RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia)

Structure/Sequence

Sequence Code 110850L

Source: *****

Sequence Code 110854H

Source: *****

Clinical Trials associated with Concizumab-mtci

NCT06831734

/ Enrolling by invitationNot Applicable

Special Use-results Surveillance on Use of Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors A Multi-centre, Open-label, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Treatment With Alhemo in Patients With Haemophilia A or Haemophilia B Without Inhibitors in Routine Clinical Practice Conditions in Japan

The purpose of the study is to investigate the safety and effectiveness of Alhemo in participants under real-world clinical practice in Japan. Total duration of this study is about 6 years. Participants enrolment will be completed in the first 4 years. The observation period of this study will last for about 2 years for each enrolled participant.

Start Date02 May 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT06285071

/ Enrolling by invitationNot Applicable

A Multi-centre, Open-label, Single-arm, Non-interventional Post-marketing Study to Investigate Safety and Clinical Parameters of Alhemo® Under Routine Clinical Practice in Japan

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.

Start Date08 Aug 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT05135559

/ Active, not recruitingPhase 3

Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors

This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.
Participants will have to inject the study medicine every day under the skin with a pen-injector.
The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.

Start Date24 Mar 2022

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Concizumab-mtci

100 Translational Medicine associated with Concizumab-mtci

100 Patents (Medical) associated with Concizumab-mtci

Literatures (Medical) associated with Concizumab-mtci

03 Jul 2025·Expert Review of Hematology

Anti-tissue factor pathway inhibitors for hemophilia: are these treatments the answer to overcoming current treatment limitations?

Review

Author: Mahlangu, Johnny

INTRODUCTION:

Non-factor therapies were developed to address the shortcomings of clotting factor concentrates (CFCs) used for hemophilia bleed management. These CFC unmet needs include high treatment burden, immunogenicity, inconsistent hemostatic cover, poor treatment outcomes, and musculoskeletal progression despite adequate prophylactic treatment. Anti-tissue factor pathway inhibitors (anti-TFPIs) that have completed Phase 3 clinical studies are concizumab and marstacimab. The role of these anti-TFPIs in the hemophilia treatment armamentarium remains unclear.

AREAS COVERED:

This review critically appraises data published in PubMed, World of Science, and peer-reviewed congress presentations to determine whether anti-TFPIs merely supplement current treatment options or represent a disruptive shift in the treatment paradigm for hemophilia. It underscores the unmet needs of replacement therapies and compares the pharmacokinetic, efficacy, and safety data of anti-TFPIs and selected FVIII and FIX products.

EXPERT OPINION:

As hemophilia treatment goals continue to evolve, the role of currently developed anti-TFPIs is still not fully defined. This review comprehensively summarizes the clinical trial data, which shows that anti-TFPIs are not intended to replace the standard of care CFCs but to expand the therapeutic arsenal for patients with hemophilia treated with these therapeutic agents.

01 Apr 2025·The Journal of the Association of Physicians of India

Revolutionizing Treatment Strategies through Inhibition of Tissue Factor Pathway Inhibitor: A Promising Therapeutic Approach for Hemophilia Management.

Review

Author: Shaikh, Bilal Ahmed ; Aggarwal, Sunita ; Seth, Tulika ; Nigam, Rajendra K ; Jain, Ankur ; Baveja, Avriti ; Atri, Sudhir ; Sharma, Vishnu ; Digra, Sanjeev Kumar ; Vyas, Bhadresh ; Gupta, Naresh

Hemophilia, an X-linked genetic bleeding disorder, is caused by the deficiency of coagulation factors VIII (hemophilia A) or IX (hemophilia B). Regular replacement therapy with the missing clotting factor is an effective standard-of-care treatment. However, it comes with a significant fallout of frequent intravenous dosing with poor compliance, the risk of inhibitor development, and a substantial treatment burden. Research has progressed from missing clotting factors and factor VIII mimetics to the most recent rebalancing therapy that suppresses tissue factor pathway inhibitor (TFPI). Thrombin generation is restricted by TFPI, which inhibits the tissue factor-mediated activation of factor VII. This promising therapeutic approach rebalances hemostasis by inhibiting TFPI, a critical regulator of the extrinsic coagulation pathway, thereby increasing thrombin generation. Novel monoclonal antibodies (concizumab and marstacimab) enhance thrombin generation by blocking TFPI to restore hemostasis. Clinical trials have demonstrated good clinical efficacy and safety of these anti-TFPI, besides their convenient subcutaneous administration using pen devices. These innovative therapies have the potential to enhance the quality of life (QoL) of people with hemophilia. This review provides a comprehensive overview of the clinical development, therapeutic potential, challenges, and prospects of anti-TFPI in the management of hemophilia.

01 Apr 2025·CLINICAL AND APPLIED THROMBOSIS-HEMOSTASIS

Evaluating the Safety and Efficacy of Concizumab in Hemophilia A/B Patients: A Systematic Review

Review

Author: Siddiqui, Erum ; Waafira, Aminath ; Khan, Muhammad Mohsin ; Khan, Muhammad Saad ; Khalid, Maliha ; Farhan, Kanza

Background:

Hemophilia A and B are X-linked recessive bleeding disorders caused by deficiencies of coagulation factors VIII and IX, respectively. These conditions lead to spontaneous bleeding, joint damage, inhibitor development, and the burden of frequent intravenous infusions. Concizumab, a monoclonal antibody targeting tissue factor pathway inhibitor (TFPI), is a novel non-factor therapy that enhances thrombin generation. This systematic review evaluates the efficacy and safety of concizumab prophylaxis in patients with hemophilia A and B.

Methods:

This systematic review was conducted in accordance with PRISMA guidelines. Randomized controlled trials (RCTs) assessing the use of concizumab in hemophilia A or B were identified through a comprehensive search of electronic databases. Outcomes of interest included annualized bleeding rate (ABR), thrombin generation, bleeding episodes, immunogenicity, and adverse events. The Cochrane Risk of Bias Tool 2.0 was used for quality assessment.

Results:

Five studies were included. Concizumab prophylaxis was associated with a notable reduction in ABR, with reported decreases from 9.4 to 1.3 episodes/year and from 19.6 to 2.9 episodes/year in hemophilia A, and from 14.9 to 1.6 episodes/year in hemophilia B. Thrombin generation increased in a dose-dependent manner and stabilized by week 24. Across all studies, bleeding episodes were significantly reduced. Adverse events were primarily mild to moderate. No thromboembolic events were reported.

Conclusion:

Concizumab appears to be an effective and safe prophylactic treatment for patients with hemophilia A and B, demonstrating consistent reductions in bleeding rates and enhanced thrombin generation. Further long-term studies are warranted to establish its sustained safety and efficacy.

News (Medical) associated with Concizumab-mtci

12 Aug 2025

·pmlive.com

Novo Nordisk’s Alhemo approved by FDA for expanded haemophilia use

Novo Nordisk’s Alhemo (concizumab-mtci) has been approved by the US Food and Drug Administration (FDA) to prevent or reduce bleeding episodes in a broader population of haemophilia A and B patients. The therapy has now been authorised for use as a once-daily prophylaxis in adult and paediatric patients aged 12 years and older with haemophilia A or B without inhibitors, building on its existing indication for haemophilia A or B patients with inhibitors. Affecting approximately 800,000 people globally, haemophilia is a rare inherited bleeding disorder that impairs the body’s ability to make blood clots. The condition is usually treated with regular intravenous infusions of clotting factor replacement products. However, some patients can develop inhibitors as an immune response to the clotting factors in these therapies, limiting treatment options. Administered as a subcutaneous injection, Novo’s Alhemo is a tissue factor pathway inhibitor antagonist that is designed to help the blood to clot and prevent bleeding, regardless of inhibitor status. Anna Windle, senior vice president, clinical development, medical and regulatory affairs, Novo Nordisk, said: “The FDA approval of an expanded indication for Alhemo marks a meaningful step forward for people with haemophilia A or B without inhibitors who are looking for a new prophylaxis treatment option.” The regulator’s latest decision on the therapy was based on results from the late-stage explorer8 trial, which demonstrated a statistically significant reduction in annualised bleeding rate (ABR) of 79% for haemophilia B patients without inhibitors and 86% for haemophilia A patients without inhibitors, compared to no prophylaxis. There were also notable reductions in the average and median ABRs, which Novo said “further reinforced the efficacy of Alhemo prophylaxis in reducing bleeds across both patient groups”. Also welcoming the decision, Allison Wheeler, scientific director, Washington Center for Bleeding Disorders, said: “For people living with haemophilia, it is important to continually monitor and discuss bleed control with their healthcare professional. “With [this] approval of Alhemo for haemophilia A or B without inhibitors, more people living with these rare blood disorders now have a daily prophylaxis option that may help decrease their bleeding rates.”

Drug ApprovalClinical Result

01 Aug 2025

·firstwordpharma.com

FDA okays broader indications for Novartis’ lipid-lowering drug, Novo’s haemophilia prophylatic

The FDA cleared additional indications for Novartis’s cholesterol-lowering drug Leqvio (inclisiran) and Novo Nordisk's haemophilia prophylactic Alhemo (concizumab-mtci), broadening their use to wider patient populations.Leqvio gets go-ahead as montherapyNovartis's twice-yearly injectable siRNA drug Leqvio was approved by the FDA as monotherapy alongside diet and exercise to lower low-denisty lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia, thereby eliminating the previous requirement for concurrent statin therapy.“With this new indication enabling Leqvio's use as monotherapy…we now have the potential to help even more patients achieve their LDL-C lowering goals earlier in their treatment journey," said Victor Bultó, president of Novartis US.The US regulator said Leqvio’s broader indication was approved based on strong LDL-C-lowering data from PCSK9-targeting therapies. Additional label updates include replacing "primary hyperlipidaemia" terminology with the more specific "hypercholesterolaemia" designation throughout the prescribing information.Novartis noted the decision also aligns with the 2025 American College of Cardiology/American Heart Association Clinical Practice Guidelines, recommending more aggressive treatment approaches for patients with acute coronary syndrome.Leqvio was discovered by Alnylam and co-developed with The Medicines Company, which Novartis acquired in 2020 for $9.7 billion. First approved in the EU for hypercholesterolaemia or mixed dyslipidaemia in 2020, the siRNA’s US approval faced initial delays owing to manufacturing issues, but was subsequently cleared by the FDA in 2021 for patients on maximally tolerated statin therapy.The Swiss drugmaker expects Leqvio not only to surpass $1 billion in sales this year, but potentially outperform consensus forecasts long term. For more, read – Spotlight On: Novartis' fastest growing drugs.Alhemo cleared for patients without inhibitorsThe FDA also okayed an expanded indication for Novo Nordisk's Alhemo (concizumab-mtci), extending its prophylactic use to adult and paediatric patients aged 12 and older with haemophilia A or B without inhibitors. The latest approval builds upon the tissue factor pathway (TFPI) inhibitor antagonist’s approval last year for patients with inhibitors after being rejected by the agency on the first attempt.Anna Windle, senior VP of clinical development, medical & regulatory affairs at Novo Nordisk, said the latest approval “marks a meaningful step forward for people with haemophilia A or B without inhibitors who are looking for a new prophylaxis treatment option."The label expansion was supported by the Phase III explorer8 study, wherein Alhemo achieved an 86% reduction in annualised bleeding rate for patients with haemophilia A and 79% reduction for those with haemophilia B versus no prophylaxis.Following a positive recommendation by the EU drug advisory body last week, the anti-TFPI monoclonal antibody is also on the verge of approval in Europe for the same indication.With the additional indication, Alhemo emerges as a potential rival to Pfizer’s once-weekly Hympavzi (marstacimab-hncq), approved last year for patients without inhibitors. Pfizer also seeks Hympavzi’s expansion to patients with inhibitors following a successful Phase III study.

Drug ApprovalPhase 3AcquisitionClinical ResultAHA

31 Jul 2025

·www.prnewswire.com

FDA approves Alhemo® as once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors

FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of Alhemo® (concizumab-mtci) injection in people 12 years and older with hemophilia A or B (HA/HB) without inhibitors1 Results showed a 79% reduction in annualized bleeding rate (ABR) in patients with HB without inhibitors and an 86% reduction in patients with HA without inhibitors, respectively, using Alhemo® prophylaxis compared to no prophylaxis2 Alhemo® was the first subcutaneous injectable pen of its kind for patients living with HA and HB with inhibitors and is now approved for those living without inhibitors1 PLAINSBORO, N.J., July 31, 2025 /PRNewswire/ -- Novo Nordisk announced today that the US Food and Drug Administration (FDA) approved Alhemo® (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B (HA/HB) without inhibitors, expanding on the December 2024 approval for HA/HB with inhibitors.1,2,3 Currently, many treatments for HA/HB without inhibitors are administered via intravenous infusions.2 With this approval, Alhemo® now offers a subcutaneous injection treatment option for this population.1 "The FDA approval of an expanded indication for Alhemo® marks a meaningful step forward for people with hemophilia A or B without inhibitors who are looking for a new prophylaxis treatment option," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs, Novo Nordisk. "By building on the initial indication for Alhemo® for those with hemophilia with inhibitors—an especially significant development in hemophilia B where challenges still exist despite advanced treatment options—Novo Nordisk continues its 35+ year legacy in rare bleeding disorders to continue to help address the unmet needs of this community." Alhemo® is designed to block a protein called tissue factor pathway inhibitor (TFPI), which stops blood from clotting. By inhibiting TFPI, Alhemo® improves the production of thrombin, which helps to clot the blood and prevent bleeding, when clotting factors VIII and IX are missing or deficient regardless of inhibitor status.4,5 "For people living with hemophilia, it is important to continually monitor and discuss bleed control with their healthcare professional," said Allison P. Wheeler, MD, Scientific Director, Washington Center for Bleeding Disorders, Seattle, WA. "With today's approval of Alhemo® for hemophilia A or B without inhibitors, more people living with these rare blood disorders now have a daily prophylaxis option that may help decrease their bleeding rates." The primary objective of the pivotal phase 3 explorer8 trial was to compare the number of treated spontaneous and traumatic bleeding episodes, as measured by the ABR, in patients aged 12 years and older with HA/HB without inhibitors, receiving Alhemo® prophylaxis versus no prophylaxis (on demand Factor VIII/Factor IX treatment).2 The study showed a statistically significant reduction in ABR of 79% for HB patients (ABR ratio: 0.21; 95% CI: 0.10–0.45; p<0.0001) and 86% for HA patients (ABR ratio: 0.14; 95% CI: 0.07–0.29; p<0.0001). Additionally, notable reductions in the average and median ABRs further reinforced the efficacy of Alhemo® prophylaxis in reducing bleeds across both patient groups, with an average ABR of 3.1 (1.9-5.0) and a median ABR of 1.6 (0.0-4.8) for HB patients, compared to 14.8 (8.1-26.9) and 14.9 (3.3-22.1), respectively, and an average ABR of 2.7 (1.6-4.6) and median ABR of 2.9 (0.0-5.2) for HA patients, compared to 19.3 (11.3-33.0) and 19.6 (17.3-30.4), respectively. In the study, the most common adverse reactions reported in ≥5% of patients randomized to receive Alhemo® were injection site reactions (7%) and headache (7%).1 Alhemo® is provided in prefilled, premixed pens for subcutaneous injection (60 mg/1.5 mL, 150 mg/1.5 mL, or 300 mg/3 mL) via thin 32 gauge, 4 mm needles, which are provided separately, offering an additional treatment choice for patients with hemophilia with inhibitors – and now without inhibitors – to further customize their care. About the explorer8 study Explorer8 is a phase 3 clinical trial that evaluated the efficacy and safety of Alhemo® for adults and pediatric patients 12 years of age and older living with hemophilia A or B (HA/HB) without inhibitors.2 In explorer8, among the 156 males with HA/HB included in the trial, 63 were randomly assigned in a 1:2 ratio to receive no prophylaxis (arm 1, n=21), or Alhemo® prophylaxis (arm 2, n=42).2,6 The median duration of treatment was 24.1 weeks in arm 1 (no prophylaxis) and 32.1 weeks in arm 2 (Alhemo® prophylaxis).The initial loading dose of Alhemo® was 1 mg per kilogram of body weight, followed by 0.2 mg per kilogram daily, and potentially individualized on the basis of concizumab-mtci plasma concentration as measured at week 4.1,2 Efficacy was evaluated separately in HA patients without inhibitors and in HB patients without inhibitors when all patients in arms 1 and 2 had completed the main part of the trial (at least 24 or at least 32 weeks, respectively), based on the number of treated bleeding episodes comparing Alhemo® prophylaxis and no prophylaxis.1 About Alhemo® (concizumab-mtci) Alhemo® is a tissue factor pathway inhibitor (TFPI) antagonist. By inhibiting the TFPI, Alhemo® enhances factor Xa (FXa) production during the initiation phase of coagulation, leading to improved thrombin generation and clot formation in patients with hemophilia A or B (HA/HB) with or without inhibitors. The effect of Alhemo® is not influenced by the presence of inhibitory antibodies to FVIII or FIX and Alhemo® does not induce or enhance the development of direct inhibitors to FVIII or FIX. Alhemo® is approved as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with HA/HB with or without inhibitors in the US.1 What is Alhemo®? Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children 12 years of age and older with hemophilia A or B with or without factor VIII or IX inhibitors. It is not known if Alhemo® is safe and effective in people receiving ongoing immune tolerance induction (ITI) or in children younger than 12 years of age Important Safety Information What is the most important information I should know about Alhemo®? It is important to follow the daily dosing schedule of Alhemo® to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established. Use Alhemo® exactly as prescribed by your healthcare provider (HCP). Do not stop using Alhemo® without talking to your HCP. If you miss doses or stop using Alhemo®, you may no longer be protected against bleeding Your HCP may prescribe factor VIII, factor IX, or bypassing agents during treatment with Alhemo®. Carefully follow your HCP's instructions regarding when to use on-demand factor VIII, factor IX, or bypassing agents and the recommended dose and schedule for breakthrough bleeds Do not use Alhemo® if you are allergic to concizumab-mtci or any of the ingredients in Alhemo®. Before using Alhemo®, tell your HCP about all of your medical conditions, including if you: Have a planned surgery. Talk to your HCP about when to stop using Alhemo® and when to start it again if you have a planned surgery Are pregnant, breastfeeding, or plan to become pregnant or breastfeed. It is not known if Alhemo® may harm your unborn baby or if Alhemo® passes into your breast milk Your HCP may do a pregnancy test before you start treatment with Alhemo® Females who are able to become pregnant, talk to your HCP about using effective birth control (contraception) methods during treatment with Alhemo® and for 7 weeks after ending treatment Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and supplements. What are the possible side effects of Alhemo®? Alhemo® may cause serious side effects, including: Blood clots (thromboembolic events). Alhemo® may cause blood clots to form in blood vessels, such as in your arms, legs, heart, lung, brain, eyes, kidneys, or stomach. You may be at risk for getting blood clots if you use high or frequent doses of factor products or bypassing agents to treat breakthrough bleeds, or if you have certain conditions. Get medical help right away if you have any signs and symptoms of blood clots, including: swelling, warmth, pain, or redness of the skin; headache; trouble speaking or moving; eye pain or swelling; sudden pain in your stomach or lower back area; feeling short of breath or severe chest pain; confusion; numbness in your face; and problems with your vision Allergic reactions. Alhemo® can cause allergic reactions, including redness of the skin, rash, hives, itching, and stomach-area (abdominal) pain. Stop using Alhemo® and get emergency medical help right away if you develop any signs or symptoms of a severe allergic reaction, including: itching on large areas of skin; trouble swallowing; wheezing; pale and cold skin; dizziness due to low blood pressure; redness or swelling of lips, tongue, face, or hands; shortness of breath; tightness of the chest; and fast heartbeat The most common side effects of Alhemo® include: bruising, redness, bleeding, itching, rash or lump at the injection site, headache, and hives. These are not all the possible side effects of Alhemo®. Call your doctor for medical advice about side effects. Please click HERE for Alhemo® Prescribing Information and Medication Guide 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.7 It is estimated to affect approximately ~800,000 people worldwide.8 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).7 Hemophilia is often treated by replacing the missing clotting factor via intravenous infusions, also known as replacement therapy.8 About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D, and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X. References Alhemo® (concizumab-mtci) injection, for subcutaneous use [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Chowdary P., et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Hematology. 2024;11:e891-904. Novo Nordisk. FDA approves drug to prevent or reduce the frequency of bleeding episodes for patients with hemophilia A with inhibitors or hemophilia B with inhibitors. Accessed May 2025. Available at . Shapiro AD. Concizumab: a novel anti-TFPI therapeutic for hemophilia. Blood Adv. 2021;5(1):279. Matsushita T, Shapiro A, Abraham A, et al. Phase 3 trial of concizumab in hemophilia with inhibitors. N Engl J Med. 2023; 389(9): 783-794. ClinicalTrials.gov. Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8). Accessed May 2025. Available at . MedlinePlus. Hemophilia. Accessed May 2025. Available at . World Federation of Hemophilia. Annual Global Survey 2023. Accessed July 2025. . Further information Liz Skrbkova (US) +1 609 917 0632 (Mobile) [email protected] Ambre James-Brown (Global) +45 3079 9289 [email protected] Alhemo® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25AHM00187 July 2025 SOURCE Novo Nordisk WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug Approval

100 Deals associated with Concizumab-mtci

External Link

KEGG	Wiki	ATC	Drug Bank
D11847	-	-	DB12820

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hemophilia	Japan	Novo Nordisk Pharma Ltd.	25 Sep 2023
Hemophilia A	Australia	Novo Nordisk Pharmaceuticals Pty Ltd.	05 Jul 2023
Hemophilia B	Canada	Novo Nordisk Canada, Inc.	10 Mar 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04082429 (explorer8, FDA_CDER) Manual	Phase 3	Hemophilia B \| Hemophilia A	156	Alhemo prophylaxis	lzqlbnxevc(iggjdxgoaf) = sodkbfyfmy tibsaeaqpo (hwxzoqaesp, 1.63 - 4.59) View more	Positive	31 Jul 2025
				No prophylaxis	lzqlbnxevc(iggjdxgoaf) = tlxwvbiomy tibsaeaqpo (hwxzoqaesp, 11.25 - 33.03) View more
NCT04083781 (explorer7, CTgov)	Phase 3	Hemophilia B \| Hemophilia A	134	concizumab (Arm 1: Previous on Demand: No Prophylaxis)	fbarqlksby(boqswqtlcq) = dfyxlqdraz ivpppauoxj (wkfrdtvgar, szsvmubewu - kgupmgaqof) View more	-	27 Apr 2025
				Concizumab (Arm 2: Previous on Demand: Concizumab Prophylaxis (PPX))	fbarqlksby(boqswqtlcq) = tzrtpjxeji ivpppauoxj (wkfrdtvgar, uxrtqwwdjz - wlmxbrvcjl) View more
NCT04082429 (explorer8, Pubmed \| Res Pract Thromb Haemost)	Phase 3	Hemophilia A	-	Concizumab prophylaxis	xwrvsczcaq(aaqnhapeqa) = nfsciiobkv idfhcmgyyx (jfrukphgrj, 2.4 - 16.7) View more	Positive	01 Feb 2025
NCT04083781 (explorer7, FDA_CDER) Manual	Phase 3	Hemophilia B \| Hemophilia A	133	Alhemo	whzwlhxbul(ecchzjkfrt) = qhhlwtpqdg kzfhxgqlmk (hmebelzffd, 1.01 - 2.87)	Positive	20 Dec 2024
				no prophylaxis	whzwlhxbul(ecchzjkfrt) = fnrurwuzbm kzfhxgqlmk (hmebelzffd, 7.03 - 19.86)
explorer7 and explorer8 (ASH2023)	Phase 3	Hemophilia	278	Concizumab prophylaxis	uwyyyxoluq(amzymvixez) = mezmyzzgqj vgtmdlfmkz (syncserlzi )	-	09 Dec 2023
NCT04083781 (explorer7, Pubmed)	Phase 3	Hemophilia	133	Concizumab prophylaxis	oajjqzlwtc(rhyjjvxsyl) = astblagsio zirrdlnppt (zjpomgpfre, 1.0 - 2.9)	Positive	31 Aug 2023
				Concizumab (No prophylaxis)	oajjqzlwtc(rhyjjvxsyl) = rkduojyvto zirrdlnppt (zjpomgpfre, 7.0 - 19.9)
ISTH2023	Phase 3	-	-	Concizumab	avhomzegmu(fzgvjzzcxs) = rgyqctaqli batbuzaoay (cbtmhlahyf )	-	24 Jun 2023
				Concizumab	avhomzegmu(fzgvjzzcxs) = qqzwmragwj batbuzaoay (cbtmhlahyf, 21)
NCT04083781 (explorer7, ASH 12022 \| ASH 22022) Manual	Phase 3	Hemophilia B \| Hemophilia A	25	Concizumab (Concizumab prophylaxis)	jabuepwbct(nubazxtbrc) = rzloxlmfgq cfeppoydpk (sqbhksweao, -23.7 to -10.3)	Positive	15 Nov 2022
				Concizumab (non-concizumab prophylaxis treatment)	jabuepwbct(nubazxtbrc) = cqbarekaty cfeppoydpk (sqbhksweao, -9.4 to 15.3)
NCT04083781 (explorer7, GlobeNewswire) Manual	Phase 3	Hemophilia B	133	Concizumab	mqnxtwtolh(npfwcuzirk) = pucyfaatcs gfyvvjccur (zvossslscl ) View more	Positive	10 Jul 2022
				no prophylaxis	nbcwvtrrfj(nkuatbfbqy) = efdexsyxyb ihreiznwqj (amzcubupuv )
NCT03196284 \| NCT03196297 (explore5 \| explore4, Pubmed \| Blood Adv) Manual	Phase 2	Hemophilia B	-	concizumab (explore4)	pqldcbklgb(fxrusbiuqn) = lwhrehmqlh zyqgydxfpi (kkdcjqjzmj, 3.2 - 7.2) View more	Positive	15 Mar 2022
				concizumab (explore5)	pqldcbklgb(fxrusbiuqn) = hjjzmlmwce zyqgydxfpi (kkdcjqjzmj, 4.1 - 9.9) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis