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baclofen (Ozobax)

✓ Approved

Metacel Pharmaceuticals · GABBR1 · 小分子

什么是 baclofen？

baclofen 是一种小分子，由Metacel Pharmaceuticals研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Ozobax
公司Metacel Pharmaceuticals
药物类别小分子
分子靶点GABBR1
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, Metacel Pharmaceuticals

作用机制

分子靶点

baclofen 作用于 1 个分子靶点：

GABBR1gamma-aminobutyric acid type B receptor subunit 1 (GABABR1, GB1)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

baclofen 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Nervous system disordersMuscle spasticity✓ Approved

相关研究文献

PubMedDrug and therapeutics bulletin2026-06-13

Update on spasticity: part-2 - physical, pharmacological and surgical management.

Chukwuocha Ikechukwu I, Nair Krishnan Padmakumari Sivaraman KPS

The management options for spasticity include non-pharmacological approaches, oral antispasticity drugs, botulinum injections, intrathecal baclofen, neuromodulation techniques and surgery. Effective management necessitates a tailored approach grounded in a comprehensive understanding of pathophysiological mechanisms, disease progression and functional outcomes. Spasticity does not always require treatment. The management should be oriented towards goals which are meaningful for individual patients. This process requires a multidisciplinary team with treatment modalities to reduce spasticity categorised into physical methods, pharmacotherapy, interventional and focal therapies as well as surgical methods.

PMID 42285756
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PubMedJournal of clinical medicine2026-06-12

Intrathecal Baclofen in Children with Cerebral Palsy: A Critical Review of Selection Criteria, Rehabilitation Goals, Outcomes, and Complications.

Retkowska-Tomaszewska Natalia N, Defort Piotr P, Barciszewska Anna-Maria AM, Patkowski Dariusz D

Background: Spasticity is a major contributor to pain, impaired mobility, contractures, and caregiver burden in children with cerebral palsy. Intrathecal baclofen (ITB) is an established treatment for severe generalized spasticity when rehabilitation, oral medications, and focal interventions are insufficient or poorly tolerated. Methods: This critical review synthesizes current evidence on ITB in children with cerebral palsy, focusing on patient selection, screening, rehabilitation goals, functional outcomes, complications, and long-term management. Results: Available evidence consistently demonstrates substantial and sustained tone reduction with ITB, with associated improvements in comfort, positioning, ease of care, pain, and selected quality-of-life domains. However, gains in gross motor function are variable and depend on baseline motor phenotype, individualized treatment goals, and careful dose titration. Device-related complications, infections, catheter dysfunction, overdose, and withdrawal remain clinically significant risks requiring specialized multidisciplinary follow-up. Compared with selective dorsal rhizotomy and botulinum toxin injections, ITB provides a reversible and programmable option particularly suited to children with severe, generalized spasticity and high caregiving needs. Conclusions: ITB represents an important component of comprehensive, goal-directed spasticity management in appropriately selected children. Further high-quality longitudinal and comparative studies are needed to define long-term functional and cost-effectiveness outcomes better.

PMID 42278952
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PubMedThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG2026-06-10

Assessment of Enteral Baclofen Prescribing Practices for Infants With Hypertonia.

DiTaranto Hope E HE, Moore Astrela A, Kendsersky Rebecca R, Zook Jessica J et al.

Baclofen is used for hypertonia in infants despite limited dosing guidance. This study describes enteral baclofen prescribing in patients 12 months of age and younger. This single-center, retrospective review evaluated infants receiving enteral baclofen from January 2013 to December 2022. Regimen information, including dose, frequency, age, weight, and duration of treatment for up to 1 year following initiation, was assessed. Other outcomes included place in therapy, safety, and tolerability. This study included 108 patients with 423 total regimens. At initiation, the median baclofen dose was 1.3 mg, corresponding to a weight-based dose (WBD) of 0.2 mg/kg, a total daily dose (TDD) of 3 mg, and a weight-based total daily dose (wTDD) of 0.5 mg/kg/day. Sixty-one patients (56.5%) received baclofen 3 times daily at initiation. The patients' longest-tolerated regimen had a median dose of 2.8 mg, corresponding to a WBD of 0.4 mg/kg, a TDD of 9 mg, and a wTDD of 1.3 mg/kg/day. Hypoxemic-ischemic encephalopathy and brain injury were the most common etiologies of hypertonia. Baclofen was the first antispastic agent for 37 patients (34.3%). Twenty-four patients (22.2%) discontinued baclofen within 1 year. Four patients (3.7%) stopped baclofen due to adverse effects (sedation and emesis). The median initiation dose of baclofen in infants was lower than the recommended dose for patients aged younger than 2 years, highlighting variability in practice. The baclofen regimens used in this study were safe and well-tolerated. These findings provide insight into baclofen prescribing for infants with hypertonia.

PMID 42267063
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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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