Tarlige (mirogabalin) / Daiichi Sankyo, Menarini - LARVOL DELTA

Patients on Regular Preoperative Weak Opioid Intake Can Achieve Successful Surgical Outcomes After Posterior Decompression Surgery for Cervical Spondylotic Myelopathy. (PubMed, Clin Spine Surg) - "Patients receiving regular weak opioids preoperatively can achieve successful surgical outcomes after posterior decompression surgery for cervical spondylotic myelopathy."

Journal • CNS Disorders • Musculoskeletal Pain • Orthopedics • Pain

Mirogabalin efficacy and safety for chemotherapy-induced peripheral neuropathy: single-centre retrospective observational study. (PubMed, BMJ Support Palliat Care) - "Treatment with an effective dose of mirogabalin suggests an improvement in CIPN induced by various neurotoxic chemotherapeutic agents regardless of whether chemotherapy was ongoing or completed."

Journal • Observational data • Retrospective data • Oncology • Pain

Reply to 'Mirogabalin: Promising Evidence, Uncertain Access'. (PubMed, Eur J Pain) - No abstract available

Journal

Efficacy and Safety of Ca2+ Channel α2δ Ligands for the Treatment of Diabetic Peripheral Neuropathic Pain: A Systematic Review and Network Meta-analysis. (PubMed, Pain Ther) - "Mirogabalin, especially at 30 mg showed superior or comparable pain relief, improved sleep interference, and favorable tolerability for diabetic peripheral neuropathic pain treatment. Ca2⁺ channel α2δ ligands demonstrated consistent efficacy in pain reduction and functional improvement, supporting their role as first-line therapies for DPNP."

Journal • Retrospective data • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

A Multicenter, Prospective, Observational, and Single-Arm Interventional Study of Mirogabalin in Diabetic Peripheral Neuropathic Pain: Rationale and Design of Dia-NeP. (PubMed, Diabetes Ther) - "This study will not only show the latest prevalence of DPN and DPNP in Japan, but is also the first study to investigate the efficacy and safety of mirogabalin in patients with DPNP having mild pain, as well as moderate-to-severe pain, and is expected to provide useful evidence for future DPN and DPNP treatment. Japan Registry of Clinical Trials (jRCTs031240623, registered 20/January/2025, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs031240623 )."

Journal • Observational data • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

Efficacy and Safety of Mirogabalin as an Add-on to Nonsteroidal Anti-inflammatory Drugs for Neuropathic Pain Caused by Lumbar Disc Herniation: A Randomized Controlled Study (Miro-Hers). (PubMed, Pain Ther) - "The addition of mirogabalin to NSAIDs treatment significantly improved pain, quality of life, and sleep disturbance in patients with LDH, with no previously undocumented safety concerns identified."

Journal • CNS Disorders • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Pain • Sleep Disorder

Mirogabalin: Promising Evidence, Uncertain Access. (PubMed, Eur J Pain) - No abstract available

Journal

EFFICACY OF MIROGABALIN IN REFRACTORY NEUROPATHIC PAIN: OBSERVATIONS FROM A SMALL COHORT STUDY (WCN 2025) - "We report the clinical effectiveness of mirogabalin in patients with treatment-resistant neuropathic pain. Thirteen patients with neuropathic pain who had shown inadequate response to existing pharmacologic treatments—including other α2δ ligands (e.g., pregabalin, gabapentin), serotonin-norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants—were included. Mirogabalin demonstrated partial effectiveness in a majority of patients with treatment-resistant neuropathic pain, including those with diabetic neuropathy, radiculopathy, and fibromyalgia. These findings suggest that mirogabalin may serve as a valuable therapeutic option when conventional agents fail and merit further validation in larger, controlled studies."

Clinical • CNS Disorders • Musculoskeletal Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Calcium Channel α2δ Ligands Mirogabalin, Pregabalin, and Gabapentin: Advancements in Diabetic Peripheral Neuropathic Pain Therapeutics. (PubMed, Pain Ther) - "This review aims to summarize the latest status of α2δ ligand development and provide a comprehensive evaluation of α2δ ligands for the management of DPNP, emphasizing the potential mechanism of action, clinical efficacy, safety profile, and pharmacoeconomics. Further perspectives are warranted for treatment strategies to address individual patient care.A Graphical Abstract is availible for this article."

Journal • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Mirogabalin for Treatment of Neuropathic Pain and Associated Sleep Interference: An Updated Meta-Analysis. (PubMed, Eur J Pain) - "This meta-analysis refines the current understanding of mirogabalin by demonstrating modest yet consistent benefits in reducing pain and pain-related sleep interference across neuropathic pain syndromes. The results contribute to ongoing efforts to optimise neuropathic pain management and provide more robust evidence to support clinical decision-making and guideline development."

Clinical • Journal • Retrospective data • Review • Musculoskeletal Pain • Neuralgia • Pain

The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=362 | Recruiting | Sponsor: Beijing Tiantan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Paclitaxel-induced Peripheral Neuropathy and Quality of Life: Sub-analysis of the MICHEL Study. (PubMed, Anticancer Res) - "Paclitaxel administration affected activities of daily living through CIPN and symptoms were primarily noted in the hands and feet with regard to fine motor hand movements and mobility. Individualized care, potentially with duloxetine or rehabilitation exercises (in addition to self-care education), may be considered stopgap measures."

HEOR • Journal • Breast Cancer • Oncology • Pain • Solid Tumor

The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=362 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

Monotherapy • New trial • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Human iPSCs : a translatable assay for screening novel peripheral analgesics (NeuPSIG 2025) - "Tetrodotoxin (TTx)-insensitive Na+ currents were isolated by manual patch-clamp (MPC) recordings using an Axon 700B amplifier/1332A digitizer interface (Molecular Devices). To functionally validate the expression of key "analgesic targets" we implemented a complementary MEA/Ca2+ imaging approach...Acute dosing with TTx, retigabine, linopirdine and mibefradil revealed that TTx-sensitive Na+, KV7 "M-current" and CaV3.x channels were key ionic mediators of spontaneous EAPs.To examine whether spontaneous EAPs provide a reliable metric for analgesic screening we applied clinically established analgesics. Strikingly, ibuprofen, naproxen, lidocaine, THC and cannabinol induced clear reductions in firing-frequency whilst vehicle controls and the centrally acting analgesic mirogabalin were without effect. In conclusion RealDRGTM hiPSC sensory neurons functionally express many key ion channels commonly targeted in analgesic drug development... In conclusion..."

Addiction (Opioid and Alcohol) • CNS Disorders • Neuralgia • Pain • CAV3 • TRPM3 • TRPM8 • TRPV1

Characterization of actions of the novel gabapentinoid drug mirogabalin on painful bladder hypersensitivity in rats with lipopolysaccharide-induced chronic cystitis. (PubMed, Life Sci) - "The therapeutic effects of MGB in hypersensitivity associated with cystitis, similar to other gabapentinoids, are mediated by spinal and supraspinal actions, likely via the α2δ-1 subunit. Additionally, MGB exerts its analgesic effects through a supraspinal mechanism via the descending noradrenergic pathway, whereas a different mechanism regulates micturition."

Journal • Preclinical • Immunology • Interstitial Cystitis • Musculoskeletal Pain • Pain

Gabapentinoids for Neuropathic Pain After Spinal Cord Injury: An Updated Meta-Analysis of Randomized Controlled Trials. (PubMed, Pain Pract) - "In this meta-analysis of RCTs evaluating patients with CNP following SCI, gabapentinoids were associated with significant improvements in pain and pain-related sleep interference compared with placebo. Nonetheless, gabapentinoids significantly increased the risk of adverse events."

Clinical • Journal • Retrospective data • Review • Central Neuropathic Pain • CNS Disorders • Neuralgia • Orthopedics • Pain

A case report: preceding diagnosis of type 2 diabetes by severe neuropathic pain arising from diabetic polyneuropathy. (PubMed, Diabetol Int) - "Management encompassed glycemic control with linagliptin and pain mitigation with mirogabalin and duloxetine. Glycemic stability was achieved with HbA1c levels averaging around 6.2%. Gradual amelioration of subjective symptoms associated with painful DPN ensued, with positive pain manifestations resolved approximately one year post-initiation of therapy; however, residual sensory neuropathic deficits, typified by diminished sensation in both toe tips, persisted."

Journal • Diabetes • Diabetic Neuropathy • Diabetic Retinopathy • Metabolic Disorders • Neuralgia • Pain • Retinal Disorders • Type 2 Diabetes Mellitus

Incidence of somnolence and dizziness induced by mirogabalin and pregabalin under opioid treatment: a single-center observational study. (PubMed, J Pharm Health Care Sci) - No abstract available

Journal • Observational data

Enhancing Duloxetine With Mirogabalin for Treating Taxane-Induced Peripheral Neuropathy in Advanced Lung Cancer. (PubMed, Cancer Control) - "The Numerical Rating Scale (NRS) was utilized to evaluate outcomes, and Wilcoxon's signed rank-sum test was used in statistical analysis.ResultsThe median Numerical Rating Scale (NRS) score decreased from 5.5 (interquartile range [IQR]: 4.5-7.0) before to 4.0 (IQR: 3.0-5.0) after mirogabalin administration (P = 0.041), indicating significant pain reduction.ConclusionThe addition of mirogabalin to duloxetine shows promise in alleviating CIPN in advanced lung cancer patients treated with taxane anticancer agents. These findings warrant further investigation and consideration for their integration into clinical practice for managing CIPN."

Journal • Observational data • Retrospective data • Lung Cancer • Oncology • Pain • Peripheral Neuropathic Pain • Solid Tumor

A case of dementia with Lewy bodies with psychosis induced by low-dose gabapentinoids. (PubMed, BMC Psychiatry) - "Although pregabalin-induced psychosis has been reported at higher doses (300-450 mg daily), it has not been reported at doses as low as those used in this patient. Gabapentinoids may cause psychosis in patients with dementia with Lewy bodies even at low doses, likely due to hypersensitivity to gabapentinoids in DLB."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Immunology • Lewy Body Disease • Movement Disorders • Neuralgia • Pain • Parkinson's Disease • Psychiatry

Safety and Efficacy of Mirogabalin in Lumbar Spinal Stenosis Patients with Peripheral Neuropathic Pain on NSAIDs: Post Hoc Analysis of the MiroTAS Study. (PubMed, Pain Ther) - "Mirogabalin was not related to specific patient characteristics regarding the onset of mrADRs and was effective for LSS regardless of patient characteristics. Caution is needed regarding the onset of mrADRs after first administration and uptitration of mirogabalin, but these may not reduce QOL or patient satisfaction. Patients with high numbness scores may be more likely to benefit from treatment with mirogabalin in terms of QOL."

Journal • Retrospective data • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain • Peripheral Neuropathic Pain

Crisugabalin, a ligand for the α2δ subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents. (PubMed, Pharmacol Biochem Behav) - "Secondly, a rat drug discrimination study was employed to determine the pharmacological similarity between crisugabalin and the training drug midazolam. In the rat spontaneous withdrawal study, crisugabalin demonstrated a very low level of physical dependence. These findings suggest that crisugabalin has minimal to no potential for abuse, thereby establishing itself as a safer option relative to pregabalin and mirogabalin."

Journal • Preclinical • CNS Disorders • Diabetic Neuropathy • Epilepsy • Neuralgia • Pain • Peripheral Neuropathic Pain

Mirogabalin and pregabalin alleviate nociplastic sensitization induced by chemogenetic activation of the central amygdala neurons in rodents. (PubMed, J Pharmacol Sci) - "Administration of an artificial ligand, deschloroclozapine (DCZ; 0.1 mg/kg, i.p.), significantly reduced the 50 %-paw withdrawal threshold, which was significantly elevated by MGB (10 mg/kg, i.p.) and PGB (30 mg/kg, i.p.), restoring it to levels not significantly different from the pre-DCZ baseline. We conclude that MGB and PGB alleviate widespread sensitization in this nociplastic pain model, likely through their action on α2δ-1 subunits within brain circuits that regulate pain sensitivity."

Journal • Preclinical • Pain

Co-treatment with Gabapentinoid and Japanese Herbal Medicine Goshajinkigan for CIPN is Associated with Longer Duration and Higher Dose of Chemotherapy. (PubMed, Adv Ther) - "Combination treatment with gabapentinoid plus GJG might prevent reductions in dose or discontinuation of chemotherapy, and might be effective for the treatment of CIPN."

Journal • Breast Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pain • Solid Tumor

Adverse events, including fractures, among older patients receiving mirogabalin versus pregabalin: A retrospective cohort study using a large claims database in Japan. (PubMed, Ann Clin Epidemiol) - "Our analyses suggest that the outcome may be less likely in the mirogabalin group; however, the difference appears to be clinically insignificant. Further studies are warranted to confirm these findings."

Adverse events • Journal • Retrospective data • Musculoskeletal Diseases • Neuralgia • Orthopedics • Pain