Stenoparib (E7449) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several clinical trials evaluate stenoparib (E7449) across various oncological indications, including advanced solid tumors, ovarian cancer, triple-negative breast cancer, small cell lung cancer, melanoma, and low-grade B-cell malignancies. Supported by pharmaceutical and academic sponsors—such as Eisai Limited, the VA Office of Research and Development, and The University of Texas Health Science Center at San Antonio—these Phase 1 and Phase 1/2 investigations explore both single-agent and combination strategies. Overall trial statuses span completed monotherapy safety evaluations, actively recruiting combination studies in relapsed small cell lung cancer, and withdrawn combination efforts in breast cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06681220	RECRUITING	Relapsed Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer	VA Office of Research and Development	2026-02-23	PHASE1; PHASE2
NCT01618136	COMPLETED	Malignant Solid Tumour; Ovarian Cancer; Triple Negative Breast Cancer; Advanced Melanoma; B-cell Malignancy, Low-grade	Eisai Limited	2012-01	PHASE1; PHASE2
NCT02396433	WITHDRAWN	Cancer of the Breast	The University of Texas Health Science Center at San Antonio	2015-04	PHASE1; PHASE2
NCT02396433	Withdrawn	Cancer of the Breast	The University of Texas Health Science Center at San Antonio	2015-04	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-03-11)

Check the Stenoparib (E7449) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stenoparib (E7449) potently binds to and inhibits PARP1 and PARP2 with IC50 values of 1.0 nM and 1.2 nM, respectively, while also targeting tankyrases TNKS1 and TNKS2 to disrupt both poly(ADP-ribose) polymerase activity and canonical Wnt/β-catenin signaling. By impairing base excision DNA repair and suppressing Wnt-mediated oncogenic gene expression, stenoparib induces synthetic lethality and tumor cell apoptosis, offering therapeutic efficacy in clinical investigations for advanced solid tumors, ovarian cancer, triple-negative breast cancer, and small cell lung 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>).