Tenofovir Disoproxil Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials are evaluating Tenofovir Disoproxil for chronic hepatitis B, spanning Phase 2 and unassigned phase protocols that assess safety, pharmacokinetics, and efficacy in both monotherapy and combination regimens. Sponsored by academic institutions such as Sohag University and pharmaceutical entities including Assembly Biosciences and Janssen Sciences Ireland UC, these studies range in status from completed trials to actively recruiting protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05874440	Recruiting	Chronic Hepatitis b Patients	Sohag University	2023-04-15	--
NCT03576066	Completed	Chronic Hepatitis B	Assembly Biosciences	2018-06-11	Phase 2
NCT03361956	Completed	Hepatitis B	Janssen Sciences Ireland UC	2018-02-13	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tenofovir disoproxil acts as a prodrug that undergoes intracellular conversion to tenofovir diphosphate, which competitively inhibits viral reverse transcriptase and induces premature DNA chain termination. By halting viral nucleic acid synthesis and suppressing replication, this mechanism effectively lowers viral burden, providing the therapeutic foundation for its use in managing chronic hepatitis B infection.

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>).