KAWASAKI, Japan, Feb 17, 2026 - (JCN Newswire via SeaPRwire.com) - Fujitsu Limited today announced the development and launch of its AI-Driven Software Development Platform, a new initiative to bring software development into the AI age and contribute to the sustainable growth of its customers and society. This platform automates the entire software development process, from requirements definition and design to implementation and integration testing. By leveraging the Takane large language model (LLM) [1] and agentic AI technology for large-scale software development developed by Fujitsu Research, the AI-Driven Software Development Platform enables AI agents to understand complex, evolving large-scale systems owned by enterprises and public organizations. The platform has multiple AI agents collaboratively execute each stage of software development, achieving full automation of the entire process without human intervention.Fujitsu aims to use this AI-Driven Software Development Platform to carry out revisions to all 67 types of medical and government business software products provided by Fujitsu Japan Limited by the end of fiscal year 2026. The revisions are necessary due to legal and regulatory changes. From January 2026, the platform has been used in Japan for software modifications made necessary by the 2026 medical fee revisions [2]. In a PoC that updated software as per the 2024 medical fee revisions, the platform demonstrated a significant reduction in development time for one of approximately 300 change requests. Using conventional software development methods [3] the modifications would have taken three person-months. With this technology that was dramatically shortened to four hours, achieving a 100-fold increase in productivity.Figure 1: AI-Driven Software Development PlatformBy utilizing this AI-driven development platform, Fujitsu will dramatically improve the speed of software modifications necessitated by legal amendments and system changes. This will significantly reduce the burden previously required for system verification during modifications, thereby freeing up time for the planning and development of measures and services that lead to improved patient, resident, and customer services, as well as enabling customers and partners to continuously adapt to ever-changing operations and societal needs. Furthermore, Fujitsu envisions that this technology will also help customers and partners to respond to expanding IT demand and alleviate the worsening shortage of IT professionals.In AI-driven development, Fujitsu positions AI-Ready Engineering—the process of preparing assets and knowledge to ensure AI correctly understands existing systems and achieves highly reliable automation—as crucial. With AI-Ready Engineering and the AI-Driven Software Development Platform working in tandem, Fujitsu will accelerate AI-driven software development. Fujitsu will promote a transformation in engineers' work styles, strengthening its Forward Deployed Engineer (FDE) complement, and shifting the paradigm of software development from a conventional person-month-based approach to a customer value-based approach.Figure 2: Dual-track approach to reliable automationMoving forward, Fujitsu plans to expand the application of the AI-Driven Software Development Platform to a wide range of sectors, including finance, manufacturing, retail, and public services, by the end of fiscal year 2026. Fujitsu will also begin offering this service to customers and partner companies to enable them to rapidly and flexibly develop systems that adapt to changes in their business environments. Through these efforts, Fujitsu aims to transform the software development process into an AI-driven model as an industry standard.Endorsements from organizations and companies(Order that companies appear is aligned with the original Japanese press release)Takashi Manabe, Senior Research Director, AI & Automation, IDC Japan“IDC forecasts that from 2026 onward, the acceleration of AI/agent-based business utilization and the modernization of existing systems will be key drivers of transformation in the Japanese IT market. Fujitsu’s announcement aims to redefine complex legacy system assets into a state where AI can accurately understand and process them, and to automate the entire waterfall development process. This initiative is expected to provide a practical pathway for many domestic enterprises facing the ongoing challenge of maintaining and operating legacy assets, while also promoting a shift in software engineering away from a labor-intensive model.”Shinji Kajitani, Director and President Executive Officer, Optima Corporation“I am deeply impressed by the concept of automating the entire software development process from upstream to downstream using AI, and even entrusting the verification process to AI. This overturns the traditional assumption that human checks are ultimately indispensable, and I see great potential, especially in targeting business packages that undergo complex system changes every year. Our company has also been involved in business package modifications for many years, and how to complete system revisions with high quality in a short period has always been a major challenge. We believe that the knowledge and expertise accumulated during that process can significantly contribute to the realization and advancement of this concept. Our company will continue to contribute to the business expansion of Fujitsu and Fujitsu Japan through ongoing cooperation, not limited to this project.”Hiroshi Nakatani, Representative Director, Executive Vice President, Kawasaki Heavy Industries, Ltd."This AI automation initiative promoted by Fujitsu is not merely about improving development efficiency; we recognize it as a significant challenge to pass on and evolve the extensive business knowledge and design philosophies cultivated by companies over many years to the next generation. In particular, the concept of providing end-to-end support, from requirements definition to design, implementation, and quality assurance, triggered by changes in laws and rules, opens up new possibilities in areas that have traditionally relied on human experience and tacit knowledge. We see great significance in AI functioning as a foundation that supports human judgment and creativity, rather than replacing it.In the manufacturing industry, challenges such as design changes, regulatory compliance, and understanding the scope of impact are becoming increasingly complex year by year. Fujitsu's approach of advancing both knowledge standardization and AI utilization in these areas offers valuable insights for enhancing the productivity and competitiveness of the entire industry.Kawasaki Heavy Industries sincerely hopes that this initiative will be a crucial step in driving the transformation of Japanese manufacturing and a wide range of other industries, and we wholeheartedly support its further development."Yasushi Matsuda, President and CEO, Kewpie Digital Innovation Co., Ltd.“Systems have become increasingly complex through years of operation and often now require significant maintenance effort. While the introduction of generative AI has improved auditing efficiency, its accuracy remains insufficient for reliable practical application. Amidst this situation, we place great expectations on “Multi-layer Quality Control,” which automatically corrects ambiguities and omissions. We are confident that this mechanism, where AI itself audits quality and autonomously repeats processes, will dramatically enhance the reliability of system development. We eagerly await its future development.”Junichi Aruji, Managing Director, Kintetsu Information System Co., Ltd.“The challenge of revamping existing systems has long been a significant one for engineers. Fujitsu’s AI-Driven Software Development Platform has the potential to dramatically transform the labor previously involved in understanding complex laws and regulations, analyzing vast historical assets, and grasping the tacit knowledge of the field.What is particularly noteworthy is the AI's ability to autonomously learn "human intelligence," thereby dramatically enhancing the accuracy of requirements definition. Furthermore, it can complete everything from program structure analysis and standardization to the extensive testing phase with incredible speed and comprehensiveness. This makes it possible to deliver high-quality products in a short period.As the role of AI expands and frees people from routine tasks, engineers can focus on more creative activities. I have high expectations for the paradigm shift in system renovation that this solution will bring.”Yumi Ueno, Managing Director, Partner Ecosystem & Corporate Business, Google Cloud Japan G.K.“This initiative to achieve comprehensive, one-stop automation spanning from requirements definition to system validation is a groundbreaking innovation for the industry. The technology enables AI to accurately understand vast assets, including long-established programs and design documentation, and we are delighted at the potential for both production-grade quality and exceptional productivity gains. We are confident that this platform will become the new standard for development and accelerate our customers' digital transformation. We remain committed to working with Fujitsu to address social challenges through AI.”Masahiro Niimi, Managing Executive Officer, Head of Information Systems Management Division, CISO, Sakura KCS Corporation“I believe Fujitsu Limited's AI-driven development framework has the potential to become the ‘new paradigm of system development.’ It cannot be achieved simply by feeding existing code or design information into AI, and while there are various hurdles, such as converting documentation to Markdown and establishing test environments, overcoming these hurdles can lead to solving traditional system development challenges (like QCD).What particularly caught my attention is not just improvements in the development process, but what comes after generative AI, i.e., the incorporation of detailed specifications and code (logic). I see tremendous potential here as a solution to the greatest challenge: visualizing and transferring the tacit knowledge of veteran software engineers’ that is traditionally missing from documentation. We expect generative AI to act as an advisor for less experienced software engineers, readily answering questions anytime, thereby dramatically advancing know-how transfer to the next generation. On the other hand, this mechanism also has the potential to dramatically change the traditional SI business model, and we are watching future developments closely.”Takao Kazama, Executive Officer, Group Companies and Accounting & Finance, The Shizuoka Shimbun and Shizuoka Broadcasting Co., Ltd."This initiative for complete automation of application development and maintenance represents a highly valuable transformation for our company. It formalizes and establishes a reproducible process for tasks that have long relied on the implicit knowledge and experience of individual staff members, and we have great expectations for it. In particular, it has the potential to significantly improve quality variations in legacy system maintenance and lost opportunities due to delayed change responses. Furthermore, the evolving ability of AI to perform root cause analysis and identify necessary additional information is a major step towards advanced and efficient system operations, with the potential to change the very nature of system development. We share Fujitsu's commitment to improving productivity across the entire industry and establishing new development standards. We look forward to its continued strong promotion as an initiative that will advance the entire industry."Shimane Prefectural Central Hospital"The AI-Driven Software Development Platform presented by Fujitsu offers a practical and robust approach to the long-standing challenges faced by medical institutions: the increasing complexity of medical fee calculations and the growing workload of claims processing. The mechanism where AI analyzes legal documents and extracts the relevant areas, while explicitly highlighting points open to interpretation to supplement human judgment, is particularly impressive. This design demonstrates a deep understanding of on-site operations and is highly commendable. Furthermore, the Japanese-specific LLM and the consideration for safety are indispensable elements for AI utilization in the medical field. Beyond medical fee claims, this technology has potential for integration with related areas such as bed management and understanding performance requirements, making a strong contribution to overall hospital operational efficiency in the future. This is a promising initiative that warrants positive consideration for adoption to alleviate the burden on medical professionals."Shinichi Aikawa, Executive Officer, Head of Systems Division, SBI Sumishin Net Bank, Ltd.“We expect Fujitsu's AI-Driven Software Development Platform to be an initiative with the potential to fundamentally transform the software development process itself. If a world can be realized where everything from requirements definition to design, coding, and testing can be automatically executed in a seamless, one-stop manner, it will be possible to achieve both a dramatic improvement in development speed and quality.Since 2024, we have been working with Fujitsu in some areas of this field. Through these initiatives, we are confident that the entire development process will be automated end-to-end in the near future. By realizing this transformation, the possibilities for the services we can provide to our customers will greatly expand. We think about ideas for new services for our customers on a daily basis. This would allow us to rough out these ideas in a short period of time and provide them to our customers quickly. We hope that this new world of value creation will arrive as soon as possible.”Masaki Murata, Vice President, IBM Japan“We strongly believe that Fujitsu’s announcement marks a significant step forward in the evolution of system development in Japan. It aligns closely with IBM Japan’s vision and represents an important initiative that will help shape the future of the industry as a whole. We look forward to driving this momentum together and contributing to the creation of a more robust and vibrant ecosystem.”Ryota Sato, Managing Executive Officer, Global Communications & IT Services Group, Microsoft Corp."We sincerely welcome Fujitsu Limited’s announcement of the AI-Driven Software Development Platform as a pioneering initiative that opens a new chapter in system development for the AI era. By orchestrating multiple AI agents to automate the end-to-end development lifecycle—from requirements definition through ongoing enhancement—while integrating human-led quality assurance, this platform embodies a new engineering model in which people and AI truly work together. We view this initiative as highly significant, as it directly addresses the critical challenges facing Japan’s system development industry, including severe talent shortages and the increasing complexity and sophistication of modern systems. We strongly expect this bold effort to drive the evolution of Japan’s system development business and to grow into a transformation model with global relevance. Moving forward, we will continue to work closely with Fujitsu, combining the strengths of both companies to strongly support our customers in their journey toward becoming Frontier Firms.”Tatsuo Ogawa, Executive Officer Group CTO, Panasonic Holdings Corporation“We believe that the AI-driven end-to-end automated system development announced this time represents not only a significant improvement in productivity, but also a bold challenge to fundamentally transform the way enterprise IT is delivered. By enabling AI to accurately understand frequently updated regulations and complex business knowledge, including implicit know-how, this approach autonomously executes processes seamlessly from requirements definition through system modification. It has the potential to provide an effective solution to the core challenges posed by legacy systems faced by many Japanese enterprises. We look forward to jointly refining this technology through hands-on practice and advancing co-creation by incorporating on-site expertise of both Panasonic and Fujitsu, with the expectation that it will become a new standard for system development and be deployed broadly not only within Panasonic but across society as a whole.”Executive at a major manufacturing company's IT subsidiary“We anticipate this initiative will bring about a new transformation in system development. This transformation will be driven by the application of advanced Japanese language processing capabilities—such as the understanding of legal documents—to diverse tasks, the reliable execution of each process through quality auditing functions, and the expansion of these capabilities to scratch development. Furthermore, we believe that AI Ready Engineering, by formalizing expert know-how and domain knowledge into explicit knowledge and transforming it into AI-usable assets, will significantly contribute to the succession of expertise from an increasingly limited pool of skilled professionals. We sincerely hope that the co-creation between the knowledge-inheriting AI and on-site personnel will generate new value and form the cornerstone for innovation in the system development industry, and indeed, across all industries.”Note[1] Takane large language model (LLM):Jointly developed by Fujitsu and Cohere Inc.[2] Medical fee revision:A national system that reviews public medical fees and adjusts cost allocation for medical procedures.[3] Conventional software development methods:Development methods where quality is verified at each stage, from software requirements definition, design, and implementation to integration testing.About FujitsuFujitsu’s purpose is to make the world more sustainable by building trust in society through innovation. As the digital transformation partner of choice for customers around the globe, our 113,000 employees work to resolve some of the greatest challenges facing humanity. Our range of services and solutions draw on five key technologies: AI, Computing, Networks, Data & Security, and Converging Technologies, which we bring together to deliver sustainability transformation. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.6 trillion yen (US$23 billion) for the fiscal year ended March 31, 2025 and remains the top digital services company in Japan by market share. Find out more: global.fujitsuPress ContactsFujitsu LimitedPublic and Investor Relations DivisionInquiries Copyright 2026 JCN Newswire via SeaPRwire.com. All rights reserved. www.jcnnewswire.com

TOKYO, Feb 16, 2026 - (JCN Newswire via SeaPRwire.com) - TOYOTA GAZOO Racing World Rally Team has locked out the podium places for the second time in as many rounds of the 2026 FIA World Rally Championship, with Elfyn Evans claiming another victory on the snow of Rally Sweden to lead a 1-2-3-4 finish.Scott Martin, Elfyn EvansFollowing a 1-2-3 finish at last month’s Rallye Monte-Carlo, this is the first time that a manufacturer has filled the podium places on consecutive rounds of the WRC since Citroën did so in 2010. The feat was last achieved on the opening two events of a season when Audi did so in Monte Carlo and Sweden in 1984.This is the second year in succession that Evans and co-driver Scott Martin have won the WRC’s only pure winter rally and their third Swedish success in total. That makes Welshman Evans one of the event’s most successful drivers from outside the Nordic countries, as he matches the number of victories achieved by team-mate Sébastien Ogier as well as Kenneth Eriksson and Tommi Mäkinen.Just as in 2025, Evans’ victory came after an exciting battle with team-mate Takamoto Katsuta that went down to the final day. Evans had conceded the lead to Katsuta late on Friday after facing tough snowy conditions running second on the road, but regained the initiative on Saturday and took a lead of 13.3 seconds into the last leg.Evans and Katsuta claimed a stage win apiece from Sunday morning’s double pass of the Västervik stage but Evans did enough in the rally-ending Power Stage to seal victory by 14.3s. He also pipped Katsuta by one second to top the Super Sunday classification and came second on the Power Stage, just 0.1s from the best time, to take a strong haul of 34 points and claim the championship lead.Guided by co-driver Aaron Johnston, Japanese driver Katsuta once more thrived on the fast snow-covered roads, finishing on the podium for the second Rally Sweden in succession and for the eighth time in his WRC career.Young Finnish driver Sami Pajari also shone in the winter conditions, putting a difficult Rallye Monte-Carlo behind him to finish third overall together with co-driver Marko Salminen. After two stage wins on Saturday, Pajari entered the final day within 12.1s of Katsuta and eventually secured his second career podium, matching the third place he achieved at Rally Japan 2025.Sweden’s own Oliver Solberg arrived at his home event leading the championship after a stunning Rallye Monte-Carlo win, but this brought a challenging first full day on Friday opening the snowy roads. He and co-driver Elliott Edmondson later recovered to finish fourth, completing the team’s excellent result and banking extra points with third on Super Sunday and fourth in the Power Stage.Italian driver Lorenzo Bertelli once more enjoyed the experience of driving one of his favourite rallies at the wheel of a GR YARIS Rally1 through the TGR-WRT customer programme. Making an enthusiastic and welcome return to the WRC service park after two years away, Bertelli and co-driver Simone Scattolin finished 15th overall following some time lost with tyre damage on Friday morning.There was also a one-two finish for the GR Yaris Rally2 car in the hands of customer teams in the WRC2 category. Roope Korhonen claimed victory with co-driver Anssi Viinikka in their Rautio Motorsport-entered, Printsport-run car, finishing 10.2s ahead of fellow Finnish crew Teemu Suninen and Janni Hussi in their Delta Rally-prepared car.Quotes:Akio Toyoda (TGR-WRT Chairman)“Elfyn, Scott, congratulations on becoming the snow rally champions for two years in a row!Elfyn took the victory, with Takamoto in second. I wanted Elfyn to score lots of points from the early stages of the season, and at the same time I wanted Takamoto to reach the top step of the podium soon... I watched the rally with the same feelings as last year.But this year's Sweden had a big difference from last year in a way: the performance of the young drivers. Thanks to Sami in third and Oliver in fourth, we achieved the 1-2-3-4 finish.I’m sure Oliver wanted to get onto the podium at his home rally in Sweden as well. He may be feeling disappointed, but I believe that experiencing the kind of adversities that come from being a top driver such as opening the road will surely help him for the future.For Sami, I think he reset himself after the frustration in Monte Carlo and came to this rally determined. This podium must have given him a lot of confidence.And Takamoto, even if he may no longer be fairly called a ‘youngster’, I really wish that he comes back even stronger for the next rally, savouring both the joy and the frustration of this second-place finish.Even for a team that has its home in Finland, rallying in such severe cold must have been very tough for all. I would like to thank everyone for the hard work. The next event is in Kenya in a month, and that will be an incredible change in temperature. I believe Jari-Matti and Juha will take good care of the team and I hope everybody in the team stays healthy and safe.”Jari-Matti Latvala (Team Principal)“We’re really happy with this 1-2-3-4 result and it’s amazing to see the performance level that we’ve had in these first two rounds of the season. After Rallye Monte-Carlo, we had been expecting to face a stronger challenge here in Sweden. Still, our drivers were able to fight closely with each other and still bring the cars home without any big mistakes. Elfyn is driving at such an amazing and consistent level right now, and he’s really becoming a master of this event. Taka also really enjoys this event and was driving very well. Even if there was some frustration for him, it’s a great result for him too. We’re also delighted by Sami’s drive. He started the event under pressure and slightly cautious, but once he could see things were going well, the confidence improved and the smile had come back. And for Oliver, these are strong points and a good comeback after a challenging start to the rally.”Elfyn Evans (Driver car 33)“It’s been a great weekend for us and the whole team here in Sweden. The car has been amazing to drive, so a big thanks to the team. It’s an incredible feeling to drive on these fast stages in such nice winter conditions, and when you feel good in the car, it’s always a pleasure. We didn’t have a huge margin coming into the final day, and with so many points available on Sundays, we had to push until the end but we can be very happy with what we came away with. It’s been a great start to the year, but it’s still early days and we need to keep working hard.”Oliver Solberg (Driver car 99)“Of course I was hoping for more from my home rally but I think I underestimated how difficult it would be on Friday. My mistake maybe cost a podium and put me on the back foot for the rest of the weekend, but fourth is probably the best I deserve. There’s been a lot of learning in my first proper snow rally with this car and my first time starting first on the road. I tried my best and scored some decent points. The support has been amazing and I’ve really enjoyed myself in the car. A big thanks to the team: they’ve done a great job and this 1-2-3-4 is a fantastic result.”Takamoto Katsuta (Driver car 18)“This is a great result for the team and I’m very happy to be part of it, so a huge thanks to the team for all their hard work. Everything was working well with the car and I was enjoying it a lot. Big congratulations to Elfyn: he was so strong here again this year and deserves this win. Hopefully next time I have a chance to fight for victory I can push harder. It’s always enjoyable to be in the fight, especially on this kind of high-speed rally when it’s so intense and you’re fighting over tenths of a second. Kenya is another rally that seems to suit me, so I’ll look forward to that.”Sami Pajari (Driver car 5)“This is an amazing result for us and for the team. I want to say a big thank you to the team and to everybody who was giving us such great support after Rallye Monte-Carlo didn’t go to plan. This time we were back on the pace and I’m of course really happy to be back on the podium. I really enjoyed the driving this week with this car in these conditions. It’s nice to be back on the level where I think we should be and where we were at the end of last year. Now we just need to keep pushing for even better results in the future.”PROVISIONAL FINAL CLASSIFICATION, RALLY SWEDEN1 Elfyn Evans/Scott Martin (Toyota GR YARIS Rally1) 2h35m53.1s2 Takamoto Katsuta/Aaron Johnston (Toyota GR YARIS Rally1) +14.3s3 Sami Pajari/Marko Salminen (Toyota GR YARIS Rally1) +46.0s4 Oliver Solberg/Elliott Edmondson (Toyota GR YARIS Rally1) +1m11.6s5 Adrien Fourmaux/Alexandre Coria (Hyundai i20 N Rally1) +1m50.3s6 Esapekka Lappi/Enni Mälkönen (Hyundai i20 N Rally1) +1m53.2s7 Thierry Neuville/Martijn Wydaeghe (Hyundai i20 N Rally1) +3m45.9s8 Jon Armstrong/Shane Byrne (Ford Puma Rally1) +4m05.5s9 Josh McErlean/Eoin Treacy (Ford Puma Rally1) +6m05.4s10 Roope Korhonen/Anssi Viinikka (Toyota GR Yaris Rally2) +10m36.2s(Results as of 14:00 on Sunday, for the latest results please visit www.wrc.com)2026 FIA World Rally Championship for drivers after round 2:1 Elfyn Evans 60 points2 Oliver Solberg 473 Takamoto Katsuta 304 Adrien Fourmaux 285 Thierry Neuville 216 Sébastien Ogier 187 Sami Pajari 178 Esapekka Lappi 99 Léo Rossel 810 Yohan Rossel 62026 FIA World Rally Championship for manufacturers after round 2:1 TOYOTA GAZOO Racing World Rally Team 117 points2 Hyundai Shell Mobis World Rally Team 663 TOYOTA GAZOO Racing WRT2 184 M-Sport Ford World Rally Team 14What's next?The legendary Safari Rally Kenya – the only African round of the WRC – hosts round three on March 12-15. Since returning to the calendar in 2021, the event continues to provide gruelling conditions on rough and rocky roads as well as high speeds across open plains. Car 33 (Elfyn Evans, Scott Martin) Car 99 (Oliver Solberg, Elliott Edmondson) Car 18 (Takamoto Katsuta, Aaron Johnston) Car 5 (Sami Pajari, Marko Salminen)Podium ceremonyFor more information, visit https://toyotagazooracing.com/wrc/release/2026/rd02-day4/ Copyright 2026 JCN Newswire via SeaPRwire.com. All rights reserved. www.jcnnewswire.com

TOKYO, Feb 16, 2026 - (JCN Newswire via SeaPRwire.com) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received an orphan drug designation for its in-house discovered and developed novel selective orexin 2 receptor agonist E2086, with prospective indication for narcolepsy, from the Ministry of Health, Labour and Welfare (MHLW).Narcolepsy is a chronic sleep disorder that is characterized by excessive daytime sleepiness (EDS). Due to problems with fatigue, cognition, and persistence of residual symptoms despite treatment, disease burden for narcolepsy is high,(1) and narcolepsy remains a disease with high unmet medical needs. While estimates vary depending on the study data, a 2025 report estimates the narcolepsy patient population in Japan to be approximately 46,000.(2) Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). The pathogenesis of narcolepsy type 1 is thought to involve a deficiency of orexin due to autoimmune destruction of orexin-producing neurons located in the hypothalamus. Although the pathogenesis of narcolepsy type 2 remains unknown, it has been suggested that a reduction in orexin neurotransmission may also be involved.(3)Orexin is a neurotransmitter that plays a central role in regulating sleep and wakefulness. Inhibiting orexinergic neurons is believed to promote a natural transition from wakefulness to sleep. Conversely, activating orexinergic neurons is believed to help maintain a more stable state of wakefulness. From the perspective of inhibiting orexinergic neuron activity, Eisai has developed the insomnia treatment DAYVIGO® (generic name: lemborexant), an orexin receptor antagonist that is approved in more than 25 countries and regions worldwide. Furthermore, leveraging the unique orexin platform established through the development of DAYVIGO, Eisai has created E2086, a selective orexin 2 receptor agonist that activates orexinergic neurons. E2086 has the potential to improve patients’ symptoms by enhancing orexin receptor activity and acting on the pathophysiology of narcolepsy. Eisai presented data from a Phase Ib clinical study in patients with narcolepsy type 1, which suggests that E2086 has the potential to improve daytime wakefulness, at the World Sleep 2025 congress.(4)Eisai considers neurology, including sleep-wake disorders such as insomnia and narcolepsy, as a therapeutic area of focus. Eisai strives to create innovative products in therapeutic areas with high unmet medical needs as soon as possible and will further contribute to addressing the diverse needs of, as well as increasing the benefits provided to, those living with neurological diseases and their families.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120About Orphan Drug Designation System in JapanThe orphan drug designation system in Japan aims to support the development of drugs for diseases for which the number of patients is small, and research and development is not progressing, despite high unmet medical need. As the requirement for designation based on Article 77-2 of the Pharmaceutical and Medical Device Act (PMD Act) of Japan, a drug must meet the following conditions in order to be considered for orphan drug designation in Japan: the number of people expected to use the drug for its intended use is fewer than 50,000 people in Japan; there is no suitable alternative drug or treatments in Japan, or the proposed drug is expected to be significantly more effective or safer than drugs already available on the Japanese market; there is a scientific rationale to support the necessity of the drug for the target disease, and the development plan for the drug is appropriate. Specific measures to support the development of orphan drugs include giving prioritized consultation regarding clinical development and conducting priority examinations, reducing application fees, extension of re-examination period, granting subsidies for research and development expenditures, and tax incentives.About narcolepsyNarcolepsy is a chronic sleep disorder and classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). The pathogenesis of narcolepsy type 1 is thought to be the autoimmune destruction of orexin-producing neurons located in the hypothalamus. Individuals with a deficiency of orexin demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels and demonstrate excessive daytime sleepiness (EDS). Although the pathogenesis of narcolepsy type 2 remains unknown, it has been suggested that a reduction in orexin neurotransmission may also be involved.3While estimates vary depending on the study data, according to a study using the JMDC Inc. insurance payer database, the number of narcolepsy patients in Japan is estimated at approximately 23,000, based on the criteria of medical claims made for two consecutive months during the study period.5 Meanwhile, the number is estimated to be 46,000 when including patients with two or more medical claims over a 12-months period.2About E2086E2086 is Eisai’s in-house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Furthermore, in a Phase Ib clinical trial with patients with narcolepsy type 1, the agent demonstrated a statistically significant reduction in excessive daytime sleepiness compared to placebo or the existing drug (modafinil).4References(1) Maski. K, et.al. Listening to the Patient Voice in Narcolepsy: Diagnostic Delay, Disease Burden, and Treatment Efficacy. J. Clinical Sleep Medicine. 2017, 13 (3) p419-, https://jcsm.aasm.org/doi/pdf/10.5664/jcsm.6494(2) Kadotani H, Matsuo M, Tran L, Parsons VL, Maguire A, Crawford S, Ghosh S, Dave S. Epidemiology of narcolepsy and idiopathic hypersomnia in Japan: A retrospective analysis of health insurance claims from the Japan Medical Data Center. Sleep Med. 2025; 126: 25–31.(3) Thannickal TC, Nienhuis R, Siegel JM. Localized loss of hypocretin (orexin) cells in narcolepsy without cataplexy. Sleep. 2009; 32: 993–8.(4) 4. Highlights from oral presentation on E2086 at World Sleep 2025 – September 11, 2025 https://www.eisai.co.jp/ir/library/presentations/pdf/4523_250911.pdf(5) Imanishi A, Kamada Y, Shibata K, Sakata Y, Munakata H, Ishii M. Prevalence, incidence, and medications of narcolepsy in Japan: a descriptive observational study using a health insurance claims database. Sleep Biol Rhythms. 2022; 20: 585–94. Copyright 2026 JCN Newswire via SeaPRwire.com. All rights reserved. www.jcnnewswire.com