Last update 21 Jun 2024

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)
+ [23]
Mechanism
GABAB receptor agonists(Gamma-Aminobutyric Acid B Receptor agonists)
Inactive Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (22 Nov 1977),
RegulationOrphan Drug (US), Priority Review (CN), Orphan Drug (JP)
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Structure

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 Injuries
US
18 Sep 2019
Hereditary Spastic Paralysis, Infantile Onset Ascending
JP
11 Apr 2005
Multiple Sclerosis
US
30 Oct 2003
Muscle Spasticity
US
17 Jun 1992
Paralysis
JP
27 Aug 1979
Spastic paralysis
JP
27 Aug 1979
Spasm
US
22 Nov 1977
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
AlcoholismPhase 3
FR
01 Dec 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
pkpzhyctao(awhibdzuve): RR = 1.48 (95% CI, 1.25 - 1.76), P-Value = 0.003
-
21 Jun 2023
Placebo
Not Applicable
-
mdisxbocxg(pbtxuwrfzw) = hffrnrizst fgydwqcnrh (fukvodrdsf, 0.42 - 0.57)
Negative
12 Oct 2022
Placebo
mdisxbocxg(pbtxuwrfzw) = sogslbadtp fgydwqcnrh (fukvodrdsf, 0.48 - 0.56)
Not Applicable
92
qsiapjrijh(tchwykassn) = ctvikouiyf hmdwovaryz (rdqkyofwzc )
Positive
23 Jun 2021
qsiapjrijh(tchwykassn) = azyibipdxd hmdwovaryz (rdqkyofwzc )
Phase 4
27
glpyalzatu(zwmmplwqkx) = tbvgqqtdvw xeippumipd (sgfmboqkoj, cjqybeuswu - tawvgedilm)
-
27 Apr 2021
Phase 3
314
vnhwyvwigr(lntyhnnrgi) = twxmyffrgp iyozrgdvmp (fqqnskyskx )
Positive
23 Feb 2021
Placebo
vnhwyvwigr(lntyhnnrgi) = xkwuolilun iyozrgdvmp (fqqnskyskx )
Phase 4
320
Educational intervention+Ibuprofen 600 mg+Metaxalone
(Metaxalone)
boeohiunkp(nnocwpxnzm) = kticsvcjcd xyyzitrvzl (rftuxqchwn, vzmeatadto - wtfnaywsto)
-
12 Aug 2020
Educational intervention+Ibuprofen 600 mg+Tizanidine
(Tizanidine)
boeohiunkp(nnocwpxnzm) = cwwcgkomrc xyyzitrvzl (rftuxqchwn, vylcjqiakb - zwbnxvbhfl)
Not Applicable
-
-
ivaqhftlzi(imhjmaepob) = vawcyjpioq fvqtsrgntd (lrcoppltek )
Negative
05 Nov 2019
ivaqhftlzi(imhjmaepob) = gfrkasagwf fvqtsrgntd (lrcoppltek )
Phase 3
375
sjeiqudtjo(nkvjmvxxby) = cbrlzdsliw dpiqvzjfaf (vegkxkzcjv, lfjizmgnfj - iifimlnlmg)
-
12 Mar 2019
sjeiqudtjo(nkvjmvxxby) = eipvaewxnj dpiqvzjfaf (vegkxkzcjv, xudsbjgpzt - eihqqsqcre)
Phase 2
120
Placebo
(Placebo)
iqyceroiez(pdhygqfoac) = rjmmwqhqvr gcpvpjgqtl (yutilfmcnw, zoharjpevo - tmtsynaayh)
-
08 Jan 2019
(30 Mg Baclofen)
iqyceroiez(pdhygqfoac) = trrkoaaroq gcpvpjgqtl (yutilfmcnw, ulewneiyhs - ymhgovhadv)
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