Venadaparib(IDX-1197) Clinical Trials

Size	Price	Qty
5mg	USD 149
25mg	USD 447

Clinical Trials

A completed Phase 1 clinical trial sponsored by Idience Co. Ltd. evaluated Venadaparib (IDX-1197) in healthy male subjects. The study assessed the safety, tolerability, and pharmacokinetic profile of single-dose administration, including the specific impacts of food administration and ethnicity. This early-stage evaluation reflects foundational pharmacokinetic assessments rather than advanced therapeutic efficacy trials in patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05202912	Completed	Healthy Male	Idience Co. Ltd.	2022-01-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Venadaparib(IDX-1197) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Venadaparib (IDX-1197) functions as a potent PARP1 and PARP2 inhibitor with IC50 values of 1.4 nM and 1.0 nM, respectively, blocking the enzymatic repair of DNA single-strand breaks and driving their conversion into lethal double-strand breaks. This accumulation of uncorrected DNA damage induces selective synthetic lethality in tumor cells, establishing the therapeutic mechanism supporting its early-phase clinical evaluation in healthy subjects.

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>).