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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

PubMedJournal of pediatric gastroenterology and nutrition2026-05-18

Rumination syndrome and eosinophilic esophagitis in children: Defining the relationship.

Yang Dennis D, Lu Peter L PL, Khoo Janice S JS, Sanchez Raul E RE et al.

While rumination syndrome (RS) and eosinophilic esophagitis (EoE) can share overlapping symptoms, their association remains unclear. Our objective was to explore the relationship between RS and EoE and understand the clinical course of children with both conditions. We conducted a retrospective cohort study of children with RS and EoE evaluated at our institution from 2016 to 2023. Patient characteristics, symptoms, treatments, and outcomes were compared. Among 230 children with RS, 22 (10%) had both RS and EoE (77% male, median age 18 years). Sixteen (70%) were first diagnosed with EoE, two (9%) with RS, and four (18%) concurrently. Most (91%) presented with regurgitation; 64% reported dysphagia at some point. EoE treatment led to mucosal remission in 73% and improved dysphagia in 41%, but 86% continued to experience regurgitation. RS treatment, including behavioral therapy and baclofen, improved or resolved regurgitation in 64%. Peak eosinophil counts were similar in children with and without dysphagia (43 vs. 51 eos/HPF, p = 0.589). Those without dysphagia responded better to RS treatment (67% vs. 22%), though the difference was not statistically significant. Among those diagnosed with EoE first, RS diagnosis occurred after a median of 15.4 months. EoE was more prevalent among children with RS than in the general population. Regurgitation seemed more responsive to RS treatment than EoE treatment. In patients with EoE and persistent regurgitation, RS should be considered, especially when symptoms persist despite EoE remission.

PMID 42148519
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PubMedCureus2026-05-15

Baclofen in Refractory Dyspepsia With Chronic Belching: A Case Report.

Rocha Mariana M, Silva Lisete L, Coelho Francisco F

Dyspeptic symptoms associated with chronic belching may substantially affect quality of life and can be challenging to manage in clinical practice. We report the case of a 40-year-old nulligravid woman with depressive disorder, bilateral cochlear implants due to deafness, a hiatal hernia, and a previous pulmonary embolism. Her medications included desvenlafaxine, multiple benzodiazepines, mirtazapine, trazodone, and apixaban. She presented with an 18-month history of persistent belching, heartburn, early satiety, and intermittent dry cough, severely impairing her quality of life and leading to social isolation. Additionally, her symptoms intensified during anxiety and depressive episodes. Physical examination was unremarkable, and upper gastrointestinal endoscopy revealed only a small hiatal hernia and mild gastropathy, with no evidence of Helicobacter pylori infection. Despite repeated medical evaluations and multiple therapeutic approaches, including proton pump inhibitors, sucralfate, domperidone, simethicone, and bilastine, symptoms persisted without significant improvement. Functional dyspepsia was therefore suspected, and treatment with baclofen 10 mg twice daily was initiated, resulting in significant clinical improvement and enhanced quality of life. This report highlights the potential benefit of baclofen in patients with persistent belching and dyspeptic symptoms refractory to conventional therapy, particularly in the context of psychiatric comorbidity.

PMID 42137706
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PubMedBMJ case reports2026-05-15

Intrathecal baclofen pump failure due to pain-induced autonomic dysreflexia.

Khawer Ahmed A, Jain Ankur A, Naji Luay L, Sheikh Amaan A et al.

Intrathecal baclofen (ITB) therapy is an established treatment for severe refractory spasticity. Although a positive ITB trial confirms efficacy, long-term success can sometimes be limited by mechanical or hardware complications. We describe a patient with multiple sclerosis (MS) and spastic quadriplegia who underwent ITB pump implantation in the posterolateral flank region, a non-standard site selected due to anatomical limitations. The pump provided marked spasticity relief, allowing discontinuation of oral antispasmodics. However, within weeks, the patient developed persistent pump-site pain and recurrent autonomic dysreflexia (AD), an uncommon manifestation in MS that was resistant to treatment. Infectious and other mechanical causes were excluded, and clinical assessment determined that pain from the atypical pump placement was the likely precipitant. The pump was explanted 1 month later, resolving the patient's AD but resulting in recurrence of severe spasticity. This case underscores the need for individualised pump planning to prevent hardware-related complications.

PMID 42134868
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PubMedOrganic letters2026-05-14

Rhodium/Bisphosphine-Thiourea System Catalyzed Asymmetric Hydrogenation of α,β-Unsaturated γ-Lactams.

Feng Ke K, Chen Lingxin L, Liu Ting T, Zhang Xuelei X et al.

Chiral γ-lactams represent an important class of five-membered nitrogen-containing heterocyclic scaffolds, widely found in natural products and bioactive drug molecules. Although multiple strategies exist for constructing this scaffold, asymmetric catalytic hydrogenation is regarded as the most direct and efficient approach owing to its atom economy and step simplicity. Here, we report a Rh/bisphosphine-thiourea catalytic system successfully applied to the asymmetric hydrogenation of various N-substituted α,β-unsaturated γ-lactams, including chiral amino acid derivatives. Excellent enantioselectivity (up to 99% ee and 99:1 dr) and exceptionally high turnover numbers (TON up to 3000) were achieved. The method has been successfully applied to the gram-scale synthesis of key intermediates for pharmaceutically relevant compounds, including brivaracetam, (R)-pregabalin, and (R)-baclofen, demonstrating its potential for application in pharmaceutical manufacture.

PMID 42129955
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PubMedAlimentary pharmacology & therapeutics2026-05-13

Letter: Unmasking the Risks-The Need for Robust Data on Baclofen in Cirrhotic Patients. Authors' Reply.

Yeo Yee Hui YH, Arab Juan Pablo JP, Leggio Lorenzo L

PMID 42120799
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PubMedFrontiers in neuroscience2026-05-11

Transcutaneous auricular vagus nerve stimulation for paroxysmal sympathetic hyperactivity syndrome after intracerebral hemorrhage: a hypothesis-generating case report.

Han Xinyuan X, Huang Zhijun Z, Gao Ziting Z, Feng Yangyang Y et al.

To observe the clinical effect of transcutaneous auricular vagus nerve stimulation (taVNS) in drug-refractory paroxysmal sympathetic hyperactivity (PSH). This case report describes the clinical course of a 63-year-old male with PSH following intracerebral hemorrhage. PSH episodes were characterized by tachypnea, tachycardia, hypertension, and increased muscle tone. After 2 weeks of combination pharmacotherapy (propranolol, baclofen, gabapentin), blood pressure, heart rate, and muscle tone improved, but tachypnea remained inadequately controlled. Although sedative agents alleviated tachypnea, they led to decreased consciousness level and could not be continued. Subsequently, taVNS was added to the ongoing pharmacotherapy. After 4 weeks of taVNS treatment, PSH episode frequency and tachypnea improved. Baclofen and gabapentin were discontinued, propranolol dosage was reduced, and the patient's consciousness level showed improvement. After another 4 weeks of continued treatment, only mild tachypnea occurred occasionally under strong stimulation, without other sympathetic symptoms. Consciousness level further improved. This case suggests that taVNS may be a safe adjunctive intervention option for drug-refractory PSH. The symptom relief and consciousness improvement observed during treatment may be related to the application of taVNS.

PMID 42110200
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