Tenofovir alafenamide hemifumarate Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 169

Clinical Trials

Several clinical trials are evaluating tenofovir alafenamide for indications including HIV-1 infection, integrase strand transfer inhibitor-associated metabolic alterations, and safety, adherence, and satisfaction during regimen switch therapy. Spanning Phase 2 through Phase 4 studies as well as prospective observational evaluations, recruitment statuses range from active recruitment to not yet recruiting. These studies are sponsored by a diverse array of federal institutions, pharmaceutical leaders, and hospital-affiliated research organizations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05652478	Not yet recruiting	Healthy Volunteer\|Weight Gain\|Metabolic Effects\|Integrase Strand Transfer Inhibitors	National Institute of Allergy and Infectious Diseases (NIAID)\|National Institutes of Health Clinical Center (CC)	2024-05-15	Phase 2
NCT06104306	Recruiting	HIV-1-infection	Gilead Sciences	2023-12-13	Phase 4
NCT05583006	Recruiting	Patient Satisfaction\|Drug Adherence\|Efficacy Self\|Safety Issues	Taichung Veterans General Hospital\|Institute of Adherence to Medication	2023-11-06	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tenofovir alafenamide is an orally bioavailable prodrug that is intracellularly metabolized to active tenofovir diphosphate, which selectively competes with natural deoxyadenosine 5'-triphosphate for incorporation into viral DNA and inhibits HIV-1 reverse transcriptase via obligate chain termination. This precise block in viral nucleic acid synthesis halts intracellular viral replication, providing the biochemical foundation for viral load suppression in HIV-1 infection and informing clinical investigations into antiretroviral efficacy, safety, and metabolic outcomes.

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>).