Drugs / Baclofen
Baclofen
also known as
(RS)-baclofen · BA-34,647 · Baclofen ER · Baclofene · Baclofeno · Baclospas-10 · Fleqsuvy · Gablofen · +12 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
US approved 1977
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| Phase 1 | NCT02001584 | ? → May 2014 | — | Gedeon Richter Plc. | Completed | No outcome recorded |
| Phase 215 trials | ||||||
| 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| Phase 2 | NCT04471714 | Jan 2020 → Mar 2022 | spinal cord injury | University of Alberta | Withdrawn | No outcome recorded |
| 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 | No outcome recorded |
| 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 | NCT00257894 | Dec 2005 → Dec 2008 | nicotine dependence | VA Office of Research and Development | Terminated | No outcome recorded |
| Phase 2 | NCT00255073 | Jan 2005 → Apr 2006 | spastic diplegia | University of Southern California | Completed | No outcome recorded |
| Phase 2 | NCT00221689 | Mar 2003 → Feb 2004 | brain hypoxia - ischemia, dysautonomia, traumatic brain injury | University Hospital, Bordeaux | Terminated | No outcome recorded |
| Phase 2 | NCT00221611 | Jan 2000 → Aug 2006 | cerebral palsy | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT00000303 | Oct 1997 → May 1999 | cocaine dependence | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2/38 trials | ||||||
| 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 |
| Phase 2/3 | NCT03199417 | May 2017 → May 2018 | osteoarthritis, knee | University of Michigan | Terminated | No outcome recorded |
| Phase 2/3 | NCT02099006 | Nov 2013 → Jun 2015 | female reproductive system disorder | University of Rochester | Completed | No outcome recorded |
| Phase 2/3 | NCT01604330 | May 2012 → Sep 2014 | alcohol dependence | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT02052440 | Mar 2014 → Jan 2017 | alcohol withdrawal | Denver Health and Hospital Authority | Terminated | No outcome recorded |
| Phase 3 | NCT01711125 | Mar 2013 → Jun 2017 | alcohol dependence, alcoholic liver disease | South West Sydney Local Health District | Completed | No outcome recorded |
| 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 3 | NCT01265550 | Aug 2012 → Dec 2016 | gastroesophageal reflux disease | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT00516503 | Feb 2008 → Apr 2009 | cancer of unknown primary site, leukemia, lymphoproliferative syndrome, myelodysplastic syndrome +4 | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 3 | NCT00488839 | Jun 2007 → May 2008 | multiple sclerosis | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 3 | NCT00139789 | Jan → Apr 2005 | multiple sclerosis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00367068 | Jan 2002 → May 2007 | cerebral palsy | Maastricht University | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| 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 | NCT01008280 | Oct 2010 → Mar 2014 | alcohol-related disorders, hepatitis C virus infection | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 4 | NCT00752934 | Oct 2010 → Jun 2015 | cerebral palsy | Shaare Zedek Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT01002105 | Jan 2010 → May 2012 | alcohol dependence | Sha'ar Menashe Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT00179114 | Aug 2002 → Feb 2006 | — | Vanderbilt University | Completed | No outcome recorded |
| 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 |
| — | 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 |
| — | NCT00871455 | Apr 2003 → Dec 2007 | spinal cord injury | US Department of Veterans Affairs | Completed | No outcome recorded |
Also used as a comparator or background therapy in 35 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03065998 Comparator | Mar 2017 → Jan 2018 | substance abuse | Ministry of Health, Israel | Unknown | No outcome recorded |
| Phase 14 trials | ||||||
| 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 |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00607542 Comparator | Nov 2008 → Jan 2011 | cerebral palsy | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Phase 1/2 | NCT00525252 Comparator | Feb 2003 → Nov 2006 | alcoholic liver cirrhosis | Catholic University of the Sacred Heart | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT05968937 Comparator | Jan 2024 → Jan 2026 | chronic pain syndrome | University of Louisville | Completed | No outcome recorded |
| Phase 2 | NCT01980706 Comparator | Dec 2013 → Oct 2017 | alcohol dependence | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT02011516 Comparator | Dec 2013 → Jun 2015 | cannabis dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01937364 Comparator | Nov 2013 → Jun 2015 | alcohol dependence, alcohol withdrawal | Essentia Health | Terminated | No outcome recorded |
| Phase 2 | NCT02003664 Comparator | Nov 2013 → Nov 2014 | cocaine dependence | University of Pennsylvania | Withdrawn | No outcome recorded |
| Phase 2 | NCT01821560 Comparator | Mar 2013 → Jun 2017 | nicotine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT01228994 Comparator | Oct 2010 → Aug 2012 | nicotine dependence | Centre for Addiction and Mental Health | Terminated | No outcome recorded |
| Phase 2 | NCT01076283 Comparator | Dec 2009 → Apr 2010 | alcohol dependence | Brown University | Completed | No outcome recorded |
| Phase 2 | NCT00082485 Comparator | Jun 2004 → Jul 2006 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT00218166 Comparator | Aug 2001 → May 2005 | cocaine abuse | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07063576 Comparator | Aug 2025 → Jul 2026 overdue | — | Adnan Imtiaj Rahul | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05975684 Comparator | Jan 2023 → Jul 2024 | rumination disorder | Nationwide Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02579759 Comparator | Dec 2015 → Mar 2018 | Charcot-Marie-Tooth disease type 1A | Pharnext S.C.A. | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT03068897 Comparator | May 2017 → Jul 2018 | — | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02529514 Comparator | Jul 2015 → Jun 2016 | — | University of Liege | Suspended | No outcome recorded |
| Phase 4 | NCT02462317 Comparator | Apr 2015 → Dec 2019 | — | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT01003249 Comparator | Sep 2009 → Mar 2013 | constipation disorder, overactive bladder | Wake Forest University Health Sciences | Terminated | No outcome recorded |
| Phase 4 | NCT01386255 Comparator | Apr 2009 → Apr 2012 | cerebral palsy, gastroesophageal reflux disease | Boston Children's Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT04523935 Comparator | Dec 2005 → Aug 2020 | cerebral palsy | Sathbhavana Brain Clinic | Completed | No outcome recorded |
| Phase 4 | NCT01955655 Comparator | Dec 2005 → Aug 2013 | breath-holding Spells | Sathbhavana Brain Clinic | Completed | No outcome recorded |
| Phase not applicable8 trials | ||||||
| — | NCT06175507 Comparator | Dec 2023 → Mar 2025 | alcoholic liver disease | Institute of Liver and Biliary Sciences, India | Unknown | No outcome recorded |
| — | NCT04509336 Comparator | Aug → Dec 2020 | cirrhosis of liver | Mansoura University | Terminated | No outcome recorded |
| — | NCT03427216 Comparator | Sep → Dec 2018 | anismus | Dr. John A. Thiel Medical Professional Corporation | Unknown | No outcome recorded |
| — | NCT02705950 Comparator | Dec 2014 → Aug 2017 | neuropathy, painful | Institut Guttmann | Completed | No outcome recorded |
| — | NCT02221570 Comparator | Jun → Nov 2014 | cirrhosis of liver | Tanta University | Unknown | No outcome recorded |
| — | NCT03835442 Comparator | Jan 2010 → Dec 2016 | gastroesophageal reflux disease | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| — | NCT01053585 Comparator | Feb 2007 → May 2011 | gastroesophageal reflux disease | University of Zurich | Completed | No outcome recorded |
| — | NCT00597701 Comparator | Apr 2003 → Feb 2008 | alcohol withdrawal delirium | Essentia Health | Completed | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 106 sources stand behind the page.
| Field | Value | Cited 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 201499“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 ↗ |
| 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 20142“(RS)-baclofen, naltrexone hydrochloride and D-sorbitol oral fixed dose combination” NCT05092841 ↗ |
| 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 ↗ |