survival proteins such as MCL-1, driving selective apoptotic cell death in vulnerable cancer cells and providing therapeutic efficacy against diverse haematological malignancies including acute myeloid leukemia and aggressive lymphomas.

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>).

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