Pyruvic acid Clinical Trials

Size	Price	Qty
100mg	USD 97

Clinical Trials

Multiple clinical trials evaluated pyruvic acid across conditions including metabolic disturbance, cognitive change, sleep disturbance, noise exposure, and type 1 diabetes. Designated as Phase Not Applicable, these completed studies assessed metabolic, cognitive, and glycemic outcomes related to sleep disruption and diabetes. The trials were sponsored by academic and research institutions, including Göteborg University, the University of Pennsylvania, the University of Manitoba, Universidade Federal do Rio de Janeiro, and FAPERJ.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05319262	Completed	Noise Exposure\|Sleep Disturbance\|Sleep Hygiene\|Metabolic Disturbance\|Cognitive Change	Göteborg University\|University of Pennsylvania\|University of Manitoba	2022-04-24	Not Applicable
NCT01713023	Completed	Type 1 Diabetes	Universidade Federal do Rio de Janeiro\|Rio de Janeiro State Research Supporting Foundation (FAPERJ)	2013-03	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a central metabolic intermediate, pyruvic acid alters cellular bioenergetics by increasing lactate dehydrogenase and creatine kinase levels while inhibiting Ca2+ Mg2+-ATPase and Na+ K+-ATPase pump activities, thereby disrupting cardiomyocyte ion homeostasis and metabolite transport. This downstream biochemical modulation of metabolic pathways directly impacts cellular energy regulation, offering clinical relevance in the management of metabolic disturbance and type 1 diabetes.

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>).