Novo Nordisk to Showcase New Haemophilia Research and Investigational Denecimig Data at ISTH 2026 Congress
Novo Nordisk has announced that it will present an extensive portfolio of new scientific data at the 34th International Society on Thrombosis and Haemostasis (ISTH) Congress, taking place from July 11 to July 15, 2026, in Paris, France. The presentations will highlight the company’s continued commitment to advancing treatment options for people living with haemophilia and other rare bleeding disorders through innovative research, long-term clinical studies, and patient-centered care.
The scientific program includes multiple oral and poster presentations covering Novo Nordisk’s haemophilia portfolio, with particular emphasis on new analyses from the ongoing Phase 3 FRONTIER4 study evaluating the investigational therapy denecimig (Mim8). Researchers will also present new findings from the Phase 3 explorer10 study investigating concizumab in children with haemophilia A or B who have inhibitors, alongside real-world evidence, patient-reported outcomes, physician treatment preferences, and preclinical research.
Collectively, the data reinforce Novo Nordisk’s long-standing investment in rare blood disorders and its strategy of developing innovative therapies designed to improve bleeding prevention, treatment convenience, and overall quality of life for patients across different age groups.
Continuing More Than Four Decades of Innovation
Novo Nordisk has been involved in haemophilia research and treatment development for more than 45 years, contributing to advances in replacement therapies, prophylactic treatment strategies, and novel non-factor therapies.
Over that period, treatment options for haemophilia have evolved significantly. While traditional clotting factor replacement therapies remain important, newer approaches—including bispecific antibodies and tissue factor pathway inhibitor (TFPI) inhibitors—are transforming disease management by providing longer-lasting protection against bleeding episodes with less frequent dosing.
The company says its current research program reflects an ongoing commitment to listening to patients and caregivers while designing therapies that better align with the realities of living with chronic bleeding disorders.
Focus on Patient-Centered Research
Martin Holst Lange, Executive Vice President of Research & Development and Chief Scientific Officer at Novo Nordisk, emphasized that every person living with haemophilia experiences the disease differently.
According to Lange, the company has spent decades engaging with patients to better understand the daily challenges associated with haemophilia, including the physical, emotional, and practical burdens of lifelong treatment.
He explained that Novo Nordisk’s research strategy increasingly focuses on person-centered innovation, seeking not only to prevent bleeding but also to improve convenience, long-term outcomes, and quality of life.
Lange said the company is particularly excited to share new findings from the investigational therapy denecimig while continuing to expand scientific understanding across its broader haemophilia portfolio.
Denecimig (Mim8) Takes Center Stage
One of the major highlights of Novo Nordisk’s scientific program will be new data from denecimig (Mim8), an investigational bispecific antibody currently being evaluated for the prevention of bleeding episodes in people with haemophilia A, both with and without inhibitors.
Denecimig is designed to mimic the activity of activated factor VIII by bridging activated factor IX and factor X, thereby restoring thrombin generation and improving blood clot formation.
Unlike traditional factor replacement therapy, denecimig aims to provide sustained protection through less frequent subcutaneous dosing.
Its development program seeks to offer flexible prophylactic treatment schedules while maintaining effective bleed prevention.
Long-Term Results from the FRONTIER4 Study
Several oral presentations at ISTH will feature interim findings from the Phase 3 FRONTIER4 long-term extension study.
The study is evaluating both the long-term safety and efficacy of denecimig in adults, adolescents, and children living with haemophilia A, regardless of inhibitor status.
Investigators are assessing multiple prophylactic dosing schedules, including:
- Once-weekly treatment
- Once every two weeks
- Once-monthly treatment
These dosing options are intended to provide physicians and patients with greater flexibility while maintaining consistent bleed protection over extended treatment periods.
The long-term extension study also evaluates patient-reported outcomes to better understand how treatment affects quality of life, treatment satisfaction, and daily functioning.
Broad Scientific Program for Denecimig
Beyond the primary efficacy analyses, Novo Nordisk will present several additional studies exploring different aspects of denecimig’s clinical and biological activity.
Researchers will report patient-reported outcomes collected during the FRONTIER4 extension study, offering insight into patients’ experiences during long-term treatment.
Additional post hoc analyses from the FRONTIER2 and FRONTIER5 Phase 3 studies will examine how denecimig restores thrombin generation to levels approaching the normal physiological range in people with haemophilia A.
Other presentations will explore:
- Consistency of drug exposure using tiered dosing strategies.
- Bleeding control achieved across multiple Phase 3 studies.
- Laboratory studies evaluating thrombin generation.
- Potential applications in acquired haemophilia A.
- Effects in von Willebrand disease models.
- Interaction with tranexamic acid.
- Coagulation potential when administered alongside warfarin.
These studies aim to deepen scientific understanding of denecimig’s mechanism of action while supporting its broader clinical development.
New Study in Acquired Haemophilia A
Among the planned presentations is the introduction of a multinational open-label study investigating denecimig in acquired haemophilia A, a rare autoimmune bleeding disorder that differs from inherited haemophilia.
The study will evaluate the safety and efficacy of denecimig in adults diagnosed with acquired haemophilia A, expanding the potential clinical applications of the investigational therapy beyond congenital haemophilia.
Enrollment for the study is expected during 2026.
Explorer10 Study to Present First Pediatric Concizumab Data
Novo Nordisk will also present, for the first time, results from the Phase 3 explorer10 study evaluating concizumab in children up to 11 years of age living with haemophilia A or haemophilia B with inhibitors.
The oral presentation will include data collected through the 32-week analysis, examining treatment efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD).
Concizumab is designed to inhibit tissue factor pathway inhibitor (TFPI), thereby enhancing thrombin generation and improving blood clot formation.
Although concizumab has been approved for certain patient populations in some regions under the brand name Alhemo®, its use in children younger than 12 years of age, with or without inhibitors, remains investigational and has not yet received regulatory approval anywhere in the world.
The pediatric findings are expected to contribute important evidence supporting future development in younger patients.
Additional Concizumab Research
Several poster presentations will further explore the biology and mechanism of action of concizumab.
These include studies examining:
- The interaction between concizumab and TFPI located within platelets and the extracellular matrix.
- Functional laboratory monitoring methods for assessing coagulation during treatment.
- Novel clotting assays designed to evaluate TFPI activity.
- Thrombin generation following inhibition of TFPI.
These mechanistic studies may help researchers better understand how concizumab influences blood coagulation and how treatment responses can be monitored more effectively.
Real-World Evidence Expands Understanding of Haemophilia Care
Novo Nordisk’s ISTH program also includes multiple presentations focused on real-world clinical practice.
One study evaluates physical activity patterns and bleeding episodes among people living with haemophilia in the United States using data collected through a digital microhealth application.
Understanding how exercise and daily activities influence bleeding risk may help physicians provide more personalized treatment recommendations while encouraging safe participation in physical activities.
Another study investigates physicians’ treatment preferences using a discrete-choice experiment, offering insight into how clinicians balance efficacy, safety, convenience, and dosing frequency when selecting haemophilia therapies.
Assessing the Economic Burden of Haemophilia
The scientific program also includes research examining the broader economic and quality-of-life impact of haemophilia.
Investigators will present findings from the CHESS-US analysis evaluating indirect costs and patient-reported outcomes among adults living with haemophilia A in the United States.
The research explores issues such as work productivity, daily functioning, treatment burden, and health-related quality of life.
These real-world studies complement clinical trial findings by providing a more comprehensive understanding of how haemophilia affects patients beyond traditional clinical endpoints.
Advancing Innovation Across Rare Blood Disorders
Novo Nordisk’s extensive scientific presence at ISTH reflects its broader strategy of advancing innovation across multiple rare bleeding disorders.
While denecimig remains one of the company’s most closely watched investigational programs, ongoing research involving concizumab and additional preclinical studies demonstrates continued investment in developing next-generation therapies capable of improving disease management across diverse patient populations.
By combining long-term clinical trials, mechanistic research, patient-reported outcomes, and real-world evidence, the company aims to build a more complete understanding of treatment effectiveness in everyday clinical practice.
The 2026 ISTH Congress will provide an important international platform for Novo Nordisk to present new evidence supporting its expanding haemophilia portfolio. With multiple oral presentations and posters spanning investigational denecimig, pediatric concizumab research, laboratory science, and real-world patient outcomes, the company will showcase the breadth of its ongoing commitment to improving care for people living with rare bleeding disorders.
Particular attention is expected to focus on the Phase 3 FRONTIER4 program, where long-term data may further clarify the potential role of denecimig as a flexible prophylactic treatment capable of delivering sustained bleed protection across adults, adolescents, and children. Meanwhile, new pediatric findings from explorer10 and additional real-world studies underscore Novo Nordisk’s continued efforts to address unmet medical needs through patient-centered innovation, scientific collaboration, and the development of therapies designed to improve both clinical outcomes and quality of life for individuals affected by haemophilia.
About denecimig
Denecimig is an investigational, bispecific antibody Factor VIIIa (FVIIIa) mimetic, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with haemophilia A (congenital FVIIIa deficiency), with or without inhibitors.1 In September 2025, Novo Nordisk submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine.
About haemophilia
Haemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding.2 While haemophilia can affect men and women, it’s most common in men and is estimated to impact 1,125,000 men worldwide.3 There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing.
Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and haemophilia B is caused by a missing or defective clotting Factor IX (FIX).2 Haemophilia is often treated by replacing the missing clotting factor via intravenous infusions, also known as replacement therapy. However, sometimes the body can produce inhibitors as an immune response to the clotting factor replacement therapy. When this happens, the therapy may not work and can limit treatment options.3
About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a heritage of more than 100 years in diabetes care. Building on this foundation, our purpose is to drive change to defeat serious chronic diseases – from diabetes and obesity to rare blood and endocrine disorders – by pioneering scientific breakthroughs, expanding access to medicines, and working to prevent and ultimately cure disease. We are committed to long-term, responsible business practices that deliver financial, social and environmental value. Headquartered in Denmark and operating in around 80 countries, Novo Nordisk employs approximately 67,900 people and markets products in roughly 170 countries
