Drug Database
BA

baclofen (Baclofen XL / baclofen SR, SPARC / baclofen SR)

✓ Approved

Sun Pharma Advanced Research Company Limited · GABBR1 · Small Molecule

What is baclofen?

baclofen is a small molecule developed by Sun Pharma Advanced Research Company Limited. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesBaclofen XL, baclofen SR, SPARC, baclofen SR
CompanySun Pharma Advanced Research Company Limited
Drug ClassSmall Molecule
Molecular TargetGABBR1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Sun Pharma Advanced Research Company Limited

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 disordersMuscle spasticity✓ Approved
Psychiatric disordersAlcoholismPhase III
Nervous system disordersMultiple sclerosisPhase III

Related Research Articles

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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PubMedDevelopmental medicine and child neurology2026-08-21

Pharmacological and non-pharmacological interventions for managing sleep disorders in children with cerebral palsy: A systematic review.

Jaiswal Nishant N, Fisher Lizzie L, Ciminata Giorgio G, Mulholland Ryan R et al.

To systematically review the effectiveness, safety, and economic evidence of pharmacological and non-pharmacological interventions for sleep disorders in children with cerebral palsy (CP). Databases including MEDLINE, Embase, CENTRAL (the Cochrane Library), International Clinical Trials Registry Platform of the World Health Organization, NHS Economic Evaluation Database, and ClinicalTrials.gov were searched up to May 2026. Randomized controlled trials and economic evaluations were eligible. Primary outcomes included sleep quality, adverse events, and tolerability. We incorporated interest holder perspectives, including clinicians and individuals with lived experience, throughout outcome prioritization and interpretation. We assessed risk of bias using the Cochrane Risk of Bias 2.0 tool and evaluated the certainty of evidence using Grades of Recommendation, Assessment, Development and Evaluation. Twelve randomized controlled trials (n = 19-142, aged 5-17 years) were included. Pharmacological (melatonin, cannabis-based medicines, baclofen, neural stem cells) and non-pharmacological interventions (massage, cranial osteopathy, music therapy, acupuncture, postural support) were evaluated. Melatonin improved sleep latency and duration modestly compared with placebo. Other interventions showed inconsistent or negligible effects. Adverse events were mild and tolerability acceptable. No completed economic evaluations were identified. Interest holders highlighted the multifactorial nature of sleep problems, the need for interventions addressing comorbidities, and improved reporting of equity factors. Evidence for managing sleep disorders in children with CP is limited, heterogeneous, and of low certainty. Robust trials and economic evaluations are urgently needed.

PMID 42625443
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PubMedJournal of opioid management2026-08-19

Comparison of oral tizanidine and baclofen for post-operative pain management after femoral fracture surgery.

Aezzi Goli G, Emadi Seyed Abdollah SA, Ghaffari Salman S, Safarpour Ali A et al.

Effective post-operative pain management enhances patients' quality of life and reduces post-operative immobility. To compare the analgesic efficacy of preoperative tizanidine versus baclofen in patients undergoing femoral fracture surgery. In this double-blind clinical trial, 50 patients were randomized to receive either 4 mg tizanidine (Group A) or 25 mg baclofen (Group B) orally before surgery. Post-operative pain was managed with an analgesic pump containing morphine and paracetamol. Pain intensity, nausea, vomiting, pruritus, and analgesic use were assessed upon entering the recovery ward and at 2, 4, 6, 12, 24, and 48 hours post-surgery. Pain intensity, measured by the Visual Analog Scale (VAS), decreased significantly over time in both the tizanidine and baclofen groups (p < 0.001). Although a group-by-time interaction was initially observed (p = 0.042), further analysis revealed this to be a trend rather than a robust difference in the primary outcome. Specifically, at 6, 24, and 48 hours post-surgery, VAS scores were 3.08 ± 1.63, 2.88 ± 1.01, and 2.08 ± 1.04 in the tizanidine group, compared to 3.92 ± 1.29, 3.56 ± 1.16, and 2.84 ± 1.57 in the baclofen group. While uncorrected p-values for these intervals were 0.049, 0.032, and 0.049, respectively, none reached statistical significance after applying the Bonferroni correction for multiple comparisons (p > 0.0167). Additionally, there were no significant differences between groups regarding total morphine consumption or the incidence of adverse effects. Preoperative administration of 4 mg tizanidine and 25 mg baclofen showed comparable efficacy in post-operative pain management. As this study lacked a placebo control, it cannot confirm the absolute analgesic efficacy of either drug over no treatment. Although tizanidine demonstrated a trend toward lower pain scores at certain intervals, these differences were not statistically significant after adjustment for multiple comparisons. Both drugs exhibited similar safety profiles and supplemental analgesic requirements.

PMID 42615299
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PubMedCureus2026-08-16

Lost in Transition: A Case Study of Oral Baclofen Withdrawal Presenting as Severe Pain.

LaCroix Kelli K, Patel Purvee P, Selod Omar O

Baclofen, a gamma-aminobutyric acid type B (GABA-B) receptor agonist commonly used for spasticity management, is known to cause withdrawal symptoms after abrupt discontinuation. Unique clinical presentations of oral baclofen withdrawal are not well documented, and severe hyperalgesia-like pain disproportionate to expected postoperative recovery has not been well described in the context of oral baclofen withdrawal. This case study depicts a rare presentation of oral baclofen withdrawal in a 46-year-old woman with complete paraplegia and chronic spasticity (Modified Ashworth Scale Grade 4) following an inadvertent 75% dose reduction in her home baclofen regimen (postoperative day 0) at an outside facility during transitions between healthcare facilities. The patient presented with agitation, tachycardia, diaphoresis, insomnia, severe postoperative lower extremity pain, increased pain sensitivity out of proportion to expected postoperative recovery, and progressive muscle spasms after ankle surgery one week prior. On Hospital Day 1, she required 141.25 oral morphine equivalents (OMEs), including scheduled, one-time, and as-needed opioid doses. Her pain symptoms were worsening despite escalating opioid therapy and the absence of postoperative signs of infection or hardware malfunction on Hospital Day 2. A detailed medication reconciliation on Hospital Day 3 revealed that her chronic baclofen dose of 20 mg four times daily was mistakenly reduced to 20 mg once daily on the day of her surgery. She was given two additional doses of baclofen 20 mg on Hospital Day 3, and her OME was 117.5. Following restoration of her full home baclofen regimen on Hospital Day 4, the patient experienced significant improvement in pain, spasticity, sleep quality, and a proportionate decrease of opioid requirements (OME of 75). This case highlights the diagnostic challenge of oral baclofen withdrawal when it presents as refractory postoperative pain and emphasizes the clinical finding of hyperalgesia-like pain and rebound spasticity as a potentially unrecognized presentation of oral baclofen withdrawal. Further, it highlights the importance of accurate medication reconciliation, continuity of antispasmodic therapy, and patient education during transitions of care to prevent avoidable complications of baclofen withdrawal and unnecessary escalations of analgesic management.

PMID 42604390
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PubMedThe American journal of tropical medicine and hygiene2026-08-13

Management of Generalized Adult Tetanus with Intermittent Intrathecal Baclofen Bolus: Overcoming Infrastructural Limitations in a Resource-Limited Setting.

Jindal Kashish K, Aymanom Chackappen C, Bairwa Mukesh M, Kant Ravi R et al.

Generalized tetanus presents a formidable therapeutic challenge, especially when refractory to conventional management. Standard treatment involves toxin neutralization, muscle spasm control (sedation and magnesium sulfate), and supportive care. However, refractory cases often necessitate prolonged intensive care and risk secondary complications. Intrathecal baclofen (ITB), a gamma-aminobutyric acid type B agonist that reduces spinal hyperexcitability, is highly effective. Although continuous ITB infusion is the established gold standard, its implementation is often constrained in resource-limited environments due to high equipment and technical demands. We studied three patients with severe, conventional treatment-resistant generalized tetanus. A history of incomplete booster immunization among these patients leaves them vulnerable. Unable to use a continuous pump for ITB, we turned to intermittent bolus ITB injections as a pragmatic clinical strategy. Administered with meticulous caution, this bolus approach-often requiring repeat, titrated doses-proved successful in achieving promising control of the dangerous muscle spasms while monitoring closely for complications.

PMID 42594856
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