Adefovir Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate adefovir for chronic hepatitis B and chronic hepatitis B accompanied by fibrosis across Phase 1 safety and pharmacokinetic assessments as well as Phase 4 post-marketing evaluations. Supported by industry and institutional sponsors—including Hoffmann-La Roche, Beijing Ditan Hospital, and other regional organizations—recruitment status across these investigations ranges from completed to unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02956850	Completed	Hepatitis B Chronic	Hoffmann-La Roche	2016-12-12	Phase 1
NCT02327689	Unknown status	Hepatitis B Chronic\|Fibrosis	Asian-Pacific Alliance of Liver Disease Beijing\|Beijing Ditan Hospital\|Hebei Medical University Pharmaceutical Factory\|National Health and Family Planning Commission P.R.China	2015-01	Phase 4
NCT02327663	Unknown status	Hepatitis B Chronic	Asian-Pacific Alliance of Liver Disease Beijing\|Beijing Ditan Hospital\|Hebei Medical University Pharmaceutical Factory\|National Health and Family Planning Commission P.R.China	2014-12	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adefovir acts as a nucleotide analog that, upon intracellular phosphorylation to its active diphosphate metabolite, competitively inhibits HBV reverse transcriptase and viral DNA polymerase to cause premature DNA chain termination. By suppressing viral replication and reducing hepatic viral load, this mechanism directly supports its clinical evaluation in patients with chronic hepatitis B and associated liver fibrosis.

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>).