Clinical Trials

Several clinical trials evaluate adenine-related interventions across various metabolic and genetic disorders, with recruitment statuses ranging from actively recruiting to not yet recruiting. These protocols encompass both Phase 1 and non-phase studies investigating Moyamoya-like cerebrovascular disease in Smooth Muscle Dysfunction Syndrome, dietary supplementation in Sickle Cell Disease, and oxidative stress and carbohydrate metabolism disorders in G6PD deficiency. The research is supported by a range of academic institutions, healthcare networks, and biotechnology sponsors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06280482 Recruiting
Smooth Muscle Dysfunction Syndrome (SMDS)
The University of Texas Health Science Center Houston
2024-03-06 Phase 1
NCT05789355 Recruiting
Sickle Cell Disease
LGD|CEN Biotech|Assistance Publique Hopitaux De Marseille|Etablissement Français du Sang
2023-04-01 Not Applicable
NCT05571748 Not yet recruiting
G6PD Deficiency|Carbohydrate Metabolism Disorder|Oxidative Stress
University of Thessaly
2023-02 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a vital purine nucleobase, adenine binds complementary pyrimidine bases via hydrogen bonding to stabilize nucleic acid architecture while serving as a fundamental constituent of energy-transferring molecules such as ATP, NAD, and FAD. By driving cellular respiration, nucleic acid synthesis, and metabolic energy transfer, adenine maintains key physiological cellular functions, which underlies its relevance in clinical investigations targeting metabolic dysfunction, oxidative stress, and hematologic conditions including Sickle Cell Disease and G6PD deficiency.

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.