BGT226 (NVP-BGT226) maleate Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 970

Clinical Trials

BGT226 has been evaluated in several clinical trials sponsored by Novartis Pharmaceuticals to assess its safety, tolerability, and preliminary efficacy in oncology. These Phase 1 and Phase 1/2 studies targeted adult patients presenting with advanced solid tumors, breast cancer, and Cowden syndrome, with individual protocols either reaching completion or being terminated. Overall, the clinical landscape reflects an early-phase development effort investigating oral BGT226 in advanced malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00600275	COMPLETED	Solid Tumors; Breast Cancer; Cowden Syndrome	Novartis Pharmaceuticals	2007-12	PHASE1; PHASE2
NCT00742105	TERMINATED	Cancer; Solid Tumor; Advanced Solid Tumor	Novartis Pharmaceuticals	2008-11-17	PHASE1
NCT00742105	Terminated	Cancer\|Solid Tumor\|Advanced Solid Tumor	Novartis Pharmaceuticals\|Novartis	2008-11-17	Phase 1
NCT00600275	Completed	Solid Tumors\|Breast Cancer\|Cowden Syndrome	Novartis Pharmaceuticals\|Novartis	2007-12	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2020-12-17)

Check the BGT226 (NVP-BGT226) maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BGT226 is a potent dual class I PI3K and mTOR inhibitor that selectively binds to PI3K isoforms and mTOR, thereby blocking the downstream activation of the AKT/mTOR signal cascade to trigger cell growth arrest, apoptosis, and autophagy. By suppressing these crucial cellular proliferation and survival pathways, BGT226 exhibits broad antitumor activity relevant to the treatment of advanced solid tumors and breast cancer evaluated in clinical studies.

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>).