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

Quantitative analysis and method validation of mirogabalin in postmortem blood and urine using liquid chromatography-tandem mass spectrometry. (PubMed, Forensic Toxicol) - No abstract available

Journal

Real-World Safety and Effectiveness of Mirogabalin in Chinese Adults with Diabetic Peripheral Neuropathic Pain: a Protocol of ReMIssion Study. (PubMed, Pain Ther) - P | "Mirogabalin may offer clinical benefits for DPNP management, including improved real-world effectiveness, tolerable safety, and favorable usage patterns, potentially enhancing patient-reported outcomes. Clinicaltrial.gov/NCT06812117."

Journal • Real-world evidence • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Medication Instruction and Mirogabalin Treatment Satisfaction in Patients with Neuropathic Pain due to Orthopedic Diseases: Results of MiroSearch, a Japanese Exploratory Interventional Study. (PubMed, Adv Ther) - "Over half of patients with NeP due to orthopedic diseases were satisfied with mirogabalin treatment. Medication instruction can improve patient understanding of their disease and medications and enhance their treatment satisfaction. Furthermore, communication between patients and physicians/pharmacists may contribute to improving patient treatment satisfaction."

Journal • Musculoskeletal Pain • Neuralgia • Orthopedics • Pain

Mirogabalin Eliminated Pain and Reduced Inflammation in Visceral Pain. (PubMed, Physiol Res) - "However, the fact that mirogabalin did not alter antioxidant systems and IL-6 levels suggests that other mechanisms are responsible for its anti-inflammatory effects. Key words Mirogabalin " Pain " Inflammation " Visceral " GABA."

Journal • Inflammation • Neuralgia • Pain • IL6

Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P4 | N=78 | Recruiting | Sponsor: Bangladesh Medical University

New P4 trial • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia (clinicaltrials.gov) - P=N/A | N=674 | Recruiting | Sponsor: Beijing Tiantan Hospital | N=362 ➔ 674

Enrollment change • Monotherapy • Fibromyalgia • Musculoskeletal Pain • Pain • Rheumatology

Mirogabalin alleviates central neuropathic pain: An investigation using a rat model of cervical spinal cord injury without radiographic abnormalities. (PubMed, J Orthop Sci) - "Administration of MGB decreased Iba-1 and α2δ-1 immunoreactivity in the dorsal horns of a rat model of cervical SCI at 4 weeks after injury. The inhibitory effect of MGB on the α2δ-1 subunit after SCI may contribute to the analgesic effect on cNeuP."

Journal • Preclinical • Central Neuropathic Pain • CNS Disorders • Immunology • Neuralgia • Orthopedics • Pain

Chronic random sleep deprivation causes prolonged pain hypersensitivity via the anterior cingulate cortex. (PubMed, iScience) - "Chemogenetic inhibition of ACC pyramidal neurons or administration of a chronic pain treatment, mirogabalin, normalized ACC activity, and attenuated the mechanical hypersensitivity in RSD mice. These results suggest that enhanced ACC activity mediates the SD-induced prolonged mechanical hypersensitivity."

Journal • CNS Disorders • Immunology • Pain • Sleep Disorder

Efficacy and safety of mirogabalin + opioids vs opioids alone for neuropathic cancer pain: Miro-Canp. (PubMed, Expert Opin Pharmacother) - "Concomitant use of mirogabalin could be a novel treatment option for NCP. Japan Registry of Clinical Trials (https://jrct.mhlw.go.jp/) identifier is jRCTs031220569."

Journal • Neuralgia • Oncology • Pain

Bioequivalence and Comparative Pharmacokinetics of Two Generic Mirogabalin Besylate Tablets (5 mg and 10 mg) and Tarlige® in Healthy Chinese Volunteers: A Pooled Analysis of Two Randomized, Open-Label, Two-Period Crossover Studies. (PubMed, Eur J Drug Metab Pharmacokinet) - "Both generic formulations met bioequivalence criteria to Tarlige® across studied doses. While both formulations showed acceptable PK profiles, the 10 mg dose exhibited more consistent exposure characteristics, as evidenced by a lower within-subject variability. The PK data are consistent with linear PK for mirogabalin within the studied dose range. Comparable safety profiles support the pharmaceutical equivalence in the studied population. These findings provide critical PK evidence for China's first generic mirogabalin products."

Journal • PK/PD data • Retrospective data • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster (clinicaltrials.gov) - P=N/A | N=750 | Recruiting | Sponsor: Beijing Tiantan Hospital | N=400 ➔ 750

Enrollment change • Herpes Zoster • Pain • Varicella Zoster

Transient Neuropathic Pain and Sensory Hypersensitivity Following Single-Pulse Transcranial Magnetic Stimulation: A Case Report. (PubMed, Cureus) - "Symptoms gradually improved with pharmacological treatment using mirogabalin, followed by non-pharmacological interventions, including vibration therapy, transcutaneous electrical nerve stimulation (TENS), and mirror therapy...This report highlights that even low-intensity single-pulse TMS can, in rare situations, induce transient neuropathic-like sensory disturbances. Recognizing such presentations may help clinicians provide appropriate reassurance, monitor symptom progression, and apply targeted therapeutic strategies when unexpected sensory effects arise after TMS."

Journal • Immunology • Neuralgia • Pain

The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster (clinicaltrials.gov) - P=N/A | N=400 | Recruiting | Sponsor: Beijing Tiantan Hospital

New trial • Herpes Zoster • Pain • Varicella Zoster

Structural and Computational Insights into the Mechanism of the Superior Pharmacological Activity of Crisugabalin: A Third-Generation Cavα2δ1 Ligand. (PubMed, J Chem Inf Model) - "Crisugabalin, a recently approved third-generation GABA analogue with a unique cage-like tricyclic scaffold, shows superior efficacy and safety over pregabalin and mirogabalin for treating neuropathic pain...Cryo-EM structures demonstrated crisugabalin's superior binding affinity for α2δ1 over gabapentin and l-leucine, driven by enhanced hydrogen bonding and hydrophobic contacts, alongside volumetric expansion of the l-leucine binding pocket...These findings establish the cage-like tricyclic motif as a novel pharmacophore that simultaneously optimizes binding entropy and enthalpy, providing a blueprint for next-generation voltage-gated calcium channel modulators. MD, τRAMD, and MM-GBSA used in this study are powerful computational tools for rational drug design, particularly for optimizing compounds with prolonged target residence times."

Journal • Neuralgia • Pain

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