At a glance
- L-Carnitine (levocarnitine) is an FDA-approved drug, marketed as Carnitor, Levocarnitine (first approval: December 27, 1985).
- PubMed lists 7,011 publications mentioning it, including 500 randomized controlled trials and 2,432 animal-only studies.
- ClinicalTrials.gov lists 314 registered studies testing it (37 active).
- FDA's adverse event system (FAERS) holds 5,427 reports mentioning it; 3,999 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA018948 | CARNITOR | Approved, marketed | December 27, 1985 | LEADIANT BIOSCI INC |
| NDA019257 | CARNITOR, CARNITOR SF | Approved, marketed | April 10, 1986 | LEADIANT BIOSCI INC |
| NDA020182 | CARNITOR | Approved, marketed | December 16, 1992 | LEADIANT BIOSCI INC |
| ANDA075567 | LEVOCARNITINE | Approved, marketed | March 29, 2001 | HIKMA |
| ANDA075881 | LEVOCARNITINE | Approved, discontinued | March 29, 2001 | TEVA PHARMS USA |
| ANDA075861 | LEVOCARNITINE | Approved, marketed | June 22, 2001 | AM REGENT |
| ANDA076851 | LEVOCARNITINE | Approved, marketed | August 10, 2004 | RISING |
| ANDA076858 | LEVOCARNITINE | Approved, marketed | September 20, 2004 | RISING |
| ANDA077399 | LEVOCARNITINE | Approved, discontinued | October 25, 2007 | HIKMA |
| ANDA211676 | LEVOCARNITINE, LEVOCARNITINE SF | Approved, marketed | August 14, 2019 | NOVITIUM PHARMA |
| ANDA212533 | LEVOCARNITINE | Approved, marketed | November 10, 2021 | SCIEGEN PHARMS |
| ANDA216384 | LEVOCARNITINE | Approved, marketed | December 9, 2022 | NOVITIUM PHARMA |
| ANDA217430 | LEVOCARNITINE | Approved, marketed | June 30, 2025 | DEVA HOLDING AS |
| ANDA217896 | LEVOCARNITINE | Approved, marketed | July 2, 2026 | BAXTER HLTHCARE CORP |
| ANDA220181 | LEVOCARNITINE | Approved, marketed | September 30, 2026 | GLAND |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Danshen-Chuanxiong alleviates cerebral ischemia by regulating carnitine metabolism and angiogenesis via activating CPT1/HIF-1α signaling axis.
- Thrombophlebitis in an Adolescent Patient With Primary Carnitine Deficiency: A Case Report.
- L-Carnitine Supplementation in Overweight Dogs: An Uncontrolled Pilot Study on Nutrient Digestibility, Metabolic Health, and Body Condition.
- Protective Effects of Serotonin, L-Carnitine, and Coenzyme Q10 on Human Sperm Cryopreservation: Functional and In Silico Evidence.
- Comparative Neuroprotective Evaluation of Mitochondria-Targeted Antioxidant MitoQ Versus Acetyl-L-Carnitine in Vincristine-Induced Peripheral Neuropathy: Electrophysiological and Structural Insights.
- The Use of Nutritional Supplements as a Therapy for Spinal Cord Injury. A Narrative Review.
- Nutritional Interventions for Patients with Intermittent Claudication: Mechanisms, Clinical Implications, and the Case for Exercise-Adjunct Strategies: A Narrative Review.
- Micronutrient deficiencies in continuous renal replacement therapy: A literature review and the emerging role of the pharmacist.
- [Clinical and genetic characteristics of children with methylmalonic acidemia presenting as spastic paraplegia].
- γ-Butyrobetaine, L-carnitine and acylcarnitines and their association with incident atrial fibrillation among men and women with suspected chronic coronary syndrome.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 314
- Active
- 37
- With posted results
- 28
Conditions studied
Show 40 more studies
All 314 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 5,427
- Serious
- 3,999
- With death outcome
- 529
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
- Electrolyte Plus
- Metabatone
- LEVOCARNITINE
- A-L-O Liquid Drops 2082
- Muscle/Ligament/Cartilage Drops 5015
- Levocarnitine
- Levocarnitine
- levocarnitine
- Levocarnitine
- Levocarnitine
- Recovatone
- Strength F
- Levocarnitine
- Carnitor SF
- CARNITOR
- Recovatone
- Cardio Tonic
- Levocarnitine
- Carnitor
- Carnitor
- A L O Formula
- Levocarnitine
- Vital Skin Hair Nails
- Levocarnitine
- Cardio Tonic
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.