{"id":"ds-5565","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Ataxia"},{"rate":null,"effect":"Tremor"}]},"_chembl":{"chemblId":"CHEMBL580785","moleculeType":"Small molecule","molecularWeight":"368.04"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DS-5565 selectively inhibits sodium channels in the nervous system, thereby reducing the firing of pain-transmitting neurons. This mechanism is intended to provide analgesia by dampening neuropathic pain signals without significantly affecting cardiac or skeletal muscle sodium channels. The drug is being developed primarily for neuropathic pain conditions.","oneSentence":"DS-5565 is a selective sodium channel inhibitor that reduces neuronal excitability by blocking voltage-gated sodium channels.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:10:03.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Neuropathic pain"},{"name":"Diabetic peripheral neuropathic pain"}]},"trialDetails":[{"nctId":"NCT07307170","phase":"NA","title":"The Analgesic Efficacy and Safety of Mirogabalin in Patients With Herpes Zoster","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-12-15","conditions":"Herpes Zoster, Mirogabalin, Pain","enrollment":750},{"nctId":"NCT07451431","phase":"PHASE4","title":"Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain","status":"RECRUITING","sponsor":"Bangladesh Medical University","startDate":"2025-10-01","conditions":"Diabetic Peripheral Neuropathic Pain (DPNP)","enrollment":78},{"nctId":"NCT07157852","phase":"NA","title":"The Efficacy and Safety of Pregabalin and Mirogabalin in Patients With Fibromyalgia","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2025-09-05","conditions":"Fibromyalgia, Pregabalin, Mirogabalin","enrollment":674},{"nctId":"NCT06328062","phase":"NA","title":"Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA","status":"RECRUITING","sponsor":"Thammasat University Hospital","startDate":"2024-04-01","conditions":"Pain Postoperative, Osteoarthritis, Total Knee Arthroplasty","enrollment":80},{"nctId":"NCT06846567","phase":"PHASE1","title":"Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults","status":"COMPLETED","sponsor":"Zhejiang Anglikang Pharmaceutical Co., Ltd.","startDate":"2024-12-01","conditions":"Diabetic Neuropathies, Diabetes Mellitus","enrollment":66},{"nctId":"NCT06812117","phase":"","title":"A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)","status":"RECRUITING","sponsor":"Daiichi Sankyo","startDate":"2025-01-25","conditions":"Diabetic Peripheral Neuropathic Pain","enrollment":720},{"nctId":"NCT06711978","phase":"NA","title":"Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors","status":"NOT_YET_RECRUITING","sponsor":"Pusan National University Yangsan Hospital","startDate":"2024-12-01","conditions":"CIPN, CIPN - Chemotherapy-Induced Peripheral Neuropathy, CIPN in Adjuvant Breast Cancer Patients","enrollment":66},{"nctId":"NCT03901352","phase":"PHASE3","title":"Study of Mirogabalin for Central Neuropathic Pain","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2019-03-12","conditions":"Central Neuropathic Pain","enrollment":300},{"nctId":"NCT05938088","phase":"NA","title":"Mirogabalin for Total Hip Arthroplasty","status":"UNKNOWN","sponsor":"Gangnam Severance Hospital","startDate":"2023-07-20","conditions":"Hip Osteoarthritis","enrollment":56},{"nctId":"NCT04094662","phase":"PHASE3","title":"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2019-09-18","conditions":"Diabetic Peripheral Neuropathic Pain","enrollment":393},{"nctId":"NCT02607280","phase":"PHASE3","title":"DS-5565 Phase III Study for Renal Impairment in Japanese Subjects","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2015-12","conditions":"Diabetic Peripheral Neuropathic Pain, Post-herpetic Neuralgia","enrollment":35},{"nctId":"NCT01496365","phase":"PHASE2","title":"Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2011-11-28","conditions":"Diabetic Peripheral Neuropathy","enrollment":452},{"nctId":"NCT02496884","phase":"PHASE3","title":"Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2015-06-26","conditions":"Fibromyalgia","enrollment":56},{"nctId":"NCT02187471","phase":"PHASE3","title":"Treatment of Pain Associated With Fibromyalgia","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2015-01-16","conditions":"Pain Associated With Fibromyalgia","enrollment":1301},{"nctId":"NCT02187159","phase":"PHASE3","title":"Treatment of Pain Associated With Fibromyalgia","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2014-11","conditions":"Pain Associated With Fibromyalgia","enrollment":1270},{"nctId":"NCT02146430","phase":"PHASE3","title":"Treatment of Pain Associated With Fibromyalgia","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2014-10-27","conditions":"Pain Associated With Fibromyalgia","enrollment":1293},{"nctId":"NCT02318719","phase":"NA","title":"DS-5565 Phase III Study for Post-herpetic Neuralgia","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2015-01","conditions":"Post-Herpetic Neuralgia","enrollment":765},{"nctId":"NCT02318706","phase":"PHASE3","title":"DS-5565 Phase III Study for Diabetic Peripheral Neuropathic Pain","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2015-01","conditions":"Diabetic Peripheral Neuropathic Pain","enrollment":854},{"nctId":"NCT02234583","phase":"PHASE3","title":"An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia","status":"COMPLETED","sponsor":"Daiichi Sankyo","startDate":"2015-02-04","conditions":"Pain Associated With Fibromyalgia","enrollment":2485},{"nctId":"NCT01504412","phase":"PHASE2","title":"Asian Phase 2 Study for Treatment of Pain Associated With Diabetic Peripheral Neuropathy","status":"COMPLETED","sponsor":"Daiichi Sankyo Co., Ltd.","startDate":"2012-01","conditions":"Pain, Diabetic Peripheral Neuropathy","enrollment":450}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":6,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["mirogabalin","Investigational product","Mirogabalin","Experimental drug","SUB60040"],"phase":"phase_3","status":"active","brandName":"DS-5565","genericName":"DS-5565","companyName":"Daiichi Sankyo Co., Ltd.","companyId":"daiichi-sankyo-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DS-5565 is a selective sodium channel inhibitor that reduces neuronal excitability by blocking voltage-gated sodium channels. Used for Neuropathic pain, Diabetic peripheral neuropathic pain.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":4,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}