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baclofen (Ozobax)

✓ Approved

Metacel Pharmaceuticals · GABBR1 · Small Molecule

What is baclofen?

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

Drug Profile

Brand NamesOzobax
CompanyMetacel Pharmaceuticals
Drug ClassSmall Molecule
Molecular TargetGABBR1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Metacel Pharmaceuticals

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
Nervous system disordersMuscle spasticity✓ Approved

Related Research Articles

PubMedExplore (New York, N.Y.)2026-06-07

Successful treatment of abnormal sensation associated with restless legs syndrome in adrenoleukodystrophy using Gunggwijohyeoleum-Jeilgagam: A case report.

Hong Sunghee S, Lee Han-Gyul HG, Kwon Seungwon S, Goto Hirozo H et al.

Adrenoleukodystrophy (ALD) is a rare neurodegenerative disorder frequently associated with restless legs syndrome (RLS), particularly in patients with the adrenomyeloneuropathy (AMN) phenotype. RLS can markedly aggravate abnormal sensations, insomnia, and gait dysfunction; however, conventional treatments, such as dopamine agonists or iron supplementation, are often ineffective or inappropriate, especially in patients without iron deficiency. Herein, we report the clinical effects of herbal medicines in a patient with ALD-associated refractory RLS. A 50-year-old Asian man with genetically confirmed AMN-type ALD presented with a 10-year history of persistent tingling and discomfort in both lower extremities, severe RLS, insomnia, and progressive gait impairment. Despite treatment with baclofen and pramipexole, his symptoms remained refractory, with an International Restless Legs Syndrome Rating Scale (IRLS) score of 31, a Short Physical Performance Battery (SPPB) score of 4, and sleep duration limited to 2-3 h per night. The serum ferritin level was 140 μg/L, indicating adequate iron stores. Based on Korean medicine (KM) pattern identification, the herbal prescription Gunggwijohyeoleum-Jeilgagam (GJG) was administered for 21 days. Following treatment, the IRLS score decreased from 31 to 13, falling below the threshold for severe RLS, while the SPPB score improved from 4 to 6. The sleep duration increased to 5 h, and these improvements were maintained for 5 months after discontinuation without recurrence. GJG demonstrated potential benefit in alleviating refractory RLS-associated abnormal sensations and improving physical function in a patient with ALD. This case suggests that KM may represent a complementary therapeutic option for chronic sensory, sleep, and functional impairments in neurodegenerative disorders when conventional treatments are insufficient.

PMID 42251809
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PubMedEuropean journal of anaesthesiology and intensive care2026-06-05

An unusual case of burst suppression electrographic pattern following intrathecal baclofen overdose in critical care: a case report.

Elhadjene Nory N, Soulier Hugo H

Baclofen is a gamma-aminobutyric acid (GABA)-B receptor agonist used to treat neurological spasticity. Several cases of baclofen intoxication have been reported with neurological symptoms. While numerous reports describe oral baclofen toxicity, the neurological consequence of intrathecal overdose remain poorly characterised. We describe an electroencephalogram (EEG) post-anoxic encephalopathy pattern following intrathecal BACLOFEN injection to treat spasticity in an intensive care unit in September 2024.

PMID 42244827
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PubMedAlcohol, clinical & experimental research2026-06-05

Baclofen Modulates Neural Intrinsic Functional Connectivity in Treatment-Seeking Individuals With Alcohol Use Disorder.

Logge Warren B WB, Hurzeler Tristan P TP, Haber Paul S PS, Mealing Laurence L et al.

Chronic alcohol use alters brain networks related to reward and stress regulation, contributing to alcohol use disorder (AUD). Baclofen, a GABAB receptor agonist, reduces cue-elicited neural responses and alcohol consumption, but its effects on intrinsic functional connectivity remain unclear. This study investigates the dose-specific effects of baclofen on intrinsic resting-state functional connectivity in treatment-seeking individuals with AUD. In this double-blind, placebo-controlled, randomized clinical trial, 29 participants with AUD were randomized to receive placebo (n = 10), low-dose baclofen (30 mg/day, n = 10), or high-dose baclofen (75 mg/day, n = 9) for 12 weeks. Resting-state fMRI data were collected at rest during week 2. A data-driven parcellation approach assessed connectivity patterns across the brain and associations with percentage of heavy drinking days and percentage of days abstinent post scan were examined in an exploratory analysis. Compared to placebo, high-dose baclofen was associated with significant differences in intrinsic connectivity in brain regions linked with reward, stress, attentional, and salience networks. Higher connectivity was observed between the somatomotor network and regions involved in stress regulation (e.g., hypothalamus) and reward processing, while lower connectivity was observed within salience and attentional networks. These changes were not observed in the low-dose or placebo groups. Although nonsignificant, associations between MES and clinical outcomes demonstrated moderate, directionally consistent effects for abstinence-related outcomes. High-dose baclofen may modulate intrinsic brain connectivity in key networks implicated in AUD, including systems involved in attention and stress regulation. Although statistically significant relationships between functional connectivity and clinical outcomes were not identified, trends suggest that connectivity differences between high-dose baclofen and placebo may be relevant to treatment response. These neurobiological findings provide additional support for baclofen as a dose-dependent pharmacotherapy for AUD and highlight the need for larger samples to clarify the relationship between intrinsic connectivity and clinical outcomes. ClinicalTrials.gov, NCT01711125, https://clinicaltrials.gov/ct2/show/NCT01711125 letter of completion.

PMID 42246466
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PubMedOperative neurosurgery (Hagerstown, Md.)2026-06-05

Externalization of Intrathecal Baclofen Pumps Using a Shoulder Sling: Technique and Clinical Outcomes.

Abdelwahab Ahmed A, Chacon Ariana A, Loulida Hasna H, Asl Mohammad Mahdi Bagheri MMB et al.

To describe a novel axillary shoulder-sling technique for externalizing intrathecal baclofen (ITB) pumps and report its clinical outcomes in a cohort of patients requiring temporary pump removal for infection management. We retrospectively reviewed 14 patients who underwent ITB pump externalization using the axillary sling technique between January 2020 and March 2025. The procedure involved tunneling a new catheter subcutaneously from the lumbar region to the midaxillary line and securing the pump within a sterile orthopedic stockinette loop positioned beneath the armpit. Pumps were maintained in the sling for approximately a median of 2 months, with weekly sterile sling changes and continuous baclofen infusion. Patients were closely monitored with regular follow-up visits, clinical examinations, and laboratory evaluations. The median age of patients was 52 years (IQR: 38-69), with an equal male-to-female distribution. Hypertension and diabetes were the most frequent comorbidities (36% each). All pumps remained externalized for the median duration without a single incident of disconnection, infection recurrence, or exacerbation of spasticity. Every patient achieved resolution of infection and successful pump reimplantation. Patients reported improved comfort, more effortless mobility, and enhanced psychological well-being, compared with previous abdominal placements. Axillary externalization of the ITB pump using a shoulder sling seems to be a secure, comfortable, and effective strategy for maintaining continuous baclofen delivery during infection management. Although this case series demonstrates favorable outcomes, the technique should be interpreted cautiously given the small, single-center cohort. This approach may offer a practical, reproducible option for temporary pump management, warranting further prospective validation.

PMID 42246613
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PubMedThe journal of spinal cord medicine2026-06-04

Ultrasound-guided Botulinum Toxin injection into the rectus abdominis muscle for intractable abdominal spasms in spinal cord injury: A case report.

Yıldız Necmettin N, Bezmez Emre E, Alkan Hakan H

Abdominal spasms following spinal cord injury (SCI) can be a source of severe pain and functional impairment, often proving resistant to systemic antispastic medications. While botulinum toxin A (BoNT-A) is widely used for limb spasticity, its application for abdominal wall spasms in SCI is documented infrequently. We present the case of a 43-year-old male with C4 AIS-C tetraplegia suffering from severe, painful spasms of the rectus abdominis (RA) muscle, which were refractory to high-dose oral baclofen. Due to the localized nature of the symptoms and the risks associated with intrathecal baclofen, ultrasound-guided BoNT-A was administered specifically to the RA muscle. The intervention resulted in a significant reduction in spasm frequency and severity (Penn Spasm Scale), improved sitting comfort, and enhanced quality of life. This case suggests that targeted RA injection may represent a safe and sustainable alternative for selected SCI patients with focal abdominal spasticity.

PMID 42240606
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PubMedActa neurochirurgica2026-06-04

Fifteen years of intrathecal baclofen therapy in China: complications, safety governance, and a multimodal neuromodulation strategy.

Lin Zhengyu Z, Pan Yixin Y, Zeng Zhitong Z, Wan Xiaonan X et al.

To share real-world experiences and insights regarding complications associated with intrathecal baclofen (ITB) therapy from a major Chinese tertiary center, providing practical guidance for regions where ITB use is still emerging. A single-center, single-surgeon retrospective analysis was conducted on all patients who received ITB pump implantation at Ruijin Hospital (Shanghai, China) between 1st Jan 2011, and 31st Oct 2025. Data on demographics, medical history, and ITB-associated complications were extracted. Clinical effectiveness was assessed using a 5-level Likert scale of goal achievement. Data from 68 individuals (44 males), representing 214.3 pump-years of therapy, were included. The most common supra-spinal pathology was cerebral palsy (10/68, 14.7%), and the predominant spinal pathology was traumatic spinal cord injury (23/68, 33.8%). 87.2% of individuals reported to have goals considered achieved or partially achieved. A total of 24 complications were documented in 19 individuals. The overall complication incidence was 0.11 events per pump-year and 0.30 per implantation. Catheter-related issues were the most frequent (8/24, 33.3%), followed by drug-related (7/24, 29.2%) and procedure-related (6/24, 25.0%) complications. Human error-related issues accounted for 25.0% (6/24) of all documented complications. Notably, refinement of surgical nuances was found to successfully mitigate wound tension and skin erosion. In addition, a multimodal neuromodulation strategy integrating sacral neuromodulation was successfully piloted in a representative case of ITB dose-limiting urinary retention. This study presents one of the largest reported ITB cohort in China. Our experiences underscore that long-term success in ITB therapy extends beyond surgical precision to encompass systemic clinical governance, including rigorous safety protocols and the management of refractory side effects through multimodal neuromodulation approaches. These insights, including the novel use of multimodal neuromodulation to manage dose-limiting adverse effects of ITB, may help optimize ITB practice, particularly in regions where its use is still emerging.

PMID 42240894
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