Clinical Trials

Multiple clinical trials across early-, mid-, and late-phase evaluations have investigated inhaled or intranasal sodium pyruvate as an antioxidant therapy for pulmonary and infectious respiratory conditions. These completed and terminated studies, sponsored by academic and corporate entities such as the University of Minnesota, Cellular Sciences Inc., and Emphycorp, targeted disorders including COVID-19, Long COVID, cystic fibrosis, moderate asthma, chronic obstructive pulmonary disease (COPD), and idiopathic pulmonary fibrosis.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06037408 COMPLETED
Idiopathic Pulmonary Fibrosis
Cellular Sciences, inc.
 2023-08-15 PHASE3
NCT04824365 COMPLETED
COVID-19
Cellular Sciences, inc.
 2021-04-12 PHASE2; PHASE3
NCT04871815 COMPLETED
Long COVID
Cellular Sciences, inc.
 2021-04-27 PHASE2; PHASE3
NCT04824365 Completed
COVID-19
Cellular Sciences inc.|Missouri State University|Dynamic DNA Labs|Trinity Health Care|Family First Medical Research Center
 2021-04-12 Phase 2|Phase 3
NCT00308243 COMPLETED
Cystic Fibrosis
Emphycorp
 2006-03 PHASE1
NCT00262652 TERMINATED
Moderate Asthma
Emphycorp
 2006-01 PHASE1; PHASE2
NCT00308243 Completed
Cystic Fibrosis
Emphycorp|Cellular Sciences inc.
 2006-03 Phase 1
NCT00332215 Terminated
Cystic Fibrosis
University of Minnesota|Cellular Sciences inc.
 2006-02 Phase 1
NCT00262652 Terminated
Moderate Asthma
Emphycorp
 2006-01 Phase 1|Phase 2
NCT00262613 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Emphycorp
 2004-09 PHASE2
NCT00332215 TERMINATED
Cystic Fibrosis
University of Minnesota
 2006-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-08-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sodium pyruvate functions as a glycolytic metabolite and direct free radical scavenger that non-enzymatically neutralizes reactive oxygen species to protect cellular membranes from oxidative damage. This inhibition of oxidative stress and associated inflammatory cascades provides the biological mechanism supporting its clinical evaluation in pulmonary conditions such as chronic obstructive pulmonary disease, asthma, and COVID-19.

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>).

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Note: Technical data last updated: Sep 1, 2026.