MK-2048 Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Multiple completed Phase 1 clinical trials have evaluated MK-2048, focusing on safety, pharmacokinetics, and human immunodeficiency virus (HIV) infections. Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and academic researcher Sharon Hillier, these studies assessed localized delivery mechanisms using intravaginal rings and vaginal films containing MK-2048 alone or combined with vicriviroc. Ultimately, these evaluations established the baseline safety parameters and pharmacokinetic profiles of these formulations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04319718	COMPLETED	Pharmacokinetics; Safety	Hillier, Sharon, PhD	2020-08-19	PHASE1
NCT02419456	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)	2015-06	PHASE1
NCT02356302	COMPLETED	HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)	2015-05	PHASE1

(data from https://clinicaltrials.gov, updated on 2023-03-03)

Check the MK-2048 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-2048 binds to retroviral integrase, blocking the strand transfer step of viral DNA insertion into host chromosomal DNA and thereby disrupting proviral establishment within infected cells. By inhibiting viral replication and overcoming resistance to early-generation integrase inhibitors, this mechanism underpins its evaluation in Phase 1 safety and pharmacokinetic clinical studies targeting 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>).