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

FibromyalgiaNeuralgia, Postherpetic

Originator Organization

Daiichi Sankyo Co., Ltd.

Active Organization

Daiichi Sankyo Co., Ltd.

Daiichi Sankyo, Inc.Jilin Tianheng Pharmaceutical Co., Ltd.

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

NCT07307170

/ RecruitingNot ApplicableIIT

The Analgesic Efficacy and Safety of Oral Medications (Mirogabalin) in Patients With Herpes Zoster

Herpes zoster (HZ) is characterized by a painful dermatomal rash and significantly affects quality of life, with acute pain increasing the risk of postherpetic neuralgia. Although early antiviral therapy limits viral replication, its analgesic effect is insufficient, and many patients experience inadequate relief despite stepwise use of non-opioids and opioids. Gabapentinoids such as gabapentin and pregabalin are recommended adjuncts, but their efficacy in acute HZ is inconsistent and often accompanied by adverse effects that limit tolerability. Mirogabalin, a newer gabapentinoid approved for peripheral neuropathic pain, has higher affinity and slower dissociation from the α2δ-1 subunit, suggesting stronger analgesia with fewer central side effects. However, its role in managing acute HZ pain remains unknown. We therefore hypothesize that adding mirogabalin to conventional therapy will provide superior pain relief compared with standard treatment alone, and propose a prospective, randomized, controlled, open-label, blinded-endpoint trial to evaluate this.

Start Date15 Dec 2025

Sponsor / Collaborator

Beijing Tiantan Hospital

CTR20254447

/ Active, not recruitingNot Applicable

苯磺酸美洛加巴林片在健康人体空腹/餐后状态下的随机、开放、双周期、双交叉设计生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of merogabarine besylate tablets in healthy subjects under fasting/postprandial conditions.

主要研究目的本研究以天方药业有限公司持证的苯磺酸美洛加巴林片（规格：15mg）为受试制剂，第一三共株式会社持证的苯磺酸美洛加巴林片（商品名：Tarlige，规格：15mg）为参比制剂，进行空腹/餐后状态下人体生物等效性试验，评价受试制剂和参比制剂在健康参与者体内的生物等效性。次要研究目的观察受试制剂和参比制剂在健康成年参与者中的安全性。

[Translation]

Primary Study Objective: This study used merogalaline besylate tablets (15mg) certified by Tianfang Pharmaceutical Co., Ltd. as the test formulation and merogalaline besylate tablets (Tarlige, 15mg) certified by Daiichi Sankyo Co., Ltd. as the reference formulation. A human bioequivalence study was conducted under fasting and postprandial conditions to evaluate the bioequivalence of the test and reference formulations in healthy participants. Secondary Study Objective: To observe the safety of the test and reference formulations in healthy adult participants.

Start Date01 Dec 2025

Sponsor / Collaborator

Topfond Pharmaceutical Co. Ltd.

CTR20254251

/ CompletedNot Applicable

苯磺酸美洛加巴林片在健康研究参与者中单中心、随机、开放、两制剂、单次给药、四周期（空腹和餐后给药）、双交叉生物等效性试验

[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period (fasting and fed) double-crossover bioequivalence study of melogabalin besylate tablets in healthy study participants

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后条件下口服受试制剂苯磺酸美洛加巴林片（规格：5mg（按C12H19NO2计），持证商：广东博卓医药科技有限公司）与参比制剂苯磺酸美洛加巴林片（规格：5mg（按C12H19NO2计），持证商：DAIICHI SANKYO CO., LTD.，商品名：德力静®）后在健康研究参与者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂苯磺酸美洛加巴林片和参比制剂苯磺酸美洛加巴林片在健康研究参与者中的安全性。

[Translation]

Primary Objective: To compare the pharmacokinetic behavior of the test formulation, Melogabalin Besylate Tablets (5 mg (calculated as C₁₂H₁₆NO₂), licensed by Guangdong Bozhuo Pharmaceutical Technology Co., Ltd.) and the reference formulation, Melogabalin Besylate Tablets (5 mg (calculated as C₁₂H₁₆NO₂), licensed by Daichi Sankyo Co., Ltd., trade name: Delijing®), in healthy study participants, using pharmacokinetic parameters as primary endpoints, after oral administration under fasting and fed conditions, and to evaluate the bioequivalence of the two formulations. Secondary Objective: To observe the safety of the test formulation, Melogabalin Besylate Tablets, and the reference formulation, Melogabalin Besylate Tablets, in healthy study participants.

Start Date27 Nov 2025

Sponsor / Collaborator

Guangdong Bozhuo Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Mirogabalin Besilate

100 Translational Medicine associated with Mirogabalin Besilate

100 Patents (Medical) associated with Mirogabalin Besilate

153

Literatures (Medical) associated with Mirogabalin Besilate

01 Dec 2025·Pain and Therapy

Efficacy and Safety of Ca2+ Channel α2δ Ligands for the Treatment of Diabetic Peripheral Neuropathic Pain: A Systematic Review and Network Meta-analysis

Review

Author: Lv, Hongjun ; Guo, Hui ; Wang, Yi ; Shi, Bingyin

INTRODUCTION:

Diabetic peripheral neuropathic pain (DPNP), a chronic complication of diabetes mellitus that impacts quality of life, is treated with Ca²⁺ channel α2δ ligands such as mirogabalin (MGB), pregabalin (PGB), and gabapentin (GBP), which are recommended as first-line treatments. However, direct comparative evidence among 3 Ca²⁺ channel α2δ ligands efficacy and safety remain limited. This study aimed to compare the efficacy and safety of MGB, PGB and GBP for DPNP through a systematic review and network meta-analysis.

METHODS:

A systematic search was conducted in PubMed, Embase, Cochrane Library, and Web of Science on July 1, 2024 from inception, to identify randomized controlled trials (RCTs) evaluating the efficacy and safety of MGB, PGB, and GBP at various doses for DPNP. Non-RCTs, observational studies, reviews, and case reports were excluded. Eligible studies with data on pain relief, sleep interference, and adverse events were selected. The Cochrane risk of bias tool was used for quality assessment, and a Bayesian hierarchical fixed-effects model was applied using Stata and R software. Primary outcomes were the comparative efficacy of MGB, PGB, and GBP, assessed by changes in average daily pain score (ADPS) and pain response rates (≥ 30% and ≥ 50% pain reduction). Secondary outcomes included comparative effects on were patient global impression of change (PGIC), sleep interference score (SIS), adverse event (AE) rates, and withdrawals due to AEs (WDAE). For continuous outcomes, results were expressed as mean differences (MDs) with 95% credible intervals (CrIs), and for dichotomous outcomes, as odds ratios (ORs) with 95% CrIs within a Bayesian network meta-analysis framework.

RESULTS:

In total, 34 RCTs involving 8630 patients and 13 dosing regimens met the inclusion criteria. The sample size ranged from 40 to 834 and the included RCTs were conducted across multiple countries. MGB 30 mg significantly reduced ADPS compared to PGB 300 mg (Mean Difference (MD) - 0.29; 95% credible interval (CrI) - 0.53 to - 0.05) and MGB 15 mg (MD - 0.32; 95% CrI - 0.64 to - 0.01) and achieved higher pain response rates (≥ 30% and ≥ 50%) than GBP 1800 mg (odds ratio (OR) 2.33; 95% CrI 1.01-5.48 and OR 2.87; 95% CrI 1.14-7.81, respectively). MGB 30 mg and GBP 3600 mg were superior to PGB 300 mg and MGB 15 mg in PGIC scores. MGB 30 mg also demonstrated better SIS improvements over GBP 1800 mg and PGB 300 mg. Fewer AEs occurred with MGB 15 mg, PGB 300 mg, and placebo compared to PGB 600 mg, with MGB 15 mg having the lowest WDAE rates. No significant inconsistency or publication bias was observed.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

PROSPERO Identifier: CRD42024584773.

01 Nov 2025·EUROPEAN JOURNAL OF PAIN

Mirogabalin: Promising Evidence, Uncertain Access

Letter

Author: Alcántara Montero, Antonio

01 Nov 2025·EUROPEAN JOURNAL OF PAIN

Mirogabalin for Treatment of Neuropathic Pain and Associated Sleep Interference: An Updated Meta‐Analysis

Review

Author: João, Rafael Batista ; Tagore Chan, Jilly Octoria ; João, André Batista ; Araújo, Luísa Mendes ; Dantas, Julyana Medeiros

ABSTRACT:

Background and Objective:

Neuropathic pain (NeP) is a common and debilitating consequence of several neurological conditions. Gabapentinoids are used on a large scale for the treatment of both central and peripheral NeP. Mirogabalin, a novel gabapentinoid, has been proposed as a promising treatment for this condition; however, its efficacy and safety profile still need to be determined in clinical practice. In this systematic review and meta‐analysis, we assessed the efficacy on pain intensity reduction, effects on sleep interference by pain, and safety of mirogabalin compared with placebo in patients affected by NeP.

Databases and Data Treatment:

We searched PubMed, Cochrane Library, Embase, Web of Science, and ClinicalTrials.gov databases for randomised controlled trials (RCTs) comparing mirogabalin with placebo in patients experiencing central or peripheral NeP. We computed mean differences (MD) and pooled risk ratios (RR) for continuous and binary outcomes, respectively, with 95% confidence intervals (CI). Pain was measured on a 0 to 10 numerical rating scale.

Results:

We included 6 RCTs involving 3048 patients. The mean age was 60.6 years, and 64.7% were male. When compared with placebo, patients treated with mirogabalin had a significant decrease in average daily pain (MD −0.60; 95% CI −0.75 to −0.45; p < 0.001) and in pain‐related sleep interference scores (MD −0.66; 95% CI −0.81 to −0.51; p < 0.001). The mirogabalin group showed a higher rate of substantial pain relief (≥ 50%) compared with the placebo group (RR 1.27; 95% CI 1.10 to 1.46; p = 0.001). Nonetheless, treatment with mirogabalin increased the risk of weight gain, peripheral oedema, somnolence and dizziness.

Conclusion:

In this meta‐analysis of RCTs evaluating patients with central and peripheral NeP, mirogabalin significantly improved pain and decreased sleep interference by pain, as compared with placebo; however, there was an increased risk of adverse events.

Significance:

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.

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

18 Dec 2020

·www.daiichisankyo.com

Daiichi Sankyo Announces Phase 3 Study Results of mirogabalin of central neuropathic pain after spinal cord injury - Press Releases - Media - Daiichi Sankyo

For Immediate Release TOKYO, Japan (December 18, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the achievement of the primary endpoint of phase 3 study (hereinafter, Study) mirogabalin for central neuropathic pain after spinal cord injury. The Study was conducted in Asia (Japan, South Korea, and Taiwan) in a double-blinded manner to evaluate the efficacy and safety of mirogabalin in comparison with the placebo in 274 patients with central neuropathic pain after spinal cord injury. Results of the primary endpoint in the Study, the change in the average daily pain score, from baseline to Week 14 with placebo, show superiority of mirogabalin over the placebo, achieving the primary objective. Furthermore, no additional safety concerns were observed. The detailed results of the Study will be presented at academic conferences and in publications. Daiichi Sankyo will continue efforts to provide new treatment options for diverse patients suffering from pain. About Daiichi Sankyo Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit:www.daiichisankyo.com.

Phase 3

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
Fibromyalgia	Phase 3	United States	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Canada	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Czechia	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Denmark	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Finland	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	France	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Germany	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Netherlands	Daiichi Sankyo Co., Ltd.	27 Oct 2014
Fibromyalgia	Phase 3	Norway	Daiichi Sankyo Co., Ltd.	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)	mswppcaotb(heqwpikybv) = hforqlhnxz lhkdtsdjvs (tjfzfvjhlf, 0.132) View more	-	23 Sep 2024
				Placebo (Placebo)	mswppcaotb(heqwpikybv) = zsiykjwoma lhkdtsdjvs (tjfzfvjhlf, 0.132) View more
NCT04094662 (Pubmed)	-	Diabetic peripheral neuropathic pain	393	美洛加巴林	ttgcqnrphv(budsvvfetv) = bfjztinrus cbaufnbzlu (ownkookxsl ) View more	Positive	01 Aug 2024
				安慰剂	ttgcqnrphv(budsvvfetv) = wsgeimuotn cbaufnbzlu (ownkookxsl ) View more
NCT03901352 (Pubmed)	Phase 3	Neuralgia	-	Mirogabalin	hywbytifpn(rbiurkdykw): 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	damdajcsnn(frydpkqphf) = tsqmyruefn birsnruymo (hlxqzvfvoi ) View more	-	28 May 2021
				Mirogabalin 15-mg once daily	damdajcsnn(frydpkqphf) = awiinnsydy birsnruymo (hlxqzvfvoi ) View more
NCT01496365 (CTgov)	Phase 2	Neuralgia \| Diabetic peripheral neuropathy	452	placebo (Placebo)	xcwhovqtcb(bvgffdovbp) = rwevudlxeu trhyyfjodc (nopgjrlxmj, 2.18) View more	-	05 Jan 2021
				Pregabalin (Pregabalin 150 mg BID)	xcwhovqtcb(bvgffdovbp) = vbbvunncmg trhyyfjodc (nopgjrlxmj, 2.27) View more
NCT02187159 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,270	Placebo capsule	rbrliwhdhn(ergwitbmhv) = qyvvgodjtv kagsanqdjk (ydjlwhdpfe, 0.130) View more	-	09 Nov 2020
NCT02187471 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,301	Placebo capsule (Placebo)	qrzwjbpqxp(xtqriijbqb) = bqjvxrbgnl goeyoviexu (kpxgcuehsv, 0.135) View more	-	09 Nov 2020
				Placebo capsule+DS-5565 (DS-5565 15 mg QD)	qrzwjbpqxp(xtqriijbqb) = kwqatmcfbe goeyoviexu (kpxgcuehsv, 0.138) View more
NCT02146430 (CTgov)	Phase 3	Pain \| Fibromyalgia	1,293	Placebo capsule (Placebo)	qdmziypfhb(dotabwxpjn) = oyirhxodtv ftlpigvesk (gcoqmxctya, 0.132) View more	-	09 Nov 2020
				Placebo tablet+Pregabalin (Pregabalin)	dhjmalpzmv(xudnedkyjf) = fxhwrnnltd sniaipamma (xfjufvorga, vxfpnsjlpi - zgmwlkazmk) View more
NCT02318706 (CTgov)	Phase 3	Diabetic peripheral neuropathic pain	854	placebo	gikpwtlqrg(tgzxvkrvel) = bctqpllpgg pefyhpqedn (ypuafwhycq, 0.79) View more	-	02 Nov 2020
NCT02607280 (CTgov)	Phase 3	Neuralgia, Postherpetic \| Diabetic peripheral neuropathic pain	35	DS-5565 (Moderate Renal Impairment)	rbcwslfkiq(xrrvkxlsvl) = oaddjtptfv jpruhelspc (lwlbteaedv, 0.680) View more	-	26 Oct 2020
				DS-5565 (Severe Renal Impairment)	rbcwslfkiq(xrrvkxlsvl) = fumphofyrs jpruhelspc (lwlbteaedv, 0.217) View more

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