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levodopa

Trade name: larodopa

Small moleculeapproved

Approved

Jun 1, 1970

Levodopa (L-DOPA) was first isolated from seedlings of Vicia faba by Marcus Guggenheim in 1913. Levodopa, a dopamine precursor, is an effective and well-tolerated dopamine replacement agent used to treat Parkinson's disease. Oral levodopa has been widely used for over 40 years, often in combination with a dopa-decarboxylase inhibitor carbidopa, which reduces many treatment complications, extending its half-life and increasing levodopa availability to the brain. Entacapone, a catechol-O-methyltransferase inhibitor, can also be used to improve the bioavailability of levodopa, especially when used in conjunction with a carbidopa. — NCATS

Clinical trial activity

261 trials · 183 clinical orgs · 37 marketing orgs

Phase 1
71
Phase 2
116
Phase 3
45
Phase 4
51

Earliest trial started Jan 1, 1998 (NCT00004733)

Timeline

1970s

  1. Jun 1, 1970

    Earliest FDA Approval

  2. Jun 4, 1970

    Roche — First NDA Organization

  3. Jun 4, 1970

    Shire — NDA Secondary Org

  4. Jun 4, 1970

    Roche — NDA Organization

  5. May 2, 1975

    Merck — Marketing Organization

  6. May 2, 1975

    Organon — NDA Secondary Org

1990s

  1. Aug 28, 1992

    Mayne Pharma — Marketing Organization

  2. Aug 28, 1992

    Dr. Reddy's Laboratories — Marketing Organization

  3. Sep 3, 1993

    Actavis — Marketing Organization

  4. Mar 25, 1994

    Boston Scientific Corporation — Marketing Organization

  5. Jun 29, 1995

    Ani Pharmaceuticals — Marketing Organization

  6. Jun 29, 1995

    IDT Australia Ltd. — Marketing Organization

  7. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

  8. Sep 30, 1999

    Mylan — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2001

    Earliest Phase 1 Sponsor(trial)

  3. Jun 11, 2003

    Orion Corporation — Marketing Organization

  4. Jun 11, 2003

    Orion Corporation — NDA Secondary Org

  5. May 14, 2004

    Impax Laboratories — Marketing Organization

  6. Jun 16, 2004

    Apotex — Marketing Organization

  7. Jun 24, 2004

    Lumara Health — Marketing Organization

  8. Aug 27, 2004

    UCB — Marketing Organization

  9. Jun 10, 2005

    Ranbaxy — Marketing Organization

  10. Sep 18, 2008

    Rising Pharmaceuticals — Marketing Organization

  11. Jul 31, 2009

    Sun Pharmaceuticals — Marketing Organization

  12. Sep 28, 2009

    PHARMOBEDIENT — Marketing Organization

2010s

  1. Nov 20, 2012

    Wockhardt — Marketing Organization

  2. Feb 8, 2013

    Accord Research — Marketing Organization

  3. Jan 7, 2015

    Impax Laboratories — NDA Secondary Org

  4. Jan 9, 2015

    AbbVie — Marketing Organization

  5. Jan 9, 2015

    AbbVie — NDA Secondary Org

  6. Dec 21, 2018

    Acorda Therapeutics — NDA Secondary Org

  7. Dec 21, 2018

    Merz — Marketing Organization

  8. Jun 5, 2019

    Alembic — Marketing Organization

2020s

  1. May 7, 2021

    Sciegen Pharmaceticals — Marketing Organization

  2. Nov 12, 2021

    Avion Pharmaceuticals — NDA Secondary Org

  3. Sep 21, 2022

    Rubicon Research — Marketing Organization

  4. Nov 28, 2022

    Aurobindo Pharma — Marketing Organization

  5. Mar 31, 2023

    Sandoz — Marketing Organization

  6. Mar 31, 2023

    Novartis — Marketing Organization

  7. Apr 4, 2023

    Zydus Discovery DMCC — Marketing Organization

  8. Jan 14, 2025

    Ascent Pharmahealth — Marketing Organization

  9. Apr 15, 2025

    Macleods Pharmaceuticals, Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • sinemet

    with carbidopa

    Also known as abbv-291, carbidopa and levodopa, carbilev, duodopa, duopa, hrg2010, parcopa, rytary, sinemet cr, wd-1603 carbidopa-levodopa extended-release tablets

  • stalevo

    with entacapone, carbidopa

Approval history

  • approvedJun 1, 1970

Chemistry & pharmacology

Loading structure…

SMILES

N[C@@H](CC1=CC(O)=C(O)C=C1)C(O)=O
Mol. weight
197.1879 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Prodrug

Sources

Also known as

  • (−)-3-(3,4-dihydroxyphenyl)-l-alanine
  • (−)-3-(3,4-dihydroxyphenyl)-l-alanine
  • 3,4-dihydroxy-l-phenylalanine
  • 3,4-dihydroxy-l-phenylalanine
  • 3-hydroxy-l-tyrosine
  • 3-hydroxy-l-tyrosine
  • 3-hydroxy-l-tyrosine
  • bendopa
  • bendopa
  • brocadopa
  • brocadopa
  • carbidopa-levodopa
  • dihydroxy-l-phenylalanine
  • dihydroxy-l-phenylalanine
  • dihydroxyphenylalanine
  • dopa
  • (−)-dopa
  • (−)-dopa
  • dopar
  • dopar
  • etilevodopa
  • etilevodopa
  • etilevodopa
  • etilevodopa
  • etilevodopa
  • l-3,4-dihydroxyphenylalanine
  • l-3,4-dihydroxyphenylalanine
  • larodopa
  • larodopa
  • larodopa
  • l-beta-(3,4-dihydroxyphenyl)alanine
  • l-beta-(3,4-dihydroxyphenyl)alanine
  • l-dopa
  • l-dopa
  • l-dopa
  • ledopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa
  • levodopa / carbidopa
  • levodopa / carbidopa / entacapone
  • levodopa ethyl ester
  • levodopum
  • levodopum
  • tv-1203
  • tv-1203
  • β-(3,4-dihydroxyphenyl)alanine
  • β-(3,4-dihydroxyphenyl)alanine
  • β-(3,4-dihydroxyphenyl)-l-alanine
  • β-(3,4-dihydroxyphenyl)-l-alanine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07246278Phase 1/Phase 2 (Phase 2)Nov 20, 2025Tanta University
NCT07229651Phase 2/Phase 3 (Phase 3)Nov 10, 2025Tanta University
NCT07151378Phase 3Sep 16, 2025University of Tuebingen
NCT06831500Phase 1/Phase 2 (Phase 2)May 31, 2025University of Lausanne
NCT07001150Phase 2May 10, 2025Tanta University
NCT06667687Phase 1Jan 29, 2025AbbVie
NCT06785298Phase 2/Phase 3 (Phase 3)Dec 10, 2024Tanta University
NCT06587217Phase 1/Phase 2 (Phase 2)Oct 31, 2024National Institute on Aging (NIA), University of Michigan
NCT06596876Phase 3Sep 20, 2024Hengrui Therapeutics, Inc.
NCT06626152Phase 2Aug 15, 2024Providence Health & Services, University of British Columbia
NCT06365515N/AMay 31, 2024German Research Foundation, University of Tuebingen, Uppsala University
NCT06219915Phase 1/Phase 2 (Phase 2)Mar 15, 2024National Institute on Aging (NIA), University of Michigan
NCT06180720Phase 1Dec 20, 2023Qingdao University
NCT06075771Phase 4Nov 30, 2023Emory University, National Institute of Mental Health (NIMH)
NCT06236230Phase 4Nov 15, 2023Soochow University
NCT06113640Phase 2/Phase 3 (Phase 3)Nov 5, 2023Tanta University
NCT06115538Phase 4Oct 1, 2023Ankara Yildirim Beyazıt University
NCT06037590Phase 1Sep 25, 2023Cooperative Clinical Drug Research and Development AG (CCDRD AG), PureIMS B.V.
NCT06013956Phase 4Aug 29, 2023The Cleveland Clinic
NCT05976737Phase 1Aug 17, 2023Qingdao University
Showing 20 of 261 trials
Page 1 / 14

Organizations

Research & Development (183)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BialFor profit181842001
Orion CorporationFor profit131242004
National Institute of Neurological Disorders and Stroke (NINDS)Government121031998
NovartisFor profit121242004
AbbVieFor profit111142006
NeuroDerm Ltd.For profit111132012
Acorda TherapeuticsFor profit101032012
Columbia UniversityAcademic/Hospital8651998
Emory UniversityAcademic/Hospital7432015
Impax LaboratoriesFor profit7722005
National Institute of Mental Health (NIMH)Government7032006
Tanta UniversityAcademic/Hospital7722023
IQVIAFor profit6022008
Northwestern UniversityAcademic/Hospital6542007
Hoosier Cancer Research NetworkAcademic/Hospital5422004
Intec Pharma Ltd.For profit5522009
National Institute on Drug Abuse (NIDA)Government5022000
Snyder, Robert W., M.D., Ph.D., P.C.Academic/Hospital5512017
University of MunsterAcademic/Hospital5512003
University of ToulouseAcademic/Hospital5422002
183 organizations
Page 1 / 10

Marketing (50)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJan 9, 2015
AbbVieFor profitNDA2Jan 9, 2015
Accord ResearchFor profitMKTGFeb 8, 2013
Acorda TherapeuticsFor profitNDA2Dec 21, 2018
ActavisFor profitMKTGSep 3, 1993
AlembicFor profitMKTGJun 5, 2019
AlembicFor profitSYNJun 5, 2019
Ani PharmaceuticalsFor profitMKTGJun 29, 1995
Ani PharmaceuticalsFor profitSYNJun 29, 1995
ApotexFor profitMKTGJun 16, 2004
ApotexFor profitSYNJun 2, 2008
Ascent PharmahealthFor profitMKTGJan 14, 2025
Aurobindo PharmaFor profitMKTGNov 28, 2022
Avion PharmaceuticalsFor profitNDA2Nov 12, 2021
Bausch Health CompaniesFor profitNDA2—
Boston Scientific CorporationFor profitMKTGMar 25, 1994
Dr. Reddy's LaboratoriesFor profitMKTGAug 28, 1992
IDT Australia Ltd.For profitMKTGJun 29, 1995
Impax LaboratoriesFor profitMKTGMay 14, 2004
Impax LaboratoriesFor profitSYNJan 7, 2015
Impax LaboratoriesFor profitNDA2Jan 7, 2015
Impax LaboratoriesFor profitSYNJan 7, 2015
Lumara HealthFor profitMKTGJun 24, 2004
Macleods Pharmaceuticals, LtdFor profitMKTGApr 15, 2025
Mayne PharmaFor profitMKTGAug 28, 1992
MerckFor profitMKTGMay 2, 1975
MerzFor profitMKTGDec 21, 2018
MylanFor profitMKTGSep 30, 1999
NovartisFor profitMKTGMar 31, 2023
OrganonFor profitNDA2May 2, 1975
OrganonFor profitSYNMay 30, 1991
Orion CorporationFor profitMKTGJun 11, 2003
Orion CorporationFor profitNDA2Jun 11, 2003
PHARMOBEDIENTFor profitMKTGSep 28, 2009
RanbaxyFor profitMKTGJun 10, 2005
Rising PharmaceuticalsFor profitMKTGSep 18, 2008
Rising PharmaceuticalsFor profitSYNSep 18, 2008
RocheFor profitNDAJun 4, 1970
Rubicon ResearchFor profitMKTGSep 21, 2022
Rubicon ResearchFor profitSYNSep 21, 2022
SandozFor profitMKTGMar 31, 2023
Sciegen PharmaceticalsFor profitMKTGMay 7, 2021
ShireFor profitNDA2Jun 4, 1970
Sun PharmaceuticalsFor profitMKTGJul 31, 2009
Sun PharmaceuticalsFor profitSYNAug 23, 2007
Sun PharmaceuticalsFor profitSYNJul 31, 2009
UCBFor profitMKTGAug 27, 2004
Watson PharmaceuticalsFor profitMKTG—
WockhardtFor profitMKTGNov 20, 2012
Zydus Discovery DMCCFor profitMKTGApr 4, 2023