Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adenosine cyclophosphate functions as a key second messenger by binding to and activating effector proteins such as protein kinase A and EPAC, thereby stimulating downstream intracellular phosphorylation cascades that modulate cellular ion fluxes and transcriptomic responses. This biochemical signaling enhances myocardial contractility and induces vascular smooth muscle relaxation, providing therapeutic relevance for improving myocardial hypoxia and mitigating cellular stress in sepsis and rheumatoid arthritis.

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.