BIA Clinical Trials

Size	Price	Qty
5mg	USD 90

Clinical Trials

Multiple clinical trials sponsored by academic and medical institutions are currently evaluating interventions across distinct therapeutic areas. These include a Phase 2 study sponsored by the University of California, Los Angeles investigating therapeutic modulation in schizophrenia, and an unassigned-phase prospective study sponsored by the Copenhagen Academy for Medical Education and Simulation evaluating artificial intelligence applications for fetal weight estimation in pregnancy complications. These clinical trials are currently listed with a recruitment status of not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06314178	Not yet recruiting	Pregnancy Complications	Copenhagen Academy for Medical Education and Simulation	2024-06-01	--
NCT05778591	Not yet recruiting	Schizophrenia	University of California Los Angeles	2024-06-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

BIA functions as a TMBIM6 antagonist that selectively disrupts the interaction between transmembrane B cell lymphoma 2-associated X protein inhibitor motif-containing 6 (TMBIM6) and mTORC2. By suppressing downstream AKT activation and cellular survival pathways, this molecular inhibition blocks aberrant cell proliferation, providing therapeutic relevance for limiting cancer progression and managing pathologies in investigated clinical conditions including schizophrenia and pregnancy complications.

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>).