Mivebresib (ABBV-075) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

AbbVie sponsored several Phase I clinical trials to evaluate the safety, pharmacokinetics, and therapeutic activity of Mivebresib (ABBV-075) across solid tumors and hematologic malignancies, including breast, non-small cell lung, and prostate cancers, acute myeloid leukemia, multiple myeloma, and non-Hodgkin's lymphoma. Additionally, a clinical trial investigated Phase Ib regimens of Mivebresib as monotherapy and in combination with ruxolitinib or navitoclax for myelofibrosis. Across these diverse neoplastic indications, the early-stage clinical evaluations are currently listed as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04480086	TERMINATED	Myelofibrosis (MF)	AbbVie	2021-03-17	PHASE1
NCT04480086	Terminated	Myelofibrosis (MF)	AbbVie	2021-03-17	Phase 1
NCT02391480	COMPLETED	Cancer; Breast Cancer; Non-Small Cell Lung Cancer; Acute Myeloid Leukemia (AML); Multiple Myeloma; Prostate Cancer; Small Cell Lung Cancer; Non-Hodgkins Lymphoma	AbbVie	2015-04-14	PHASE1
NCT02391480	Completed	Cancer\|Breast Cancer\|Non-Small Cell Lung Cancer\|Acute Myeloid Leukemia (AML)\|Multiple Myeloma\|Prostate Cancer\|Small Cell Lung Cancer\|Non-Hodgkins Lymphoma	AbbVie	2015-04-14	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-08-29)

Check the Mivebresib (ABBV-075) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mivebresib acts as a selective BET family bromodomain inhibitor that tightly binds to BRD2, BRD4, and BRDT to disrupt bromodomain-chromatin interactions and block downstream transcriptional elongation of oncogenic driver genes. This transcriptional inhibition triggers selective apoptosis in malignant cells, providing the mechanistic rationale for its clinical evaluation in hematologic and solid neoplasms, such as acute myeloid leukemia, myelofibrosis, and prostate cancer.

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>).