levocarnitine

Trade name: carnitor

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 27, 1985

Levocarnitine propionate or Propionyl L-carnitine (PLC) is the propionyl ester of L-carnitine. Propionyl-L-carnitine stimulates energy production in ischaemic muscles by increasing citric acid cycle flux and stimulating pyruvate dehydrogenase activity. The free radical scavenging activity of the drug may also be beneficial. Propionyl-L-carnitine improves coagulative fibrinolytic homeostasis in vasal endothelium and positively affects blood viscosity. It exhibits a high affinity for the muscle enzyme, carnitine acyl transferase, and as such readily converts into propionyl-CoA and free carnitine. Most studies of the therapeutic use of PLC are focused on the prevention and treatment of ischemic heart disease, congestive heart failure, hypertrophic heart disease, and peripheral arterial disease. PLC is marketed under the trade name Dromos®. It is indicated for patients with peripheral arterial occlusive disorders and for exercise intolerance enhancement in patients with chronic congestive heart failure. Dromos is marketed in Italy. — NCATS

Clinical trial activity

156 trials · 163 clinical orgs · 16 marketing orgs

Phase 1
14
Phase 2
63
Phase 3
32
Phase 4
17

Earliest trial started Dec 1, 1996 (NCT00001082)

Timeline

1980s

  1. Feb 28, 1984

    Orphan Drug Designation

  2. Dec 27, 1985

    Leadiant Biosciences, Inc. — Earliest FDA Approval

  3. Dec 27, 1985

    Leadiant Biosciences, Inc. — NDA Secondary Org

  4. Dec 27, 1985

    Leadiant Biosciences, Inc. — NDA Organization

1990s

  1. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Mar 29, 2001

    Teva — Marketing Organization

  2. Mar 29, 2001

    West-Ward Pharmaceutical — Marketing Organization

  3. Mar 29, 2001

    Hikma — Marketing Organization

  4. Jun 22, 2001

    Sankyo — Marketing Organization

  5. Jun 22, 2001

    Lutipold — Marketing Organization

  6. Aug 10, 2004

    Lyne Laboratories — Marketing Organization

  7. Sep 20, 2004

    Rising Pharmaceuticals — Marketing Organization

  8. Sep 20, 2004

    ANDA Repository — Marketing Organization

  9. Oct 25, 2007

    Hi Tech Pharmaceuticals — Marketing Organization

  10. Oct 25, 2007

    Akorn, Inc. — Marketing Organization

  11. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Aug 14, 2019

    Novitium Pharma — Marketing Organization

2020s

  1. Nov 10, 2021

    Saptalis Pharmaceuticals — Marketing Organization

  2. Nov 10, 2021

    Sciegen Pharmaceticals — Marketing Organization

  3. Dec 9, 2022

    Ani Pharmaceuticals — Marketing Organization

  4. Jun 30, 2025

    Deva Holding A.S. — Marketing Organization

Indications

Studied for

Mechanism of action

  • carnitineSupplementation

    carnitine supplementation

Approval history

  • approvedPriority reviewDec 27, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CCC(=O)O[C@H](CC(=O)O)C[N+](C)(C)C
Mol. weight
218.27 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 3-carboxy-2-hydroxy-n,n,n-trimethyl-1-propanaminium hydroxide, inner salt
  • 3-carboxy-2-hydroxy-n,n,n-trimethyl-1-propanaminium hydroxide, inner salt
  • bicarnesine
  • bicarnesine
  • biocarn
  • carniking
  • carnilean
  • carnitene
  • carnitine
  • carnitine
  • carnitine
  • carnitine
  • carnitine
  • carnitine
  • carnitine
  • (-)-carnitine
  • (-)-carnitine
  • (-)-carnitine
  • carnitine chloride
  • carnitine chloride
  • carnitor
  • carnitor
  • carnitor
  • carnitor
  • carnitor sf
  • carnitor sf
  • carnivit
  • (-)-l-carnitine
  • (-)-l-carnitine
  • (-)-l-carnitine
  • l-carnitine
  • l-carnitine
  • l-carnitine
  • l-carnitine
  • l-carnitine
  • levocarnitin
  • levocarnitin
  • levocarnitina
  • levocarnitina
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levocarnitine
  • levo-carnitine
  • lévocarnitine
  • lévocarnitine
  • levocarnitine chloride
  • levocarnitine chloride
  • levocarnitine hcl
  • levocarnitine hydrochloride
  • levocarnitine propionate
  • levocarnitine propionate
  • levocarnitine propionate
  • levocarnitine propionate
  • levocarnitine propionate
  • levocarnitine propionate hcl
  • levocarnitine propionate hydrochloride
  • levocarnitine tartrate
  • levocarnitinum
  • levocarnitinum
  • (r)-carnitine
  • (r)-carnitine
  • (r)-carnitine
  • vitamin bt
  • vitamin bt
  • vitamin bt

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07298564N/AJan 30, 2026Azad University
NCT07201714Early Phase 1 (Phase 1)Dec 1, 2025London Health Sciences Centre, University of Western Ontario
NCT07216001Phase 2Nov 30, 2025Emory University
NCT07266259N/ASep 19, 2025Bangladesh Medical University
NCT07160452Phase 4Sep 15, 2025Sheikh Zayed Medical College
NCT07108777Phase 2Aug 10, 2025Tanta University
NCT06845046N/AJul 15, 2025Department of Veteran Affairs
NCT07035444N/AJun 30, 2025People's Liberation Army of China
NCT06960694Phase 2May 31, 2025Bangladesh Medical University
NCT06901323Phase 4Feb 1, 2025Mansoura University
NCT06564909Phase 2Oct 31, 2024Ain Shams University
NCT07016867N/ASep 1, 2024South Valley University
NCT06849115Phase 4Jul 18, 2024Capital Medical University
NCT07303088N/AJun 17, 2024University of Sfax
NCT05948124Early Phase 1 (Phase 1)Aug 1, 2023Ain Shams University
NCT05980884N/AJul 24, 2023National Taiwan University
NCT05632094Phase 2Jun 30, 2023Alexandria University
NCT05905692Phase 3May 30, 2023Ain Shams University
NCT05602194Phase 3Mar 22, 2023National Cancer Institute (NCI)
NCT05792527Phase 3Mar 5, 2023Tanta University
Showing 20 of 156 trials
Page 1 / 8

Organizations

Research & Development (163)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ain Shams UniversityAcademic/Hospital8852015
Iperboreal Pharma SrlFor profit7722004
Tanta UniversityAcademic/Hospital7542016
National Institute of Allergy and Infectious Diseases (NIAID)Government6531996
D'Annunzio University of Chieti–PescaraAcademic/Hospital5012004
Assiut UniversityAcademic/Hospital4412012
Bangladesh Medical UniversityAcademic/Hospital4422017
Gdansk University of Physical Education and SportAcademic/Hospital4422015
Gilead SciencesFor profit4421999
Isfahan UniversityAcademic/Hospital4322009
Medical University of GdanskAcademic/Hospital4012015
National Cancer Institute (NCI)Government4132002
Icahn School of Medicine at Mount SinaiAcademic/Hospital3022002
LonzaFor profit3222014
Maastricht UniversityAcademic/Hospital3312014
National Taiwan UniversityAcademic/Hospital3322004
Nazareth HospitalAcademic/Hospital3312012
Poznan UniversityAcademic/Hospital3312016
Alexandria UniversityAcademic/Hospital2212022
Canadian Institutes of Health Research (CIHR)Academic/Hospital2022006
163 organizations
Page 1 / 9

Marketing (18)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGSep 20, 2004
Akorn, Inc.For profitMKTGOct 25, 2007
Ani PharmaceuticalsFor profitMKTGDec 9, 2022
Deva Holding A.S.For profitMKTGJun 30, 2025
Hi Tech PharmaceuticalsFor profitMKTGOct 25, 2007
HikmaFor profitMKTGMar 29, 2001
Leadiant Biosciences, Inc.For profitNDA2Dec 27, 1985
Leadiant Biosciences, Inc.For profitNDADec 27, 1985
LutipoldFor profitMKTGJun 22, 2001
Lyne LaboratoriesFor profitMKTGAug 10, 2004
Novitium PharmaFor profitMKTGAug 14, 2019
Rising PharmaceuticalsFor profitMKTGSep 20, 2004
Rising PharmaceuticalsFor profitSYNSep 20, 2004
SankyoFor profitMKTGJun 22, 2001
Saptalis PharmaceuticalsFor profitMKTGNov 10, 2021
Sciegen PharmaceticalsFor profitMKTGNov 10, 2021
TevaFor profitMKTGMar 29, 2001
West-Ward PharmaceuticalFor profitMKTGMar 29, 2001