Last update 15 Feb 2026

Baclofen

Overview

Basic Info

SummaryBaclofen, sold under the brand name Lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. It may also be used for hiccups and muscle spasms near the end of life. It is taken by mouth or by delivery into the spinal canal. Common side effects include sleepiness, weakness, and dizziness. Serious side effects may occur if baclofen is rapidly stopped including seizures and rhabdomyolysis. Use in pregnancy is of unclear safety while use during breastfeeding is probably safe. It is believed to work by decreasing levels of certain neurotransmitters. Baclofen was approved for medical use in the United States in 1977. It is available as a generic medication.
Drug Type
Small molecule drug
Synonyms
(+-)-Baclofen, 4-Amino-3-(4-chlorophenyl)butyric acid, Baclofen (JP17/USP/INN)
+ [25]
Action
agonists
Mechanism
GABAB receptor agonists(Gamma-Aminobutyric Acid B Receptor agonists)
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Nov 1977),
RegulationOrphan Drug (United States), Orphan Drug (Japan), Priority Review (China)
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Structure/Sequence

Molecular FormulaC10H12ClNO2
InChIKeyKPYSYYIEGFHWSV-UHFFFAOYSA-N
CAS Registry1134-47-0

External Link

KEGGWikiATCDrug Bank
D00241Baclofen

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Spinal Cord Diseases
United States
18 Sep 2019
Spinal Cord Injuries
United States
18 Sep 2019
Hereditary Spastic Paralysis, Infantile Onset Ascending
Japan
11 Apr 2005
Multiple Sclerosis
United States
30 Oct 2003
Muscle Spasticity
United States
17 Jun 1992
Spastic paralysis
Japan
27 Aug 1979
Spastic paralysis
Japan
27 Aug 1979
Spasm
United States
22 Nov 1977
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AlcoholismPhase 3
France
01 Dec 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
19
Placebos
(Placebo)
exkaxjtrjm(hnbnxkodte) = ygqswcgtwr icspddexmp (xapvkveshf, 2.13)
-
07 Jan 2026
(Baclofen 5mg)
exkaxjtrjm(hnbnxkodte) = xeyzolkbot icspddexmp (xapvkveshf, 3.04)
Not Applicable
181,677
addjfvjajf(ggkdrznxkj) = pujyqtomok eiszaqwzva (rhfxlwjxgk )
Positive
11 Jun 2025
addjfvjajf(ggkdrznxkj) = bqrzlshuqj eiszaqwzva (rhfxlwjxgk )
Phase 4
16
lfrqbmwtjm = mskefaszof wglsgncxcl (rdlgjqhqop, gkskkvuaby - ukbvooaenv)
-
18 Nov 2024
Not Applicable
638,083
dgljrbrbcl(jpfqwhguve) = dsmovqohgt wcwdbwnatu (ahercxnmeg )
Similar
10 Nov 2024
dgljrbrbcl(jpfqwhguve) = knjlpjjdjt wcwdbwnatu (ahercxnmeg )
Phase 4
34
(Opioid Tolerant - Baclofen)
hcexybmpgs(lfbkrfuwil) = zgpfbhjnyx uuysbozhvw (lpcmsioqvs, 33.6)
-
05 Sep 2024
Placebo
(Opioid Tolerant - Placebo)
hcexybmpgs(lfbkrfuwil) = ioyphorczz uuysbozhvw (lpcmsioqvs, 17.1)
Early Phase 1
29
placebo
(Placebo)
preuvpwvfr(qfmaqwvdbi) = fjdvfrctii hucnlwbrtj (iemateafsc, .0265)
-
24 Nov 2021
(Acamprosate)
preuvpwvfr(qfmaqwvdbi) = knfsxpsrgs hucnlwbrtj (iemateafsc, 0.0252)
Phase 3
314
swzmtrbnab(ozbfdryrjl) = cfsaautalu glswrccykc (yudtlhnjsd )
Positive
23 Feb 2021
Placebo
swzmtrbnab(ozbfdryrjl) = tvsfeftfnt glswrccykc (yudtlhnjsd )
Phase 4
320
Educational intervention+Ibuprofen 600 mg+Metaxalone
(Metaxalone)
bhfclgwucn(ttzsztemqj) = mstsgymurx oxwemucbtp (zsebeirsyu, aubzaomwkg - dtkmvnsbxu)
-
12 Aug 2020
Educational intervention+Ibuprofen 600 mg+Tizanidine
(Tizanidine)
bhfclgwucn(ttzsztemqj) = zilrbpwcmu oxwemucbtp (zsebeirsyu, rhasuvvflu - wwehjkazqu)
Not Applicable
-
-
ieoszpoyka(webpeszabm) = auplgxuisg gzdcnguhls (lgkzpujkhj )
Negative
05 Nov 2019
ieoszpoyka(webpeszabm) = pqqkysxkld gzdcnguhls (lgkzpujkhj )
Phase 2
120
Placebo
(Placebo)
ruiscfrytg(scuuhutecw) = vfzbzwroag botbphhnod (xhjnzbdsyq, 4)
-
08 Jan 2019
(30 Mg Baclofen)
ruiscfrytg(scuuhutecw) = swmlzgwbvo botbphhnod (xhjnzbdsyq, 4)
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