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baclofen (Fleqsuvy)

✓ Approved

Azurity Pharmaceuticals, Inc. · GABBR1 · Small Molecule

What is baclofen?

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

Drug Profile

Brand NamesFleqsuvy
CompanyAzurity Pharmaceuticals, Inc.
Drug ClassSmall Molecule
Molecular TargetGABBR1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Azurity Pharmaceuticals, Inc.

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 3 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Nervous system disordersMultiple sclerosis✓ Approved
Nervous system disordersMuscle spasticity✓ Approved
Injury, poisoning and procedural complicationsSpinal cord injury✓ Approved

Related Research Articles

PubMedMultiple sclerosis and related disorders2026-08-28

Differences in efficacy, safety and procedure during a continuous intrathecal baclofen trial to treat severe spasticity in multiple sclerosis compared to other aetiologies.

van der Gaag Simone Me SM, Frankema Sander Pg SP, Wijffels Markus Pjm MP, Baart Sara J SJ et al.

Spasticity is a common issue following from various conditions and affects daily functioning and quality of life. Intrathecal baclofen (ITB) therapy is offered to patients unresponsive to conventional treatments. Before a permanent ITB-pump is installed, a trial treatment is administered. In our daily practice, we observed that patients with Multiple Sclerosis (MS) experience continuous trials differently compared to patients with other aetiologies. Thus, we aim to compare efficacy, safety, and procedure of continuous ITB-trials between patients with MS and those with other underlying causes of spasticity. Adult and ambulatory patients with disabling spasticity, who underwent continuous ITB-trials between January 2014 and January 2022 were included. Data from their medical records were analyzed retrospectively. The study population's characteristics, procedure details, spasticity, (Serious) Adverse Events ((S)AE), patient goals and satisfaction were abstracted and compared between an MS- and a comparator-group. Records of 54 patients were included; one third had MS. Spasticity improved significantly after the ITB-trial in both groups. Overall, 67% of patients had one or more adverse events. The most common AE was postdural puncture headache (PDPH), which occurred significantly more often in patients with MS than in the comparison group (67%vs. 33%). Severe PDPH was reported in 44% of MS patients compared to 13.9% in the other group. Despite this, MS patients reported greater satisfaction with trial outcomes and were more often seen as suitable for permanent pump implantation. Continuous ITB-trials effectively reduce spasticity but adverse events, especially (severe) PDPH, were common and particularly impacted patients with MS. These results raise doubts about whether continuous ITB-trials should be the first choice for ambulatory MS patients.

PMID 42664641
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PubMedIn vivo (Athens, Greece)2026-08-28

Identification of Factors Associated With Clinically Problematic Hiccups in Male Patients Receiving Cisplatin-based Treatment With Dexamethasone and Aprepitant: A Subgroup Analysis.

Saito Yoshitaka Y, Takekuma Yoh Y, Sakakibara-Konishi Jun J, Shimizu Yasushi Y et al.

Hiccups frequently occur during cisplatin (CDDP)-based treatment, and dexamethasone and neurokinin-1 receptor inhibitors may also induce these symptoms. We have previously reported that male sex is a significant risk factor for clinically problematic hiccups in patients receiving CDDP-based chemotherapy with these antiemetics. This study aimed to further evaluate factors associated with the symptoms in male patients receiving CDDP, dexamethasone, and aprepitant through a subgroup analysis. Male patients with thoracic cancer who received their first cycle of CDDP-based treatment (≥75 mg/m2) in combination with dexamethasone, palonosetron, and aprepitant (n=186) were retrospectively evaluated. The primary endpoint was the identification of factors associated with grade ≥2 hiccups during the first cycle. The incidence of grade ≥2 hiccups was 46.8%, while the overall incidence of hiccups of any grade was 60.8%, including 8.1% grade 3 cases. The median time to symptom onset was two (range=1-5) days, and the median duration was two (range=1-12) days. Most patients (97.7%) received metoclopramide as first-line treatment, with an efficacy rate of 55.3%. Efficacy rates were 76.1% for baclofen, 86.4% for chlorpromazine, and 50.0% for Shakuyaku-Kanzo-To. Multivariable logistic regression analysis showed that hypoalbuminemia and concomitant bevacizumab use were significant risk factors for grade ≥2 hiccups [adjusted odds ratio (95% confidence interval)=2.53 (1.06-6.03), p=0.04; and 4.11 (1.26-13.38), p=0.02, respectively]. Hypoalbuminemia and concomitant bevacizumab use are significant risk factors for clinically problematic hiccups in male patients receiving CDDP-based treatment with dexamethasone and aprepitant for thoracic cancer.

PMID 42665391
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PubMedMedicina2026-08-27

[Pharmacologic treatment of dystonia].

Zea Vera Alonso A, Guerrero Ruiz Graciela Del Pilar GDP

Dystonia is a significant cause of morbidity and disability in children. Treatment aims to improve function, reduce pain and disability, and enhance the child's quality of life. This review describes the most used pharmacological options for treating persistent dystonia. The main medications used to treat dystonia include anticholinergics, baclofen, and benzodiazepines. Botulinum toxin is also effective, particularly in focal dystonias. Other drugs such as levodopa, gabapentin, clonidine, and vesicular monoamine transporter inhibitors are also frequently used. The most common adverse effects are discussed. Medication selection should consider etiology, subtype of dystonia, potential adverse effects, and associated comorbidities.

PMID 42659548
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PubMedPM & R : the journal of injury, function, and rehabilitation2026-08-27

Predicting functional outcomes following surgical intervention and inpatient rehabilitation stay in children with cerebral palsy.

Barbuto Amy A, Seymour Michelle L ML, Thomas Sruthi P SP, Mitchell Katy K et al.

The ability to predict functional outcomes in children with cerebral palsy (CP) after surgical procedures and a subsequent inpatient rehabilitation unit (IRU) stay is limited based on current literature. To determine if length of stay (LOS) and functional outcomes could be predicted in children with CP following a surgical procedure and IRU stay based on the surgical procedure performed, pattern of involvement, etiology, and Gross Motor Function Classification System level. Retrospective cohort study. Tertiary care pediatrics. Pediatric patients with CP (N = 139) who underwent one of three surgical procedures followed by an IRU stay. Selective dorsal rhizotomy, single-event multilevel orthopedic surgery, or intrathecal baclofen pump implantation and subsequent IRU stay. IRU LOS, Functional Independence Measure for Children (WeeFIM) total score, subscores (mobility, self-care, and cognition), efficiency, and change score. Surgical procedure and WeeFIM mobility subscore at admission were significantly predictive of LOS (p < .001). Type/pattern of limb involvement, age, etiology, Gross Motor Function Classification System, and admission WeeFIM total were significantly predictive of total WeeFIM score at discharge (p < .001) and explained 86% of the variance. All WeeFIM subscores at admission were significant predictors of subscores at discharge (p < .001). Type/pattern of limb involvement, as an individual predictor, was most associated with WeeFIM efficiency (r = .398) and WeeFIM change (r = .445, p < .001). Cognition was found to be a significant mediator of the relationship between both admission mobility and self-care and the gains attained during an IRU stay (p ≤ .004). LOS and functional outcomes could be predicted with a minimal set of factors accounting for 86% of the variance. Cognition at IRU admission has an important influence on functional outcomes during the postoperative rehabilitation period.

PMID 42656068
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PubMedNatural products and bioprospecting2026-08-24

Cornepalenins A-D, picrotoxane-type sesquiterpenes from the flowers of Coriaria nepalensis associated with modulation of GABAB receptor-related signaling.

Tan Min M, Xie Rong R, Liu Dan D, Bai Yao Y et al.

Three new picrotoxane-type sesquiterpenes (PSTs) cornepalenins A-C (1-3), along with eight known analogues (4-11), were isolated and identified from the flowers of Coriaria nepalensis. In addition, the spectroscopic data and absolute configurations of the known compound cornepalenin D (4) are reported for the first time. Biological evaluation results showed that multiple compounds exhibited certain inhibitory effects on GABAB receptor-mediated signaling pathways in both primary cerebellar granule neurons and GABAB receptor-overexpressing HEK 293 T cells. Among them, compound 6 displayed relatively stronger inhibitory activity under stimulation with GABA and baclofen, and was more potent than the positive control CGP54626. The IC50 value of compound 6 was 1.41 ± 0.86 μM under GABA stimulation and 1.45 ± 0.55 μM under baclofen stimulation. In addition, mechanistic studies indicated that this compound suppressed the phosphorylation of ERK1/2. Collectively, this study demonstrates that PSTs can modulate GABAB receptor-related signaling pathways and provides experimental evidence for their further investigation in central nervous system-related disorders.

PMID 42635878
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PubMedAmerican journal of physical medicine & rehabilitation2026-08-21

Hidden Risks of Multimodal Neuromodulation: Suspected Intrathecal Baclofen Pump Motor Stall Induced by a Vagus Nerve Stimulator Magnet.

Sharma Priya P, Deck Brigid B, Dudiak Gregor J GJ, Shi Weibin W et al.

The increasing use of implantable neuromodulation devices in patients with chronic post-stroke sequelae raises the possibility of unintended device-device interactions. We report a case of recurrent intrathecal baclofen pump motor stalls in a patient with longstanding spasticity following an intracranial hemorrhage, ultimately attributed to magnetic interference from a recently implanted vagus nerve stimulator (VNS) activator magnet. Recognition of this interaction led to prompt resolution and highlights the importance of interdisciplinary awareness and patient education in individuals with multiple implanted neuromodulation systems.

PMID 42625252
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