Novobiocin Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

A Phase 1 clinical trial sponsored by the National Cancer Institute is actively recruiting patients to evaluate Novobiocin for oncology applications. The study focuses on individuals with advanced, unresectable, or metastatic malignant solid neoplasms harboring BRCA mutations or other DNA damage repair deficiencies. By targeting polymerase theta, the trial aims to assess the drug's safety, tolerability, dosing parameters, and preliminary efficacy in these genetically defined tumor populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05687110	RECRUITING	Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-07-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Novobiocin acts as an inhibitor of bacterial DNA gyrase, eukaryotic topoisomerase II, heat shock protein 90 (Hsp90), and DNA polymerase theta (POLθ), thereby disrupting essential enzymatic machinery required for DNA replication, repair, and protein stability. This targeted impairment of DNA maintenance selectively induces genomic instability and apoptosis in repair-deficient tumor cells, providing a rationale for its therapeutic evaluation in unresectable and metastatic malignant solid neoplasms.

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>).