ABBV-744 Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 227

Clinical Trials

Multiple clinical trials sponsored by AbbVie evaluate ABBV-744 at Phase 1 or Phase 1b stages for hematologic malignancies, primarily acute myeloid leukemia (AML) and myelofibrosis (MF). A clinical trial assessing the compound's safety and pharmacokinetics in AML was terminated, whereas a clinical trial investigating ABBV-744 as monotherapy and in combination with ruxolitinib or navitoclax for myelofibrosis remains active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04454658	ACTIVE_NOT_RECRUITING	Myelofibrosis (MF)	AbbVie	2020-11-11	PHASE1
NCT03360006	TERMINATED	Acute Myeloid Leukemia (AML)	AbbVie	2018-03-16	PHASE1
NCT04454658	Active not recruiting	Myelofibrosis (MF)	AbbVie	2020-11-11	Phase 1
NCT03360006	Terminated	Acute Myeloid Leukemia (AML)	AbbVie	2018-03-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-07-16)

Check the ABBV-744 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABBV-744 selectively binds to the second bromodomain (BDII) of BET proteins BRD2, BRD3, and BRD4, thereby disrupting histone acetylation recognition and downstream oncogenic gene expression. This targeted transcriptional blockade inhibits cellular proliferation and induces apoptosis in malignant hematopoietic cells, underlying its therapeutic evaluation in conditions like acute myeloid leukemia and myelofibrosis.

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>).