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 DiseaseOther Diseases

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-

License Organization

Daiichi Sankyo Co., Ltd.

A. Menarini Asia-Pacific Holdings Pte Ltd.

Drug Highest PhaseApproved

First Approval Date

Japan (08 Jan 2019),

Neuralgia

Regulation-

Structure/Sequence

Molecular FormulaC18H25NO5S

InChIKeyOKJXJRVWXYRSAN-TXULWXBWSA-N

CAS Registry1138245-21-2

Clinical Trials associated with Mirogabalin Besilate

CTR20250501

/ Active, not recruitingNot Applicable

苯磺酸美洛加巴林片在健康受试者中的生物等效性试验

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

主要目的：本研究以成都倍特药业有限公司生产的苯磺酸美洛加巴林片（5mg，按C12H19NO2计）为受试制剂，持证商第一三共株式会社在日本上市的未进口原研苯磺酸美洛加巴林片（5mg，按C12H19NO2计）（商品名：Tarlige®）为参比制剂，评价受试制剂和参比制剂在空腹及餐后条件下给药的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: This study used melogabalin besylate tablets (5 mg, calculated as C12H19NO2) produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation and the original melogabalin besylate tablets (5 mg, calculated as C12H19NO2) (trade name: Tarlige®) marketed in Japan by the licensed manufacturer Daiichi Sankyo Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting and postprandial conditions. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date13 Mar 2025

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

KCT0010305

/ Not yet recruitingNot ApplicableIIT

Efficacy and Safety of Adding Mirogabalin to Duloxetine Medication in Patients with Oxaliplatin induced Peripheral Neuropathy (Multicenter Prospective Randomized Controlled Trial, Open label)

Start Date06 Mar 2025

Sponsor / Collaborator

Seoul National University Bundang Hospital

NCT06846567

/ CompletedPhase 1

A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison with Melogabalin Besilate Tablets after Single and Multiple Oral Administrations of BM2216 Extended-Release Tablets in Healthy Adult Subjects. To evaluate the pharmacokinetic characteristics of BM2216 Extended-Release Tablets in healthy adult subjects under fasting and postprandial conditions, and to assess the impact of food; to evaluate the dose proportionality following a single administration.To compare the single and multiple dose pharmacokinetic characteristics of BM2216 Extended-Release Tablets with those of Melogabalin Besilate Tablets, and to determine the relative bioavailability.To assess the safety of BM2216 Extended-Release Tablets in healthy adult subjects following single and multiple oral administrations.

Start Date01 Dec 2024

Sponsor / Collaborator

Zhejiang Anglikang Pharmaceutical Co. Ltd.

100 Clinical Results associated with Mirogabalin Besilate

100 Translational Medicine associated with Mirogabalin Besilate

100 Patents (Medical) associated with Mirogabalin Besilate

164

Literatures (Medical) associated with Mirogabalin Besilate

01 Jul 2025·PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR

Crisugabalin, a ligand for the αδ subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents

Article

Author: Wang, Ju ; Liu, Yijiang ; Lu, Yao ; Ye, Qidi ; Zeng, Linggao ; Gou, Xiaoli ; Li, Yao ; Shi, Zongjun ; Chen, Ying ; Dong, Yansheng ; Meng, Qingyuan ; He, Lingzhi

Crisugabalin, a novel third-generation ligand targeting the α2δ subunit of voltage-gated calcium channels, has been approved in China for the treatment of pain associated with diabetic peripheral neuropathy and postherpetic neuralgia. Existing research suggests that ligands for the α2δ subunit of voltage-gated calcium channels may carry a risk of abuse. To evaluate the abuse potential of crisugabalin, five well-recognized animal models were utilized in these preclinical studies. Firstly, an intravenous self-administration paradigm was implemented in rats that were self-administering propofol to assess the reinforcing effects of crisugabalin. Secondly, a rat drug discrimination study was employed to determine the pharmacological similarity between crisugabalin and the training drug midazolam. Then, a conditioned place preference (CPP) paradigm in rats was utilized to evaluate the rewarding properties of crisugabalin. After that, a spontaneous withdrawal study was conducted in rats chronically treated with crisugabalin to examine the liability of developing physical dependence. Finally, a mouse pentylenetetrazol-induced convulsion model was used following chronic exposure to crisugabalin to assess its potential for physical dependence. The results indicated that crisugabalin showed no positive reinforcing effects and did not display midazolam-like discriminative stimulus effects. Moreover, crisugabalin did not induce significant CPP in rats and there was no risk of physical dependence in the pentylenetetrazol-induced convulsion model. 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.

01 Jun 2025·Journal of Orthopaedics

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

Article

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

Aims & objectives:

Carpal 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 & methods:

This 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).

Results:

MGB 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.

Conclusions:

MGB 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 evidence:

Level IV.

01 Jun 2025·JOURNAL OF PHARMACOLOGICAL SCIENCES

Mirogabalin and pregabalin alleviate nociplastic sensitization induced by chemogenetic activation of the central amygdala neurons in rodents

Article

Author: Yajima, Manami ; Uezono, Yasuhito ; Takahashi, Yukari ; Kato, Fusao

Nociplastic pain represents the third mechanistic descriptor of pain, alongside neuropathic and nociceptive pain, as proposed in 2017 by the International Association for the Study of Pain (IASP). It describes pain occurring in the absence of nociceptor activation, tissue damage, or neuropathy. The underlying brain mechanisms of nociplastic pain remain poorly understood. Despite the potentially large patient population with chronic pain of this class, effective pharmacological treatments for nociplastic pain are still limited, highlighting the urgent need for drug development using appropriate preclinical models. In this study, we investigated the anti-sensitization effects of two gabapentinoids-mirogabalin besylate (MGB) and pregabalin (PGB)-using a rodent model of nociplastic pain. This model involves experimental excitation of central amygdala neurons via designer receptors exclusively activated by designer drugs (DREADDs), causing widespread sensitization. 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.

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

18 Dec 2020

·www.biospace.com

Daiichi Sankyo’s Mirogabalin Displays Significant Reduction in Post-SCI Neuropathic Pain

A phase 3 study from Daiichi Sankyo Company conducted in Japan, South Korea and Taiwan found that mirogabalin, an orally administered gabapentinoid, was associated with a significantly greater improvement in pain among patients with central neuropathic pain after spinal cord injury compared with placebo. A phase 3 study from Daiichi Sankyo Company conducted in Japan, South Korea and Taiwan found that mirogabalin, an orally administered gabapentinoid, was associated with a significantly greater improvement in pain among patients with central neuropathic pain after spinal cord injury compared with placebo. The study included 274 patients with central neuropathic pain after spinal cord injury who were randomly assigned to either mirogabalin or placebo. Researchers of the study assessed the change in the average daily pain score, from baseline to week 14. The study found mirogabalin was superior to placebo for improving pain scores over this time period. In addition, the study investigators found no additional safety concerns. Daiichi Sankyo started Phase III trials for mirogabalin in 2015 starting with the REDUCER (An Asian, phase 3, multicenter, RandomizEd, Double-blind, placebo-controlled 14-week stUdy of DS-5565 in patients with diabetiC pEripheral neuRopathic pain followed by a 52-week open-label extension) study and the NEUCOURSE (An AsiaN, phasE 3, mUltiCenter, randomized, dOUble-blind, placebo-contRolled 14-week study of DS-5565 in patientS with postherpetic neuralgia followed by a 52-week open-label Extension) study. The recent study findings support results from prior studies conducted by the company in the field of chronic and disease-related pain. Back in 2017, Daiichi Sankyo announced top-line results from a Phase III trial showing mirogabalin was superior to placebo for reducing diabetic peripheral neuropathic pain. Similar to the recent study in central neuropathic pain, investigators in the 2017 study found mirogabalin resulted in significantly greater reductions in the weekly average daily pain score from baseline to week 14. There were also no significant safety concerns in this trial. Pain management has been of particular interest to Daiichi Sankyo, but so far the most promising late-stage studies have been primarily centered in Asia. Just last year, the Japanese pharmaceutical company pulled out of the U.S. pain management market after the company’s CEO decided to shift its focus to oncology. Also, Daiichi Sankyo gave back Movantik , an opioid-induced constipation therapy, to AstraZeneca last year. As it shifts to oncology in the U.S., Daiichi Sankyo announced plans to create an oncology business unit, appointing the company’s president and CEO of the U.S. Ken Keller to the role of U.S. business chief once it opens April 2021. A statement made by the company says the new business unit will align “The U.S. and European oncology businesses, global oncology functions of marketing, market access and pricing, medical affairs as well as alliance management under one team singularly devoted to people with cancer.” This transition from a small-molecule metabolic and cardiovascular pharmaceutical organization to an oncology biologics maker is part of Daiichi Sankyo’s 2025 business plan. So far, the shift to oncology has landed the company one major approval, with other imminent approvals likely on their way. In January, the company and AstraZeneca’s HER2-targeting therapy Enhertu was approved as a third-line therapy for hard-to-treat metastatic breast cancer therapy. The approval triggered a milestone payment of $125 million from AstraZeneca to Daiichi Sankyo. Also, Enhertu was recently granted priority review from the U.S. Food and Drug Administration (FDA) for the treatment of HER2-positive, metastatic gastric or gastroesophageal junction cancer. The FDA will make the final decision on whether to approve this drug in early 2021. Featured Jobs on BioSpace

Phase 3Drug ApprovalExecutive ChangeClinical ResultPriority Review

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	China	Daiichi Sankyo Co., Ltd.	28 Jun 2024
Neuralgia	Japan	Daiichi Sankyo Co., Ltd.	08 Jan 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neuralgia, Postherpetic	Phase 3	Japan	Daiichi Sankyo Co., Ltd.	01 Dec 2015
Chronic Kidney Diseases	Phase 3	United States	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Bulgaria	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Czechia	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Hungary	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Poland	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Romania	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	South Africa	Daiichi Sankyo, Inc.	26 Jun 2015
Chronic Kidney Diseases	Phase 3	Spain	Daiichi Sankyo, Inc.	26 Jun 2015
Fibromyalgia	Phase 3	Canada	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)	omyixzbion(mixrkfamga) = tjgqwoyhra iztjtaiuay (yjhvhrucoj, 0.132) View more	-	23 Sep 2024
				Placebo (Placebo)	omyixzbion(mixrkfamga) = awmkbblsoq iztjtaiuay (yjhvhrucoj, 0.132) View more
NCT03901352 (Pubmed)	Phase 3	Neuralgia	-	Mirogabalin	rnouklgvrx(dvekgkelyt): odds ratio = 1.91 (95% CI, 1.11 - 3.27)	Positive	14 Dec 2022
				Placebo
NCT02318719 \| NCT02318706 (Pubmed \| Clin Ther)	Phase 3	Neuralgia	1,587	Placebo	lpeahaqozu(lnnbpvkzrh) = oumuvemdjn zvpjrsighj (lclojfznrl ) View more	-	28 May 2021
				Mirogabalin 15-mg once daily	lpeahaqozu(lnnbpvkzrh) = jkivbfnwkd zvpjrsighj (lclojfznrl ) View more
NCT01496365 (CTgov)	Phase 2	Neuralgia \| Diabetic peripheral neuropathy	452	placebo (Placebo)	kcvyukcogj(mucwgpflyd) = qqxqwayhsk nnkydeqyke (cpdfzfbjxk, 2.18) View more	-	05 Jan 2021
				Pregabalin (Pregabalin 150 mg BID)	kcvyukcogj(mucwgpflyd) = ozthjatltp nnkydeqyke (cpdfzfbjxk, 2.27) View more
Pubmed \| Korean J Pain	Not Applicable	-	-	Mirogabalin besylate (DS-5565, Tarlige®)	illiniqznp(hqiloxahyy) = wvutfrgpdr rmjliwhesl (gmthnpgcji ) View more	-	01 Jan 2021
				Pregabalin	illiniqznp(hqiloxahyy) = sfrcfhpmoy rmjliwhesl (gmthnpgcji ) View more
NCT02146430 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,293	Placebo capsule (Placebo)	jlvmymibfk(civlsjnscd) = uedbkeweus skwdkqngma (fypjuvgjwb, 0.132) View more	-	09 Nov 2020
				Placebo tablet+Pregabalin (Pregabalin)	clwmtvgugd(yyxaonfuet) = ozighuyvnn cipqeswbwz (octxxxpfgq, xbtouyzlhj - yarkupvvvn) View more
NCT02187159 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,270	Placebo capsule	kajbybgelv(mdgzcgpbdl) = ifblcomtjx qaylyfglsm (mohbkeqymw, 0.130) View more	-	09 Nov 2020
NCT02187471 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,301	Placebo capsule (Placebo)	bjjvzxiihh(vxjiicqtqw) = ybskqaaeqz kndwzxgjgg (ygcpqkhdec, 0.135) View more	-	09 Nov 2020
				Placebo capsule+DS-5565 (DS-5565 15 mg QD)	bjjvzxiihh(vxjiicqtqw) = itujgnatzh kndwzxgjgg (ygcpqkhdec, 0.138) View more
NCT02318706 (CTgov)	Phase 3	Diabetic peripheral neuropathic pain	854	placebo	drfnalkyoo(hqlgixehfk) = pxsyeluohd igbjaascjd (ngxidjhjtu, 0.79) View more	-	02 Nov 2020
NCT02607280 (CTgov)	Phase 3	Neuralgia, Postherpetic \| Diabetic peripheral neuropathic pain	35	DS-5565 (Moderate Renal Impairment)	qbbjhoacwl(qqwfharwcg) = hbinvkapuz fotothcevy (orvbcicbne, 0.680) View more	-	26 Oct 2020
				DS-5565 (Severe Renal Impairment)	qbbjhoacwl(qqwfharwcg) = ojnvgsguvr fotothcevy (orvbcicbne, 0.217) View more

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