Marimastat (BB-2516) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 570

Clinical Trials

Several clinical trials spanning Phase 1, Phase 2, and Phase 3 evaluate the therapeutic potential of Marimastat across conditions such as lung cancer, breast cancer, vascular anomalies, and snakebite envenoming. Sponsored by academic, pediatric, and cooperative research entities, the oncology and vascular malformation studies have completed recruitment. Conversely, a Phase 2 trial exploring Marimastat for snakebite envenoming is currently listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07500233	NOT_YET_RECRUITING	Snakebite	Liverpool School of Tropical Medicine	2027-01	PHASE2
NCT00003010	COMPLETED	Breast Cancer	Eastern Cooperative Oncology Group	1997-12-02	PHASE3
NCT00003011	COMPLETED	Lung Cancer	NCIC Clinical Trials Group	1997-01-31	PHASE3
NCT00261391	COMPLETED	Vascular Anomalies	Boston Children's Hospital	2000-10	PHASE1
NCT00002911	COMPLETED	Lung Cancer	ILEX Oncology Services, Incorporated	1996-12	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-05-12)

Check the Marimastat (BB-2516) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Marimastat functions as a potent, broad-spectrum matrix metalloproteinase inhibitor that selectively targets MMP-9, MMP-1, MMP-2, MMP-14, and MMP-7 with IC50 values of 3 nM, 5 nM, 6 nM, 9 nM, and 13 nM, respectively, thereby preventing extracellular matrix degradation and suppressing cellular migration and invasion. By blocking enzyme-mediated degradation of structural extracellular components, this compound limits pathological tissue degradation and matrix remodeling, providing therapeutic rationale for its clinical evaluation in oncology conditions like lung and breast cancer, as well as vascular anomalies and snakebite envenoming.

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>).