Clinical Trials

Numerous clinical trials evaluate the therapeutic potential and metabolic effects of L-carnitine across early phase through Phase 4 studies, including completed, active, recruiting, and terminated protocols. Investigated indications encompass neuromuscular and neurodegenerative disorders such as amyotrophic lateral sclerosis and diabetic peripheral neuropathic pain, alongside metabolic conditions including non-alcoholic fatty liver disease, insulin resistance, and organic acidemias. These initiatives are sponsored by academic entities like the Mario Negri Institute for Pharmacological Research and the University of Nottingham, as well as pharmaceutical companies such as Haisco Pharmaceutical Group.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06845046 RECRUITING
HIV; Obesity
VA Office of Research and Development
 2025-07-15
NCT07216001 NOT_YET_RECRUITING
Childhood Apraxia of Speech; Verbal Apraxia; Autism
Claudia R. Morris
 2026-11 PHASE2
NCT07768228 RECRUITING
Diabetic Foot Ulcer; Diabetic Foot Ulcer (DFU)
Ain Shams University
 2026-09-01 PHASE2
NCT06518343 ACTIVE_NOT_RECRUITING
Healthy
Quadram Institute Bioscience
 2024-08-12
NCT04913805 RECRUITING
Heart Failure With Preserved Ejection Fraction
University of Pennsylvania
 2021-10-11 PHASE2
NCT06126315 RECRUITING
Amyotrophic Lateral Sclerosis
Mario Negri Institute for Pharmacological Research
 2025-03-26 PHASE2; PHASE3
NCT07201714 RECRUITING
Heart Failure; Carnitine Deficiency
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2025-11-12 EARLY_PHASE1
NCT03994874 RECRUITING
Congestive Heart Failure
Iperboreal Pharma Srl
 2025-04-16 PHASE1; PHASE2
NCT06564909 ACTIVE_NOT_RECRUITING
Reperfusion Injury, Myocardial; Myocardial Infarction
Ain Shams University
 2025-06-01 PHASE2
NCT07642076 RECRUITING
Hepatic
Beni-Suef University
 2026-06 PHASE4
NCT07783399 RECRUITING
Infertility (IVF Patients)
The Obstetrics and Gynaecology Clinic Narodni Front
 2026-05-15
NCT07108777 RECRUITING
Nephrotoxicity
Tanta University
 2025-08-10 PHASE2
NCT07660081 ACTIVE_NOT_RECRUITING
Osteoarthritis; Type 2 Diabetes; Obesity
Khyber Medical University Peshawar
 2025-11-01
NCT07437391 RECRUITING
Respiratory Distress Syndrome
Muhammad Aamir Latif
 2026-01-01
NCT07035444 NOT_YET_RECRUITING
Non-Small Cell Lung Cancer; Cachexia
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
 2025-06-30
NCT07402759 ACTIVE_NOT_RECRUITING
Oligoasthenozoospermia; Male Infertility
South Valley University
 2026-01-01 PHASE3
NCT05251207 COMPLETED
Insulin Resistance
Poznan University of Physical Education
 2022-02-07
NCT05980884 ACTIVE_NOT_RECRUITING
Gut Dysbiosis for TMAO Production From L-carnitine Consumption
National Taiwan University Hospital
 2023-07-24
NCT06901323 ACTIVE_NOT_RECRUITING
Phenylketonuria
Mansoura University
 2025-02-01 PHASE4
NCT07669402 COMPLETED
Idiopathic Oligoasthenoteratozoospermia; Male Infertility
Tehran University of Medical Sciences
 2023-12-01 PHASE2; PHASE3
NCT06960694 COMPLETED
Knee Osteoarthritis
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2025-06-28 PHASE2
NCT07804641 COMPLETED
Diabetic Kidney Disease (DKD)
Taipei Medical University WanFang Hospital
 2024-11-06 PHASE2
NCT07016867 RECRUITING
Teratozoospermia
South Valley University
 2024-09-01
NCT06689501 COMPLETED
Overweight and Obesity
Société des Produits Nestlé (SPN)
 2024-10-30
NCT04946123 COMPLETED
Hyperthyroidism
Lo.Li.Pharma s.r.l
 2021-07-05
NCT06753565 RECRUITING
Rheumatoid Arthritis (RA)
German University in Cairo
 2024-12-31 PHASE2
NCT05355311 COMPLETED
Alcohol Use Disorder
Brown University
 2024-09-27 PHASE1
NCT07492446 COMPLETED
Recovery Methods; Exercise and Recovery; Exercise Fatigue; Carnitine Ingestion; Exercise Ergogenics
Istanbul Sabahattin Zaim University
 2025-05-09
NCT05792527 UNKNOWN
Rheumatoid Arthritis
Tanta University
 2023-03-05 PHASE3
NCT05601479 UNKNOWN
Acetylcarnitine; Chemotherapy-induced Peripheral Neuropathy
Nanfang Hospital, Southern Medical University
 2022-11-01 PHASE2
NCT06849115 COMPLETED
Amyotrophic Lateral Sclerosis (ALS)
ChaodongWang
 2024-07-18 PHASE4
NCT02664753 TERMINATED
Severe Sepsis; Shock, Septic; Acute Kidney Injury
Centre Hospitalier Universitaire de Nīmes
 2018-03-05 PHASE3
NCT07303088 COMPLETED
Oxidative Stress Response; Hemodialysis; End Stage Kidney Disease (ESRD)
University of Sfax
 2024-06-17
NCT05632549 UNKNOWN
Moderate Persistent Asthma
Tanta University
 2022-08-08 PHASE3
NCT06342856 UNKNOWN
Infertility Unexplained; Oligospermia
Ain Shams University
 2023-06-15 EARLY_PHASE1
NCT05632094 UNKNOWN
Clozapine Poisoning
Alexandria University
 2023-06 PHASE2
NCT06122012 UNKNOWN
Diabetic Peripheral Neuropathic Pain
Haisco Pharmaceutical Group Co., Ltd.
 2023-05-01
NCT05767515 COMPLETED
Infertility, Female; PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Khyber Medical University Peshawar
 2023-07-15
NCT05948124 UNKNOWN
Carnitine Deficiency Due to Hemodialysis
Ain Shams University
 2023-08-01 EARLY_PHASE1
NCT06198803 UNKNOWN
l Carnitine With Ketogenic Diet
Ain Shams University
 2022-01-03 EARLY_PHASE1
NCT05905692 UNKNOWN
Intradialytic Hypotension
Ain Shams University
 2023-05-30 PHASE3
NCT06255873 COMPLETED
Ketogenic Diet
Ain Shams University
 2023-01-20
NCT05584956 UNKNOWN
Beta Thalassemia With Increased Tricuspid Regurgitant Jet Velocity
Tanta University
 2022-07-08 PHASE3
NCT05817799 COMPLETED
Hemodialysis Complication
Bahria University
 2023-01-01 PHASE2; PHASE3
NCT05673239 COMPLETED
Renal Dialysis
The First Affiliated Hospital of Zhejiang Chinese Medical University
 2023-01-15 PHASE4
NCT04908397 COMPLETED
Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Primary Pulmonary Hypertension; Lung Diseases; Carnitine Nutritional Deficiency
Vanderbilt University Medical Center
 2021-09-29 PHASE1
NCT06122012 Recruiting
Diabetic Peripheral Neuropathic Pain
Haisco Pharmaceutical Group Co. Ltd.
 2023-05-01 Not Applicable
NCT05647707 UNKNOWN
Carbon Monoxide Poisoning
Alexandria University
 2022-12-15 PHASE2
NCT05083637 COMPLETED
Malnutrition
International Centre for Diarrhoeal Disease Research, Bangladesh
 2021-10-19
NCT06255873 Completed
Ketogenic Diet
Ain Shams University
 2023-01-20 Not Applicable
NCT04672720 COMPLETED
Polycystic Ovary Syndrome
Royan Institute
 2020-03-01
NCT04086212 WITHDRAWN
End Stage Renal Disease (ESRD)
Iperboreal Pharma Srl
 2019-10-02 PHASE2
NCT05616000 COMPLETED
Infertility
Khyber Medical University Peshawar
 2022-08-06 PHASE2
NCT04001036 TERMINATED
End Stage Renal Disease
Iperboreal Pharma Srl
 2019-09-01 PHASE2
NCT05322447 COMPLETED
Respiratory Failure
Ain Shams University
 2022-04-15 PHASE4
NCT05487781 UNKNOWN
Healthy
Molecule X LLC
 2022-05-24 EARLY_PHASE1
NCT04509258 UNKNOWN
the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage
Cairo University
 2020-10 PHASE4
NCT05446961 COMPLETED
COVID-19 Virus Infection
SENAI CIMATEC
 2021-03-01 PHASE2
NCT04623619 UNKNOWN
Covid19
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
 2020-12-15
NCT04732429 Terminated
Methylmalonic Acidemia|Propionic Acidemia
HemoShear Therapeutics
 2021-03-15 Phase 2
NCT07249229 COMPLETED
End-stage Renal Disease (ESRD); Hemodialysis
Darya Chamani
 2020-11-30 PHASE2
NCT01783041 COMPLETED
Prematurity; Neurodevelopmental Disorder; Carnitine Deficiency
Montefiore Medical Center
 2013-01 PHASE2; PHASE3
NCT02645942 WITHDRAWN
Obstructive Sleep Apnea
Poznan University of Medical Sciences
 2020-08
NCT03630367 WITHDRAWN
Premature Birth
Assiut University
 2018-10-03 PHASE4
NCT03439917 COMPLETED
Non-Alcoholic Fatty Liver Disease; Insulin Resistance
University of Nottingham
 2018-04-02
NCT03604016 UNKNOWN
Hepatitis B
IlDong Pharmaceutical Co Ltd
 2018-09-23 PHASE4
NCT01825369 WITHDRAWN
Heart Septal Defects, Ventricular; Atrioventricular Septal Defect
University of California, San Francisco
 2014-12 PHASE1
NCT04346862 UNKNOWN
Mild Cognitive Impairment
Hanmi Pharmaceutical Company Limited
 2016-01-26 PHASE4
NCT04420377 COMPLETED
Muscle Soreness; Muscle Damage; Resistance Training; Oxidative Stress; Muscle Strength
Applied Science & Performance Institute
 2020-03-02
NCT05081349 COMPLETED
Sickle Cell Disease
Assiut University
 2017-01-10 PHASE4
NCT03588949 UNKNOWN
Infertility, Male
NATURAmedicatrix Sàrl
 2018-10-01
NCT04002024 COMPLETED
Acne Vulgaris; Acne
Mahidol University
 2019-06-01
NCT04113889 COMPLETED
PCOS
Khyber Medical University Peshawar
 2019-10-15 PHASE2
NCT04145245 UNKNOWN
Patient Compliance
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2018-04-17 PHASE2
NCT03426722 COMPLETED
Gastrointestinal Stromal Tumors (GISTs)
Asan Medical Center
 2018-03-01 PHASE3
NCT03230812 COMPLETED
Glucose Intolerance
Maastricht University Medical Center
 2018-03-01
NCT03781011 COMPLETED
Dietary Modification; Cardiovascular Diseases
National Taiwan University Hospital
 2018-10-19
NCT01617772 UNKNOWN
Non-alcoholic Steatohepatitis
Tehran University of Medical Sciences
 2016-01-01 PHASE2
NCT04434404 COMPLETED
Breast Cancer
Horus University
 2018-09-10 PHASE4
NCT03660293 COMPLETED
Diabetes Mellitus, Type 1
Tanta University
 2017-04-01
NCT03151291 UNKNOWN
Cancer; Cancer Cachexia; Weight Loss; Muscle Loss; Muscle Weakness
University of Erlangen-Nürnberg Medical School
 2016-12
NCT03696940 UNKNOWN
Dyslipidemias; Cardiovascular Risk Factor
Laboratorios Grossman, S.A.
 2018-05-28 PHASE3
NCT03436277 UNKNOWN
Body Weight Changes
University of Guadalajara
 2018-12-17 PHASE2
NCT02955706 COMPLETED
Alzheimer Disease
Dong-A ST Co., Ltd.
 2016-04-01 PHASE4
NCT03907592 COMPLETED
Sarcopenia
Gdansk University of Physical Education and Sport
 2017-09-01
NCT05120011 COMPLETED
Osteoporosis
Poznan University of Physical Education
 2017-09-01
NCT03164421 COMPLETED
PCOS
Zagazig University
 2017-01 PHASE2
NCT03193125 COMPLETED
Diabetes Mellitus, Type 2; Insulin Resistance; Obesity
Pennington Biomedical Research Center
 2017-05-15
NCT03021876 UNKNOWN
Ammonia Metabolism
Kochi University
 2016-04 PHASE2; PHASE3
NCT03630341 COMPLETED
Polycystic Ovary Syndrome
Assiut University
 2016-02-01 PHASE4
NCT03476356 COMPLETED
Polycystic Ovary Syndrome
Ain Shams University
 2017-11-01
NCT03108963 COMPLETED
PCOS
Zagazig University
 2017-01 PHASE2
NCT02971878 COMPLETED
Culture Media; Blastocyst; Antioxidants; Embryo; Human
Fertilitetscentrum AB
 2016-11
NCT03008356 COMPLETED
Copd; Fatigue
Mayo Clinic
 2017-01 PHASE2; PHASE3
NCT06256276 COMPLETED
Heart Failure
University of Arkansas
 2016-07-26
NCT03319199 COMPLETED
Fatty Liver, Nonalcoholic
Rawi Hazzan
 2017-10-30
NCT03953248 COMPLETED
Toxicity
Heba Allah Ali Abd El-Halim Mabrouk
 2016-01 EARLY_PHASE1
NCT03014882 UNKNOWN
Endocrine Disease; Fertility Decreased Male; DNA Damage
Ain Shams University
 2015-02 PHASE1; PHASE2
NCT02838732 COMPLETED
Dietary Exposure
National Taiwan University Hospital
 2016-05-18
NCT03180424 UNKNOWN
Carnitine; Muscle; Functional Status; Old Age; Debility
Hospital de Clínicas Dr. Manuel Quintela
 2017-01-01 PHASE2; PHASE3
NCT02117661 COMPLETED
Metabolic Syndrome
Dr. Amer Johri
 2015-01 PHASE2
NCT02141035 COMPLETED
Carpal Tunnel Syndrome; Compression Neuropathy
University of Alberta
 2015-09 PHASE2; PHASE3
NCT01921868 UNKNOWN
Friedreich's Ataxia
University of South Florida
 2013-08
NCT02722902 TERMINATED
Glucose Intolerance
Maastricht University Medical Center
 2016-05
NCT05009654 COMPLETED
Muscle Loss
Gdansk University of Physical Education and Sport
 2016-10-01
NCT02538146 TERMINATED
Chronic Pancreatitis
Karin High
 2015-08 EARLY_PHASE1
NCT05009641 COMPLETED
Muscle Loss
Gdansk University of Physical Education and Sport
 2015-11-15
NCT02197299 UNKNOWN
Type 2 Diabetes
University of Nottingham
 2014-08 PHASE2
NCT02635594 COMPLETED
Healthy Volunteers; Recovery; Endothelial Function
Lonza Ltd.
 2015-12
NCT02072759 COMPLETED
Glucose Intolerance
Maastricht University Medical Center
 2014-03
NCT02042482 UNKNOWN
Myelodysplastic Syndrome
Kaplan Medical Center
 2013-05 PHASE2; PHASE3
NCT01381354 COMPLETED
Multiple Sclerosis
University of Iowa
 2010-10 PHASE1
NCT01524861 COMPLETED
Apical Ballooning Syndrome; Nervous System Diseases, Sympathetic
University of Campania Luigi Vanvitelli
 2011-12 PHASE4
NCT02786043 COMPLETED
Peripheral Arterial Diseases
Lee's Pharmaceutical Limited
 2015-06 PHASE1
NCT02786069 COMPLETED
Peripheral Arterial Disease
Lee's Pharmaceutical Limited
 2015-06 PHASE1
NCT01786824 TERMINATED
Acute Kidney Injury; Renal Insufficiency
Centre Hospitalier Universitaire de Nīmes
 2014-12 PHASE3
NCT01492920 WITHDRAWN
Fatigue; Malignant Ovarian Mixed Epithelial Tumor; Neuropathy; Neurotoxicity Syndrome; Ovarian Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Pain; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
Gynecologic Oncology Group
 2012-04 PHASE3
NCT01107730 COMPLETED
Atrial Fibrillation
Attikon Hospital
 2010-04 PHASE3
NCT02173054 COMPLETED
Acne
Mahidol University
 2014-07 PHASE3
NCT02124590 COMPLETED
Elderly; Pre-diabetic
Duke University
 2014-06
NCT01379976 TERMINATED
Non Small Cell Lung Cancer
Mario Negri Institute for Pharmacological Research
 2011-04 PHASE3
NCT02322697 COMPLETED
Disorder of Fatty Acid Metabolism
Toujinkai Hospital
 2013-08
NCT02226419 COMPLETED
Carnitine Transporter, Plasma-membrane, Deficiency of
Karen Lindhardt Madsen
 2013-08
NCT02007889 UNKNOWN
Acute Pyelonephritis(APN)
Shahid Beheshti University
 2013-11 PHASE3
NCT01695317 COMPLETED
Migraine
Norwegian University of Science and Technology
 2013-04 PHASE4
NCT01956825 UNKNOWN
Non Alcoholic Fatty Liver Disease
Meir Medical Center
 2014-01 PHASE4
NCT02535897 COMPLETED
Muscle, Skeletal
University of Nottingham
 2013-07 PHASE1
NCT01523106 WITHDRAWN
Crohn's Disease; Fatigue
University of California, San Francisco
 2013-08
NCT01819701 COMPLETED
Coronary Artery Disease
Taichung Veterans General Hospital
 2013-01 PHASE2; PHASE3
NCT02173132 COMPLETED
Work Stress; Work Ability; Work Performance
University of Catania
 2010-04 PHASE3
NCT01567956 TERMINATED
Ulcerative Colitis
sigma-tau i.f.r. S.p.A.
 2012-04 PHASE3
NCT00755404 WITHDRAWN
End Stage Renal Disease; Diabetes
Iperboreal Pharma Srl
 2007-06 PHASE2
NCT01538251 TERMINATED
Ulcerative Colitis
sigma-tau i.f.r. S.p.A.
 2012-04 PHASE3
NCT01537549 COMPLETED
Progressive Supranuclear Palsy
Weill Medical College of Cornell University
 2010-09-14 PHASE1; PHASE2
NCT01665547 UNKNOWN
Treatment Resistant Disorders
Woman's Health University Hospital, Egypt
 2012-07 PHASE4
NCT01769157 COMPLETED
Hypothyroidism
Korea University Anam Hospital
 2012-08 PHASE4
NCT01054768 COMPLETED
Anemia, Sickle Cell
UCSF Benioff Children's Hospital Oakland
 2009-08 PHASE2
NCT01232907 COMPLETED
Spinal Cord Injury (SCI)
University of British Columbia
 2010-10 PHASE2
NCT00841295 COMPLETED
Complication of Prematurity
University Hospital, Tours
 2008-07
NCT01149525 COMPLETED
Multiple Sclerosis
University Hospital, Bordeaux
 2010-06 PHASE3
NCT01549847 WITHDRAWN
Postpoliomyelitis Syndrome
Biolab Sanus Farmaceutica
 PHASE3
NCT00858182 WITHDRAWN
End-Stage Renal Disease
Iperboreal Pharma Srl
 2009-05 PHASE2
NCT00851838 COMPLETED
End-Stage Renal Disease
Iperboreal Pharma Srl
 2009-06 PHASE2
NCT00755456 COMPLETED
End Stage Renal Disease; Insulin Resistance
Iperboreal Pharma Srl
 2008-01 PHASE2
NCT02281253 COMPLETED
Metabolic X Syndrome; Overweight; Dyslipidemias
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
 2010-04
NCT01231828 COMPLETED
Cirrhosis
University Hospital, Caen
 2009-09
NCT00984750 COMPLETED
Diabetes Type 2; Hypertension
Mario Negri Institute for Pharmacological Research
 2008-04 PHASE3
NCT02598622 TERMINATED
Vincristine Induced Neuropathy
Indiana University
 2009-09 PHASE2
NCT01580553 COMPLETED
Heart Failure,
Lee's Pharmaceutical Limited
 2011-01 PHASE2; PHASE3
NCT01193777 TERMINATED
Septic Shock
Wake Forest University Health Sciences
 2010-09 PHASE1
NCT00775645 COMPLETED
Breast Cancer; Chemotherapeutic Agent Toxicity; Fatigue; Neuropathy; Neurotoxicity
SWOG Cancer Research Network
 2009-09 PHASE3
NCT01909557 COMPLETED
Quality of Life; Daily Activity; Fatigue
University of Catania
 2010-01 PHASE3
NCT00719706 COMPLETED
Bipolar Depression
Mclean Hospital
 2008-08 PHASE2
NCT01526564 COMPLETED
Peripheral Sensory Neuropathy
Lee's Pharmaceutical Limited
 2008-08 PHASE3
NCT00572429 WITHDRAWN
HIV Infections; Hyperlipidemia; Exercise
University of California, Davis
 2008-07
NCT00581919 COMPLETED
Multiple Myeloma
University of Wisconsin, Madison
 2004-02 PHASE2
NCT00822172 COMPLETED
Peripheral Vascular Disease; Intermittent Claudication; Peripheral Arterial Disease
Colorado Prevention Center
 2008-09 PHASE4
NCT00247975 TERMINATED
Heart Failure
Ottawa Heart Institute Research Corporation
 2006-03 PHASE2; PHASE3
NCT01278693 COMPLETED
Complication of Hemodialysis
Isfahan University of Medical Sciences
 2009-08 PHASE2
NCT00322322 COMPLETED
Complication of Hemodialysis; Hyperthyroidism Treated or Under Control
Assistance Publique - Hôpitaux de Paris
 2006-06 PHASE3
NCT00751205 COMPLETED
Prostate Cancer; Ovarian Cancer
Bayer
 2008-08 PHASE2
NCT00386971 COMPLETED
Hyperlipidemia; HIV Infections
University of California, Davis
 2006-10
NCT01330823 SUSPENDED
Pancreatic Carcinoma
University Medicine Greifswald
 2006-06 PHASE3
NCT00809497 COMPLETED
Peripheral Arterial Disease
Lee's Pharmaceutical Limited
 2008-05 PHASE3
NCT00592488 COMPLETED
Septic Shock
Vanderbilt University
 2006-08 PHASE1; PHASE2
NCT00516516 TERMINATED
Muscle Cramp
University of Southern California
 2008-07
NCT01026857 COMPLETED
Ulcerative Colitis
sigma-tau i.f.r. S.p.A.
 2006-05 PHASE2
NCT00202228 COMPLETED
HIV Infections; AIDS; Lactic Acidosis; Lipodystrophy
Queen's University
 2002-07 PHASE4
NCT00555841 TERMINATED
Breast Cancer
Sigma-Tau Research, Inc.
 2007-03 PHASE2
NCT00754767 TERMINATED
Breast Cancer; Chemotherapeutic Agent Toxicity; Neurotoxicity
HealthPartners Institute
 2007-01-02 PHASE4
NCT00399919 COMPLETED
Peripheral Vascular Diseases; Intermittent Claudication
Sigma-Tau Research, Inc.
 2006-04 PHASE3
NCT00809042 COMPLETED
β-Thalassemia Intermedia
Shiraz University of Medical Sciences
 2007-06 PHASE2
NCT00079599 COMPLETED
HIV Infections; AIDS
National Institute of Nursing Research (NINR)
 2002-11 PHASE2
NCT00393770 COMPLETED
Type 2 Diabetes Mellitus
Mario Negri Institute for Pharmacological Research
 2004-02 PHASE2
NCT00922701 COMPLETED
End-Stage Renal Disease
Iperboreal Pharma Srl
 2004-06 PHASE2
NCT01913964 COMPLETED
Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis; Fatigue in Workers With Chronic C Hepatitis; Fatigue
University of Catania
 1997-10 PHASE4
NCT00225160 UNKNOWN
HIV Infections; Distal Symmetric Polyneuropathy
Royal Free Hampstead NHS Trust
 2003-11 PHASE2
NCT01223768 COMPLETED
Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
University of Catania
 2002-07
NCT01223729 COMPLETED
Minimal Hepatic Encephalopathy
University of Catania
 2002-04
NCT01223742 COMPLETED
Hepatic Encephalopathy
University of Catania
 2002-06
NCT00050271 COMPLETED
HIV Infections; Peripheral Nervous System Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00034450 COMPLETED
Neoplasms
National Center for Complementary and Integrative Health (NCCIH)
 2002-01 PHASE2
NCT00173706 UNKNOWN
Cardiac Complications; Signs and Symptoms; Muscle Weakness; Anemia; Hypotension
National Taiwan University Hospital
 2004-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-26)

Check the L-carnitine (Levocarnitine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

L-carnitine binds to mitochondrial translocases and carnitine palmitoyltransferase enzymes to facilitate the transport of long-chain fatty acids across the inner mitochondrial membrane, thereby driving mitochondrial fatty acid beta-oxidation and ATP generation. By enhancing lipid metabolism and mitochondrial bioenergetics, this pathway mitigates cellular energy deficits, providing the physiological rationale for its clinical study in metabolic and neuromuscular conditions such as non-alcoholic fatty liver disease and amyotrophic lateral sclerosis.

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.