Miransertib (ARQ 092) HCl Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate Miransertib (ARQ 092) across Phase I and Phase II studies in both adult and pediatric populations. These trials target oncology indications—such as advanced solid tumors, recurrent malignant lymphoma, ovarian cancer, and endometrial cancer—as well as rare overgrowth disorders like Proteus syndrome and PIK3CA-related overgrowth spectrum. Sponsored by industry developers such as ArQule Inc. and government bodies like the National Human Genome Research Institute, recruitment statuses span completed and active to terminated or unavailable expanded access programs.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04980872	ACTIVE_NOT_RECRUITING	PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)	Merck Sharp & Dohme LLC	2021-11-02	PHASE2
NCT04316546	ACTIVE_NOT_RECRUITING	Proteus Syndrome	National Human Genome Research Institute (NHGRI)	2022-05-20	PHASE2
NCT03094832	TERMINATED	PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	2017-05-16	PHASE1; PHASE2
NCT02476955	TERMINATED	Solid Tumors; Ovarian Cancer; Endometrial Cancer	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	2015-06-09	PHASE1
NCT02594215	COMPLETED	Proteus Syndrome	National Human Genome Research Institute (NHGRI)	2015-11-16	PHASE1
NCT01473095	COMPLETED	Solid Tumor; Malignant Lymphoma; Tumor	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	2011-11	PHASE1
NCT01473095	Completed	Solid Tumor\|Malignant Lymphoma\|Tumor	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2011-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-02-07)

Check the Miransertib (ARQ 092) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Miransertib (ARQ 092) HCl is a potent, selective AKT pathway inhibitor that binds to the AKT protein kinase, thereby preventing target activation and blocking downstream signaling through effector pathways such as mTOR. By disrupting cell survival, proliferation, and abnormal tissue expansion, this targeted inhibition leads to apoptosis and growth attenuation, which underlies its clinical application in treating advanced solid tumors, malignant lymphomas, and PIK3CA-driven overgrowth disorders including Proteus syndrome.

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>).