Multiple clinical trials investigate adenosine cyclophosphate pathway signaling and downstream targets across diverse conditions, including rheumatoid arthritis, sepsis, anxiety disorders, lumbar spinal stenosis, and spinal instability. Protocol designs range from Phase 3 evaluations of adjunctive treatments to non-applicable or unassigned phases, encompassing both recruiting and not yet recruiting studies. These trials are sponsored by academic research universities and hospital institutions, including Tanta University, Tianjin Nankai Hospital, Rijnstate Hospital, and the University of Coimbra.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05633550 | Not yet recruiting | Lumbar Spinal Stenosis|Spinal Instability |
Rijnstate Hospital|Medical Metrics Diagnostics Inc |
2024-08-01 | -- |
| NCT06045780 | Not yet recruiting | Sepsis |
Tianjin Nankai Hospital |
2023-09-15 | -- |
| NCT05747131 | Not yet recruiting | Anxiety Disorders |
University of Coimbra|Fundação para a Ciência e a Tecnologia|University of Lisbon |
2023-09 | Not Applicable |
| NCT05594680 | Recruiting | Rheumatoid Arthritis |
Tanta University |
2022-10-01 | Phase 3 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
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>).
- Adenosine Cyclophosphate Solubility in DMSO
- Adenosine Cyclophosphate Stock Solution
- Adenosine Cyclophosphate Storage
- Adenosine Cyclophosphate Stability
- Adenosine Cyclophosphate Molecular Weight
- Adenosine Cyclophosphate SMILES
- Adenosine Cyclophosphate CAS Number
- Adenosine Cyclophosphate Chemical Structure (2D and 3D)
- Adenosine Cyclophosphate SDS|MSDS