OSU-03012 (AR-12) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple industry- and academically sponsored clinical trials have evaluated OSU-03012 (AR-12), including a completed Phase 1 interventional study by Arno Therapeutics in adult patients with advanced solid tumors and lymphoma. Additional investigator-initiated and observational studies of unspecified phases have examined secondary parameters, such as circadian rhythm disturbances and anxiety in breast cancer patients, as well as quality of life in chronic developmental conditions. Overall recruitment statuses range from completed to unknown across these therapeutic and supportive care evaluations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00978523	COMPLETED	Solid Tumors; Lymphoma	Arno Therapeutics	2009-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2014-01-29)

Check the OSU-03012 (AR-12) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

OSU-03012 potently inhibits phosphoinositide-dependent kinase-1 (PDK-1), which prevents the critical downstream phosphorylation and activation of the pro-survival kinase AKT. This blockade suppresses key intracellular survival cascades and induces robust apoptotic cell death, offering a strong mechanistic basis for controlling disease progression in solid tumors, lymphoma, and breast 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>).