Darunavir Ethanolate Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Several clinical trials evaluate darunavir formulations to optimize human immunodeficiency virus (HIV) antiviral regimens and assess bioequivalence in healthy participants. Ranging from completed studies to those not yet recruiting, these Phase 1 and Phase 1/Phase 2 investigations focus on pediatric and adult fixed-dose combinations. The research is sponsored by academic, governmental, and industry entities, including the PENTA Foundation, INSERM France, Baylor College of Medicine, and Janssen Research & Development LLC.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06139796	Not yet recruiting	HIV Infections	PENTA Foundation\|AMS-PHPT Research Collaboration\|Institut National de la Santé Et de la Recherche Médicale France\|Centre Mère et Enfant de la Fondation Chantal Biya\|Centre Hospitalier National d''Enfants Albert Royer\|University of Zimbabwe Clinical Research Centre (UZCRC)\|Baylor College of Medicine	2024-06	Phase 1\|Phase 2
NCT05197075	Completed	Human Immunodeficiency Virus (HIV)	Janssen Research & Development LLC	2022-08-03	Phase 1
NCT05378906	Completed	Healthy	Janssen Research & Development LLC	2022-06-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Darunavir ethanolate selectively binds to the active site of the HIV protease enzyme, inhibiting catalytic cleavage of viral gag-pol polyprotein precursors essential for viral maturation. By arresting the processing of structural proteins and enzymes, it prevents the assembly of infectious viral particles, thereby halting viral replication to manage human immunodeficiency virus (HIV) 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>).