Clinical Trials

Several clinical trials spanning Phase I, Phase I/II, and Phase II have evaluated Miransertib (ARQ-092) in oncology conditions—such as advanced solid tumors, malignant lymphoma, ovarian cancer, and endometrial cancer—and rare overgrowth disorders including Proteus syndrome and PIK3CA-related overgrowth spectrum (PROS). Sponsored by industry and government entities, these studies evaluate dosage, safety, and clinical efficacy. Recruitment statuses across the trials include completed, active but not recruiting, terminated, and expanded access no longer available.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Miransertib is a potent, allosteric inhibitor that selectively binds to Akt isoforms Akt1, Akt2, and Akt3, preventing activation of the PI3K/Akt signaling cascade and inhibiting downstream biochemical pathways crucial for cellular proliferation and survival. By dampening hyperactive Akt signaling, Miransertib suppresses abnormal cellular proliferation and induces apoptosis, offering targeted therapeutic efficacy in Akt-driven conditions such as solid tumors, malignant lymphoma, Proteus syndrome, and PIK3CA-related overgrowth spectrum.

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>).

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Note: Technical data last updated: Sep 1, 2026.