Clinical Trials

Several clinical trials explore therapeutic interventions associated with this metabolic constituent across conditions including Smooth Muscle Dysfunction Syndrome, Sickle Cell Disease, and glucose-6-phosphate dehydrogenase deficiency linked with oxidative stress and carbohydrate metabolic disorders. Encompassing Phase I and Phase Not Applicable studies, these efforts are sponsored by academic institutions, health systems, and biotechnology entities such as The University of Texas Health Science Center Houston and the University of Thessaly. Recruitment status across these trials ranges from actively recruiting to not yet recruiting participants.

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an essential purine nucleobase, adenine hydrochloride integrates into cellular metabolic pathways to facilitate the synthesis of nucleic acids and energy-carrying cofactors including adenosine triphosphate and nicotinamide adenine dinucleotide. This central role in nucleotide metabolism maintains biochemical energy transfer and cellular nucleic acid stability, mitigating metabolic stress in clinical conditions such as Sickle Cell Disease and glucose-6-phosphate dehydrogenase 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>).

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Note: Technical data last updated: Sep 1, 2026.