Lioresal
(Baclofen)ApprovedSmall molecule
NovartisBaclofen is used to treat muscle spasticity (stiffness and involuntary muscle contractions) caused by conditions like spinal cord injuries, multiple sclerosis, or cerebral palsy. It helps relax tight muscles and reduce muscle pain.[2] Lioresal is currently approved and in use across 30 indications[4].[1]
Lioresal is one of 373 small molecule programs targeting Brain Injury. It is currently in Approved.
30
Indications
73
Total Trials
6
Active Trials
372
Competitors
7
FDA Applications
NDA/BLA/ANDA regulatory filings
8
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 29 indications
Competition
Competitive Landscape
65 competitors in Spinal Cord Injury
#DrugCompanyPhaseTrials
1Lioresal
NovartisApproved
Zometa
PfizerApproved
Ozempic
Novo NordiskApproved
Keppra
UCBApproved
Levitra
BayerApproved
Calciferol
Jazz PharmaceuticalsApproved
Lyrica
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Approved
Xarelto
WWim Janssens
Approved
Jatenzo
GGrupo Espanol de Tumores Neuroendocrinos
Approved
Bendopa
MMerz North America, Inc.
Approved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Alcohol Withdrawal5 trials
Preventing Alcohol Withdrawal Syndrome With Oral Baclofen
Terminated·—·Phase 3·NCT02052440·102 enrolled
Treatment5 trials
Alcohol Dependence4 trials
Show 1 more trial
Baclofen for the Treatment of Alcohol Dependence
Completed·—·Phase 2/3·NCT01266655·56 enrolled
ACL4 trials
Spasticity4 trials
Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1/2·NCT00607542·61 enrolled
44 more indications
Muscle Cramp2 trials
Function2 trials
Withdrawal2 trials
Cerebral Palsy2 trials
Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
Withdrawn·—·Phase 4·NCT01386255
Alcohol Use Disorder2 trials
Bulimia Nervosa1 trial
Gastroesophageal Reflux Disease1 trial
Laparoscopic Sleeve Gastrectomy1 trial
Intrathecal Baclofen1 trial
Nausea and vomiting1 trial
Anxiety1 trial
Baclofen for Treating Anxiety and Alcoholism
Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT01751386·39 enrolled
Muscle spasm1 trial
Alcohol Drinking1 trial
A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Completed·—·Phase 2·NCT01076283·14 enrolled
Alcohol Addiction1 trial
Efficacy of Baclofen in the Treatment of Alcohol Addiction
Completed·—·Phase 1/2·NCT00525252·86 enrolled
Lower Urinary Tract Symptom1 trial
Efficacy and Safety1 trial
Opiate Dependence1 trial
Randomized1 trial
Single Dose1 trial
Evaluating the Neurophysiologic and Clinical Effects of Single Dose Drug Challenge
Active, not recruiting·—·Phase 2·NCT05418049·45 enrolled
Hepatocellular Carcinoma1 trial
Acute1 trial
Neurophysiological and Acute Pharmacological Studies in FXS Patients
Completed·—·Phase 1·NCT02998151·29 enrolled
Alcoholism1 trial
Spinal Cord Injuries1 trial
Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity
Active, not recruiting·UUniversity of Mississippi Medical Center·Preclinical·NCT07792616·12 enrolled
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
LIORESAL
NDA NDA017851
Nov 7, 1996
LIORESAL
NDA NDA020075
Oct 30, 2003
KEMSTRO
NDA NDA021589
Nov 19, 2010
GABLOFEN
NDA NDA022462
Sep 18, 2019
OZOBAX
NDA NDA208193
Nov 22, 2021
LYVISPAH
NDA NDA215422
Feb 4, 2022
FLEQSUVY
NDA NDA215602
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Lioresal drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Baclofen. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]