AZD5991 Clinical Trials

Size	Price	Qty
1mg	USD 170
5mg	USD 570

Clinical Trials

Multiple clinical trials evaluate AZD5991 in patients with relapsed or refractory acute myeloid leukemia (AML) as well as previously untreated AML across Phase 1, Phase 2, and Phase 3 evaluations. AstraZeneca initiated a terminated Phase 1/1b/2a trial to assess the safety, pharmacokinetics, and initial efficacy of AZD5991 in relapsed or refractory AML. Additionally, Beat AML, LLC sponsored an actively recruiting, biomarker-based master protocol trial spanning Phase 2 and Phase 3 interventions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03013998	RECRUITING	Previously Untreated Relapsed Refractory Acute Myeloid Leukemia	Beat AML, LLC	2016-11	PHASE2; PHASE3
NCT03218683	TERMINATED	Relapsed or Refractory Acute Myeloid Leukemia (AML)	AstraZeneca	2017-08-02	PHASE1
NCT03218683	Terminated	Relapsed or Refractory Acute Myeloid Leukemia (AML)	AstraZeneca	2017-08-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the AZD5991 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD5991 is a macrocyclic small-molecule inhibitor that selectively binds to myeloid cell leukemia-1 (MCL-1) with sub-nanomolar affinity (Ki = 0.13 nM), blocking its anti-apoptotic binding interactions. By suppressing MCL-1 activity, AZD5991 promotes mitochondrial outer membrane permeabilization and induces apoptotic cell death in dependent malignant cells, demonstrating therapeutic potential for the treatment of relapsed or refractory acute myeloid leukemia.

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>).