Drugs / Baclofen
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Baclofen

Small molecule

Developed for
alcohol dependence · alcohol-related disorders · multiple sclerosis · spinal cord injury · cerebral palsy · alcohol withdrawal · Alzheimer disease · fragile X syndrome
+40 more · alcoholic liver disease · ataxia telangiectasia · autism spectrum disorder · bulimia nervosa · cannabis dependence · central sleep apnea due to periodic breathing · Charcot-Marie-Tooth disease · Charcot-Marie-Tooth disease type 1A · chronic hiccup · cirrhosis of liver · cocaine dependence · drug dependence · dysautonomia · female reproductive system disorder · gas bloat syndrome · gastroesophageal reflux disease · hepatocellular carcinoma · herpes zoster · lumbar disk disease · lumbar spinal stenosis · nicotine dependence · opiate dependence · osteoarthritis, hand · osteoarthritis, knee · rumination disorder · spastic diplegia · spastic hemiplegia · stroke disorder · toxic polyneuropathy · traumatic brain injury · alcohol withdrawal delirium · alcoholic liver cirrhosis · anismus · breath-holding Spells · chronic pain syndrome · cocaine abuse · constipation disorder · neuropathy, painful · overactive bladder · substance abuse
Investigated by
Medtronic · Pharnext S.C.A. · VA Office of Research and Development · Vanderbilt University · Ascopharm Groupe Novasco · Assistance Publique - Hôpitaux de Paris
+77 more · Children's Hospital Medical Center, Cincinnati · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Impax Laboratories, LLC · Imperial College London · McMaster University · National Institute of Mental Health (NIMH) · National Institute on Drug Abuse (NIDA) · New York State Psychiatric Institute · Tanta University · University of Alabama at Birmingham · Albert Einstein College of Medicine · Allergan · Alliance for Clinical Trials in Oncology · Beijing Tiantan Hospital · Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Charite University, Berlin, Germany · Chinese University of Hong Kong · Chittagong Medical College · Denver Health and Hospital Authority · Ethypharm · Gedeon Richter Plc. · Groupement Interrégional de Recherche Clinique et d'Innovation · Hospices Civils de Lyon · Hôpital Cochin · Johns Hopkins University · KAZM Pharmaceuticals Inc. · Kessler Foundation · Maastricht University · Mae Stone Goode Foundation · Mclean Hospital · Medical Research Council · Methodist Rehabilitation Center · Ministry of Health, France · Ministry of Health, Israel · Montefiore Medical Center · Mustafa Kemal University · Nantes University Hospital · National Cancer Institute (NCI) · National Health and Medical Research Council, Australia · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Oakville Trafalgar Memorial Hospital · Osmotica Pharmaceutical US LLC · Paralyzed Veterans of America Research Foundation · Piramal Critical Care, Ltd. · Prof. Daniele Zullino · RVL Pharmaceuticals, Inc. · Région Nord-Pas de Calais, France · Second Affiliated Hospital of Nanchang University · Sha'ar Menashe Mental Health Center · Shaare Zedek Medical Center · Société de Formation Thérapeutique du Généraliste · South West Sydney Local Health District · Tasly GeneNet Pharmaceuticals Co., Ltd · The Craig H. Neilsen Foundation · Transdermal Therapeutics, Inc. · UCB Pharma · URC-CIC Paris Descartes Necker Cochin · US Department of Veterans Affairs · Universitaire Ziekenhuizen KU Leuven · University Hospital Brussels · University Hospital, Bordeaux · University Hospital, Ghent · University Hospital, Lille · University of Alberta · University of California, Los Angeles · University of Manitoba · University of Michigan · University of Minnesota · University of Mississippi Medical Center · University of Missouri-Columbia · University of North Carolina, Chapel Hill · University of Rochester · University of Southern California · University of Sydney · all 83 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LIORESAL — 1996-06-14 fda.gov ↗
Approved US (FDA) LIORESAL — 1977-11-22 fda.gov ↗

Trials 68 · started per year

today
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1977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT07560878 Mar 2026 → Dec 2030 expected major depressive disorder Mclean Hospital Recruiting No outcome recorded
Phase 0 NCT06274021 Mar 2024 → Dec 2025 spinal cord injury University of Mississippi Medical Center Unknown No outcome recorded
Phase 0 NCT02998151 Jan 2016 → Nov 2020 fragile X syndrome Children's Hospital Medical Center, Cincinnati Completed No outcome recorded
Phase 0 NCT02485145 Jul → Dec 2015 osteoarthritis, hand Transdermal Therapeutics, Inc. Unknown No outcome recorded
Phase 0 NCT00640003 Apr 2007 → Feb 2011 ataxia telangiectasia Johns Hopkins University Completed No outcome recorded
Phase 14 trials
Phase 1 NCT01931319 Jan → Jun 2014 baclofen withdrawal syndrome University of Minnesota Completed No outcome recorded
Phase 1 NCT01095679 Mar 2010 → Sep 2011 central sleep apnea due to periodic breathing Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
Phase 1 NCT00280280 Feb 2006 → Feb 2009 — Vanderbilt University Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT02001584 ? → May 2014 — Gedeon Richter Plc. Completed No outcome recorded
Phase 215 trials · 2 missed
Phase 2 NCT05418049 Sep 2022 → Oct 2025 overdue fragile X syndrome Children's Hospital Medical Center, Cincinnati Active not recruiting No outcome recorded
Phase 2 NCT04471714 Jan 2020 → Mar 2022 spinal cord injury University of Alberta Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT03034408 Jul 2016 → Dec 2018 alcohol-related disorders Prof. Daniele Zullino Completed No outcome recorded
Phase 2 NCT02361242 Jun 2013 → Dec 2015 Alzheimer disease Pharnext S.C.A. Completed No outcome recorded
Phase 2 NCT02361424 Feb 2013 → Jun 2015 Alzheimer disease Pharnext S.C.A. Completed No outcome recorded
Phase 2 NCT01751386 Dec 2012 → Aug 2016 alcohol dependence, anxiety disorder National Institute on Alcohol Abuse and Alcoholism (NIAAA) Completed Missed primary
Phase 2 NCT02298868 Oct 2012 → Nov 2013 cirrhosis of liver University of Virginia Completed No outcome recorded
Phase 2 NCT00914290 Apr 2009 → Jan 2010 multiple sclerosis Impax Laboratories, LLC Completed No outcome recorded
Phase 2 NCT00493428 Jul 2007 → Jan 2011 hepatocellular carcinoma University of Manitoba Withdrawn No outcome recorded
Phase 2 NCT00373295 May 2006 → Jan 2008 cannabis dependence New York State Psychiatric Institute Completed No outcome recorded
Phase 2/38 trials · 1 met primary · 1 missed
Phase 2/3 NCT05935553 Jan 2026 → Oct 2028 expected drug dependence Hospices Civils de Lyon Recruiting No outcome recorded
Phase 2/3 NCT05516953 Aug 2022 → Dec 2024 morbid obesity Tanta University Completed No outcome recorded
Phase 2/3 NCT04251819 Jan 2021 → Jun 2024 — University of Alabama at Birmingham Terminated No outcome recorded Stop: Business
Phase 2/3 NCT03199417 May 2017 → May 2018 osteoarthritis, knee University of Michigan Terminated No outcome recorded Stop: Enrollment
Phase 2/3 NCT02099006 Nov 2013 → Jun 2015 female reproductive system disorder University of Rochester Completed Missed primary
Phase 2/3 NCT01604330 May 2012 → Sep 2014 alcohol dependence Assistance Publique - Hôpitaux de Paris Completed Met primary
Phase 2/3 NCT01266655 Feb 2011 → May 2014 alcohol dependence Charite University, Berlin, Germany Completed No outcome recorded
Phase 2/3 NCT00877734 Apr 2005 → May 2007 alcohol dependence University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 315 trials · 4 met primary · 1 missed
Phase 3 NCT06202989 Sep 2024 → May 2026 — KAZM Pharmaceuticals Inc. Completed No outcome recorded
Phase 3 NCT05921604 Jun 2023 → Aug 2025 overdue — Tanta University Active not recruiting No outcome recorded
Phase 3 NCT05092841 Sep 2021 → Mar 2024 Charcot-Marie-Tooth disease type 1A Tasly GeneNet Pharmaceuticals Co., Ltd Completed No outcome recorded
Phase 3 NCT04762758 Mar 2021 → Apr 2024 Charcot-Marie-Tooth disease Pharnext S.C.A. Unknown No outcome recorded
Phase 3 NCT02723383 Jun 2016 → Aug 2019 alcohol dependence Nantes University Hospital Completed Met primary
Phase 3 NCT02052440 Mar 2014 → Jan 2017 alcohol withdrawal Denver Health and Hospital Authority Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT01711125 Mar 2013 → Jun 2017 alcohol dependence, alcoholic liver disease South West Sydney Local Health District Completed Met primary
Phase 3 NCT01520545 Dec 2012 → Aug 2016 — Piramal Critical Care, Ltd. Completed No outcome recorded
Phase 3 NCT01738282 Dec 2012 → Jul 2014 alcohol dependence Ethypharm Completed No outcome recorded
Phase 3 NCT01743651 Nov 2012 → Apr 2014 multiple sclerosis RVL Pharmaceuticals, Inc. Completed No outcome recorded
Phase 413 trials · 1 met primary
Phase 4 NCT06564714 Dec 2024 → Dec 2028 expected spinal cord injury Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal Not yet recruiting No outcome recorded
Phase 4 NCT05161351 Jul 2021 → Nov 2022 opiate dependence Imperial College London Completed No outcome recorded
Phase 4 NCT03720717 Oct 2020 → Oct 2022 — University of Alabama at Birmingham Terminated No outcome recorded
Phase 4 NCT03778281 Dec 2018 → Dec 2019 chronic hiccup Second Affiliated Hospital of Nanchang University Unknown No outcome recorded
Phase 4 NCT03860662 May 2018 → Mar 2019 spastic hemiplegia, stroke disorder Mustafa Kemal University Completed No outcome recorded
Phase 4 NCT02903823 Apr 2016 → Feb 2019 — Vanderbilt University Completed No outcome recorded
Phase 4 NCT03293017 Feb 2016 → Feb 2022 alcohol withdrawal, alcohol-related disorders University Hospital Brussels Unknown No outcome recorded
Phase 4 NCT02596763 Dec 2015 → Dec 2018 alcohol-related disorders University Hospital, Lille Terminated No outcome recorded
Phase 4 NCT03113396 Feb 2012 → Dec 2016 gas bloat syndrome, rumination disorder Universitaire Ziekenhuizen KU Leuven Completed No outcome recorded
Phase 4 NCT00752934 Oct 2010 → Jun 2015 cerebral palsy Shaare Zedek Medical Center Terminated No outcome recorded Stop: Business
Phase not applicable8 trials
— NCT07378046 Dec 2025 → Sep 2027 expected herpes zoster Beijing Tiantan Hospital Recruiting No outcome recorded
— NCT05392361 Jun 2022 → Mar 2023 lumbar spinal stenosis Yonsei University Completed No outcome recorded
— NCT05021718 Jul 2018 → Sep 2019 lumbar disk disease Chittagong Medical College Completed No outcome recorded
— NCT01352611 Sep 2014 → Apr 2015 autism spectrum disorder University of Missouri-Columbia Withdrawn No outcome recorded Stop: Enrollment
— NCT01563224 Jul 2013 → Sep 2014 glutamic acid decarboxylase, brain, membrane form Imperial College London Completed No outcome recorded
— NCT00320047 Apr 2005 → Jun 2006 bulimia nervosa New York State Psychiatric Institute Completed No outcome recorded
— NCT00164801 Nov 2004 → Jan 2007 — Chinese University of Hong Kong Terminated No outcome recorded Stop: Business
— NCT00871455 Apr 2003 → Dec 2007 spinal cord injury US Department of Veterans Affairs Completed No outcome recorded
Comparator or background therapy36 trials
Phase 0 NCT03065998 Comparator Mar 2017 → Jan 2018 substance abuse Ministry of Health, Israel Unknown No outcome recorded
Phase 1 NCT01749319 Comparator Jan 2013 → Jan 2014 baclofen withdrawal syndrome University of Minnesota Completed No outcome recorded
Phase 1 NCT00802035 Comparator Nov → Dec 2008 alcohol dependence Alkermes, Inc. Completed No outcome recorded
Phase 1 NCT00614328 Comparator Jul 2007 → Jan 2010 alcohol dependence University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 1 NCT00647738 Comparator Oct → Nov 2003 — Mylan Pharmaceuticals Inc Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2008-12-11 Impax Laboratories, LLC Results Impax Provides Update On Meeting With FDA To Review Phase III Trial Results For IPX056 amneal.com ↗
The primary efficacy endpoint, a reduction in spasticity as measured by Ashworth score following a single dose, was statistically significant for all active treatments, including IPX056 formulations and baclofen, compared to placebo.
2008-08-07 Impax Laboratories, LLC Results IMPAX Reports Positive Results in Phase III Trial with IPX056 amneal.com ↗
IPX056, an investigational extended-release formulation of baclofen, has met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients.

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 107 sources stand behind the page.

FieldValueCited text
Known as baclofen “Combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol, termed PXT3003, improved myelination in the Pmp22 transgenic co-culture cellular model, and moderately...” PMID 25491744 ↗ Dec 2014
100

“Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%).” NCT06202989 ↗

“1 orange capsule containing 0.4 mg of acamprosate and 1 white capsule containing 6 mg of baclofen are taken orally b.i.d during 24 weeks.” NCT02361242 ↗

“Experimental - A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.” NCT03199417 ↗

“Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks” NCT05021718 ↗

“PXT00864 is a fixed-dose combination of baclofen and acamprosate” NCT02361424 ↗

“baclofen 10 mg capsule (for the 30 mg-baclofen 30 mg arm)” NCT05935553 ↗

“IPX056 Extended Release capsule containing 20 mg baclofen” NCT00488839 ↗

“Baclofen 2% - an agonist for the GABAB receptors.” NCT02485145 ↗

“Triazolam, tiagabine, baclofen” NCT00218166 ↗

“Baclofen” NCT07296770 ↗

Show 90 more sources

Known as (RS)-baclofen “Combination of (RS)-baclofen, naltrexone hydrochloride and D-sorbitol, termed PXT3003, improved myelination in the Pmp22 transgenic co-culture cellular model, and moderately...” PMID 25491744 ↗ Dec 2014
2

“(RS)-baclofen, naltrexone hydrochloride and D-sorbitol oral fixed dose combination” NCT05092841 ↗

NCT04762758 ↗

Known as BA-34,647 ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Baclofen ER “Drug: Baclofen ER” NCT00802035 ↗
Known as Baclofene ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Baclofeno ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Baclospas-10 ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Fleqsuvy ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Gablofen ClinicalTrials.gov intervention name — accepted as the source's own label NCT01520545 ↗
Known as Kemstro ClinicalTrials.gov intervention name — accepted as the source's own label NCT00139789 ↗
Known as Liofen “Baclofen(Liofen®),Diazepam,(Valium®),Clonazepam,(Klonopin®),Trihexyphenidyl(Artane®),Tetrabenazine(Xenazine®),Gabapentin(Neurontin®),Topiramate(Topamax®),Lamotrigine(Lamictal®),...” NCT04523935 ↗
Known as Lioresal ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Lioresal intrath ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Lyflex ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Lyvispah ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as NSC-755906 ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Ozobax ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as Ozobax ds ChEMBL registry synonym — accepted as the source's own label CHEMBL701 ↗
Known as racemic baclofen “Neurophysiologic target engagement was evaluated using single doses of the GABAB selective agonist racemic baclofen (RBAC).” PMID 36167501 ↗ Sep 2022
Known as RBAC “Neurophysiologic target engagement was evaluated using single doses of the GABAB selective agonist racemic baclofen (RBAC).” PMID 36167501 ↗ Sep 2022
Known as Xylka “A Randomized, Multicentric, Double Blind Study to Assess the Efficacy of Xylka® (Baclofen) at the Target Dosage of 180mg/Day Compared to Placebo, for Maintenance of Abstinence...” NCT01738282 ↗
Action Activate “Baclofen is a GABA(B) receptor agonist” PMID 19414226 ↗ May 2009
Modality Small molecule — CHEMBL701 ↗
Route Intrathecal “Intrathecal baclofen administered” NCT00179114 ↗