Clinical Trials

Multiple clinical trials evaluate conditions associated with this profile, focusing on mobile application interventions for expectant fathers, intrapartum ultrasound during labor, exercise regimens for chronic lung and cardiopulmonary disease, and attachment tracking in perinatal disorders. Sponsored by academic and clinical institutions such as Pamukkale University, the University of Padova, Columbia University, and Fundación IVI, these studies feature phases categorized as Not Applicable or unassigned. Recruitment statuses across the trials range from not yet recruiting to actively recruiting and completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06168656 Not yet recruiting
Mobile Application|Expectant Fathers|Antenatal Education
Pamukkale University
2023-12-31 Not Applicable
NCT05718180 Not yet recruiting
Labor Obstetric
University of Padova|Azienda Ospedaliera di Padova
2023-06-01 Not Applicable
NCT05776264 Completed
Chronic Lung Disease|Cardiopulmonary Disease
Columbia University
2023-03-29 Not Applicable
NCT05895175 Recruiting
Perinatal Disorder
Fundación IVI
2022-07-01 --

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phosphonoacetic acid directly interacts with viral DNA polymerase to block pyrophosphate binding, thereby inhibiting nucleic acid chain elongation and disrupting downstream viral DNA biosynthesis. This suppression of viral genomic replication inhibits viral propagation in host cells, offering a mechanistic rationale for its antiviral properties and therapeutic potential across cardiopulmonary and perinatal conditions evaluated 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>).

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