Clinical Trials

Multiple clinical trials are evaluating the diagnostic and therapeutic applications of RGD peptides across early-stage development, spanning Phase I to Phase II. These investigations focus on safety in healthy individuals alongside periodontal conditions such as intrabony defects, periodontitis, and alveolar bone loss. Sponsored by academic institutions including Minia University and corporate entities like RDO Pharm, trial statuses range from completed pharmacokinetic assessments to upcoming interventions involving hydrogel delivery systems for regenerative dental procedures.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06936605 NOT_YET_RECRUITING
Intrabony Defect; Periodontal Diseases; Alveolar Bone Loss
Minia University
2025-04-15
NCT05653245 COMPLETED
Periodontitis
Minia University
2021-03-15 PHASE1; PHASE2
NCT03974685 COMPLETED
Healthy
RDO Pharm.
2018-12-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-04-20)

Check the RGD peptide (GRGDNP) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RGD peptide (GRGDNP) selectively binds to cell-surface integrin receptors, thereby disrupting integrin-mediated cell adhesion to the extracellular matrix and triggering apoptosis via direct activation of caspase-3. By modulating integrin-dependent cellular attachment and matrix remodeling, this mechanism provides the biological rationale for its application in hydrogel delivery formulations targeted at treating periodontal intrabony defects and alveolar bone loss.

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.