Clinical Trials

Multiple clinical trials across Early Phase I, Phase III, and unspecified protocol designs are currently evaluating carnitine metabolism in conditions such as asthenozoospermia, cardiovascular diseases, monoclonal gammopathy of undetermined significance, and pediatric carnitine deficiency secondary to hemodialysis. Sponsored by academic centers and hospital trusts, these studies currently range from not yet recruiting to actively recruiting. Together, they aim to assess outcomes in reproductive seminal health, dietary cardiovascular interventions, long-term patient care, and pediatric metabolic supplementation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05436080 Not yet recruiting
Asthenozoospermia
Assiut University
 2024-08-01 --
NCT06120400 Not yet recruiting
Cardiovascular Diseases
Penn State University|American Egg Board
 2024-05 Phase 3
NCT05539079 Recruiting
MGUS
Oxford University Hospitals NHS Trust
 2023-09-06 --
NCT05948124 Recruiting
Carnitine Deficiency Due to Hemodialysis
Ain Shams University
 2023-08-01 Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

D-Carnitine hydrochloride interacts with carnitine transporter proteins to modulate endogenous carnitine shuttle mechanisms, thereby disrupting mitochondrial acyl-CoA transfer and inhibiting cellular energy production from amino acid catabolism. This alteration in cellular fatty acid and amino acid metabolic pathways provides essential insights into therapeutic interventions for clinical conditions such as carnitine deficiency and cardiovascular diseases.

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.