TheraRadar
Data updated: May 26, 2026

CARNITOR SF (levocarnitine)

Rare Disease Approved 1986-04-10

CARNITOR SF is indicated for the treatment of Carnitine Deficiency; Reye-like Encephalopathy; Hypoglycemia; Cardiomyopathy; Inborn Error of Metabolism.

Source: FDA Label • LEADIANT BIOSCI INC
1
Indication
--
Phase 3 Trials
1
Priority Reviews
40
Years on Market

Details

Status
Prescription
First Approved
1986-04-10
Routes
ORAL
Dosage Forms
SOLUTION

Companies

Active Ingredient: LEVOCARNITINE

CARNITOR SF Approval History

1987
1988
1989
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1995
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1997
1998
1999
2000
2001
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2003
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2005
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2026
Original
New Indication
New Form
Label Update
13 FDA actions from 1986 to 2018
Apr 2018 SUPPL
Label · Labeling
May 2015 SUPPL
Label · Labeling
Mar 2007 SUPPL
Mfg · Manufacturing (CMC)

What CARNITOR SF Treats

5 indications

CARNITOR SF is approved for 5 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Carnitine Deficiency
  • Reye-like Encephalopathy
  • Hypoglycemia
  • Cardiomyopathy
  • Inborn Error of Metabolism
Source: FDA Label

CARNITOR SF Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CARNITOR SF

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CARNITOR
LEVOCARNITINE
5 shared
LEADIANT BIOSCI INC
Shared indications:
Carnitine DeficiencyReye-like EncephalopathyHypoglycemia +2 more
LEVOCARNITINE
LEVOCARNITINE
5 shared
AM REGENT
Shared indications:
Carnitine DeficiencyReye-like EncephalopathyHypoglycemia +2 more
LEVOCARNITINE SF
LEVOCARNITINE
5 shared
NOVITIUM PHARMA
Shared indications:
Carnitine DeficiencyReye-like EncephalopathyHypoglycemia +2 more
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03953703 irb200020 Ph 2 completed Levocarnitine for Dry Eye in Sjogren's Syndrome
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CARNITOR SF FDA Label Details

Indications & Usage

FDA Label (PDF)

CARNITOR SF is indicated for the treatment of Carnitine Deficiency; Reye-like Encephalopathy; Hypoglycemia; Cardiomyopathy; Inborn Error of Metabolism.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.