Clinical Trials

Several clinical trials evaluate formulations and therapeutic applications involving meglumine across Phase 1, Phase 2/3, and unassigned phases, with recruitment status ranging from currently recruiting to completed. Investigated conditions encompass myocardial perfusion magnetic resonance imaging, perioperative pain management in hip fracture interventions, and cutaneous leishmaniasis. These studies are sponsored by academic medical centers, healthcare foundations, and industry partners, including the Medical University of South Carolina, Guerbet, Aarhus University Hospital, and the Oswaldo Cruz Foundation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03937921 Recruiting
Myocardial Perfusion Imaging|Magnetic Resonance Imaging
Medical University of South Carolina|Guerbet
 2019-07-03 --
NCT02593370 Completed
Hip Fractures|Anesthesia Local|Pain Perioperative
Thomas F. Bendtsen|AP Moeller Foundation|Aarhus University Hospital|University of Aarhus
 2015-10 Phase 1
NCT01301924 Completed
Cutaneous Leishmaniasis
Oswaldo Cruz Foundation|Rio de Janeiro State Research Supporting Foundation (FAPERJ)|Conselho Nacional de Desenvolvimento Científico e Tecnológico
 2008-10 Phase 2|Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Meglumine is a sorbitol-derived amino sugar that functions as an organic base and counterion, binding cellular metabolic components and exhibiting inhibitory activity against THP-1 monocytic cells with an IC50 of 22 μg/mL. By modulating intracellular osmotic pressure and cellular membrane dynamics, it alters cellular viability and facilitates drug solubilization. This mechanism underlies its clinical relevance in diagnostic magnetic resonance imaging, perioperative local anesthesia management, and therapeutic interventions for cutaneous leishmaniasis.

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.