EIDD-1931 (NHC) Clinical Trials

Size	Price	Qty
5mg	USD 357
25mg	USD 997

Clinical Trials

Several clinical trials evaluate the therapeutic and pharmacokinetic profiles of this compound across Phase 1 and unassigned phases. Sponsored by entities including Merck Sharp & Dohme LLC and the University of Colorado Denver, these studies investigate renal impairment, hepatic impairment, contraceptive usage, overweight or obesity, and eating behaviors. Trial statuses encompass both completed Phase 1 pharmacokinetic evaluations in organ-impaired participants and active, non-recruiting studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05386758	Completed	Renal Impairment	Merck Sharp & Dohme LLC	2022-06-29	Phase 1
NCT05386589	Completed	Hepatic Impairment	Merck Sharp & Dohme LLC	2022-06-14	Phase 1
NCT05061472	Active not recruiting	Contraceptive Usage\|Overweight or Obesity\|Body Weight Changes\|Appetitive Behavior\|Eating Behavior	University of Colorado Denver	2022-05-23	--

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

Check the EIDD-1931 (NHC) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

EIDD-1931 functions as an active nucleoside analog that is incorporated into viral RNA by RNA-dependent RNA polymerase, inducing lethal mutagenesis that disrupts viral replication. This broad-spectrum antiviral mechanism provides the biological basis for target viral inhibition, supporting clinical assessments to determine drug pharmacokinetics in specific populations such as patients with renal or hepatic impairment.

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>).