PKR-IN-C16 Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 509

Clinical Trials

Several clinical trials investigate diverse therapeutic areas using both interventional and observational designs across Phase 1, Phase 2, Phase 4, and unassigned phase classifications. These studies focus on clinical conditions including relapsed or refractory acute myeloid leukemia, major depressive disorder, sleep-deprivation-associated cardiometabolic risk, and dietary effects on inflammation. Sponsored by academic institutions, governmental organizations, and research entities—including the University of Utah, the VA Office of Research and Development, Centre Hospitalier Universitaire de Besancon, and Keystone Nano Inc.—recruitment statuses range from completed and currently recruiting to not yet recruiting and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04716452	Not yet recruiting	Acute Myeloid Leukemia in Relapse\|Acute Myeloid Leukemia Refractory	Keystone Nano Inc\|University of Virginia\|Milton S. Hershey Medical Center	2024-06-01	Phase 1
NCT06180837	Recruiting	Lifestyle Factors\|Overweight and Obesity\|Insulin Sensitivity\|Eating Habit\|Sleep Hygiene\|Type 2 Diabetes\|Sleep\|Sleep Deprivation\|Insufficient Sleep Syndrome	University of Utah	2024-02-12	Not Applicable
NCT05554627	Withdrawn	Depressive Disorder Major	VA Office of Research and Development	2023-10-27	Phase 4
NCT05280015	Recruiting	Depression\|Depressive Disorder\|Depressive Disorder Major	Centre Hospitalier Universitaire de Besancon\|Fondation FondaMental\|GYNOV	2022-06-08	Phase 2
NCT05791370	Completed	Diet\|Healthy	Malaysia Palm Oil Board\|Universiti Putra Malaysia	2019-01-01	Not Applicable

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

Check the PKR-IN-C16 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PKR-IN-C16 selectively targets and inhibits double-stranded RNA-dependent protein kinase (PKR/EIF2AK2), blocking its autophosphorylation and downstream phosphorylation of eukaryotic initiation factor 2 alpha. By reversing translation suppression and suppressing pro-inflammatory cytokine production, such as IL-1β, this inhibition attenuates cell death pathways relevant to acute leukemia and neuroinflammatory conditions studied in clinical trials.

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>).