Rubitecan Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated protocols associated with this compound, focusing primarily on influenza and immunologic testing. These completed studies include a Phase 1 trial sponsored by the National Institute of Allergy and Infectious Diseases assessing universal influenza vaccination strategies, alongside an unphased exploratory study evaluating humoral immune responses supported by GlaxoSmithKline in collaboration with the Icahn School of Medicine at Mount Sinai.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03816878	Completed	Influenza	National Institute of Allergy and Infectious Diseases (NIAID)	2019-01-08	Phase 1
NCT02415842	Completed	Immunologic Tests	GlaxoSmithKline\|Icahn School of Medicine at Mount Sinai	2015-10-26	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rubitecan specifically binds to topoisomerase I and stabilizes topoisomerase I-DNA cleavable complexes, thereby blocking the DNA religation step during replication. This inhibition induces double-strand DNA breaks and triggers apoptotic cell death, providing the mechanistic basis for its investigation in cellular proliferation and immunologic condition studies including influenza.

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>).