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)
Mechanism and Biochemical Profile
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>).
- RGD peptide (GRGDNP) Solubility in DMSO
- RGD peptide (GRGDNP) Stock Solution
- RGD peptide (GRGDNP) Storage
- RGD peptide (GRGDNP) Stability
- RGD peptide (GRGDNP) Molecular Weight
- RGD peptide (GRGDNP) SMILES
- RGD peptide (GRGDNP) CAS Number
- RGD peptide (GRGDNP) Chemical Structure (2D and 3D)
- RGD peptide (GRGDNP) SDS|MSDS