Desciclovir Clinical Trials

Size	Price	Qty
5mg	USD 297

Clinical Trials

Multiple clinical trials sponsored by Bristol-Myers Squibb and Nanjing Sanhome Pharmaceutical Co. Ltd. evaluate therapeutic management strategies for chronic hepatitis C and related viral hepatitis conditions. Encompassing Phase 2 and Phase 3 trials alongside observational post-marketing surveillance programs, these studies assess the efficacy, safety, and surveillance parameters of combination antiviral regimens. Across these investigations, recruitment statuses vary, including completed, terminated, withdrawn, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04070235	Unknown status	Hepatitis C Chronic	Nanjing Sanhome Pharmaceutical Co. Ltd.	2019-03-29	Phase 2\|Phase 3
NCT03208322	Withdrawn	Hepatitis C	Bristol-Myers Squibb	2018-11-30	--
NCT03500562	Terminated	Chronic Hepatitis C	Bristol-Myers Squibb	2018-05-08	--
NCT03071133	Completed	Hepatitis C	Bristol-Myers Squibb	2018-01-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Desciclovir acts as a prodrug that is converted by host xanthine oxidase into the active antiviral agent acyclovir, which selectively inhibits viral DNA polymerase and terminates viral DNA elongation. This blockade of genomic replication prevents viral progeny production in infected host cells, supporting its clinical relevance in antiviral treatment protocols targeting viral hepatitis and herpesvirus infections.

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>).