Latest news with #ClickTherapeutics
Medscape
6 days ago
- Health
- Medscape
Digital App Effective for Schizophrenia in Phase 3 Trial
CT-155 (Boehringer Ingelheim and Click Therapeutics), an investigational prescription digital therapeutic, was both safe and effective in reducing negative symptoms of schizophrenia in a new phase 3 trial, its manufacturers announced in a press release. Top-line results from the CONVOKE trial, which included 464 US adults with schizophrenia, showed that CT-155 plus standard-of-care antipsychotic therapy was associated with significantly reduced negative symptoms between baseline and week 16, meeting the study's primary endpoint. CT-155 was well tolerated and demonstrated a favorable safety profile similar to previous studies, the release said. 'The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need,' Shaheen Lakhan, MD, PhD, chief medical and scientific officer of Click Therapeutics, said in the release. Unmet Need Although available treatments have been used to help manage negative symptoms of schizophrenia, there is currently no approved treatment specifically for negative symptoms in the US, the companies noted. CT-155 was granted Breakthrough Device Designation by the FDA in 2024. So far, it is the only app designed solely for schizophrenia to have received this designation. Last year, the FDA approved the first new schizophrenia treatment in decades. But research reported earlier this year offered disappointing results from a phase 3 trial of that drug, xanomeline/trospium chloride (Cobenfy, Bristol Myers Squibb). As reported by Medscape Medical News , this has resulted in many clinicians becoming more open to exploring digital and technical solutions — including at this year's American Psychiatric Association (APA) annual meeting, where most research poster sessions featured presentations on apps targeting psychiatric conditions, including schizophrenia. CT-155 is a mobile app-based software designed to address negative symptoms of schizophrenia by providing interactive psychosocial techniques when used alongside standard pharmaceutical treatment. The app needs to be prescribed by a healthcare professional and is then installed onto smartphones. While the World Health Organization estimates that approximately 24 million people worldwide have schizophrenia, about 60% of them experience negative symptoms. These types of symptoms involve an absence or reduction of behaviors and functions considered normal, including blunted affect, reduced speech, and social withdrawal. Positive schizophrenia symptoms, on the other hand, are those that add experiences or perceptions, such as hallucinations, delusions, and paranoia. Detailed Results Coming Soon CONVOKE is a randomized, double-blind, multicenter, phase 3 trial. Its primary endpoint was reduction in experiential negative symptoms from baseline to week 16, as measured using the Clinical Assessment Interview for Negative Symptoms, Motivation, and Pleasure Scale (CAINS-MAP), for CT-155 vs a digital control app used along with standard-of-care antipsychotic therapy. Other endpoints, including change from baseline to week 8 on the CAINS-MAP and improvement on the Patient Global Impression of Improvement Scale at weeks 8 and 16 have not been released yet. However, detailed results from CONVOKE are scheduled to be presented in October at the European College of Neuropsychopharmacology Congress' Novel Therapeutics Symposium. Before today's results were announced, John Torous, MD, psychiatrist and director of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, voiced his optimism about the study at the APA meeting and told Medscape Medical News he hoped the product could roll out quickly if it proved to be effective. After the results were released, he tweeted, 'Impressive results for a new app to support people with schizophrenia, given the study features a rigorous digital control group.' Torous added that he is 'excited to see such advances in digital health.'
Yahoo
07-08-2025
- Health
- Yahoo
Boehringer and Click Therapeutics' investigational prescription digital therapeutic CT-155 meets primary endpoint in CONVOKE study for negative symptoms in schizophrenia
Boehringer Ingelheim library CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP. CT-155 is an investigational prescription digital therapeutic being evaluated to target negative symptoms of schizophrenia in a registrational randomized clinical trial.1,2 Often underappreciated and less recognized, negative symptoms impact more than half of people living with schizophrenia.3 Ingelheim, Germany / Ridgefield, Connecticut / New York, New York Boehringer Ingelheim and Click Therapeutics today announced that the pivotal Phase III CONVOKE study (NCT05838625) of CT-155 (BI 3972080), an investigational prescription digital therapeutic (PDT), met its primary endpoint. The randomized, double-blind, controlled study investigated the effectiveness and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia experiencing negative symptoms.1 The study's primary endpoint was change in experiential negative symptoms from baseline to week 16 as measured by the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).1 In the CONVOKE study, CT-155 was well tolerated and demonstrated a favorable safety profile consistent with past studies. 'Today's positive results from the CT-155 pivotal trial are an important moment for people living with the negative symptoms of schizophrenia,' said Emmanuelle Clerisme-Beaty, Medical Director US, SVP Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. 'Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated for the negative symptoms of schizophrenia to date. This is one of the largest unmet needs for these patients and those who care for them. We are proud to work in partnership with multiple stakeholders and innovative partners like Click Therapeutics on this journey.' Approximately 2.8 million adults in the U.S. live with schizophrenia, which places a profound burden on individuals, families and society.4,5 About 60% of people living with schizophrenia experience negative symptoms.3 'Findings from CONVOKE provide the first Phase III evidence supporting the potential of a prescription digital therapeutic as an adjunct to standard of care antipsychotic therapy to treat a core element of schizophrenia,' said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 'The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need.' Detailed results will be presented during the Novel Therapeutics Symposium on Monday, October 13 at the 38th Annual European College of Neuropsychopharmacology (ECNP) Congress being held in Amsterdam, The Netherlands. About CT-155 CT-155 (BI 3972080) is an investigational prescription digital therapeutic that aims to provide interactive psychosocial intervention techniques as an adjunct to standard antipsychotic therapy to people living with schizophrenia experiencing negative symptoms.1,2,6 CT-155 is being developed by Click Therapeutics, Inc. and Boehringer Ingelheim.1,6 In 2024, CT-155 was granted Breakthrough Device designation by regulatory authorities in the U.S.6 CT-155 has not been authorized by any regulatory authorities. Safety and effectiveness have not been established by any regulatory authority. About the CONVOKE study CONVOKE (NCT05838625) was a Phase III, multicenter, randomized, double-blind, 16-week study evaluating the efficacy and safety of CT-155 versus a digital control app as an adjunct to standard of care antipsychotic therapy in people diagnosed and living with schizophrenia and experiential negative symptoms.1 The study enrolled adults and late adolescents with schizophrenia who were stable on antipsychotic medication.1 The primary endpoint evaluated improvement in experiential negative symptoms as an adjunct to standard of care as measured by changes from baseline to week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP).1 Other endpoints include: change from baseline in CAINS-MAP at week 8; change from baseline in CAINS expressivity scale (CAINS-EXP) at weeks 8 and 16; change from baseline in positive symptoms measured by the Positive and Negative Syndrome Scale (PANSS) at weeks 8 and 16; change from baseline in social functioning measured by the Personal and Social Performance Scale (PSP) at weeks 8 and 16; and patient global impression of improvement measured by Patient Global Impression of Improvement Scale (PGI-I) at weeks 8 and 16.1 About prescription digital therapeutics (PDTs) PDTs are software-based interventions prescribed by healthcare professionals and installed on smartphones to help address behavioral dimensions of diseases and conditions.7,8 PDTs are designed to be convenient, user friendly and accessible at all times of day, potentially helping to address barriers to care such as costs and mental health provider shortages—a shortage that is particularly exacerbated in rural areas.7,8,9,10 Additionally, the care provided can be patient-centered and flexible, to meet the patient where they are in their own treatment journey.7,8 About negative symptoms of schizophrenia Schizophrenia affects approximately 24 million people worldwide, and about 60% of people living with the condition experience negative symptoms.3,4 Negative symptoms are one of the three core symptoms domains of schizophrenia, along with positive symptoms and cognitive impairment.11 Negative symptoms include both experiential or expressive symptoms.3,12 Experiential negative symptoms include lack of motivation (avolition), decreased social interactions (asociality) and diminished ability to feel pleasure (anhedonia).3,12 Expressive negative symptoms refer to decreased expression of emotions (blunted affect) and reduction in speaking (alogia).3,12 In a U.S. single retrospective analysis, schizophrenia was associated with a significant economic burden, accounting for over $60 billion in direct healthcare costs in 2019.13 In another U.S. retrospective cohort study assessing claims from 2016-2023, the economic burden was greater for those who experience negative symptoms than those without negative symptoms, as these symptoms were associated with higher healthcare resource utilization, including higher costs, more outpatient/inpatient visits and longer hospitalizations.14 Although treatments are being used to help manage negative symptoms, there are no U.S. regulatory authority-approved treatments indicated for negative symptoms of schizophrenia to date.3,6 About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at Boehringer About Click Therapeutics Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. Operating at the intersection of biology and technology, Click uses a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes. Digital therapeutics on Click's platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Click's commitment to advancing digital medicine means they continually improve their platform technologies, ensuring they stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Their diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit and connect with Click on LinkedIn. Media Contacts Boehringer Ingelheim: Tereza Urbankova Senior Media Relations Manager press@ +49 (6132) 77-184817 Click Therapeutics: Emily Flint pr@ +1 (978) 412-7273 References Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE). Available from: Accessed August 2025. CT-155 (BI 3972080): Prescription digital therapeutic. Boehringer Ingelheim. Available from: Accessed August 2025. Correll CU, Schooler NR. Negative Symptoms in Schizophrenia: A Review and Clinical Guide for Recognition, Assessment, and Treatment. Neuropsychiatr Dis Treat. 2020;16:519–534. Schizophrenia. WHO. Available from: Accessed August 2025. Schizophrenia Fact Sheet. Treatment Advocacy Center. Available from: Accessed August 2025. Boehringer Ingelheim and Click Therapeutics receive FDA breakthrough device designation for schizophrenia prescription digital therapeutic. Boehringer Ingelheim. Available from: Accessed August 2025. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. May 2023;8(4):e10536. DTx Value Assessment & Integration Guide. DTx Alliance. Available from : Accessed August 2025. Health Resources and Services Administration. Health Workforce Shortage Areas. Available from: Accessed August 2025. Health Resources and Services Administration. State of the Behavioral Health Workforce, 2024. Available from: Accessed August 2025. Hany M, Rizvi A. Schizophrenia. StatPearls [Internet]. Available from: Accessed August 2025. Llerena K, Reddy LF, Kern RS. The role of experiential and expressive negative symptoms on job obtainment and work outcome in individuals with schizophrenia. Schizophr Res. 2018;192:148-153. Kadakia A, Catillon M, Fan Q, et al. The Economic Burden of Schizophrenia in the United States. J Clin Psychiatry. 2022 Oct 10;83(6):22m14458. Vaccaro J, Nili M, Xiang P, et al. Economic Burden Associated with Negative Symptoms Identified Through Natural Language Processing Among Patients with Schizophrenia in the United States. Schizophr Bull. 2025 Jun 3: Boehringer Ingelheim libraryError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
26-05-2025
- Business
- Yahoo
Digital Therapeutics Market Analysis and Forecasts, 2025-2035: Rising Fundings and Investment in Digital Therapeutics and Expanding Applications Driving Opportunities
The global digital therapeutics market is rapidly transforming healthcare with evidence-based software and devices that enhance both physical and behavioral health management. Key drivers include increased accessibility, patient engagement, data insights, and reduced healthcare costs. Notable developments in the market feature major collaborations between prominent firms like Vida Health and Click Therapeutics. With challenges like data privacy and reimbursement hindrances, expanding applications and rising investment present vast opportunities for growth. This dynamic market is fueled by technological advances, cost-effectiveness, and expanding global reach, signifying a new era in personalized, patient-centered care. Dublin, May 26, 2025 (GLOBE NEWSWIRE) -- The "Digital Therapeutics Market - A Global and Regional Analysis: Focus on Product Type, Application, Sales Channel, and Country - Analysis and Forecast, 2025-2035" report has been added to global digital therapeutics market includes clinically validated software and devices that are evidence-based. These tools are intended for the treatment of a wide range of diseases and conditions. Furthermore, digital therapeutics can be used either on their own or in combination with other devices to manage both physical and behavioural health issues. China led the Asia-Pacific digital therapeutics market in 2024, driven by its large population facing chronic conditions like diabetes, hypertension, and cardiovascular diseases. Digital therapeutics provides effective and accessible solutions for managing these health issues. The Chinese government acknowledges the potential of digital therapeutics and is actively supporting its development and adoption to improve healthcare delivery and outcomes. How can this report add value to an organization?Product/Innovation Strategy: The global digital therapeutics market is extensively segmented across various categories, such as product type, application, sales channel, and region. Each region undergoes a detailed analysis based on digital therapeutics product type, application, and sales channel. This segmentation offers readers a clear overview of which digital therapeutics segments currently dominate the market, and which ones are well-positioned for growth in the Strategy: Synergistic activities represented the largest share of key developments, with approximately 64.44% of all developments in the global digital therapeutics market occurring between January 2020 and November Strategy: The global digital therapeutics market is home to numerous established players, each offering product portfolios that address a wide array of conditions. Key players analysed and profiled in the study include prominent companies providing diverse digital therapeutics solutions for treatment, patient care, and preventive Dynamics Impact Analysis: Increased Accessibility of Care Improved Patient Engagement and Adherence Enhanced Data Collection and Analysis Reduced Costs of Healthcare Delivery Market Demand Drivers Multiple Benefits Provided by Digital Therapeutics over Traditional Treatment Continuous Technological Advancements Driving the Adoption of Digital Therapeutics Increasing Demand for Cost-Effective Solutions Creating a Demand for Digital Therapeutics Market Restraints: Data Privacy and Security Concerns Lack of Standardized Reimbursement Models Market Opportunities: Expanding Applications of Digital Therapeutics Rising Fundings and Investment in Digital Therapeutics Key Market Players Akili Interactive Labs, Inc. Lark Technologies, Inc. 2Morrow Inc. Click Therapeutics, Inc. Biofourmis Inc. Glooko, Inc. CureApp, Inc. Cognoa, Inc. Omada Health, Inc. Cara Care Neurotrack Technologies, Inc. Kaia Health ResMed Inc. Vida Health Vivante Health, Inc. Key Topics Covered: Executive SummaryScope of the Study1. Global Digital Therapeutics Market Overview1.1 Trends: Current and Future Impact Assessment1.1.1 Trend 1: Expansion across Therapeutic Area1.1.2 Trend 2: Integration with the Healthcare Ecosystem1.1.3 Trend 3: Utilization of Artificial Intelligence (AI) and Machine Learning (ML) with Digital Therapeutics1.2 Value Chain Analysis1.3 Funding Activities1.4 Regulatory Framework1.5 Patent Analysis2. Market Dynamics2.1.1 Impact Analysis2.1.2 Market Drivers2.1.3 Market Restraints2.1.4 Market Opportunities3. Global Digital Therapeutics Market Analysis (By Product Type), $Million, 2024-20353.1 Overview3.2 Growth-Share Matrix3.3 Product Type3.4 Software3.5 Devices4. Global Digital Therapeutics Market Analysis (By Application), $ Million, 2024-20354.1 Overview4.2 Growth-Share Matrix4.3 Application Summary4.4 Treatment/Patient Care-Related Applications4.4.1 Diabetes4.4.2 Neurological Disorders4.4.3 Smoking Cessation4.4.4 Chronic Respiratory Disorders4.4.5 Gastrointestinal Disorders4.4.6 Cardiovascular Disorders4.4.7 Medication Adherence4.4.8 Rehabilitation and Patient Care4.4.9 Others4.5 Preventive Applications4.5.1 Nutrition Management4.5.2 Lifestyle Management4.5.3 Others5. Global Digital Therapeutics Market Analysis (By Sales Channel), $Million, 2024-20355.1 Overview5.2 Sales Channel Summary5.3 Business-to-Business5.3.1 Insurance Providers/Corporate Employer5.3.2 Pharmaceutical Companies5.3.3 Others5.4 Business-to-Customer5.4.1 Patients5.4.2 Caregivers6. Global Digital Therapeutics Market Analysis (By Region), $ Million, 2024-20356.1 Regional Summary6.2 North America6.2.1 Regional Overview6.2.2 Driving Factors for Market Growth6.2.3 Factors Challenging the Market Growth6.2.4 U.S.6.2.5 Canada6.3 Europe6.3.1 Regional Overview6.3.2 Driving Factors for Market Growth6.3.3 Factors Challenging the Market Growth6.3.4 U.K.6.3.5 Germany6.3.6 France6.3.7 Italy6.3.8 Spain6.3.9 Rest-of-Europe6.4 Asia-Pacific6.4.1 Regional Overview6.4.2 Driving Factors for Market Growth6.4.3 Factors Challenging the Market Growth6.4.4 China6.4.5 Japan6.4.6 India6.4.7 Australia6.4.8 South Korea6.4.9 Rest-of-Asia-Pacific6.5 Latin America6.5.1 Regional Overview6.5.2 Driving Factors for Market Growth6.5.3 Factors Challenging the Market Growth6.5.4 Brazil6.5.5 Mexico6.5.6 Rest-of-Latin America6.6 Middle East and Africa6.6.1 Regional Overview6.6.2 Driving Factors for Market Growth6.6.3 Factors Challenging the Market Growth6.6.4 KSA6.6.5 U.A.E.6.6.6 Israel6.6.7 South Africa6.6.8 Rest-of-Middle East and Africa7. Global Digital Therapeutics Market - Competitive Benchmarking and Company Profiles7.1 Next Frontiers7.2 Competitive Analysis7.3 Global Ecosystem Glimpse7.4 Geographic Assessment7.4.1 Company Overview7.4.2 Product Portfolio7.4.3 Key Competitors7.4.4 Target Customers7.4.5 Analyst Perspective For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Yahoo
26-05-2025
- Business
- Yahoo
Digital Therapeutics Market Analysis and Forecasts, 2025-2035: Rising Fundings and Investment in Digital Therapeutics and Expanding Applications Driving Opportunities
The global digital therapeutics market is rapidly transforming healthcare with evidence-based software and devices that enhance both physical and behavioral health management. Key drivers include increased accessibility, patient engagement, data insights, and reduced healthcare costs. Notable developments in the market feature major collaborations between prominent firms like Vida Health and Click Therapeutics. With challenges like data privacy and reimbursement hindrances, expanding applications and rising investment present vast opportunities for growth. This dynamic market is fueled by technological advances, cost-effectiveness, and expanding global reach, signifying a new era in personalized, patient-centered care. Dublin, May 26, 2025 (GLOBE NEWSWIRE) -- The "Digital Therapeutics Market - A Global and Regional Analysis: Focus on Product Type, Application, Sales Channel, and Country - Analysis and Forecast, 2025-2035" report has been added to global digital therapeutics market includes clinically validated software and devices that are evidence-based. These tools are intended for the treatment of a wide range of diseases and conditions. Furthermore, digital therapeutics can be used either on their own or in combination with other devices to manage both physical and behavioural health issues. China led the Asia-Pacific digital therapeutics market in 2024, driven by its large population facing chronic conditions like diabetes, hypertension, and cardiovascular diseases. Digital therapeutics provides effective and accessible solutions for managing these health issues. The Chinese government acknowledges the potential of digital therapeutics and is actively supporting its development and adoption to improve healthcare delivery and outcomes. How can this report add value to an organization?Product/Innovation Strategy: The global digital therapeutics market is extensively segmented across various categories, such as product type, application, sales channel, and region. Each region undergoes a detailed analysis based on digital therapeutics product type, application, and sales channel. This segmentation offers readers a clear overview of which digital therapeutics segments currently dominate the market, and which ones are well-positioned for growth in the Strategy: Synergistic activities represented the largest share of key developments, with approximately 64.44% of all developments in the global digital therapeutics market occurring between January 2020 and November Strategy: The global digital therapeutics market is home to numerous established players, each offering product portfolios that address a wide array of conditions. Key players analysed and profiled in the study include prominent companies providing diverse digital therapeutics solutions for treatment, patient care, and preventive Dynamics Impact Analysis: Increased Accessibility of Care Improved Patient Engagement and Adherence Enhanced Data Collection and Analysis Reduced Costs of Healthcare Delivery Market Demand Drivers Multiple Benefits Provided by Digital Therapeutics over Traditional Treatment Continuous Technological Advancements Driving the Adoption of Digital Therapeutics Increasing Demand for Cost-Effective Solutions Creating a Demand for Digital Therapeutics Market Restraints: Data Privacy and Security Concerns Lack of Standardized Reimbursement Models Market Opportunities: Expanding Applications of Digital Therapeutics Rising Fundings and Investment in Digital Therapeutics Key Market Players Akili Interactive Labs, Inc. Lark Technologies, Inc. 2Morrow Inc. Click Therapeutics, Inc. Biofourmis Inc. Glooko, Inc. CureApp, Inc. Cognoa, Inc. Omada Health, Inc. Cara Care Neurotrack Technologies, Inc. Kaia Health ResMed Inc. Vida Health Vivante Health, Inc. Key Topics Covered: Executive SummaryScope of the Study1. Global Digital Therapeutics Market Overview1.1 Trends: Current and Future Impact Assessment1.1.1 Trend 1: Expansion across Therapeutic Area1.1.2 Trend 2: Integration with the Healthcare Ecosystem1.1.3 Trend 3: Utilization of Artificial Intelligence (AI) and Machine Learning (ML) with Digital Therapeutics1.2 Value Chain Analysis1.3 Funding Activities1.4 Regulatory Framework1.5 Patent Analysis2. Market Dynamics2.1.1 Impact Analysis2.1.2 Market Drivers2.1.3 Market Restraints2.1.4 Market Opportunities3. Global Digital Therapeutics Market Analysis (By Product Type), $Million, 2024-20353.1 Overview3.2 Growth-Share Matrix3.3 Product Type3.4 Software3.5 Devices4. Global Digital Therapeutics Market Analysis (By Application), $ Million, 2024-20354.1 Overview4.2 Growth-Share Matrix4.3 Application Summary4.4 Treatment/Patient Care-Related Applications4.4.1 Diabetes4.4.2 Neurological Disorders4.4.3 Smoking Cessation4.4.4 Chronic Respiratory Disorders4.4.5 Gastrointestinal Disorders4.4.6 Cardiovascular Disorders4.4.7 Medication Adherence4.4.8 Rehabilitation and Patient Care4.4.9 Others4.5 Preventive Applications4.5.1 Nutrition Management4.5.2 Lifestyle Management4.5.3 Others5. Global Digital Therapeutics Market Analysis (By Sales Channel), $Million, 2024-20355.1 Overview5.2 Sales Channel Summary5.3 Business-to-Business5.3.1 Insurance Providers/Corporate Employer5.3.2 Pharmaceutical Companies5.3.3 Others5.4 Business-to-Customer5.4.1 Patients5.4.2 Caregivers6. Global Digital Therapeutics Market Analysis (By Region), $ Million, 2024-20356.1 Regional Summary6.2 North America6.2.1 Regional Overview6.2.2 Driving Factors for Market Growth6.2.3 Factors Challenging the Market Growth6.2.4 U.S.6.2.5 Canada6.3 Europe6.3.1 Regional Overview6.3.2 Driving Factors for Market Growth6.3.3 Factors Challenging the Market Growth6.3.4 U.K.6.3.5 Germany6.3.6 France6.3.7 Italy6.3.8 Spain6.3.9 Rest-of-Europe6.4 Asia-Pacific6.4.1 Regional Overview6.4.2 Driving Factors for Market Growth6.4.3 Factors Challenging the Market Growth6.4.4 China6.4.5 Japan6.4.6 India6.4.7 Australia6.4.8 South Korea6.4.9 Rest-of-Asia-Pacific6.5 Latin America6.5.1 Regional Overview6.5.2 Driving Factors for Market Growth6.5.3 Factors Challenging the Market Growth6.5.4 Brazil6.5.5 Mexico6.5.6 Rest-of-Latin America6.6 Middle East and Africa6.6.1 Regional Overview6.6.2 Driving Factors for Market Growth6.6.3 Factors Challenging the Market Growth6.6.4 KSA6.6.5 U.A.E.6.6.6 Israel6.6.7 South Africa6.6.8 Rest-of-Middle East and Africa7. Global Digital Therapeutics Market - Competitive Benchmarking and Company Profiles7.1 Next Frontiers7.2 Competitive Analysis7.3 Global Ecosystem Glimpse7.4 Geographic Assessment7.4.1 Company Overview7.4.2 Product Portfolio7.4.3 Key Competitors7.4.4 Target Customers7.4.5 Analyst Perspective For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
22-04-2025
- Health
- Business Wire
Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc., ('Click') a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company's prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Re duction in M onthly Mi graine D ays, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product's FDA premarket review. 'This marks a significant milestone for the more than 37 million adults in the US who live with migraine,' said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 'As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.' Click Therapeutics recently presented CT-132 pivotal study results at the American Academy of Neurology Annual Meeting, where co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click shared in a post-conference Medscape article, 'I think this is very exciting as a clinician who takes care of patients because we don't have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don't have access to them.' 'With this landmark, first-in-class FDA authorization in episodic migraine, Click's interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,' said David Benshoof Klein, chief executive officer of Click Therapeutics. 'As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas.' Built on Click's industry-leading AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management. Intended for adjunctive use alongside other treatments for migraine, CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy. CT-132 is thus well-positioned for further development in the future as a software-enhanced drug™ therapy. Click's software-enhanced drug therapies combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients. Click launched its new product offering, Click SE™, in October 2024 to pioneer this new therapeutic category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS). This marketing authorization announcement follows Click's recent Series C funding round news, announced in March 2025. Indication: The CT-132 prescription digital therapeutic is indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. Safety Information: There are no contraindications to using CT-132. CT-132 is not intended to be used as a standalone therapy. CT-132 does not replace or substitute other migraine treatments, including medication for migraine. Patients should continue their current treatment as directed. About the ReMMi-D Pivotal Study and ReMMiD-C Bridging study The indications for use for CT-132 are supported by the results from two double-blind decentralized randomized controlled trials, a pivotal study (ReMMi-D) and a bridging study (ReMMiD-C). The pivotal ReMMi-D study evaluated the effectiveness and safety of CT-132 for the prevention of episodic migraine in patients 18 years and older, compared to a sham digital control and included patients (n=558) on the most commonly prescribed migraine medications. ReMMiD-C was designed identically to ReMMi-D but required that participants (n=110) be taking at least one calcitonin gene-related peptide (CGRP) inhibitor, though participants were also permitted use of non–migraine-specific acute or preventive medications. The study designs mirrored those of contemporary randomized control trials for migraine drugs. However, unlike in drug studies, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated. Both studies demonstrated that CT-132 reduced monthly migraine days (MMDs) compared to a sham digital control in patients already using acute and preventive migraine medications, with no device-related adverse events reported. At the completion of the pivotal ReMMi-D study, CT-132 demonstrated a statistically significant reduction in monthly migraine days (MMDs) after 12 weeks of treatment compared to the sham digital control (n=568, ITT population; treatment difference: –0.9 MMDs; p =0.005). Participants in the treatment arm experienced a mean reduction of –3.04 MMDs by the end of the intervention. Further, migraine related quality of life, assessed by the Migraine-Specific Quality-of-Life Questionnaire (MSQ, revealed a difference between the CT-132 and sham digital control arms from as early as 4 weeks and through weeks 8 and 12. Migraine disability, as measured by the Migraine Disability Assessment (MIDAS) score, improved more in the CT-132 arm than in the sham arm at the end of treatment. Note that the analysis of secondary effectiveness endpoints did not include multiplicity adjustment or formal hypothesis testing. Engagement and adherence were high and sustained over the full 12-week duration of the treatment, with a median of 81 daily lessons out of 84 completed by those receiving the sham digital control and a median of 84 completed by those receiving CT-132. CT-132 was well-tolerated, with no discontinuations due to treatment-emergent adverse events (TEAEs). The ReMMiD-C bridging study provided supportive information, also evaluated versus a sham digital control but without formal hypothesis testing, that demonstrated similar performance of CT-132 in patients taking the new-class of migraine-specific medications, CGRP inhibitors. About Migraine Migraine is a complex and debilitating condition that affects more than 37 million adults and is the second leading cause of disability in the United States. 1,2 It is characterized by episodes of moderate-to-severe headache and is generally associated with nausea and increased sensitivity to light and sound. 3 For those living with migraine, attacks unfold over hours to days and negatively impact key domains of life including employment, educational attainment, and relationships. 4 Despite the availability of preventive migraine medications, there remains a significant unmet need in migraine management. Many patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed. 5 About Prescription Digital Therapeutics Prescription Digital Therapeutics (PDTs) deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated. PDTs can be used independently or in combination with traditional pharmaceutical treatments. About Click Therapeutics Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease. Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click's platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. In 2024, in response to FDA guidance on prescription drug use-related software (PDURS) and building off the capabilities of our platform, we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients. To date, three Click Therapeutics devices have received FDA marketing authorizations. The company's self-developed CT-132, a first-in-class prescription digital therapeutic for preventing episodic migraine, was granted De Novo classification by the FDA. Click Therapeutics, in collaboration with Otsuka, developed Rejoyn™, which became the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms. Additionally, the company expanded its portfolio into cardiometabolic disease with AspyreRx, which received FDA marketing authorization for the treatment of type 2 diabetes. Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit and connect with us on LinkedIn. References
