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Lioresal

(Baclofen)

ApprovedSmall molecule

Baclofen 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 38 indications[4].[1]

Lioresal is one of 675 small molecule programs targeting Charcot-Marie-Tooth disease. It is currently in Approved.

38

Indications

72

Total Trials

5

Active Trials

674

Competitors

7

FDA Applications

NDA/BLA/ANDA regulatory filings

8

Patents

Pipeline

Status by Indication[4][1]

Indication

Charcot-Marie-Tooth DiseaseApproved

Myofascial Pain SyndromeApproved

Muscle SpasmActive, not recruiting

RigidityActive, not recruiting

Nicotine DependenceApproved

Neuropathic PainApproved

Low Back PainActive, not recruiting

Cerebral PalsyActive, not recruiting

SpasticityActive, not recruiting

Cocaine AbuseActive, not recruiting

Charcot-Marie-Tooth DiseaseApproved

Approved

Myofascial Pain SyndromeApproved

Approved

Muscle SpasmPhase 2

Active, not recruiting

RigidityApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

Neuropathic PainApproved

Approved

Low Back PainApproved

Active, not recruiting

Cerebral PalsyApproved

Active, not recruiting

SpasticityApproved

Active, not recruiting

Cocaine AbusePhase 2

Active, not recruiting

Showing 10 of 36 indications

Competition

Competitive Landscape

797 competitors in Hepatocellular Carcinoma

#DrugCompanyPhaseTrials

Lioresal

Viread

Sovaldi

Ibrance

Hepsera

Coreg

Akero Therapeutics

Apatinib

LLaNova Medicines Zhejiang Co., Ltd.

Doptelet

Miraclid

TTechpool Bio-Pharma Co., Ltd.

Vermox

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 2/3Recruiting

MPR

NCT05935553

Clinical

Trials by Indication[1]

Treatment5 trials

Baclofen for the Treatment of Alcohol Drinkers

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT01604330·323 enrolled

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Unknown status·MMinistry of Health, Israel·Phase 1·NCT03065998·140 enrolled

A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response

Completed·UUniversitaire Ziekenhuizen KU Leuven·N/A·NCT03835442·60 enrolled

Show 2 more trials

Novel Topical Therapies for the Treatment of Genital Pain

Completed·UUniversity of Rochester·Phase 2/3·NCT02099006·9 enrolled

Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients

Completed·SSha'ar Menashe Mental Health Center·Phase 4·NCT01002105·75 enrolled

Alcohol Withdrawal5 trials

Baclofen in Managing Acute Alcohol Withdrawal

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 4·NCT03293017·90 enrolled

Treating Alcohol Withdrawal With Oral Baclofen

Completed·EEssentia Health·N/A·NCT00597701·79 enrolled

Safety & Efficacy of Baclofen for Alcohol Withdrawal in Chronic Liver Disease With Active Alcohol Consumption

Enrolling by invitation·CCorporacion Parc Tauli··NCT06840652·120 enrolled

Show 2 more trials

Preventing Alcohol Withdrawal Syndrome With Oral Baclofen

Terminated·—·Phase 3·NCT02052440·102 enrolled

Preventing Alcohol Withdrawal With Oral Baclofen

Terminated·EEssentia Health·Phase 2·NCT01937364·17 enrolled

ACL4 trials

Effect of Low-Dose Baclofen Administration on the GH-IGF1 Axis Study

Completed·UUS Department of Veterans Affairs·N/A·NCT00871455·20 enrolled

Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647738·27 enrolled

Baclocur® Post-Authorisation Safety Study in Real-life Settings in France

Unknown status·EEthypharm··NCT04679142·975 enrolled

Show 1 more trial

Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT05257447·19 enrolled

Alcohol Dependence4 trials

Efficacy and Tolerability of Baclofen for Alcohol Dependence

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2/3·NCT00877734·80 enrolled

Baclofen for the Treatment of Alcohol Dependence

Completed·—·Phase 2/3·NCT01266655·56 enrolled

Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06175507·110 enrolled

Show 1 more trial

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

Completed·UUniversity of North Carolina, Chapel Hill·Phase 2·NCT01980706·120 enrolled

Spasticity4 trials

The Effect of Oral Baclofen and Botulinum Toxin Treatments in Hemiplegic Spasticity on the Nociceptive Flexor Reflex

Completed·MMustafa Kemal University·Phase 4·NCT03860662·29 enrolled

Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment

Completed·UUniversity Hospital, Toulouse·Phase 4·NCT02462317·184 enrolled

Does Reducing Spasticity Permit an Increase in Strength?

Completed·UUniversity of Southern California·Phase 2·NCT00255073·10 enrolled

Show 1 more trial

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

43 more indications

Adult2 trials

A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults

Completed·GGedeon Richter Plc.·Phase 1·NCT02001584

Oral and IV Baclofen in Adult Volunteers

Completed·UUniversity of Minnesota·Phase 1·NCT01749319·12 enrolled

Rumination2 trials

Baclofen for Children With Rumination Syndrome

Completed·NNationwide Children's Hospital·Phase 3·NCT05975684·50 enrolled

Baclofen for Rumination

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT03113396·20 enrolled

Cerebral Palsy2 trials

Recurrent Crying Spells in Cerebral Palsy

Completed·SSathbhavana Brain Clinic·Phase 4·NCT01955655·70 enrolled

Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Withdrawn·—·Phase 4·NCT01386255

Withdrawal2 trials

Effect of Baclofen on Marijuana Withdrawal and Relapse

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00373295·13 enrolled

Baclofen Effects on Smoking Urge and Withdrawal

Terminated·VVA Office of Research and Development·Phase 2·NCT00257894·41 enrolled

Muscle Cramp2 trials

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

Unknown status·TTanta University·N/A·NCT02221570·100 enrolled

Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients

Terminated·MMansoura University·N/A·NCT04509336·5 enrolled

Function2 trials

GABA-B Receptor Function in Healthy Volunteers

Completed·IImperial College London·N/A·NCT01563224·8 enrolled

Structure and Function of the Gastro-esophageal Junction

Completed·UUniversity of Zurich·N/A·NCT01053585·24 enrolled

Alcohol Use Disorder2 trials

Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder

Terminated·UUniversity Hospital, Lille·Phase 4·NCT02596763·239 enrolled

Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Completed·PProf. Daniele Zullino·Phase 2·NCT03034408·37 enrolled

Alcohol Drinking1 trial

A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

Completed·—·Phase 2·NCT01076283·14 enrolled

Agitation1 trial

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

Completed·NNantes University Hospital·Phase 3·NCT02723383·314 enrolled

Anxiety1 trial

Baclofen for Treating Anxiety and Alcoholism

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT01751386·39 enrolled

Post-Traumatic Stress Disorder1 trial

Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

Completed·NNantes University Hospital··NCT05877807·94 enrolled

Multiple Sclerosis1 trial

Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Completed·RRVL Pharmaceuticals, Inc.·Phase 3·NCT01743651·353 enrolled

Chemotherapy1 trial

Treatment of Chemotherapy-related Hiccups With Baclofen

Unknown status·SSecond Affiliated Hospital of Nanchang University·Phase 4·NCT03778281·120 enrolled

Cigarette Smoker1 trial

Baclofen Effects in Cigarette Smokers

Completed·UUniversity of Pennsylvania·Phase 2·NCT01821560·44 enrolled

Cocaine Dependence1 trial

Baclofen for the Treatment of Cocaine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00082485·160 enrolled

Randomized1 trial

A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors

Completed·VVA Office of Research and Development·Phase 3·NCT01265550·366 enrolled

After Cardiac Surgery1 trial

Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Suspended·UUniversity of Liege·Phase 4·NCT02529514·30 enrolled

Marijuana1 trial

Baclofen Effects on Marijuana Dependence

Completed·UUniversity of Pennsylvania·Phase 2·NCT02011516·47 enrolled

Lower Urinary Tract Symptom1 trial

Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen

Terminated·WWake Forest University Health Sciences·Phase 4·NCT01003249·12 enrolled

Acute1 trial

Neurophysiological and Acute Pharmacological Studies in FXS Patients

Completed·—·Phase 1·NCT02998151·29 enrolled

Opiate Dependence1 trial

Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence.

Completed·IImperial College London·Phase 4·NCT05161351·16 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients

Completed·EEthypharm·Phase 3·NCT01738282·316 enrolled

Intravenous1 trial

Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers

Completed·UUniversity of Minnesota·Phase 1·NCT01931319·39 enrolled

Intrathecal Baclofen1 trial

Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients

Terminated·UUniversity Hospital, Bordeaux·Phase 2·NCT00221689·4 enrolled

Nausea and vomiting1 trial

Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Completed·TTanta University·Phase 2/3·NCT05516953·100 enrolled

TED1 trial

Repeated Dose IV Baclofen Safety/Bioequivalence Study

Unknown status·AAllaysis, LLC·Phase 1/2·NCT02760992·42 enrolled

MPR1 trial

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

Recruiting·HHospices Civils de Lyon·Phase 2/3·NCT05935553·93 enrolled

Gastroesophageal Reflux Disease1 trial

Effect of Baclofen in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Recruiting·AAdnan Imtiaj Rahul·Phase 2/3·NCT07063576·60 enrolled

Myofascial Pain Syndrome1 trial

BTA vs Baclofen for Pelvic Myofascial Pain Syndrome

Unknown status·SSaint Petersburg State University, Russia··NCT05617118·52 enrolled

Analgesic1 trial

Baclofen as a Perioperative Analgesic Adjuvant

Terminated·UUniversity of Alabama at Birmingham·Phase 4·NCT03720717·34 enrolled

Buprenorphine1 trial

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

Terminated·UUniversity of Alabama at Birmingham·Phase 2/3·NCT04251819·19 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Active, not recruiting·TTanta University·Phase 3·NCT05921604·100 enrolled

Muscle spasm1 trial

Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study

Completed·UUniversity of Virginia·Phase 2·NCT02298868·10 enrolled

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

Treatment of Non-Metastatic Hepatocellular Carcinoma in Humans by Increasing Gabaergic Activity: A Pilot Study

Withdrawn·UUniversity of Manitoba·Phase 2·NCT00493428

Alcohol Use1 trial

Baclofen to Reduce Alcohol Use in Veterans With HCV

Completed·VVA Office of Research and Development·Phase 4·NCT01008280·180 enrolled

Cocaine Abuse1 trial

Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00000303

Humans1 trial

Effects of Baclofen on Presynaptic Inhibition in Humans

Withdrawn·UUniversity of Alberta·Phase 2·NCT04471714

Hypoxia1 trial

Baclofen and Hypoxia-induced Periodic Ventilation

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT01095679·53 enrolled

Low back pain1 trial

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

Completed·MMontefiore Medical Center·Phase 4·NCT03068897·320 enrolled

Ataxia-telangiectasia1 trial

Baclofen Treatment of Ataxia Telangiectasia

Completed·JJohns Hopkins University·Phase 1·NCT00640003·10 enrolled

Alcohol Addiction1 trial

Efficacy of Baclofen in the Treatment of Alcohol Addiction

Completed·—·Phase 1/2·NCT00525252·86 enrolled

Bulimia Nervosa1 trial

Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

Completed·NNew York State Psychiatric Institute·N/A·NCT00320047·10 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]
ClinicalTrials.gov — 72 trial records for Baclofen. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lioresal drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Baclofen compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Baclofen. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215602). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lioresal. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-B Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Sep 8, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11446246Sep 8, 2037

11324696Sep 29, 2037

11654124Jul 29, 2039

10792262Jul 29, 2039

11931328Jul 29, 2039

3 more patents

10610502Aug 30, 2039

11850225Sep 29, 2041

11491125Sep 29, 2041

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