Nesuparib Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 890

Clinical Trials

Multiple clinical trials evaluate the dual PARP and tankyrase inhibitor Nesuparib across early- and mid-stage clinical development. A completed Phase 1 dose-escalation trial sponsored by Onconic Therapeutics Inc. and Jeil Pharmaceutical Co. Ltd. evaluated the safety, tolerability, and pharmacokinetic profiles of the compound in patients with advanced solid tumors. Additionally, a recruiting Phase 2 clinical trial sponsored by Yonsei University is investigating Nesuparib in combination with chemotherapy and immunotherapy as a maintenance regimen for patients with endometrial cancer and related gynecological malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06502743	RECRUITING	Endometrial Cancer; Recurrent Endometrial Carcinoma; Endometrial Carcinoma; Gynecologycal Cancer; Endometrial Neoplasms	Yonsei University	2024-09-12	PHASE2
NCT04335604	Completed	Advanced Solid Tumors	Onconic Therapeutics Inc.\|Jeil Pharmaceutical Co. Ltd.	2017-12-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-04-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nesuparib selectively binds to and inhibits poly(ADP-ribose) polymerase 1/2 (PARP1/2) and tankyrases (TNKS1/2), thereby disrupting single-strand DNA break repair mechanisms and Wnt/β-catenin signaling pathways to induce synthetic lethality and suppress cellular proliferation in tumor cells. By targeting these critical oncogenic signaling pathways, Nesuparib effectively inhibits tumor growth, demonstrating therapeutic relevance in clinical trials for advanced solid tumors and endometrial cancers.

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>).