Meldonium Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials across Phase I, Phase II, and Phase IV evaluate Meldonium for indications including asthenia, post-COVID-19 cognitive impairment, metastatic renal cell carcinoma, treatment-related fatigue, lipid metabolism, and athletic performance safety. Investigations sponsored by Promomed, LLC and the Kidney Cancer Research Bureau have reached completed status. Additional clinical initiatives led by sponsors such as Riga Stradins University and Enhanced Emirates Limited evaluate mitochondrial lipid metabolism and performance-enhancing substance usage, maintaining recruitment statuses spanning from completed to enrolling by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07568574	ENROLLING_BY_INVITATION	Safety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes	Enhanced Emirates Limited	2026-03-12
NCT06648902	COMPLETED	Renal Cell Cancer Metastatic; Kidney Cancer; Fatigue Related to Cancer Treatment	Kidney Cancer Research Bureau	2022-02-01	PHASE1; PHASE2
NCT07304921	COMPLETED	Lipid Metabolism; Omega-3 Polyunsaturated Fatty Acids; Supplementation	Riga Stradins University	2023-04-06	PHASE1
NCT05939622	COMPLETED	Asthenia; COVID-19; Functional MRI; Cognitive Impairment	Promomed, LLC	2022-05-18	PHASE4
NCT05689827	COMPLETED	Asthenia; COVID-19	Promomed, LLC	2022-04-05	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Meldonium competitively inhibits gamma-butyrobetaine hydroxylase and renal carnitine reabsorption, thereby depleting intracellular L-carnitine pools and downregulating mitochondrial fatty acid oxidation. This metabolic shift toward glycolytic energy production decreases toxic metabolite accumulation and cellular stress, offering functional relevance in mitigating asthenia, cancer treatment-related fatigue, and metabolic impairment evaluated in clinical trials for renal carcinoma and post-viral recovery.

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>).