NDAORALSOLUTIONPriority Review
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
CARNITOR (levocarnitine) by Leadiant Biosciences is clinical pharmacology carnitor (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. Approved for hiv infection, peripheral arterial disease, heart failure and 2 more indications. First approved in 1986.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARNITOR (levocarnitine) is a naturally occurring carnitine analog that facilitates long-chain fatty acid entry into cellular mitochondria for energy production. It treats primary and secondary carnitine deficiency, inborn errors of metabolism (glutaric aciduria II, methylmalonic aciduria, propionic acidemia, medium-chain fatty acyl-CoA dehydrogenase deficiency), and multiple indications including HIV infection, heart failure, and spinal muscular atrophy. The drug works by promoting fatty acid oxidation and clearing toxic acylCoA compounds through acylcarnitine formation and urinary excretion.
$56KPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with minimal Part D spending ($56K, 131 claims in 2023), indicating a niche market with limited commercial opportunity and likely small brand team.
Mechanism of Action
CLINICAL PHARMACOLOGY CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.