CACNA2D1 blockers(Voltage-gated calcium channel alpha2/delta subunit 1 blockers), CACNA2D2 blockers(Voltage-gated calcium channel alpha2/delta subunit 2 blockers)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetic peripheral neuropathic painNeuralgia

Inactive Indication

Chronic Kidney DiseasesFibromyalgiaNeuralgia, Postherpetic

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (08 Jan 2019),

Neuralgia

RegulationSpecial Review Project (CN)

Structure/Sequence

Molecular FormulaC18H25NO5S

InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N

CAS Registry1138245-21-2

View All Structures (2)

Clinical Trials associated with Mirogabalin Besilate

CTR20243712

/ CompletedNot Applicable

苯磺酸美洛加巴林片餐后人体生物等效性试验

[Translation] Postprandial bioequivalence study of melogabalin besylate tablets in healthy volunteers

主要目的：以健康受试者为试验对象，采用开放、随机、两周期、双交叉试验设计，考察健康受试者餐后单次口服由江苏万禾制药有限公司生产（南京万融健诚医药科技有限公司持证）的苯磺酸美洛加巴林片（受试制剂，规格：5mg）与第一三共株式会社生产的苯磺酸美洛加巴林片（参比制剂， TARLIGE ®，规格：5mg）后美洛加巴林的体内经时过程，估算其相关药代动力学参数及相对生物利用度，评价其餐后状态下的生物等效性，为受试制剂的生产注册申请提供依据。次要目的：评价苯磺酸美洛加巴林片受试制剂和参比制剂（商品名：TARLIGE®）在健康受试者中的安全性。

[Translation]

Main purpose: To use healthy subjects as test subjects, adopt an open, randomized, two-period, double-crossover design, to investigate the in vivo time course of melogabalin after a single oral administration of melogabalin besylate tablets (test preparation, specification: 5 mg) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. (certified by Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd.) and melogabalin besylate tablets (reference preparation, TARLIGE ®, specification: 5 mg) produced by Daiichi Sankyo Co., Ltd. after meals, estimate their relevant pharmacokinetic parameters and relative bioavailability, evaluate their bioequivalence in the postprandial state, and provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of melogabalin besylate tablets (trade name: TARLIGE®) in healthy subjects.

Start Date14 Nov 2024

Sponsor / Collaborator

Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd.

CTR20243713

/ CompletedNot Applicable

苯磺酸美洛加巴林片空腹人体生物等效性试验

[Translation] Bioequivalence study of melogabalin besylate tablets in fasting volunteers

主要目的：以健康受试者为试验对象，采用开放、随机、两周期、双交叉试验设计，考察健康受试者空腹单次口服由江苏万禾制药有限公司生产（南京万融健诚医药科技有限公司持证）的苯磺酸美洛加巴林片（受试制剂，规格：5mg）与第一三共株式会社生产的苯磺酸美洛加巴林片（参比制剂， TARLIGE ®，规格：5mg）后美洛加巴林的体内经时过程，估算其相关药代动力学参数及相对生物利用度，评价其空腹状态下的生物等效性，为受试制剂的生产注册申请提供依据。次要目的：评价苯磺酸美洛加巴林片受试制剂和参比制剂（商品名：TARLIGE®）在健康受试者中的安全性。

[Translation]

Main purpose: Using healthy subjects as test subjects, an open, randomized, two-period, double-crossover design was used to investigate the in vivo time course of melogabalin after a single oral administration of melogabalin besylate tablets (test preparation, specification: 5 mg) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. (certified by Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd.) and melogabalin besylate tablets (reference preparation, TARLIGE ®, specification: 5 mg) produced by Daiichi Sankyo Co., Ltd. on an empty stomach, to estimate their relevant pharmacokinetic parameters and relative bioavailability, to evaluate their bioequivalence under fasting conditions, and to provide a basis for the production registration application of the test preparation. Secondary purpose: To evaluate the safety of the test preparation and reference preparation of melogabalin besylate tablets (trade name: TARLIGE®) in healthy subjects.

Start Date14 Oct 2024

Sponsor / Collaborator

Nanjing Wanrong Jiancheng Pharmaceutical Technology Co., Ltd.

CTR20243376

/ CompletedNot Applicable

评估受试制剂苯磺酸米洛巴林片（规格：15 mg）与参比制剂苯磺酸米诺巴林片（Tarlige®，规格：15 mg）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test product, minobalin besylate tablets (strength: 15 mg), and the reference product, minobalin besylate tablets (Tarlige®, strength: 15 mg), in healthy adult subjects in the fasting and fed state.

主要试验目的：研究空腹和餐后状态下单次口服受试制剂苯磺酸米洛巴林片（规格：15 mg，成都苑东生物制药股份有限公司生产）与参比制剂苯磺酸米诺巴林片（Tarlige®，规格：15 mg，第一三共株式会社生产）在健康受试者体内的药代动力学特征，评价空腹和餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂苯磺酸米洛巴林片（规格：15 mg）和参比制剂苯磺酸米诺巴林片（Tarlige®，规格：15 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Milobarlin Besylate Tablets (Specification: 15 mg, produced by Chengdu Yuandong Biopharmaceutical Co., Ltd.) and the reference preparation Minobarlin Besylate Tablets (Tarlige®, Specification: 15 mg, produced by Daiichi Sankyo Co., Ltd.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. Secondary purpose of the study: to study the safety of the test preparation Milobarlin Besylate Tablets (Specification: 15 mg) and the reference preparation Minobarlin Besylate Tablets (Tarlige®, Specification: 15 mg) in healthy subjects.

Start Date23 Sep 2024

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Mirogabalin Besilate

100 Translational Medicine associated with Mirogabalin Besilate

100 Patents (Medical) associated with Mirogabalin Besilate

125

Literatures (Medical) associated with Mirogabalin Besilate

01 Jun 2025·Journal of Orthopaedics

Short-term clinical outcomes of mirogabalin for carpal tunnel syndrome: A single-center retrospective pilot study

Article

Author: Takano, Takehito ; Suzuki, Nobuaki ; Kawashima, Hiroyuki ; Oinuma, Takeo ; Nakadai, Masato ; Yoda, Takuya

Aims & objectivesCarpal tunnel syndrome (CTS) is a common condition caused by compression of the median nerve, leading to neuropathic pain such as numbness and nocturnal discomfort, thus impacting daily life. Mirogabalin besylate (MGB), a novel gabapentinoid, shows promise for neuropathic pain, but its efficacy in CTS remains unclear.Therefore, this pilot study aimed to evaluate the short-term clinical outcomes of MGB for CTS.Materials & methodsThis retrospective observational study examined 21 patients with CTS who received MGB between April 2022 and March 2023. Evaluations included the Carpal Tunnel Syndrome Instrument (CTSI), Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH), and Visual Analog Scale (VAS) before and 12 weeks after treatment. The primary outcome was the change in CTSI-total. Secondary outcomes included CTSI subparts (symptom severity and functional status), Quick DASH, VAS, and adverse drug reactions (ADRs).ResultsMGB led to significant improvement in CTSI-total (p=0.022), with medium standardized response mean (SRM) and effect size (ES). CTSI-symptom severity (p<0.01) and VAS (p<0.001) also improved, showing medium SRM and ES for CTSI and large SRM and ES for VAS. No significant changes were observed in CTSI-functional status (p=0.349) or Quick DASH (p=0.102). ADRs occurred in 42.9 % of patients, mostly mild.ConclusionsMGB demonstrated significant short-term efficacy in improving CTS symptoms and reducing pain, though mild ADRs were common. Further studies are needed to assess long-term outcomes and compare MGB with other treatments.Levels of evidenceLevel IV.

01 Jan 2025·Journal of Orthopaedic Research

Analgesic effects of co‐administration of mirogabalin and diclofenac sodium on neuropathic pain in rats

Article

Author: Orita, Sumihisa ; Suzuki‐Narita, Miyako ; Inoue, Masahiro ; Nozaki‐Taguchi, Natsuko ; Tajiri, Ikuko ; Inage, Kazuhide ; Ohtori, Seiji ; Shiga, Yasuhiro ; Shimizu, Keisuke ; Mukai, Michiaki ; Chikubu, Hiroto

AbstractCo‐administration of mirogabalin besylate and nonsteroidal anti‐inflammatory drugs is effective for neuropathic pain; however, mechanism of its action remains unknown. We aimed to evaluate the mechanism of this synergistic effect of the concomitant administration for neuropathic pain using chronic constriction injury model rats. Fifty male Wister rats of 7‐week‐old were used. Right sciatic nerve ligation was performed in 40 rats and they were sub‐divided into four groups: vehicle, mirogabalin, diclofenac sodium and co‐administration of them. Ten rats underwent sham surgery. Fluorogold was attached to sciatic nerve during surgery. Von Frey filament and weight bearing tests were performed on postoperative Day 6 as behavioral assessments and drug was administrated intraperitoneally. Half rats in each group underwent behavioral assessment and perfusion fixation using 4% paraformaldehyde on postoperative Day 7 and remaining on postoperative Day 14. Subsequently, dorsal root ganglion at L4 to L6 was collected and examined immunohistochemistry for calcitonin gene‐related peptide, and their immunoreactivity in fluorogold‐labeled neurons was measured. Spinal cord at lumbar swelling was resected, immunostained for ionized‐calcium‐binding adapter molecule‐1 and glial fibrillary acidic protein, and immunoreactive neurons in dorsal horn of spinal cords were calculated as the occupancy of them. Mirogabalin suppresses the neuropeptide‐release from presynaptic afferent neuron directly and it resulted in suppressing glia cells activation. Diclofenac sodium inhibits cyclooxygenase‐2 and prostaglandin production, related to allodynia. These effects of mirogabalin and diclofenac sodium, respectively, inhibited glia cells strongly, which is presumed to be one of the mechanisms for the effectiveness of their co‐administration for neuropathic pain.

01 Dec 2024·Journal of Endodontics

Mirogabalin as a Therapeutic Option for Neuropathic Pain Emerging Postendodontic Treatment: An Observational Study

Article

Author: Hayashi, Makoto ; Izumida, Takuro ; Takizawa, Keita ; Ozasa, Kana ; Shimizu, Kohei ; Noma, Noboru ; Yasukawa, Takuya ; Takeichi, Osamu

INTRODUCTIONWe have recently reported the clinical efficacy of mirogabalin for occlusal pain due to post-traumatic trigeminal neuropathic pain (PTTN-occlusal pain) after endodontic treatment according to the International Classification of Orofacial Pain criteria. This study aimed to determine the mirogabalin administration period and timing of dose reduction and suspension for treating this condition based on managing a certain number of cases.METHODSPatients diagnosed with PTTN-occlusal pain after or during endodontic treatment were included in the study. An endodontist retreated if necessary. Patients who initially experienced occlusal pain but gradually adapted to bite well without medication were classified into the provisional restoration group (n = 13). Patients who experienced severe pain during mastication and could not chew with a provisional restoration were classified into the mirogabalin medication group (n = 15). Mirogabalin (10 mg/day) was prescribed once a day before bedtime. The patients receiving visual analog scale (VAS) were instructed to record daily changes in pain intensity in a VAS diary. The practitioners also recorded scores during consultations.RESULTSIn the provisional restoration group, VAS scores significantly decreased from week 6 and plateaued from week 11 (P < .05). This adaptation period was applied to reduction or discontinuation of mirogabalin treatment in the mirogabalin medication group. After initiating mirogabalin, VAS scores significantly decreased gradually from week 1 (P < .05). Although the dose was tapered around week 7 and discontinued by week 11, no recurrence of pain was observed following dose reduction or discontinuation.CONCLUSIONSMirogabalin was effective in treating PTTN-occlusal pain.

News (Medical) associated with Mirogabalin Besilate

28 Aug 2024

·www.prnewswire.com

Peripheral Neuropathic Pain Market to Exhibit Growth at a CAGR of 4.1% by 2034 | DelveInsight

The increasing cases of peripheral neuropathic pain, rise in screening for diabetic neuropathic pain among diabetics, increase in the geriatric population, and launch of new approved drugs, among other reasons are likely to fuel the growth of the peripheral neuropathic pain market size during the forecast period (2024–2034). LAS VEGAS, Aug. 28, 2024 /PRNewswire/ --DelveInsight's Peripheral Neuropathic Pain Market Insights report includes a comprehensive understanding of current treatment practices, peripheral neuropathic pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peripheral Neuropathic Pain Market Report According to DelveInsight's analysis, the market size for peripheral neuropathic pain was found to be ~ USD 12 billion in the 7MM in 2023. The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The total cases of peripheral neuropathic pain in the 7MM were approximately 60 million cases in 2023, which are expected to increase during the study period (2020–2034). Leading peripheral neuropathic pain companies such as Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, and others are developing novel peripheral neuropathic pain drugs that can be available in the peripheral neuropathic pain market in the coming years. The promising peripheral neuropathic pain therapies in the pipeline include LX9211, XEOMIN (incobotulinumtoxinA), Adezunap (AP707), Suzetrigine (VX-548), HALNEURON (Tetrodotoxin or TTX), SEMDEXA (SP-102), and others. Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the peripheral neuropathic pain market of the 7MM by 2034. In November 2023, Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS (A Phase IIb, dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension in patients with diabetic peripheral neuropathic pain) studying LX9211. Discover which therapies are expected to grab the major peripheral neuropathic pain market share @ Peripheral Neuropathic Pain Market Report Peripheral Neuropathic Pain Overview Peripheral neuropathies refer to conditions affecting peripheral nerve cells and fibers, arising from a variety of underlying causes. These nerves include the cranial nerves, spinal nerve roots and ganglia, nerve trunks and divisions, and the autonomic nervous system nerves. Peripheral neuropathies can be classified in several ways, such as mononeuropathies, multifocal neuropathies, and polyneuropathies. Mononeuropathy involves damage to a single nerve, while multiple mononeuropathy affects two or more nerves in different locations. Polyneuropathy typically impacts many or most nerves. The diversity of symptoms associated with peripheral neuropathy allows for the identification of distinct clinical phenotypes, which is important for guiding the diagnostic process. Nerve conduction studies are crucial for determining the phenotype and assessing severity. Additional diagnostic tools, such as laboratory tests, genetic testing, cerebrospinal fluid examination, nerve imaging, and nerve biopsy, may be useful in specific clinical situations. Peripheral Neuropathic Pain Epidemiology Segmentation The peripheral neuropathic pain epidemiology section provides insights into the historical and current peripheral neuropathic pain patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peripheral neuropathic pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of PNP Type-specific Cases of PNP Treated Cases of PNP Peripheral Neuropathic Pain Treatment Market The treatment of peripheral neuropathic pain depends on the underlying cause and the severity of symptoms. Initial management typically involves conservative measures, including medications such as NSAIDs, acetaminophen, and, in more severe cases, opioids. For radicular symptoms, neuroleptic agents may be used, and systemic steroids are sometimes prescribed for acute low back pain. Nonpharmacological treatments like physical therapy, acupuncture, chiropractic manipulation, and traction are also employed, though their effectiveness is debated. Interventional procedures, such as epidural steroid injections and percutaneous disc decompression, are commonly performed, while surgical options like decompression and spinal fusion are considered for cases that do not respond to other treatments. Pain management for PNP also includes the use of drugs such as NSAIDs, anticonvulsants, and antidepressants, with specific medications like QUTENZA, NUCYNTA ER, and TARLIGE approved for certain patient groups. TARLIGE (mirogabalin besylate) is an oral gabapentinoid developed by Daiichi Sankyo to treat peripheral neuropathic pain (PNP), including diabetic PNP and postherpetic neuralgia. In January 2019, Daiichi Sankyo announced that TARLIGE received approval for marketing in Japan for PNP treatment, offering patients in Japan a new therapeutic option for managing PNP. NUCYNTA ER (tapentadol) is an opioid agonist available as an extended-release film-coated tablet for oral use. It is prescribed for managing neuropathic pain related to diabetic peripheral neuropathy (DPN). In August 2012, the US FDA approved a sNDA for NUCYNTA ER, allowing it to be used as an oral analgesic taken twice daily to manage neuropathic pain in adults with DPN when ongoing, around-the-clock opioid treatment is required for a prolonged duration. The QUTENZA (capsaicin) 8% topical system delivers capsaicin through a localized dermal application. Capsaicin acts as an agonist for the TRPV1 receptor. In July 2020, Grünenthal's US subsidiary, Averitas Pharma, obtained FDA approval for the QUTENZA 8% patch to treat neuropathic pain related to diabetic peripheral neuropathy in the feet of adults. To know more about peripheral neuropathic pain treatment guidelines, visit @ Peripheral Neuropathic Pain Management Peripheral Neuropathic Pain Pipeline Therapies and Key Companies LX9211: Lexicon Pharmaceuticals XEOMIN (IncobotulinumtoxinA): Merz Therapeutics Adezunap (AP707): Apurano Pharmaceuticals Suzetrigine (VX-548): Vertex Pharmaceuticals HALNEURON (Tetrodotoxin or TTX): WEX Pharmaceuticals SEMDEXA (SP-102): Scilex Holding Company Discover more about peripheral neuropathic pain drugs in development @ Peripheral Neuropathic Pain Clinical Trials Peripheral Neuropathic Pain Market Dynamics The peripheral neuropathic pain market dynamics are expected to change in the coming years. Emerging disease-modifying therapies for diabetic neuropathy, CIPN, and LSR are gaining attention due to the growing prevalence of cancer, increased chemotherapy usage, and the large patient pool in need of pain management. The lack of disease-modifying treatment options in the current landscape, which relies solely on symptomatic relief, highlights the market potential for these therapies. Recent developmental activities targeting novel pathways, such as adapter-associated kinase 1 (AAK1) and the Nav1.8 voltage-gated sodium channel, aim to provide opioid-free pain relief, which could lead to a high uptake and the ability to charge a premium price. Furthermore, potential therapies are being investigated for the treatment of peripheral neuropathic pain, and it is safe to predict that the treatment space will significantly impact the peripheral neuropathic pain market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peripheral neuropathic pain market in the 7MM. However several factors may impede the growth of the peripheral neuropathic pain market. The management of DPN is challenging due to the persistent and severe nature of neuropathic pain, which is frequently ineffectively treated and negatively impacts the quality of life, further complicated by pharmacogenetic and genetic variations in patients; additionally, while improving glycemic control in Type-2 diabetes remains uncertain, the availability of low-cost generics in the treatment landscape may significantly hamper the uptake of emerging therapies, increasing the burden and associated health costs. Moreover, peripheral neuropathic pain treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, peripheral neuropathic pain market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact peripheral neuropathic pain market growth. Scope of the Peripheral Neuropathic Pain Market Report Therapeutic Assessment: Peripheral Neuropathic Pain current marketed and emerging therapies Peripheral Neuropathic Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Peripheral Neuropathic Pain Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peripheral Neuropathic Pain Market Access and Reimbursement Download the report to understand which factors are driving peripheral neuropathic pain market trends @ Peripheral Neuropathic Pain Market Trends Table of Contents Related Reports Peripheral Neuropathic Pain Epidemiology Forecast Peripheral Neuropathic Pain Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain epidemiology trends. Peripheral Neuropathic Pain Pipeline Peripheral Neuropathic Pain Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Peripheral Neuropathic Pain companies, including Haisco Pharmaceutical Group, GlaxoSmithKline, Algiax Pharmaceuticals, Apurano Pharmaceuticals GmbH, Eli Lilly and Company, Shanghai SIMR Biotechnology, Lexicon Pharmaceuticals, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Novo Nordisk, Ionis Pharmaceuticals, Pfizer, Regeneron, NeuroMetrix, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Drug ApprovalPhase 2

07 Nov 2016

·www.bioportfolio.com

JP Giants leaning in for becoming a Speciality Global PharmaSakigake designation A Push from government to Innovate!Essential drugs exemption from Z2 rule Balancing long listed pricing pressure!Authorized Generics, Biosimilars, and Patent Litigations Av

Sakigake designation A Push from government to Innovate! Essential drugs exemption from Z2 rule Balancing long listed pricing pressure! Authorized Generics, Biosimilars, and Patent Litigations Avenues to grow in JP Generic market! Increasing decline in long listed products sales, and a few success in R D in the last decade had put JP giants under pressure to refocus on Innovation with specialty therapy area to strengthen their global presence. Eisai Ajinomoto JV, TevaTakeda partnership for Speciality Generics is the actions in this direction. Fast track approval based on Sakigake designation is the step by PMDA/MHLW to encourage JP Pharmas to research in the area of high unmet medical need/orphan disease where US biotech has taken a successful leap in last decade. In innovation space, Nivolumab, Alectinib, Dolutegravir global success again demonstrate ability of JP pharma/university research house to contribute Pharma Innovation, while encouraging regulatory environment for Regenerative Medicine Drug Development and Drug Repurposing will make Japan front runner in this space. From late stage pipeline/new launch, Mirogabalin approval in Neuropathic Pain, Brintellix Cognition label expansion, Edoxaban uptake in EU, Alectinib uptake in US and ACE910 approval for hemophilia will decide Japanese Innovator growth in Global market. The biennial price cut scheduled in April2016 will balance Innovation premium with long listed price cut Z2 rule to increase R D productivity. In next 3 years, 950b drugs will go off patent in Japan and as happened in 2015, substantial volume growth due to new patent expiry opportunities will help Japanese generic companies to withstand NHI pricing pressure. Consolidation activities like TevaTakeda JV will make this growing domestic generic market more competitive and companies with direct sales model may fetch upper hand due to less dependence on wholesale distribution channel. Challenging Alimta patent and Evista patent against Lilly in Japan, and Livalo ANDA filing in US by JP Generic companies is indicative of the changing breadth of the JP generic giants from launching generics in Japan to becoming a patent challenger Intellectual property rights challenging generic company. This is a step towards finding its place against the world generic players in the coming time. Successful launch of Blopress AG, Plavix AG in last few years stamps Authorized Generics as one of the attractive opportunity for Generic players in Japan. Encouraging Uptake of Filgrastim BS and Lantus BS in Japan is indicative of Japan to be the next important market after EU in the next five years for growth of Biosimilar players. In contrast, there is a very slow uptake post launch of Remicade biosimilar 1% volume share. In this report we analyzed therapy focus, changing Strategies, pipeline and key growth drivers of 12 major Japanese biopharma companies Pure play innovators/ Innovators+ Generics/Pure play generics and detailed our view on their strategic action to withstand in domestic market and expand globally with their interest for inlicensing external innovation from the globe for increasing RD productivity and priorities on M A side.

Generic DrugBiosimilarFast Track

100 Deals associated with Mirogabalin Besilate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Mirogabalin Besilate	N	DB11825

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Diabetic peripheral neuropathic pain	CN	Daiichi Sankyo Co., Ltd.	28 Jun 2024
Neuralgia	JP	Daiichi Sankyo Co., Ltd.	08 Jan 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fibromyalgia	Discovery	FR	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	DE	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	CZ	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	RS	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	NO	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	SE	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	FI	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	NL	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	CA	Daiichi Sankyo, Inc.	27 Oct 2014
Fibromyalgia	Discovery	US	Daiichi Sankyo, Inc.	27 Oct 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03901352 (CTgov)	Phase 3	Neuralgia	300	Mirogabalin (Mirogabalin)	ifkfxyxzjz(aaubujxnyq) = aduxrnrpmt appexylkkb (lbykqunqpm, ihudasazwp - egrcjeplsm) View more	-	23 Sep 2024
				Placebo (Placebo)	ifkfxyxzjz(aaubujxnyq) = mmxwripmzs appexylkkb (lbykqunqpm, rdrowknwvy - iurbzgkugf) View more
NCT03901352 (Pubmed)	Phase 3	Neuralgia	-	Mirogabalin	pskdiczdgv(djwpsyebnp): odds ratio = 1.91 (95% CI, 1.11 - 3.27)	Positive	14 Dec 2022
				Placebo
NCT01496365 (CTgov)	Phase 2	Neuralgia \| Diabetic peripheral neuropathy	452	placebo (Placebo)	shpmovbdtk(tmkdaijtea) = cowduzonnw xcqkagevss (yfnsgsgqgt, zhwexfqfje - lvutxlhifk) View more	-	05 Jan 2021
				Pregabalin (Pregabalin 150 mg BID)	shpmovbdtk(tmkdaijtea) = igwnsjotzr xcqkagevss (yfnsgsgqgt, gmlpcszlkx - nrquzfskeq) View more
NCT02187159 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,270	Placebo capsule	bdoetwyiut(oikyqqyhav) = gtvmqjehib pipkuiadfm (wxarwhizds, dzbcgzozuh - ghkzsutwkq) View more	-	09 Nov 2020
NCT02187471 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,301	Placebo capsule (Placebo)	rahstivpdj(sfpxwhehqr) = tthejuxdxg jrbeayywgl (xgvreusnyq, gqpzyuqtwc - sneidzabev) View more	-	09 Nov 2020
				Placebo capsule+DS-5565 (DS-5565 15 mg QD)	rahstivpdj(sfpxwhehqr) = lavsreipkq jrbeayywgl (xgvreusnyq, zfotimkwuh - opndxlnpei) View more
NCT02146430 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,293	Placebo capsule (Placebo)	ahosnghnux(qfwmjcnucj) = qbadrlwwva joyalrzznz (ypfphvhdwy, aqkpgkvhib - nnobyohzlm) View more	-	09 Nov 2020
				Placebo tablet+Pregabalin (Pregabalin)	ymqgpqedia(psanjlewkb) = rxbzenhpzf obvhryioed (churqqikou, tqfohkzroh - hjepdeotal) View more
NCT02318706 (CTgov)	Phase 3	Diabetic peripheral neuropathic pain	854	placebo	qlamdninbk(hdnodusjgp) = shdsosntjw gswaaptrya (xopyerciqg, etqodrwvit - sfmwckvnhw) View more	-	02 Nov 2020
NCT02607280 (CTgov)	Phase 3	Neuralgia, Postherpetic \| Diabetic peripheral neuropathic pain	35	DS-5565 (Moderate Renal Impairment)	znklkrowmw(fmzfzwszah) = bepbljiuyu kvpxwrjfyr (sapobogspw, urewdvspgt - kbinwrfblq) View more	-	26 Oct 2020
				DS-5565 (Severe Renal Impairment)	znklkrowmw(fmzfzwszah) = qcayuruuey kvpxwrjfyr (sapobogspw, zygvzjwcug - eaymhvnshr) View more
NCT02496884 (CTgov)	Phase 3	Pain \| Fibromyalgia \| Chronic Kidney Diseases	56	Placebo (M-CKD Placebo)	oirvcgnxhm(ridjruacuy) = awwchhhnem csohsyrdmp (kdqyfkwoaj, kvvcdqlxcf - tfosgjguny) View more	-	12 Oct 2020
				DS-5565 (M-CKD DS-5565 7.5 mg BID)	oirvcgnxhm(ridjruacuy) = ysuzlboiwf csohsyrdmp (kdqyfkwoaj, kurfmzdovt - tdtktbjrry) View more
NCT02318719 (Pubmed \| Medicine (Baltimore)) Manual	Phase 3	Neuralgia, Postherpetic	184	mirogabalin	tdgnvxmtxb(vihzkstmmt) = All SF-MPQ scales decreased from baseline to week 52 gezhhvbizj (jztmwhwiin ) View more	Positive	04 Sep 2020

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