Drug

Baclofen

In clinical development

ClassGABA-B receptor agonistEmerging researchLate-stage developmentSteady momentum

Also known as 4-Amino-3-(4-chlorophenyl)butyric acid, Fleqsuvy, Gablofen, Lioresal+10 more

4-Amino-3-(4-chlorophenyl)butyric acid, Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax, beta-(4-Chlorophenyl)gaba, beta-(Aminomethyl)-4-chlorobenzenepropanoic acid, beta-(Aminomethyl)-p-chlorohydrocinnamic acid, beta-(p-Chlorophenyl)-gamma-aminobutyric acid, gamma-Amino-beta-(p-chlorophenyl)butyric acid, Baclofeno, Baclofène, Baclofenum.

RxNorm1292 ChEMBLCHEMBL701 ATCM03BX01UNIIH789N3FKE8

Research papers

Active clinical trials

Protein targets

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effect of Baclofen as an Add on Therapy in Management of Patients With Gastroesophageal Reflux Disease Symptoms

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression

Clinical trial2026-05-13Results expected Q4 2030 · ClinicalTrials.gov

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

Clinical trial2026-05-11Results expected Q4 2028 · ClinicalTrials.gov

Evaluating the Neurophysiologic and Clinical Effects of Single-Dose Baclofen, Roflumilast, Memantine, and Placebo in Fragile X Syndrome

Clinical trial2025-10-28Primary completion · ClinicalTrials.gov

Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve

Clinical trial2025-08-28Primary completion · ClinicalTrials.gov

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

Clinical trial2025-03-31Primary completion · ClinicalTrials.gov

Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Clinical trial2025-02-28Completed · ClinicalTrials.gov

A Randomized Controlled Pilot Trial of Baclofen for Children With Rumination Syndrome

Clinical trial2025-01-27Completed · ClinicalTrials.gov

FORWARDS-1: an adaptive, single-blind, placebo-controlled ascending dose study of acute baclofen on safety parameters in opioid dependence during methadone-maintenance treatment-a pharmacokinetic-pharmacodynamic study.

Research2022-10-18Trials

Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study.

Research2017-04-25Translational psychiatry

Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline.

Research2014-04-14Journal of clinical oncology : official journal of the American Society of Clinical Oncology

A human laboratory pilot study with baclofen in alcoholic individuals.

Research2012-12-19Pharmacology, biochemistry, and behavior

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Baclofen

Aliases & brands

4-Amino-3-(4-chlorophenyl)butyric acidFleqsuvyGablofenLioresalLyvispahOzobaxbeta-(4-Chlorophenyl)gababeta-(Aminomethyl)-4-chlorobenzenepropanoic acidbeta-(Aminomethyl)-p-chlorohydrocinnamic acidbeta-(p-Chlorophenyl)-gamma-aminobutyric acidgamma-Amino-beta-(p-chlorophenyl)butyric acidBaclofenoBaclofèneBaclofenum

RxNorm CUI

1292

ChEMBL ID

CHEMBL701

ATC codes

M03BX01

UNII

H789N3FKE8

Primary mechanism

GABA-B receptor agonist

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Gamma-aminobutyric acid type B receptor subunit 1

GABBR1 · Q9UBS5

AGONISTGABA-B receptor agonist

Gamma-aminobutyric acid type B receptor subunit 2

GABBR2 · O75899

AGONISTGABA-B receptor agonist

Clinical trials

70 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 70

Early Phase 14Phase 16Phase 1 / 23Phase 217Phase 2 / 38Phase 37Phase 415Phase N / A10

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Evaluating the Safety of Acute Baclofen in Methadone-maintained Individuals With Opiate Dependence. An Adaptive, Single-blind, Placebo-controlled Ascending Dose Study of Acute Baclofen on Safety Parameters in Opioid Dependence During Methadone-maintenance Treatment; a Pharmacokinetic-pharmacodynamic Study

CompletedPH IVImperial College Londonn=162022

Baclofen as a Perioperative Analgesic Adjuvant

TerminatedPH IVUniversity of Alabama at Birminghamn=342022

Baclofen Bij de Behandeling Van Acute Alcoholontwenning

Unknown statusPH IVUniversitair Ziekenhuis Brusseln=902022

Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.

CompletedPH IVUniversity Hospital, Toulousen=1842020

Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups

Unknown statusPH IVSecond Affiliated Hospital of Nanchang Universityn=1202019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

CompletedPH II/IIITanta Universityn=1002025

A Randomized Controlled Pilot Trial of Baclofen for Children With Rumination Syndrome

CompletedPH IIINationwide Children's Hospitaln=502025

Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial

CompletedN/AYonsei Universityn=402023

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

CompletedPH IUniversity of Texas Southwestern Medical Centern=192022

CompletedPH IVImperial College Londonn=162022

Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment: Double Blinded Comparison Between Botulinum Toxin and Baclofen.

CompletedPH IVUniversity Hospital, Toulousen=1842020

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20132022

Most influential

Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2014 · 831 cites

A human laboratory pilot study with baclofen in alcoholic individuals.

Pharmacology, biochemistry, and behavior · 2013 · 60 cites

Biobehavioral effects of baclofen in anxious alcohol-dependent individuals: a randomized, double-blind, placebo-controlled, laboratory study.

Translational psychiatry · 2017 · 49 cites

Trials · 2022 · 2 cites

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Amitriptyline

Studied across 3 of the same disease areas as Baclofen in the shared literature.