Lonidamine (AF 1890) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate Lonidamine across indications ranging from Phase 2 to Phase 4 and unassigned study designs. Threshold Pharmaceuticals sponsored Phase 2 and Phase 3 trials investigating Lonidamine's efficacy and safety for symptomatic benign prostatic hyperplasia and enlarged prostate, which were ultimately terminated. Additionally, completed academic trials supported by institutions such as Massachusetts General Hospital and the University of Roma La Sapienza evaluated indications including posttraumatic stress disorder, depression, and colonic diverticula.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02758860	Completed	Colonic Diverticula	University of Roma La Sapienza	2016-06	--
NCT00435448	TERMINATED	Benign Prostatic Hyperplasia; Enlarged Prostate	Threshold Pharmaceuticals	2005-06	PHASE3
NCT00237536	TERMINATED	Benign Prostatic Hyperplasia	Threshold Pharmaceuticals	2005-06	PHASE2
NCT00182078	Completed	Posttraumatic Stress Disorder\|Depression	Massachusetts General Hospital	2002-11	Phase 4

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

Check the Lonidamine (AF 1890) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lonidamine functions as an orally active hexokinase inhibitor that selectively suppresses cellular glycolysis and mitochondrial respiration, leading to a profound depletion of intracellular ATP levels and the induction of mitochondrial membrane depolarization and apoptosis. By disrupting glycolytic energy metabolism and promoting programmed cell death in metabolically active cells, this compound targets hyperproliferative tissue growth relevant to clinical evaluations in benign prostatic hyperplasia and related urological conditions.

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>).