ABTL-0812 Clinical Trials

Size	Price	Qty
5mg	USD 399
25mg	USD 1,197

Clinical Trials

Multiple early- to mid-stage clinical trials, primarily sponsored by Ability Pharmaceuticals SL alongside academic centers like the Hospital Clinic of Barcelona and Institut Català d'Oncologia, have evaluated ABTL-0812 for advanced solid tumors, endometrial cancer, squamous non-small cell lung cancer, and pancreatic cancer. These investigations encompass Phase 1 dose-escalation studies as well as Phase 1/2 trials combining the drug with standard chemotherapy. While the majority of these clinical trials have completed recruitment, a Phase 1/2 combination study in pancreatic cancer has been suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04431258	COMPLETED	Pancreatic Cancer	Ability Pharmaceuticals SL	2021-05-06	PHASE1; PHASE2
NCT03417921	SUSPENDED	Pancreatic Cancer	Ability Pharmaceuticals SL	2021-04-26	PHASE1; PHASE2
NCT03366480	COMPLETED	Endometrial Cancer; Squamous Non-Small Cell Lung Cancer	Ability Pharmaceuticals SL	2016-12-01	PHASE1; PHASE2
NCT02201823	COMPLETED	Cancer	Ability Pharmaceuticals SL	2014-02	PHASE1
NCT02201823	Completed	Cancer	Ability Pharmaceuticals SL\|Hospital Clinic of Barcelona\|Institut Català d''Oncologia	2014-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-03-18)

Check the ABTL-0812 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ABTL-0812 induces TRIB3 overexpression to inhibit the Akt/mTOR signaling pathway while simultaneously promoting AMP-activated protein kinase activation and reactive oxygen species accumulation. This signaling cascade triggers robust autophagic cell death, providing a mechanistic basis for its therapeutic evaluation in clinical trials for squamous non-small cell lung, endometrial, and pancreatic cancers.

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>).