Acetylcarnitine

Generic Name: Acetylcarnitine

Drug Type: Small Molecule

Chemical Formula: C_₉H_₁₇NO_₄

CAS Number: 3040-38-8

Unique Ingredient Identifier: 6DH1W9VH8Q

Background: Acetylcarnitine is an investigational drug in the United states, Italy, United Kingdom, China, Israel, and Norway, and it is approved in Italy, Portugal, Argentina, Chile, Philippines, Australia, and India. Acetylcarnitine can be synthesized, but it is also naturally found in adequate amounts in healthy humans. In human plasma and tissues, acetylcarnitine is the most predominant acylated ester of carnitine, which is an amino acid derivative that is made in the kidney, liver, and brain from lysine and methionine. The main role of acetylcarnitine is to help transport fatty acids into the mitochondrial matrix where fatty acid metabolism occurs.

Indication: Acetylcarnitine is not approved for any indication in the United states and Canada, but it is approved and indicated in Italy for cerebrovascular disorders, mental function disorders, peripheral nerve disorders, diabetic neuropathy, and nutritional supplementation; Portugal for mental function disorders; Argentina for cerebral vasculopathy, nutritional supplementation, and peripheral neuropathy; Chile for dementia; Philippines for cerebrovascular disorders and mental function disorders; Australia for nutritional supplementation; and India for nutritional supplementation to increase sperm count. Acetylcarnitine also has several potential therapeutic indications for which it is still being investigated: in Norway, acetylcarnitine is in a phase IV trial for prophylactic treatment of migraines; in Italy acetylcarnitine is in a phase II trial for use in patients with type 2 Diabetes Mellitus, a phase III trial for alleviating fatigue in patients with chronic hepatitis C, and for use in patients with Minimal Hepatic Encephalopathy; in the United States acetylcarnitine is in a phase II trial for the neurodegenerative disorder Progressive Supranuclear Palsy, a phase II and III trial for reducing peripheral neuropathy in cancer patients as an adjunct to chemotherapy, a phase I and II trial for treating patients in septic shock, a phase II trial for bipolar depression, a phase II trial to reduce oxidative stress in patients with Sickle Cell disease, a phase I and II trial for chronic fatigue syndrome, and a study for preventing nerve damage in HIV patients; in China acetylcarnitine is in a phase III trial for reducing peripheral neuropathy in cancer patients as an adjunct to chemotherapy; in the United Kingdom acetylcarnitine is being investigated for preventing nerve damage in HIV patients; and in Israel acetylcarnitine is being studied for the treatment of male infertility.

Associated Conditions: Peripheral nerve lesion

Clinical Trials

Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS

Phase 2

Not yet recruiting

Conditions: Amyotrophic Lateral Sclerosis

Interventions: Drug: Acetyl-l-carnitine
Drug: Placebo

First Posted Date: 2023-11-13

Last Posted Date: 2025-03-07

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 246

Registration Number: NCT06126315

Preventive Effect of Acetyl-L-carnitine on Oxaliplatin-induced Peripheral Neuropathy

Phase 2

Not yet recruiting

Conditions: Chemotherapy-induced Peripheral Neuropathy
Acetylcarnitine

Interventions: Drug: Acetyl-L-carnitine

First Posted Date: 2022-11-01

Last Posted Date: 2022-11-01

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 100

Registration Number: NCT05601479

Locations: 🇨🇳
Nanfang Hospital, Southern Medical University/The First School of Clinical Medicine, Southern Medical University, Guangzhou, Guangdong, China

Evaluation the Effect of Acetyl-L-carnitine in Patients With Mild Cognitive Impairment Accompanied With Chronic Cerebrovascular Disease

Phase 4

Conditions: Mild Cognitive Impairment

Interventions: Drug: Acetyl-L-carnitine hydrochloride 500mg
Drug: Placebo

First Posted Date: 2020-04-15

Last Posted Date: 2020-04-21

Lead Sponsor: Hanmi Pharmaceutical Company Limited

Target Recruit Count: 636

Registration Number: NCT04346862

Locations: 🇰🇷
Catholic Kwandong University International St. Mary'S Hospital, Incheon, Korea, Republic of

Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease

Phase 4

Completed

Conditions: Alzheimer Disease

Interventions: Drug: Acetyl-L-Carnitine
Drug: Placebo of Acetyl-L-Carnitine

First Posted Date: 2016-11-04

Last Posted Date: 2021-04-14

Lead Sponsor: Dong-A ST Co., Ltd.

Target Recruit Count: 265

Registration Number: NCT02955706

Locations: 🇰🇷
Konkuk university medical center, Seoul, Korea, Republic of

A Pilot Study Investigating the Effects of Acetyl-L-Carnitine and Vincristine-Induced Neuropathy in Pediatric Patients With ALL

Phase 2

Terminated

Conditions: Vincristine Induced Neuropathy

Interventions: Drug: Acetylcarnitine
Drug: Placebo

First Posted Date: 2015-11-06

Last Posted Date: 2017-03-03

Lead Sponsor: Indiana University

Target Recruit Count: 8

Registration Number: NCT02598622

Acetyl-L-Carnitine Reduces Perceived Work Stress and Improves Work Ability and Work Performance in Hepatic Encephalopathy

Phase 3

Completed

Conditions: Work Stress
Work Ability
Work Performance

Interventions: Other: Placebo
Drug: Acetyl-L-carnitine

First Posted Date: 2014-06-24

Last Posted Date: 2014-06-24

Lead Sponsor: University of Catania

Target Recruit Count: 94

Registration Number: NCT02173132

Locations: 🇮🇹
University of Catania, Catania, Italy

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome

Phase 2

Completed

Conditions: Compression Neuropathy
Carpal Tunnel Syndrome

Interventions: Drug: Acetyl-l-carnitine
Drug: placebo

First Posted Date: 2014-05-16

Last Posted Date: 2017-10-27

Lead Sponsor: University of Alberta

Target Recruit Count: 20

Registration Number: NCT02141035

Locations: 🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇨🇦
Glenrose Hosptial, Edmonton, Alberta, Canada
🇨🇦
Royal Alexandra Hospital, Edmonton, Alberta, Canada