- FRONTIER4 data on investigational denecimig: Exploring efficacy and safety across dosing frequencies for pediatric, adolescent, and adult hemophilia A patients, with or without inhibitors
- Explorer10 data on concizumab (Alhemo®): Details presented for pediatric hemophilia A or B patients (up to 11 years old), with inhibitors
- Data underscores the breadth of Novo Nordisk's hemophilia portfolio, building on Novo Nordisk's legacy across rare blood disorders
PLAINSBORO, N.J. and BAGSVÆRD, Denmark, June 26, 2026 /PRNewswire/ -- Novo Nordisk today announced that new data will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Congress, July 11-15 in Paris, France. The broad range of oral and poster presentations spans the Novo Nordisk hemophilia portfolio and is highlighted by multiple analyses of the phase 3 FRONTIER4 study evaluating the long-term efficacy and safety of investigational denecimig (Mim8) across a range of age groups and dosing frequencies, including once-monthly, once-every-two-weeks, and once-weekly prophylaxis. Additional insights from the portfolio will span clinical and real-world treatment data as well as patient-reported outcomes.
"Everyone's experience with hemophilia is different, and we have a deep responsibility to meet the real-world needs of the community. For more than 45 years, we have listened to the lived experiences of patients, and we continue to advance scientific innovation to improve care," said Martin Holst Lange, chief scientific officer and executive vice president, Research & Development at Novo Nordisk. "We are excited to share data across our portfolio, including for denecimig, as each of our studies accounts for that lived reality as we focus on advancing person-centric research that will help bring meaningful impact to the rare blood disorders community."
Additionally, data from the open-label phase 3 explorer10 study will be presented for the first time, evaluating the efficacy and safety of concizumab in children up to 11 years of age living with hemophilia A or B (HA/HB), with inhibitors. The use of concizumab in children below 12 years of age with hemophilia A or B, with or without inhibitors, is investigational and not approved by regulatory authorities or available anywhere in the world.
Summary of all presentations
Accepted data at the 34th ISTH Congress include the following poster and oral presentations. Additional information can be found on the ISTH website.
Full details of Novo Nordisk abstracts to be presented:
- Investigational denecimig
1. | Oral presentation: Mim8 (denecimig) prophylaxis in adults and adolescents with haemophilia A with or without inhibitors: Interim results from the FRONTIER4 long-term safety and efficacy study | |||||
2. | Oral presentation: Mim8 (denecimig) prophylaxis in children with haemophilia A with or without inhibitors: Interim safety and efficacy results from the FRONTIER4 long-term extension study | |||||
3. | Poster presentation: Mim8 (denecimig) prophylaxis in adults, adolescents and children with haemophilia A with or without inhibitors: Interim patient-reported outcomes from the long-term extension study (FRONTIER4) | |||||
4. | Poster presentation: Denecimig (Mim8) restores thrombin generation into the normal range in people with haemophilia A: Post hoc analysis of the phase 3 FRONTIER2 and FRONTIER5 studies | |||||
5. | Poster presentation: Thrombin generation of hemophilia B-causing factor IX variants with non-factor therapies | |||||
6. | Poster presentation: Denecimig (Mim8) tiered dosing achieves consistent exposure and bleed control in phase 3 FRONTIER studies | |||||
7. | Poster presentation: A multinational, open-label study to investigate efficacy and safety of denecimig (Mim8) in adults with acquired haemophilia A: study enrolment 2026 | |||||
8. | Poster presentation: Denecimig (Mim8) enhances in vitro thrombin generation in von Willebrand disease type 3 plasma | |||||
9. | Poster presentation: Effects of denecimig (Mim8) and tranexamic acid in an in vitro clot lysis assay | |||||
10. | Poster presentation: FVIIIa-mimetic bispecific antibody (Mim8) enhances thrombus formation of von Willebrand disease (VWD) under high shear flow condition | |||||
11. | Poster presentation: The coagulation potential in the copresence of Mim8 and warfarin |
- Concizumab (Alhemo®) injection
12. | Oral presentation: Concizumab prophylaxis in paediatric participants with haemophilia A/B with inhibitors in the phase 3 explorer10 study: Efficacy, safety and PK/PD results from the 32-week cut-off | |||||
13. | Poster presentation: Association of Concizumab with Tissue Factor Pathway Inhibitor (TFPI) within Platelets and the Extracellular Matrix (ECM) | |||||
14. | Poster presentation: Mechanism-based functional monitoring of concizumab focusing on coagulation initiation: from comprehensive global assays to TFPI-oriented assessment | |||||
15. | Poster presentation: The effect of anti-TFPI antibodies in a novel rapid automatable clotting assay measuring the activity of TFPI and in a thrombin generation assay |
- Pre-clinical data & general hemophilia
16. | Poster presentation: Evaluation of Physical Activity and Related Bleeds in Patients with Hemophilia in the US: A Real-World Microhealth App Study | |||||
17. | Poster presentation: Physicians' Preferences in the Treatment of Hemophilia: A Discrete-Choice Experiment | |||||
18. | Poster presentation: Real-World Indirect Cost Burden and Patient-Reported Outcomes in Adults with Hemophilia A in the United States – A CHESS-US Analysis |
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 hemophilia 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 Hemophilia
Hemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding.2 While hemophilia 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 hemophilia, which are characterized by the type of clotting factor protein that is defective or missing. Hemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and hemophilia B is caused by a missing or defective clotting Factor IX (FIX).2 Hemophilia 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. In the United States, Novo Nordisk has a 40-year presence, is headquartered in New Jersey and employs approximately 10,000 people across more than 10 manufacturing, R&D, and corporate locations in seven states plus Washington, D.C. For more information, visit novonordisk.com and novonordisk-us.com, and follow us on Facebook, Instagram, X, LinkedIn, and YouTube.
Contacts for further information
Media: | |
Liz Skrbkova (US) | Ambre James-Brown (Global) |
Investors: | |
Frederik Taylor Pitter (US) +1 609 613 0568 | Michael Novod (Global) +45 3075 6050 |
Jacob Martin Wiborg Rode (Global) | Sina Meyer (Global) +45 3079 6656 |
Max Ung (Global) +45 3077 6414 | Christoffer Sho Togo Tullin (Global) +45 3079 1471 |
Alex Bruce (Global) +45 3444 2613 | Mads Berner Bruun (Global) |
References
- Bowyer AE, Hickey K, Kitchen S, Ezban M. The effect of a next generation FVIII mimetic bispecific antibody (Mim8) the impact on assays of factor VIII activity and thrombin generation. Journal of Thrombosis and Haemostasis. 2023;21:480-487
- MedlinePlus. Hemophilia. Last accessed June 2026. Available at https://medlineplus.gov/genetics/condition/hemophilia.
- Srivastava A, Santagostino E, Dougall A, et al. WFH Guidelines for the Management of Hemophilia, 3rd edition. Haemophilia. 2020: 26(Suppl 6): 1-158. https://doi.org/10.1111/hae.14046
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