(R)-(-)-Gossypol (AT-101) acetic acid Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 470

Clinical Trials

Multiple Phase 1 and Phase 1/2 clinical trials sponsored by commercial entities such as AbClon and Ascenta Therapeutics alongside academic institutions like the University of Alabama at Birmingham have evaluated AT-101 in B-cell non-Hodgkin lymphoma, advanced non-small cell lung carcinoma, and locally advanced esophageal or gastroesophageal junction cancer. Currently, a clinical trial for B-cell non-Hodgkin lymphoma is actively recruiting, whereas several clinical trials targeting non-small cell lung and gastroesophageal junction cancers have been withdrawn or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05338931	Recruiting	B-cell Non Hodgkin Lymphoma	AbClon	2022-03-15	Phase 1\|Phase 2
NCT00934076	Withdrawn	Carcinoma Non Small Cell Lung	University of Alabama at Birmingham\|Ascenta Therapeutics	2010-02	Phase 1
NCT00561197	Terminated	Locally Advanced Esophageal or GE Junction Cancer	Ascenta Therapeutics	2007-08	Phase 1\|Phase 2

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

Check the (R)-(-)-Gossypol (AT-101) acetic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(R)-(-)-Gossypol (AT-101) acetic acid selectively binds to the anti-apoptotic Bcl-2 family proteins Bcl-2, Bcl-xL, and Mcl-1, thereby disrupting their sequestration of pro-apoptotic factors to induce mitochondrial outer membrane permeabilization, caspase activation, and autophagy. This targeted inhibition triggers apoptotic cell death in resistant tumor cells, demonstrating therapeutic relevance in clinical investigations for B-cell non-Hodgkin lymphoma, non-small cell lung carcinoma, and esophageal 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>).