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baclofen (Xylka / Baclocur / baclofen, Ethypharm)

✓ Approved

Ethypharm Corp. · GABBR1 · Small Molecule

What is baclofen?

baclofen is a small molecule developed by Ethypharm Corp.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesXylka, Baclocur, baclofen, Ethypharm
CompanyEthypharm Corp.
Drug ClassSmall Molecule
Molecular TargetGABBR1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Ethypharm Corp.

Mechanism of Action

Molecular Targets

baclofen acts on 1 molecular target:

GABBR1gamma-aminobutyric acid type B receptor subunit 1 (GABABR1, GB1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

baclofen is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersAlcoholism✓ Approved

Related Research Articles

PubMedbioRxiv : the preprint server for biology2026-11-08

MR-Guided Focused Ultrasound Neuromodulation of Nucleus Accumbens to Attenuate Oral Fentanyl Motivation in A Self-Administration Rat Model.

Martin David A DA, Eldirdiri Abubakr A, Ernst Thomas T, Cunningham Eric E et al.

Transcranial low-intensity focused ultrasound (LIFU) is being explored as a non-invasive approach for neuromodulation to treat opioid use disorder (OUD). We evaluated MR-guided focused ultrasound, with LIFU, targeting nucleus accumbens (MRgLIFU-NAc) bilaterally, using MR-acoustic radiation force-imaging (MR-ARFI) to ensure accurate targeting and adjust for FUS intensity delivered at the target. Male and female rats were trained to self-administer fentanyl/sucrose (70ug/ml fentanyl citrate in 5% sucrose) or 5% sucrose alone. Three cohorts of rats (total n=76) were evaluated on progressive ratio (PR) responding for oral fentanyl/sucrose at either 4 or 24 hours post-MRgLIFU-NAc. Animals in the first two cohorts received repeated rounds of LIFU or sham (anesthesia-duration matched). In cohort 3, we used a counterbalanced within-subjects design in which rats received both LIFU and sham one week apart. Reducing sucrose concentrations decreased responding for sucrose alone more than for fentanyl/sucrose, demonstrating a role for fentanyl in the reinforcing properties of fentanyl/sucrose. Across three sonication schemes, MRgLIFU-NAc did not attenuate PR performance for oral fentanyl/sucrose at 4 or 24-hours post-LIFU relative to controls. Adjusting LIFU intensity with MR-ARFI did not correlate with changes in PR from baseline. We confirmed that NAc is the correct target by bilateral inactivation of NAc with muscimol/baclofen mixture (50 + 50 ng/side), which reduced PR responding for fentanyl/sucrose. The three sets of LIFU parameters, with repeated MRgLIFU-NAc sessions, did not produce detectable changes in oral fentanyl/sucrose motivation. Further studies are required to determine effective LIFU parameters needed to reduce NAc-dependent fentanyl motivation.

PMID 42995866
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PubMedAmerican journal of obstetrics and gynecology2026-11-05

Baclofen Vaginal Suppositories in Chronic Pelvic Pain: a Randomized, Double-Blind, Placebo Controlled Trial.

Rothenberger Rodger W RW, Abraham Alyce A, Gaskins Jeremy T JT, Carbone Laurel L et al.

Pelvic floor muscle dysfunction is a common contributor to chronic pelvic pain (CPP), yet targeted treatment options remain limited. To determine whether baclofen vaginal suppositories in CPP is safe and effective when compared with placebo. This randomized, double-blind, placebo-controlled trial compared 20mg baclofen vaginal suppositories to placebo suppositories nightly in women with CPP. Women older than18 years without allergy to baclofen or the suppository base were included if they had ≥40/100 mm pain on a visual analogue scale (VAS) with palpation of the obturator internus or levator ani on standardized pelvic exam. Improvement in this standardized pelvic exam 100mm VAS pain score represented the primary outcome. Participants completed Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference, PROMIS global health, PROMIS sexual function at baseline, 4, and 8 weeks, with repeat pelvic examination at 8 weeks. The study was powered to detect the minimum clinically important difference (MCID) of 20mm on a 100mm VAS pain scale on a standardized pelvic floor muscle examination with a total sample size of 34, 17 in each group. Adverse events, pill count, and other treatments for CPP during the study period were collected. Differences between treatment groups were assessed using the Mann-Whitney test, and multiple imputation was used to account for missing data. A total of 39 women were enrolled in the study with 37 randomized.19 patients received baclofen vaginal suppositories and 18 received placebo suppositories. Demographic data was similar between groups, with similar mean age (42.5 ± 12.5 baclofen vs 46.3 ± 12.2 placebo) and body mass index (29.4 ± 6.7 vs 29.8 ± 7.6). There was a statistically and clinically significant improvement in the primary outcome of change in the 100mm VAS pain score on pelvic floor muscle examination at 8 weeks relative to baseline in the baclofen group as compared to placebo (median improvement of 33.5 mm [IQR: 30 to 46.230.0] baclofen vs 7.2 mm [0.0 to 10.0] placebo, p=<0.001). Further, patient-reported overall 100mm VAS pain was also significantly improved with baclofen when compared to placebo (median improvement 32.0 mm [14.0 to 43.0] baclofen vs 0.0 mm [-6.5 to 11.8] placebo, p=0.001) (Figure 2). Other validated questionnaires demonstrated no significant differences between baclofen and placebo. Medication compliance, assessed using Spearman correlation between the number of missed doses and the survey score at 8 weeks, did not impact the outcomes among those in the baclofen arm. There were no adverse events in the baclofen group. In the placebo group one participant had intermittent headaches and one participant had irritated vaginal skin. In this appropriately powered, randomized trial, patients experienced statistically and clinically significantly less pain with 8 weeks of nightly baclofen vaginal suppositories when compared to placebo. Baclofen suppositories were shown to be well tolerated with no adverse events.

PMID 42988098
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PubMedInfection2026-11-03

Contemporary management of severe generalized tetanus: an evidence-based review.

Pothumarthy Venkata Swathi Kiran VSK, Tirlangi Praveen Kumar PK, Nagesh Savan Kumar SK, Bhat Rachana R et al.

Severe generalized tetanus remains associated with substantial mortality despite being vaccine preventable. Management is complicated by limited high-quality evidence, conflicting trial results, and the need to balance effective control of spasms and autonomic dysfunction against the risks of prolonged mechanical ventilation. We describe the management of a 57-year-old man with Ablett grade III generalized tetanus and use this case as a clinical framework for an expert narrative review. The review synthesizes randomized controlled trials, systematic reviews, meta-analyses, prospective studies, and relevant observational literature addressing neuromodulatory therapy, airway management, autonomic dysfunction, intrathecal antitoxin, and supportive critical care. The patient was managed using a multimodal strategy comprising continuous midazolam infusion, magnesium sulphate, oral baclofen, dexmedetomidine, intramuscular and intrathecal human tetanus immunoglobulin, and meticulous low-stimulation supportive care. Therapy was titrated using serial bedside assessment of neuromuscular burden. He recovered without endotracheal intubation, neuromuscular blockade, or tracheostomy and was discharged on day 21. We argue that discordant findings in tetanus trials are substantially attributable to heterogeneity in disease severity, clinical practice, airway management thresholds, and resource availability, rather than to true therapeutic inconsistency. Available evidence supports a physiology-directed multimodal approach using agents with complementary mechanisms to suppress spasms and autonomic dysfunction while preserving spontaneous ventilation whenever safely feasible. Management of severe tetanus should focus on achieving physiological targets rather than escalating individual drugs. A structured, individualized, multimodal neuromodulatory strategy delivered within an experienced, low-stimulation critical care environment may allow selected patients to be managed without mechanical ventilation; safety cannot be established from a single case and requires prospective evaluation. Greater emphasis should also be placed on preventive adult immunization, as vaccination remains the intervention most likely to reduce the burden of severe tetanus.

PMID 42975860
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PubMedSeminars in perinatology2026-11-01

Motor manifestations of kernicterus spectrum disorder: Diagnosis and treatment.

Can Afra A, Gelineau-Morel Rose R

Kernicterus Spectrum Disorder (KSD) is a chronic neurologic condition resulting from bilirubin neurotoxicity and remains a leading global cause of dyskinetic cerebral palsy (CP). Injury to the globus pallidus and related neural networks leads to characteristic movement disorders, most commonly dystonia and choreoathetosis, which often emerge months after the episode of hyperbilirubinemia. This delay contributes to underrecognition and missed opportunities for early intervention. In this review, we summarize motor manifestations of KSD and evaluate current approaches to early diagnosis and treatment. Available predictive and diagnostic tools include the modified Bilirubin-Induced Neurologic Dysfunction (BIND) score, brain magnetic resonance imaging, dystonia rating scales, and the KSD diagnostic toolkit. Although evidence for treatment of movement disorders specific to KSD remains limited, management can be informed by the broader literature on dyskinetic CP and acquired dystonia. Current interventions include oral medications, botulinum neurotoxin injections, intrathecal baclofen, deep brain stimulation (DBS), and rehabilitation therapies. Interventions should be individualized according to motor phenotype, functional goals, and patient priorities. Future research is needed to define effective interventions, identify individuals most likely to benefit from specific therapies, and develop personalized treatment strategies.

PMID 42966715
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PubMedBMJ case reports2026-10-30

Life-threatening delayed intrathecal baclofen overdose following catheter contrast study.

Elmowafy Ramiz R, Pinto Aimee A, Falzon Andrew A, Dalton Catherine C

PMID 42963065
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PubMedInternational journal of MS care2026-10-29

Radial Extracorporeal Shock Wave Therapy for Triceps Surae Spasticity in People With Multiple Sclerosis: A Pilot Study.

Di Giovanni Rachele R, Grange Erica E, Masuccio Fabio Giuseppe FG, Bodrero Matteo M et al.

Spasticity represents a major symptom of people with multiple sclerosis (MS), frequently causing disability, pain, and abnormal postures. The aim of this study is the evaluation of safety and efficacy of radial extracorporeal shock wave therapy (RESWT) for triceps surae muscle spastic hypertonia in people with MS. Two centers recruited people 18 years or older with MS and triceps surae muscle hypertonia. People were excluded if they had other neurological conditions; had used anticoagulants; had intrathecal baclofen, botulinum toxin, and/or physiotherapy within the past 8 months; or had oral antispasmodics therapy modification in the past 4 weeks. The participants underwent triceps surae RESWT once a week for 4 weeks. Participants were scored on the Modified Ashworth Scale (MAS), the Numerical Rating Scale for spasticity (NRS-Sp), the Medical Research Council (MRC) scale, the Timed Up and Go (TUG) test, and the Timed 25-Foot Walk (T25-FW) test before RESWT (T0) and immediately after RESWT (T1). Self-perceived effect was evaluated via the Global Perceived Effect (GPE) at T1. Twenty-six people with MS were included (10 women and 16 men; mean age ± SD, 52.46 ± 8.39 years; mean Expanded Disability Status Scale score ± SD, 5.44 ± 1.34; mean disease duration ± SD, 14.88 ± 10.83 years), and 36 triceps surae were treated. MAS and NRS-Sp scores decreased at T1, whereas TUG, T25-FW, and MRC scores were comparable over time. Via the GPE, 73% of participants reported a self-perceived positive effect of RESWT on spasticity. RESWT may be efficacious and safe for treating spasticity in people with MS and does not adversely affect gait, strength, or dynamic balance. Further long-term studies are needed to evaluate the possibility of using RESWT as a treatment for spasticity in people with MS.

PMID 42953461
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