Clinical Trials

A completed clinical trial evaluated the therapeutic potential of β-glycerophosphate sodium salt to improve implant stability and osseointegration. Sponsored by an individual academic investigator, Manar Ziad Foura-Matar, the study carried no assigned phase designation and examined a topical combination of dexamethasone, ascorbic acid, and β-glycerophosphate. Overall, human clinical evidence for this small molecule remains focused on localized bone tissue regeneration and enhancing osteogenic outcomes around surgical implants.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07060859 COMPLETED
Implant Stability and Osseointegration
Manar Ziad Foura-Matar
 2023-01-15

(data from https://clinicaltrials.gov, updated on 2025-07-15)

Check the β-Glycerophosphate sodium salt hydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

β-Glycerophosphate functions as a protein phosphatase inhibitor and an organic phosphate donor that maintains cellular signaling cascades and fuels alkaline phosphatase-mediated hydroxyapatite formation in osteoblasts. This sustained enzymatic phosphorylation and mineral deposition promote extracellular matrix calcification, providing the biochemical foundation required to enhance implant stability and osseointegration.

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.