Saquinavir Mesylate Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

A clinical trial evaluated saquinavir mesylate in combination with ritonavir for the management of human immunodeficiency virus infection. Sponsored by The HIV Netherlands Australia Thailand Research Collaboration, this combined Phase 2/Phase 3 study aimed to assess the pharmacokinetics and efficacy of the antiretroviral regimen. However, recruitment for the trial was recorded as withdrawn, leading to the discontinuation of the study prior to full execution.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00476983	Withdrawn	Saquinavir/Ritonavir BID or Lopinavir/Ritonavir BID	The HIV Netherlands Australia Thailand Research Collaboration		Phase 2\|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saquinavir mesylate selectively binds to the active site of HIV protease, inhibiting the enzymatic cleavage of viral Gag and Gag-Pol polyprotein precursors into mature, functional retroviral proteins. By halting retroviral particle maturation within infected host cells, this mechanism prevents the formation of infectious virions to control viral load in human immunodeficiency virus antiretroviral therapy.

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>).