Pipobroman Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Several clinical trials, encompassing Phase 1/2, Phase 2, and Phase 3 protocols, are currently registered to evaluate therapeutic applications for chronic lymphocytic leukemia, small lymphocytic lymphoma, and intracranial atherosclerotic plaque stenosis. Primary trial sponsors include academic institutions and collaborative groups, such as the Nordic CLL Study Group, the German CLL Study Group, the Institute of Hematology & Blood Diseases Hospital China, and The First Affiliated Hospital with Nanjing Medical University. Across these protocols, participant recruitment status ranges from not yet recruiting to currently recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06367374	Not yet recruiting	Chronic Lymphocytic Leukemia\|Small Lymphocytic Lymphoma	Institute of Hematology & Blood Diseases Hospital China	2024-05-30	Phase 2
NCT05791409	Recruiting	CLL/SLL	Stichting Hemato-Oncologie voor Volwassenen Nederland\|Nordic CLL Study Group\|German CLL Study Group	2024-04-10	Phase 1\|Phase 2
NCT06080256	Not yet recruiting	Intracranial Atherosclerosis\|Atherosclerotic Plaque\|Stenosis	The First Affiliated Hospital with Nanjing Medical University	2023-12-30	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a neutral piperazine derivative, pipobroman acts as an alkylating agent that covalently cross-links DNA strands to disrupt nucleic acid synthesis and impair cellular replication. This antiproliferative cytotoxic effect halts aberrant cell growth, providing the rationale for its clinical investigation in hematologic conditions such as chronic lymphocytic 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>).