Clinical Trials

Multiple clinical trials evaluate β-alanine across physiological performance states and health conditions, spanning Phase 2 to Phase 4 as well as non-interventional studies. Conducted primarily by academic institutions and medical centers, these investigations target diverse indications, including muscle weakness, muscle fatigue in older adults, traumatic brain injury, prediabetes, and advanced hepatocellular carcinoma. Trial recruitment statuses currently encompass active, recruiting, completed, and suspended.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07317414 RECRUITING
Hepatocellular Carcinoma
Peking Union Medical College Hospital
 2025-12-24 PHASE2
NCT07650162 COMPLETED
Cyclists; Healthy Adult Male
The Jerzy Kukuczka Academy of Physical Education in Katowice
 2019-11-20
NCT07641907 ACTIVE_NOT_RECRUITING
Healthy; Athletes
China Medical University Hospital
 2026-04-11
NCT07092930 RECRUITING
Supplementation; Sports; Female Athletes
Poznan University of Physical Education
 2023-10-01 PHASE3
NCT07319052 COMPLETED
Athletic Performance Enhancement (Kickboxing); Anaerobic Performance; Strength Endurance; Neuromuscular Power; Nutritional Supplementation (β-Alanine)
Salih ÇABUK
 2025-04-30
NCT06214338 COMPLETED
Bioavailability
Universidad Católica San Antonio de Murcia
 2024-02-12
NCT06167395 COMPLETED
Beta Alanine Supplementation
Universidad Católica San Antonio de Murcia
 2023-12-04
NCT06191055 COMPLETED
Beta Alanine Supplementation
Universidad Católica San Antonio de Murcia
 2023-12-04
NCT05479409 RECRUITING
Breast Neoplasms
Fudan University
 2021-03-01 PHASE2
NCT06180512 COMPLETED
Beta Alanine Supplementation
Universidad Católica San Antonio de Murcia
 2023-12-04
NCT06059911 UNKNOWN
Sport Performance
Athanasios Z. Jamurtas
 2022-06-15
NCT05329610 COMPLETED
Prediabetes; Hyperglycemia; Overweight or Obesity
Nottingham Trent University
 2022-04-05
NCT05860088 Recruiting
Muscle Weakness|Muscle; Fatigue Heart|Older Adults
Indiana University
 2023-07-10 Not Applicable
NCT05334121 COMPLETED
Product Safety
Universidad Católica San Antonio de Murcia
 2022-03-21
NCT04949607 Completed
Brain Injury Chronic|Brain Injuries Traumatic
Centre for Neuro Skills|University of Texas
 2021-07-28 Not Applicable
NCT04941742 Completed
Eosinophilic Esophagitis
The University of Texas Health Science Center Houston
 2020-09-22 --
NCT04427319 COMPLETED
Supplementation; Cyclists
Universidad Católica San Antonio de Murcia
 2020-02-10
NCT02770417 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD)
Hasselt University
 2016-05
NCT03708185 Completed
Healthy
University of Exeter
 2018-06-04 Not Applicable
NCT04250480 COMPLETED
Cognitive Impairment
University of Central Florida
 2017-10-02
NCT03111979 SUSPENDED
Muscle Function
Nottingham Trent University
 2014-04 PHASE4
NCT03418376 COMPLETED
Multiple Sclerosis; Exercise Therapy; Dietary Supplement
Hasselt University
 2017-02-01
NCT03655041 COMPLETED
Sports Nutritional Physiological Phenomena
University of Sao Paulo
 2013-02-01
NCT02819505 COMPLETED
Muscle Function
Nottingham Trent University
 2014-12 PHASE4
NCT07404540 COMPLETED
Dietary Supplementation; Healthy Vollunteer
University of Pecs
 2012-01
NCT00813553 COMPLETED
Healthy
Société des Produits Nestlé (SPN)
 2008-12

(data from https://clinicaltrials.gov, updated on 2026-01-05)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

β-Alanine acts as a naturally occurring amino acid agonist that selectively activates GABA and glycine receptors, triggering chloride ion influx to hyperpolarize neuronal membranes and supporting carnosine biosynthesis. This inhibitory action dampens central neuronal hyperexcitability while buffering metabolic acid accumulation in skeletal muscle tissue, providing therapeutic rationale for its clinical evaluation in muscle weakness, fatigue, and oncological adjuvant therapy.

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.