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baclofen

Trade name: lioresal

Small moleculeapproved

Approved

Nov 22, 1977

Baclofen (brand names Kemstro, Lioresal, and Gablofen) is a derivative of gamma-aminobutyric acid (GABA). Baclofen is a muscle relaxer and an antispastic agent and is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness. It is primarily used to treat spasticity and is under investigation for the treatment of alcoholism. Although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. Baclofen is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen is excreted primarily by the kidney in unchanged form and there is relatively large intersubjective variation in absorption and/or elimination. Baclofen is a direct agonist at GABA-B receptors. The precise mechanism of action of baclofen is not fully known. It is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. — NCATS

Clinical trial activity

102 trials · 115 clinical orgs · 35 marketing orgs

Phase 1
18
Phase 2
41
Phase 3
25
Phase 4
21

Earliest trial started Oct 1, 1997 (NCT00000303)

Timeline

1970s

  1. Nov 22, 1977

    Ciba — Earliest FDA Approval

  2. Nov 22, 1977

    Novartis — NDA Secondary Org

  3. Nov 22, 1977

    Ciba — NDA Organization

1990s

  1. Sep 18, 1991

    Watson Pharmaceuticals — Marketing Organization

  2. Feb 27, 1992

    Teva — Marketing Organization

  3. Jun 17, 1992

    Saol Therapeutics — NDA Secondary Org

  4. Jun 17, 1992

    Amneal Pharmaceuticals — Marketing Organization

  5. Jun 17, 1992

    Amneal Pharmaceuticals — NDA Secondary Org

  6. Aug 19, 1996

    Upsher-Smith Laboratories — Marketing Organization

  7. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Oct 30, 2003

    UCB — NDA Secondary Org

  4. Jul 29, 2005

    Mylan — Marketing Organization

  5. Aug 30, 2005

    Vintage — Marketing Organization

  6. Dec 20, 2005

    Lannett Company, Inc. — Marketing Organization

  7. Aug 14, 2006

    Sun Pharmaceuticals — Marketing Organization

  8. Oct 26, 2007

    Impax Laboratories — Marketing Organization

  9. Oct 31, 2007

    Oxford Pharmaceuticals — Marketing Organization

  10. Sep 18, 2009

    Northstar Healthcare — Marketing Organization

2010s

  1. Feb 18, 2010

    Appco Pharma — Marketing Organization

  2. Nov 19, 2010

    Piramal — NDA Secondary Org

  3. May 3, 2016

    Emerald Health Pharmaceuticals — Marketing Organization

  4. Nov 28, 2017

    Rubicon Research — Marketing Organization

  5. Nov 23, 2018

    Zydus Discovery DMCC — Marketing Organization

  6. Feb 1, 2019

    Eywa Pharma — Marketing Organization

  7. Jul 30, 2019

    Maia Pharms Inc — Marketing Organization

  8. Sep 18, 2019

    Metacel Pharmaceuticals LLC — Marketing Organization

  9. Sep 18, 2019

    Metacel Pharmaceuticals LLC — NDA Secondary Org

2020s

  1. Jul 9, 2020

    Unichem — Marketing Organization

  2. Oct 9, 2020

    Innogenix — Marketing Organization

  3. Mar 5, 2021

    Kartha — Marketing Organization

  4. Mar 5, 2021

    Rising Pharmaceuticals — Marketing Organization

  5. Jul 13, 2021

    Aurobindo Pharma — Marketing Organization

  6. Jul 16, 2021

    Beximco — Marketing Organization

  7. Jan 25, 2022

    Mankind Pharma — Marketing Organization

  8. Feb 4, 2022

    Azurity — Marketing Organization

  9. Feb 4, 2022

    Azurity — NDA Secondary Org

  10. Jun 8, 2023

    Slayback Pharma Llc — Marketing Organization

  11. Jun 8, 2023

    Ani Pharmaceuticals — Marketing Organization

  12. Aug 10, 2023

    Acic Pharmaceuticals — Marketing Organization

  13. Nov 8, 2023

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 22, 1977

Chemistry & pharmacology

Loading structure…

SMILES

NCC(CC(O)=O)C1=CC=C(Cl)C=C1
Mol. weight
213.661 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 4-amino-3-(4-chlorophenyl)butyric acid
  • 4-amino-3-(4-chlorophenyl)butyric acid
  • ba-34647
  • ba-34647
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • baclofen
  • (+-)-baclofen
  • (+-)-baclofen
  • baclofene
  • baclofene
  • baclofeno
  • baclofeno
  • baclofenum
  • baclofenum
  • baclon
  • baclospas-10
  • beta-(4-chlorophenyl)gaba
  • beta-(4-chlorophenyl)gaba
  • beta-(aminomethyl)-4-chlorobenzenepropanoic acid
  • beta-(aminomethyl)-4-chlorobenzenepropanoic acid
  • beta-(aminomethyl)-p-chlorohydrocinnamic acid
  • beta-(aminomethyl)-p-chlorohydrocinnamic acid
  • beta-(p-chlorophenyl)-gamma-aminobutyric acid
  • beta-(p-chlorophenyl)-gamma-aminobutyric acid
  • dl-4-amino-3-p-chlorophenylbutanoic acid
  • dl-4-amino-3-p-chlorophenylbutanoic acid
  • dl-baclofen
  • dl-baclofen
  • dl-baclofen
  • gablofen
  • gablofen
  • gamma-amino-beta-(p-chlorophenyl)butyric acid
  • gamma-amino-beta-(p-chlorophenyl)butyric acid
  • ipx056
  • ipx056
  • kemstro
  • kemstro
  • l-baclofen
  • l-baclofen
  • l-baclofen
  • lioresal
  • lioresal
  • lioresal
  • lioresal
  • lioresal intrath
  • lyflex
  • sparc0921
  • sparc1104

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07063576Phase 2/Phase 3 (Phase 3)Aug 1, 2025Dhaka Medical College
NCT06564714Phase 4Dec 31, 2024Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
NCT05935553Phase 2/Phase 3 (Phase 3)Mar 1, 2024University of Lyon
NCT06274021Early Phase 1 (Phase 1)Mar 1, 2024Methodist Rehabilitation Center, The Craig H. Neilsen Foundation, University of Mississippi
NCT05968937Phase 2Jan 1, 2024University of Louisville
NCT06175507N/ADec 25, 2023Institute of Liver and Biliary Sciences, India
NCT05921604Phase 3Jun 30, 2023Tanta University
NCT05975684Phase 3Jan 31, 2023Ohio State University
NCT05418049Early Phase 1 (Phase 1)Sep 1, 2022National Institutes of Health (NIH), University of Cincinnati
NCT05516953Phase 2/Phase 3 (Phase 3)Aug 22, 2022Tanta University
NCT05392361N/AJun 30, 2022Yonsei University
NCT05257447Phase 1Apr 27, 2022The University of Texas, Dallas, Tufts University
NCT05161351Phase 4Jan 31, 2022Imperial College London
NCT04762758Phase 3Mar 30, 2021Aix-University of Marseille, Pharnext SA, University of Miami, Worldwide Clinical Trials
NCT06583551N/AJan 3, 2021Saglik Bilimleri Universitesi
NCT04251819Phase 2/Phase 3 (Phase 3)Jun 30, 2020University of Alabama, Birmingham
NCT04509336N/AMay 20, 2020Mansoura University, Tanta University
NCT04471714Phase 2Jan 10, 2020University of Alberta
NCT03720717Phase 4Jul 1, 2019University of Alabama, Birmingham
NCT03860662Phase 4Feb 26, 2019Mustafa Kemal University
Showing 20 of 102 trials
Page 1 / 6

Organizations

Research & Development (115)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Department of Veteran AffairsGovernment5442003
MedtronicFor profit5132002
National Institute on Drug Abuse (NIDA)Government5211997
Tanta UniversityAcademic/Hospital4322014
National Institutes of Health (NIH)Government3122008
University of MinnesotaAcademic/Hospital3222013
University of North Carolina at Chapel HillAcademic/Hospital3332005
University of PennsylvaniaAcademic/Hospital3312013
Vanderbilt UniversityAcademic/Hospital3322002
Columbia UniversityAcademic/Hospital2222005
Essentia HealthAcademic/Hospital2222003
Government of IsraelGovernment2122010
Harvard UniversityAcademic/Hospital2222009
Impax LaboratoriesFor profit2222007
Katholieke Universiteit LeuvenAcademic/Hospital2222010
Paralyzed Veterans of America Research FoundationAcademic/Hospital2012013
Sathbhavana Brain ClinicAcademic/Hospital2212005
SPARCFor profit2212012
The University of Texas, DallasAcademic/Hospital2122012
University of Alabama, BirminghamAcademic/Hospital2222019
115 organizations
Page 1 / 6

Marketing (44)

OrganizationOrg typeRelationshipDate
Acic PharmaceuticalsFor profitMKTGAug 10, 2023
Amneal PharmaceuticalsFor profitMKTGJun 17, 1992
Amneal PharmaceuticalsFor profitNDA2Jun 17, 1992
Ani PharmaceuticalsFor profitMKTGJun 8, 2023
Appco PharmaFor profitMKTGFeb 18, 2010
Aurobindo PharmaFor profitMKTGJul 13, 2021
AzurityFor profitMKTGFeb 4, 2022
AzurityFor profitNDA2Feb 4, 2022
BeximcoFor profitMKTGJul 16, 2021
CibaFor profitNDANov 22, 1977
Emerald Health PharmaceuticalsFor profitMKTGMay 3, 2016
Eywa PharmaFor profitMKTGFeb 1, 2019
Impax LaboratoriesFor profitMKTGOct 26, 2007
Impax LaboratoriesFor profitSYNOct 26, 2007
InnogenixFor profitMKTGOct 9, 2020
KarthaFor profitMKTGMar 5, 2021
Lannett Company, Inc.For profitMKTGDec 20, 2005
Maia Pharms IncFor profitMKTGJul 30, 2019
Mankind PharmaFor profitMKTGJan 25, 2022
Metacel Pharmaceuticals LLCFor profitMKTGSep 18, 2019
Metacel Pharmaceuticals LLCFor profitNDA2Sep 18, 2019
Micro Labs Ltd IndiaFor profitMKTGNov 8, 2023
MylanFor profitMKTGJul 29, 2005
MylanFor profitSYNMar 6, 2018
MylanFor profitSYNFeb 18, 2010
Northstar HealthcareAcademic/HospitalMKTGSep 18, 2009
NovartisFor profitNDA2Nov 22, 1977
Oxford PharmaceuticalsFor profitMKTGOct 31, 2007
PiramalFor profitNDA2Nov 19, 2010
Rising PharmaceuticalsFor profitMKTGMar 5, 2021
Rubicon ResearchFor profitMKTGNov 28, 2017
Saol TherapeuticsFor profitNDA2Jun 17, 1992
Slayback Pharma LlcFor profitMKTGJun 8, 2023
Sun PharmaceuticalsFor profitMKTGAug 14, 2006
TevaFor profitSYNJul 21, 1988
TevaFor profitMKTGFeb 27, 1992
UCBFor profitNDA2Oct 30, 2003
UnichemFor profitMKTGJul 9, 2020
UnichemFor profitSYNJul 9, 2020
Upsher-Smith LaboratoriesFor profitSYNAug 19, 1996
Upsher-Smith LaboratoriesFor profitMKTGAug 19, 1996
VintageFor profitMKTGAug 30, 2005
Watson PharmaceuticalsFor profitMKTGSep 18, 1991
Zydus Discovery DMCCFor profitMKTGNov 23, 2018