Clinical Trials

Several clinical trials are currently evaluating interventions across diverse conditions, including child sexual abuse, overweight and obesity, ischemic stroke associated with CYP2C19 polymorphism, and amputation. Reflecting exploratory, behavioral, or diagnostic designs, these protocols feature unspecified or non-applicable trial phases. Managed by various academic, healthcare, and commercial sponsors, participant recruitment statuses range from not yet recruiting to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06126926 Not yet recruiting
Child Sexual Abuse
University of Minnesota
2024-06-15 Not Applicable
NCT04433273 Not yet recruiting
Overweight and Obesity
Neurovalens Ltd.|Compliance Solutions Ltd.|RD Gardi Medical College
2024-05 Not Applicable
NCT06292117 Recruiting
Ischemic Stroke|CYP2C19 Polymorphism
University of Virginia|American Heart Association
2024-04-16 --
NCT06406491 Recruiting
Amputation
Median|Johannes Gutenberg University Mainz
2024-04-23 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the 5'-Adenylic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

5'-Adenylic acid directly binds to the regulatory gamma subunits of AMP-activated protein kinase (AMPK), inducing conformational changes that promote kinase phosphorylation and downstream metabolic signaling cascades. This activation suppresses energy-consuming anabolic biochemical pathways while stimulating ATP-generating catabolic processes, resulting in enhanced cellular energy homeostasis and metabolic regulation relevant to clinical conditions such as overweight and obesity.

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.