Novobiocin Sodium (Cathomycin, Albamycin) Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 970

Clinical Trials

Sponsored by the National Cancer Institute (NCI), a Phase 1 clinical trial is currently evaluating the safety and efficacy of novobiocin in oncology applications. The study is actively recruiting patients with metastatic or unresectable malignant solid neoplasms, specifically exploring the drug's therapeutic utility in tumors exhibiting DNA damage repair deficiencies, particularly BRCA gene mutations.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Novobiocin competitively binds to the ATP-binding site of bacterial DNA gyrase and inhibits polymerase theta, thereby suppressing essential DNA replication and repair biochemical pathways. This pathway blockade impairs cellular genomic stability and survival, providing a mechanistic rationale for investigating novobiocin in clinical trials for metastatic or unresectable 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>).