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pregabalin (pregabalin, YuHan / YHD 1119 / YHD1119)

✓ Approved

YuHan · CACNA2D1 · 小分子

什么是 pregabalin？

pregabalin 是一种小分子，由YuHan研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名pregabalin, YuHan, YHD 1119, YHD1119
公司YuHan
药物类别小分子
分子靶点CACNA2D1
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, YuHan

作用机制

分子靶点

pregabalin 作用于 1 个分子靶点：

CACNA2D1calcium voltage-gated channel auxiliary subunit alpha2delta 1 (LINC01112, CACNA2)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

pregabalin 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Nervous system disordersDiabetic neuropathy✓ Approved
Nervous system disordersPost herpetic neuralgia✓ Approved

相关研究文献

PubMedTrials2026-09-10

PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA): study protocol for a double-blind randomised controlled trial set in the UK.

Duffy Larisa L, Chew-Graham Carolyn A CA, Ching Brian C F BCF, Chipp Beverley B et al.

Generalised anxiety disorder (GAD) is common and increasingly recognised in primary care. Although antidepressants and psychological therapies are first-line treatments, many patients have residual anxiety and limited access to therapy. Evidence for effective next-step pharmacological options for treatment resistant anxiety remains limited. This paper describes the protocol for the PETRA trial, which will evaluate the clinical and cost-effectiveness of adding pregabalin to antidepressant treatment, compared with placebo, for people with GAD who have not responded or partially responded to antidepressant treatment. PETRA is a multicentre, individually randomised, double-blind, placebo-controlled superiority trial conducted in UK primary care. Participants are recruited by the study team from approximately 150 General Practices and randomised in a 1:1 ratio, using minimisation, to either pregabalin or a matching placebo for 26 weeks (followed by a tapering period where their dosage is reduced over approximately 4 weeks). Sample size is 498. Eligible participants are adults aged 18-74 years, who have been taking antidepressant medication for at least 8 weeks, received treatment with at least one other antidepressant before their current antidepressant and meet ICD-11 criteria for GAD and score ≥ 12 on the revised clinical interview schedule (CIS-R) total score. Follow-up assessments are at 3, 6, 12, 26 and ~ 30 weeks. Our primary outcome measure will be anxiety symptoms measured with GAD-7 at 12 weeks (continuous score). Secondary outcomes are anxiety (GAD-7) at other time points, depressive and panic symptoms, suicidal thoughts, self-rated global improvement, adherence to study medication, serious adverse events, adverse effects, alcohol consumption and benzodiazepine use, quality of life and resources and costs used. The ~ 30-week assessment will investigate symptoms during the withdrawal from pregabalin. Exploratory analyses will include cognitive tasks. A cost-effectiveness analysis and a nested qualitative study will evaluate the implementation and intervention acceptability. The trial findings will inform primary care prescribing practice by providing an accurate and generalisable estimate of the clinical and cost-effectiveness of prescribing pregabalin to individuals with generalised anxiety who have not responded or only partially responded to antidepressant treatment. Controlled Trials ISRCTN Registry, ISRCTN 16993990, registered on 19/09/2023. First participant enrolled in January 2024.

PMID 42717383
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PubMedJournal of analytical toxicology2026-09-10

Validation of the Neogen® ELISA Gabapentin Kit for Blood and Urine.

Tiscione Nicholas B NB, Rosenberger Chloe E CE, Placencia Leonela L, Zumaeta Edward X EX

The validation of a semi-quantitative method for the rapid screening of whole blood and urine specimens using the Neogen® Gabapentin kit is presented. Decision points were validated at 1,000 ng/mL for whole blood and urine. The validation design was based on ANSI/ASB 036 and internal laboratory requirements. Experiments included the evaluation of sensitivity, precision, specificity, carryover, hook effect, drift, ruggedness/robustness, interference, and an authentic case sample comparison. The experimental limit of detection (LOD) for gabapentin was determined to be at least 500 ng/mL in whole blood and urine. Excellent precision was demonstrated when the assay was evaluated using the mean of three replicates from five separate runs (n = 15) at the decision point and at concentration levels -50% and +100% of the decision point. The assay was reliably able to detect gabapentin without interference from matrix components or other substances routinely detected in authentic case samples with the exception of levamisole in urine if present at unusually high concentrations. Urine samples with 50 µg/mL or more of levamisole yielded a false positive screening result. Other case sample results were comparable to those obtained with liquid chromatography tandem high-resolution mass spectrometry or liquid chromatography tandem mass spectrometry for blood and urine, respectively. The Neogen® Gabapentin kit exhibited minimal cross-reactivity for pregabalin and demonstrated excellent precision and appropriate sensitivity in both whole blood and urine, making it an efficient and reliable method to screen for gabapentin.

PMID 42717438
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PubMedFrontiers in pharmacology2026-09-09

Sex-specific pharmacovigilance signals and time-to-onset patterns of drug-related myoclonus and epileptic seizures: a real-world pharmacovigilance analysis.

Zhang Fu F, Yuan Wenjun W, Yao Jingxi J, Wei Yushu Y et al.

Drug-related myoclonus and epileptic seizures are neurological adverse events that may cause trauma, impaired consciousness, hospitalization, treatment interruption, and life-threatening outcomes. In practice, these events may be difficult to distinguish from neurological diseases, metabolic abnormalities, disease progression, or complications of comorbidities and polypharmacy. Research has focused on individual drugs, case reports, or specific populations, leaving the risk-drug spectrum, sex-related reporting patterns, and onset characteristics insufficiently characterized. Systematic evaluation of these features is important for early identification, optimized monitoring, and individualized risk management. FAERS reports from 2004Q1 to 2025Q4 were analyzed. Drug names were standardized using RxNorm, and adverse events were identified using MedDRA 27.1 preferred terms. Primary suspect drugs were evaluated by reporting odds ratio (ROR)-based disproportionality analysis. Sex-stratified analysis, ATC classification, time-to-onset (TTO) analysis, Weibull modeling, and cross-database validation using CVARD were performed. Reports were concentrated in North America, Europe, and East Asia, with female predominance and most patients aged 18-65 years. A total of 165 myoclonus-related and 235 epileptic seizure-related risk drugs were identified. Nervous system agents predominated, while antiinfectives, antineoplastic and immunomodulating agents, metabolic drugs, and cardiovascular agents also contributed. Bupropion had the highest report count (1,412; 265 myoclonus and 1,147 epileptic seizure reports), followed by tramadol (829). For myoclonus, gabapentin showed strong signals in males (ROR = 23.31, 95% CI: 20.95-25.95) and females (ROR = 18.06, 95% CI: 16.24-20.08), whereas tranexamic acid showed the strongest male signal (ROR = 128.41, 95% CI: 98.29-167.75). For epileptic seizures, bupropion showed signals in males (ROR = 18.08, 95% CI: 16.21-20.17) and females (ROR = 20.21, 95% CI: 18.70-21.85), with tramadol signals in both sexes. Drugs exhibited early-failure Weibull patterns (β < 1). Median TTOs were 16.5 days for pregabalin-related myoclonus and 31.0 days for tramadol-related seizures, but 214.0 days for lamotrigine and 387.0 days for interferon beta-1a. CVARD identified 498 myoclonus-related and 940 seizure-related drugs and reproduced core signals, including clozapine, gabapentin, baclofen, pregabalin, sertraline, bupropion, quetiapine, and olanzapine. Integrating signal detection, sex-stratified analysis, TTO modeling, and cross-database validation identified core risk drugs and monitoring windows, supporting earlier recognition and individualized management of drug-related neurological adverse events.

PMID 42712776
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PubMedCureus2026-09-07

A Toothache That Was a Stroke: Acute Right Parietal Infarction Presenting As Isolated Left-Sided Odontogenic-Like Pain.

Rraklli Ereida E, Abazaj Arlinda A, Elpenoria Kjanda K, Isufi Almira A

Pain as a presenting symptom of acute ischemic stroke is uncommon and may delay diagnosis when typical focal neurological deficits are absent. A 52-year-old man with arterial hypertension and a history of tobacco and alcohol use presented to the ED with sudden, severe left-sided toothache-like pain perceived as arising from the teeth. He had no recent dental procedure, trauma, fever, or systemic infectious symptoms. An oral and dental examination revealed no gingival swelling, facial cellulitis, dental abscess, percussion tenderness, or other convincing odontogenic cause. Neurological examination revealed no facial weakness, dysarthria, aphasia, hemiparesis, limb ataxia, visual field deficit, cranial nerve abnormality, or definite objective sensory loss. Non-contrast CT of the brain excluded intracranial hemorrhage. Brain MRI with diffusion-weighted imaging demonstrated an acute right parietal cortico-subcortical ischemic lesion. The patient was treated with aspirin for secondary stroke prevention, and pregabalin was prescribed for the symptomatic management of presumed central neuropathic pain. The odontogenic-like pain improved substantially during follow-up. This case demonstrates that acute parietal ischemic stroke may present as isolated contralateral toothache-like pain. Acute, severe dental or orofacial pain without a clear odontogenic explanation should prompt consideration of a neurological cause, particularly in patients with vascular risk factors. Diffusion-weighted MRI may be necessary when clinical suspicion of acute ischemic stroke persists despite an otherwise unremarkable neurological examination.

PMID 42703573
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PubMedCurrent neuropharmacology2026-09-04

Pregabalin: A Multifunctional Modulator in Neuropathic Pain and Beyond.

Al-Samydai Ali Mahmoud AM, Ali Kadhim Adnan KA, Alburghaif Ali Hikmat AH, Al-Hussaniy Hany Akeel HA

Pregabalin is a structural analogue of γ-aminobutyric acid (GABA) that functions as a potent modulator of excitatory neurotransmission through high-affinity binding to the α2δ subunit of voltage-gated calcium channels. This review provides a comprehensive overview of its pharmacological properties, clinical efficacy, and therapeutic scope across neuropathic and non-neuropathic conditions. This review is a narrative, descriptive, and integrative type of review conducted using current evidence regarding pharmacology, therapeutic applications, comparative efficacy, and pregabalin safety profile. Pregabalin exhibits rapid absorption, high bioavailability, linear pharmacokinetics, renal elimination, and minimal hepatic metabolism, supporting predictable dosing. Clinically, it demonstrates proven efficacy in neuropathic pain syndromes, including diabetic neuropathy, postherpetic neuralgia, fibromyalgia, and spinal cord injury-related pain, where it acts as a first-line or adjunctive agent. Beyond analgesia, pregabalin serves as an adjunct in partial seizures, a recognized treatment for generalized anxiety disorder, and an emerging option for sleep disturbances and comorbid psychiatric conditions. Comparative analyses indicate similar or superior efficacy to gabapentin and other first-line agents, with added benefit in improving sleep and global function. Adverse effects such as dizziness, somnolence, and peripheral edema are generally mild and dose-related. Future studies should clarify its role in treatment-resistant pain, psychiatric comorbidities, and sleep-related disorders to optimize its clinical use. Owing to its favorable safety profile, limited drug-drug interactions, and broad therapeutic potential, pregabalin remains an essential component of neuropathic pain.

PMID 42693837
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PubMedFrontiers in pharmacology2026-09-04

Treatment outcomes in primary nummular headache: a systematic review.

Almutairi Aqeel M AM

Nummular headache is a rare primary headache disorder characterized by pain strictly confined to a small, coin-shaped area of the scalp. In the absence of standardized treatment guidelines, management relies on heterogeneous, low-level evidence. To systematically synthesize the available evidence on treatment outcomes in primary nummular headache, focusing on complete remission, clinically meaningful response (≥50% improvement), and treatment tolerability. This systematic review followed PRISMA guidelines and was registered in PROSPERO (CRD420261375695). Five electronic databases were searched from inception to March 2026 for studies including ≥5 patients with primary nummular headache according to ICHD criteria. The primary outcome was complete remission; secondary outcomes included ≥50% clinical response and discontinuation due to adverse events. A descriptive synthesis was performed because of substantial clinical and methodological heterogeneity. Risk of bias was assessed with the Newcastle-Ottawa Scale and Joanna Briggs Institute checklists. Thirty-seven studies (1,012 patients) were included, predominantly case reports, case series, and uncontrolled observational cohorts. OnabotulinumtoxinA was the most robustly evaluated intervention, achieving complete remission in 47.5%-48.8% and ≥50% response in 62.5%-77.4% of patients, with no reported treatment discontinuations due to adverse events. Gabapentin showed complete remission rates of 35.2%-45.5% and ≥50% response rates of 43.7%-65.7%, but was associated with a 21.1% discontinuation rate because of adverse effects. Evidence for amitriptyline, lamotrigine, pregabalin, and other therapies was limited to smaller samples and showed variable efficacy. Outcome definitions varied considerably across studies, and no randomized comparative trials were identified. Current evidence suggests that onabotulinumtoxinA offers the most favorable efficacy-tolerability profile, while gabapentin is effective but limited by tolerability concerns. The overall evidence base remains predominantly uncontrolled and heterogeneous. Prospective comparative studies with standardized outcome measures are urgently needed to establish definitive treatment guidelines for this disabling headache disorder. Identifier CRD420261375695.

PMID 42694915
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