NDAORALSOLUTIONPriority Review
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
CARNITOR SF (levocarnitine) by Leadiant Biosciences is clinical pharmacology carnitor (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. Approved for hiv infections, heart failure, peripheral arterial disease and 3 more indications. First approved in 1986.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARNITOR SF (levocarnitine) is a naturally occurring compound required for mammalian energy metabolism that facilitates long-chain fatty acid entry into mitochondria for oxidation and ATP 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 conditions including HIV infection, heart failure, and spinal muscular atrophy. The drug clears toxic acylCoA compounds by forming acylcarnitine, which is rapidly excreted, thereby alleviating metabolic abnormalities in deficient patients.
$7KPart D
LOE ApproachingDeclining
Minimal commercial infrastructure; niche orphan/rare disease positioning with low team headcount and limited growth opportunity.
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.