Open-label Safety Study in Adults and Adolescents With Haemophilia A With and Without FVIII Inhibitors Switching Directly From Emicizumab Prophylaxis to NNC0365-3769 (Mim8) Prophylaxis

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Start Date26 Jun 2023

Sponsor / Collaborator

Novo Nordisk A/S

NCT05685238

/ Active, not recruitingPhase 3

Open-label, Long-term Safety and Efficacy Study of Mim8 in Participants With Haemophilia A With or Without Inhibitors

This study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). The study will last for up to 5.5 years. The duration of the study depends on when the participant enrolled in this study. The study will end if Mim8 is approved and marketed in participant's country during the study, or the study will end in June 2028, whichever comes first. Participants will get up to 262 injections; the number of injections depends on how often participants will get injections and how long time participants take part in the study. While taking part in this study, there are some restrictions about what medicine participants can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Start Date13 Feb 2023

Sponsor / Collaborator

Novo Nordisk A/S

NCT05681845

/ CompletedPhase 1

A Study to Demonstrate Bioequivalence of a Single Subcutaneous Administration of NNC0365-3769 (Mim8) With the DV3407-C1 Pen Injector Versus a Syringe and Enhanced Cartridge in Healthy Male Participants

Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.

Start Date02 Jan 2023

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Denecimig

100 Translational Medicine associated with Denecimig

100 Patents (Medical) associated with Denecimig

Literatures (Medical) associated with Denecimig

30 Apr 2026·NEW ENGLAND JOURNAL OF MEDICINE

Mim8 Bispecific Antibody Prophylaxis in Hemophilia A with or without Inhibitors.

Article

Author: Chowdary, Pratima ; Rakhmatullin, Ilgiz ; Oldenburg, Johannes ; Lentz, Steven R ; Shanmukhaiah, Chandrakala ; Mancuso, Maria Elisa ; Chan, Anthony K C ; Lyu, Chuhl Joo ; Mahlangu, Johnny ; van Vulpen, Lize F D ; Matsushita, Tadashi ; Yang, Renchi ; Zdziarska, Joanna ; Clausen, Wan Hui Ong

BACKGROUND:

Mim8 (denecimig), a bispecific antibody mimicking activated factor VIII, was developed for bleeding prophylaxis in patients with hemophilia A with or without factor VIII inhibitors.

METHODS:

In this phase 3, randomized trial, we assigned patients 12 years of age or older with hemophilia A with or without inhibitors to receive subcutaneous Mim8 once weekly or once monthly at a dose tiered according to body weight and given in a fixed injection volume (0.8 ml). Patients who had been receiving on-demand treatment before the trial were assigned in a 1:1:1 ratio to continue on-demand treatment (group 1) or receive Mim8 once weekly (group 2a) or once monthly (group 2b). Patients who had been receiving clotting factor concentrates during a run-in phase were assigned in a 1:1 ratio to receive Mim8 once weekly (group 3) or once monthly (group 4). The first primary end point was the annualized rate of treated bleeding events (those treated with a coagulation factor product) in an evaluation of Mim8 in group 2a and Mim8 in group 2b as compared with on-demand treatment in group 1. The second was the annualized rate of treated bleeding events in an intrapatient evaluation of Mim8 in group 3 and Mim8 in group 4 as compared with clotting factor concentrate prophylaxis during the run-in phase.

RESULTS:

Of the 58 patients in the pretrial on-demand treatment cohort, 17 were assigned to group 1, 21 to group 2a, and 20 to group 2b. The estimated mean annualized rate of treated bleeding events was 0.57 (95% confidence interval [CI], 0.25 to 1.30) in group 2a and 0.20 (95% CI, 0.06 to 0.71) in group 2b, as compared with 15.76 (95% CI, 10.70 to 23.20) in group 1 (relative decrease, 96.4% and 98.7%, respectively; P<0.001 for both comparisons). Of the 196 patients in the pretrial prophylaxis cohort, 98 each were assigned to group 3 or group 4. The estimated mean annualized rate of treated bleeding events was 2.25 (95% CI, 1.37 to 3.71) in group 3, as compared with 4.90 (95% CI, 3.65 to 6.56) during the run-in phase (relative decrease, 54.0%; P = 0.006), and 1.78 (95% CI, 1.18 to 2.71) in group 4, as compared with 3.12 (95% CI, 2.25 to 4.32) (relative decrease, 42.8%; P = 0.006). Injection-site reactions were reported in 103 of 4005 injections (2.6%). No patient was reported to have a thromboembolic event or clinical evidence of neutralizing anti-Mim8 antibodies.

CONCLUSIONS:

Among patients with hemophilia A with or without inhibitors, Mim8 prophylaxis was superior to on-demand treatment and clotting factor concentrate prophylaxis regarding the annualized rate of treated bleeding events. (Funded by Novo Nordisk; FRONTIER2 ClinicalTrials.gov number, NCT05053139.).

04 Mar 2026·Expert Review of Clinical Pharmacology

Factor-VIII mimetic bispecific antibodies for the treatment of hemophilia A: an update

Review

Author: Camelo, Ricardo Mesquita ; Alvares-Teodoro, Juliana ; Muniz Júnior, Roberto Lúcio ; Lamounier de Almeida, Douglas ; Eduarda Alves de Jesus, Vitória ; Pierce, Glenn F

INTRODUCTION:

Bispecific antibodies are used to treat various conditions, with notable results in hemophilia A, a rare bleeding disorder characterized by reduced or absent activity of the coagulation factor VIII (FVIII). Emicizumab is a bispecific antibody that mimics FVIII activity, reducing bleeds in people with hemophilia A (PwHA). The real-world effectiveness and safety profile of emicizumab stimulated the development of additional FVIII-mimetic antibodies.

AREAS COVERED:

This review covers recent progress in hemophilia A treatment, focusing on FVIII-mimetic bispecific antibodies. Emicizumab, the only currently approved FVIII-mimetic bispecific antibody, has shown effectiveness in reducing bleeding rates in PwHA with and without inhibitors, enabling improved musculoskeletal health and quality of life. Other FVIII-mimetic bispecific antibodies are in clinical trials (Mim8 and NXT007). We discuss mechanisms, preclinical and clinical outcomes, real-world data, safety, and new molecules expanding the therapeutic repertoire under development.

EXPERT OPINION:

The advent of FVIII-mimetic bispecific antibodies marks a shift in hemophilia A prophylaxis away from FVIII replacement therapies. Next-generation agents may offer enhanced activity and safety. Despite advances, challenges remain in monitoring activity, managing breakthrough bleeds, and understanding non-hemostatic FVIII roles. As long-acting, subcutaneous agents mature, they may redefine care, enabling personalized, safer, and more accessible prophylaxis across the lifespan.

01 Jan 2026·Research and Practice in Thrombosis and Haemostasis

Factor VIII in vitro bioequivalence of denecimig (Mim8) hemostatic effect by thrombin generation assays

Article

Author: Lund, Jacob ; Lillicrap, David ; Jensen, Kasper ; Ezban, Mirella

Background:

Denecimig (Mim8, Novo Nordisk A/S) is a next-generation bispecific antibody designed to mimic activated factor (F)VIII and restore hemostasis in persons with hemophilia A. The extent to which activated FVIII mimetics, such as denecimig and emicizumab, can correct clotting deficiency remains unclear.

Objectives:

To assess the in vitro FVIII bioequivalence of denecimig hemostatic activity using thrombin generation assays (TGAs).

Methods:

Thrombin generation was analyzed in severe hemophilia A platelet-poor plasma, spiked with various levels of FVIII or with clinical doses of denecimig (5 μg/mL) or emicizumab (50 μg/mL), using a sequence-identical analog (SIA). TGA used 4 trigger conditions: tissue factor (TF), activated FXI, a combination of TF and activated FXI, or activated FIX.

Results:

The average FVIII bioequivalence estimate using 1 pM TF trigger was 42 IU/dL (SD, 14) for 5 μg/mL denecimig and 14 IU/dL (SD, 5) for 50 μg/mL emicizumab-SIA using peak thrombin. The FVIII bioequivalence estimates of denecimig and emicizumab-SIA for hemostatic activity were generally highest for endogenous thrombin potential, followed by peak thrombin and velocity index across trigger concentrations. FVIII bioequivalence increased with decreasing trigger concentrations. Denecimig demonstrated a higher thrombin peak in conditions with limited activated FIX compared with emicizumab-SIA, suggesting differences in mechanisms of action.

Conclusion:

Estimation of denecimig in vitro FVIII bioequivalence with TGA depends on the TGA parameter and the type and concentration of the trigger. Denecimig demonstrated higher in vitro FVIII bioequivalence than emicizumab-SIA, indicating the potential for effective hemostatic coverage. Further studies are needed to fully understand the hemostatic effects of bispecific antibodies.

News (Medical) associated with Denecimig

21 Sep 2026

·firstwordpharma.com

Novo's Frehemgo, Incyte's Povofortay among key CHMP nods in September

The EMA's drug advisory panel backed a dozen new medicines for approval at its September meeting, including Novo's Frehemgo (denecimig) for haemophilia A, Incyte's Povofortay (povorcitinib) in severe hidradenitis suppurativa (HS) and two therapies for ovarian cancer.Among the more closely watched decisions announced Friday, the agency's Committee for Medicinal Products for Human Use (CHMP) recommended Frehemgo for the routine prophylaxis of bleeding episodes in patients with haemophilia A, regardless of inhibitor status. The decision was supported by findings from the FRONTIER programme, in which Frehemgo significantly reduced the annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment. The next-generation factor VIIIa mimetic bispecific antibody, previously known as Mim8, has also shown comparable effectiveness in children.The drug's dosing flexibility – it can be given once-monthly, once every two weeks, or once-weekly via single-use pre-filled pens – could be a possible key differentiator (see — KOL Views Q&A: Novo Nordisk’s denecimig may struggle to displace entrenched Hemlibra in haemophilia A). A similar application for Frehemgo is under review in the US.On Friday, Novo also received a positive CHMP opinion to expand use of Sogroya (somapacitan) to include children living with idiopathic short stature with persistent growth disturbance. The once-weekly, long-acting human growth hormone analogue is already authorised in the EU for the treatment of growth hormone deficiency in adults and in children ages 3 years and older.Povofortay nears first OKMeanwhile, the positive opinion for Povofortay moves Incyte's oral JAK1 inhibitor one step closer to securing its first approval. CHMP's decision covers the treatment of active moderate-to-severe HS in adults who have responded inadequately to, or who are intolerant or contraindicated to an anti-TNF therapy.The submission is supported by findings from the Phase III STOP-HS1 and STOP-HS2 studies, which both met their primary endpoints by demonstrating significant reductions in abscess and nodule count. Longer-term results presented at this year's American Academy of Dermatology (AAD) meeting showed that up to 57% of HS patients taking Povofortay achieved ≥75% reduction in inflammatory lesions after one year in the trials.A filing in this indication is also under review in the US, while Incyte is planning applications in vitiligo based on data released earlier this year. Pair of ovarian cancer drugsIn ovarian cancer, CHMP backed the approval of drugs with two different mechanisms of action: Corcept Therapeutics' selective glucocorticoid receptor modulator Lifyorli (relacorilant) and IMPACT Therapeutics' oral PARP1/2 inhibitor Sepalna (senaparib).Lifyorli's positive opinion is for use in combination with nab-paclitaxel to treat platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. The drug, which was approved earlier this year in the US, is seen as an advancement in ovarian cancer treatment. Deanna Gerber, an assistant professor of obstetrics and gynaecology at Weill Cornell Medicine, previously told FirstWord that Lifyorli is "going to be the next big thing" in the field (see – KOL Views Q&A: Relacorilant set for early uptake in platinum-resistant ovarian cancer).The recommendation was based on clinical data including from the Phase III ROSELLA trial, in which patients given Lifyorli plus nab-paclitaxel achieved improved progression-free and overall survival compared to nab-paclitaxel alone, without an increase in adverse events.The EMA panel also endorsed Sepalna as a maintenance treatment for advanced epithelial ovarian, fallopian tube and primary peritoneal cancer. The decision was supported by findings from the Phase III FLAMES study, in which Sepalna reduced the risk of disease progression of death by 57% compared to placebo when used as first-line maintenance monotherapy in a broad patient population with advanced ovarian cancer.Sepalna is already approved in China in the ovarian cancer maintenance setting, while IMPACT recently out-licensed certain rights to the drug to Pharmanovia, including in the EU.Other new drugs recommended for approval at CHMP's latest meeting include Xcovery's Gevalka (ensartinib) for adults with ALK-positive advanced non–small-cell lung cancer, AstraZeneca's Klygefa (gefurulimab) for generalised myasthenia gravis, Sanofi's rabies vaccine VaxRabeo, and Zealand Pharma's Zeydovio (glepaglutide) for the treatment of short bowel syndrome.

Clinical ResultPhase 3Drug Approval

21 Sep 2026

·www.fiercepharma.com

Europe's CHMP endorses slew of new medicines, including new offerings from Novo and AZ

European drug regulators just wrapped another stack of reviews , and the EU bloc now has a sizeable list of likely new treatments to show for it. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has signed off on eight new medicines, two biosimilars and two generics, while also recommending label extensions for 11 other therapies. Among the most notable developments is a positive recommendation for Novo’s Frehemgo, also known as denecimig, to treat or prevent bleeding episodes in adults and children with hemophilia A. Novo is positioning the drug as a next-generation factor VIIIa mimetic. The bispecific antibody works by binding Factor IXa and Factor X to increase thrombin production and improve clotting. Frehemgo is in direct competition with Roche’s blockbuster and current market leader Hemlibra, which made 4.8 billion Swiss francs ($5.81 billion) in sales last year. The CHMP recommendation comes just days after Frehemgo’s first approval in Saudi Arabia and makes way for a possible approval from the European Commission in the coming weeks. It’s a welcome win for Novo after suffering a string of late-stage disappointments in its cardiovascular pipeline amid mounting competition in metabolic medicine markets. The Danish drugmaker expects an initial launch of Frehemgo by years' end, with a broader rollout in early 2027. AstraZeneca’s rare disease business Alexion also snagged a recommendation from the CHMP, setting up dual-binding nanobody C5 inhibitor Klygefa for a formal approval from the EC. Klygefa, also known as gefurulimab, received the CHMP go-ahead as a treatment for adult patients with generalized myasthenia gravis (gMG), a chronic autoimmune disease marked by muscle weakness caused by the immune system’s attack on the connection points between the nerves and muscles. The treatment marks AstraZeneca’s continued investment in the C5 inhibitor class after Soliris and Ultomiris. But unlike those earlier infused drugs, Klygefa is a self-administered injection, offering patients more control and flexibility. If approved, Europe will be Klygefa’s second approval after Japan earlier this month and it will be the first dual-binding nanobody C5 inhibitor approved for gMG patients. Beyond those meds, new offerings from SFL Pharmaceuticals, Corcept, Incyte Biosciences and Sanofi also made the cut at CHMP this week. SFL scored double with a positive recommendation for both Gevalka and Sepalna. Gevalka was recommended in adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, a version of the disease more common in young patients who have never smoked. And Sepalna was recommended as a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube, or primary perineal cancer. Corcept’s Lifyorli, meanwhile, snagged a recommendation as a combo treatment with chemotherapy for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Incyte Biosciences’ Povofortay will take a positive review to the European Commission for acne inversa. And rounding out the list of endorsements was Sanofi’s rabies vaccine VaxRabeo. Alfasigma’s Jyseleca, AstraZeneca and Daiichi Sankyo's Enhertu, Merk & Co.'s Keytruda, Novartis’ Cosentyx, Leo’s Anzupgo, and Roche’s Ocrevus, among others, took positive opinions for their proposed label expansions. In a setback for MaaT Pharma, the CHMP elected—after reexamination—to uphold its decision to recommend against Xervyteg as a treatment for acute graft-versus-host disease, a life-threatening condition in which donor bone marrow or stem cells attack the patient. The agency maintained that MaaT’s single-arm trial did not show a sufficient benefit-risk profile. In response, the pharma proposed a phase 3 trial evaluating Xervyteg against a best available therapy to satisfy regulator concerns. All CHMP recommendations now head for the European Commission for final sign-off.

Drug ApprovalPhase 3Clinical Result

20 Sep 2026

·www.novonordisk.com

Novo: CHMP recommends EU approval of FREHEMGO® (denecimig), the first factor VIIIa mimetic offering monthly, once every two weeks and weekly dosing in a pre-filled pen, for the treatment of haemophilia A

Bagsværd, Denmark, 17 September 2026 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A (HA), with or without inhibitors, in adults and children. FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people living with HA, with or without inhibitors. The CHMP recommendation is based on the FRONTIER trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment in people with HA, with or without inhibitors. In children younger than 12 years, results from FRONTIER 3 were consistent with the efficacy observed in adolescents and adults. 1 - 2 Across the FRONTIER programme, denecimig has demonstrated consistently low mean annualised bleeding rates, generally below 1 in the reported phase 3 population, and with a substantial proportion of participants experiencing zero treated bleeds. 1- 3 Furthermore, in the FRONTIER 5 trial, no new safety signals were identified following direct switching from emicizumab to denecimig prophylaxis. The study also showed a clear preference for the denecimig device. 4 “The recommendation by the CHMP for approval of FREHEMGO® builds on Novo’s commitment of over 40 years in haemophilia and marks an important advancement for people living with haemophilia A, with or without inhibitors”, said Mike Doustdar, president and CEO of Novo. “The combination of strong bleed protection, flexible dosing frequency and a prefilled pen offers a differentiated treatment option that can reduce treatment burden and give people with haemophilia A greater freedom in managing their disease.” In September 2025, Novo submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA). About the FRONTIER trials The FRONTIER clinical programme includes FRONTIER1-5 and investigates denecimig as a prophylactic treatment to prevent bleeding episodes across paediatric and adult populations with haemophilia A, with or without inhibitors. FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application (MAA) submission. FRONTIER2 evaluated denecimig treatment once every month and once every week in adults and adolescents 12 years of age and older; FRONTIER3 evaluated denecimig treatment once every month and once every week in children below the age of 12; FRONTIER4 was an open-label extension trial evaluating the efficacy of denecimig once every two weeks (Q2W) as well as investigating the long-term safety of denecimig across all dosing regimens (once every month, once every two weeks, and once every week) in subjects with haemophilia A, with or without inhibitors. About FREHEMGO ® ( denecimig) FREHEMGO® (denecimig) is an FVIIIa mimetic bispecific antibody designed with the aim to deliver once monthly, every two weeks and weekly prophylaxis for people living with haemophilia A, with or without inhibitors. FREHEMGO®, which is administered under the skin, ‘mimics’ the role of FVIIIa by bridging factor IXa and factor X. This action mimics the cofactor function of FVIIIa, which helps restore the body’s thrombin generation capacity, helping blood to clot. FREHEMGO® is currently pending marketing approval from the EMA and other regulatory authorities. Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com and follow us on Instagram , LinkedIn , TikTok , Facebook , X and YouTube . Publication of inside information pursuant to Market Abuse Regulation, Article 17. Contacts for further information Company announcement No 55 / 2026 1 NCT5053139; Mancuso ME, Chan AKC, Shanmukhaiah C, et al. N Engl J Med . 2026; doi: 10.1056/NEJMoa2517384 2 NCT05306418 3 NCT05685238 4 NCT05878938; Hermans C, Benson G, Matino D, et al. J Thromb Haemost . 2026; doi: 10.1016/j.jtha.2026.09.004

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Denecimig

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KEGG	Wiki	ATC	Drug Bank
D12797	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	NDA/BLA	European Union	Novo Nordisk A/S	01 Sep 2025
Acquired hemophilia	Phase 3	United States	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Japan	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Argentina	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Australia	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Brazil	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Canada	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Denmark	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	France	Novo Nordisk A/S	09 Oct 2026
Acquired hemophilia	Phase 3	Germany	Novo Nordisk A/S	09 Oct 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05685238 (Company_Website)	Phase 3	Hemophilia A	426	Mim8 (adults and adolescents)	ixylleusgw(hexreqnjlt) = amdldaarfo yfrcoqpqlo (rsvlulhern ) View more	Positive	11 Jul 2026
				Mim8 (children)	ixylleusgw(hexreqnjlt) = nhzsmerodz yfrcoqpqlo (rsvlulhern ) View more
NCT05685238 (FRONTIER4, ISTH2026)	Phase 3	Hemophilia A	365	Denecimig once-every-week (QW)	yjynnutyir(vpefrfbzvb) = Of the serious AEs, 1 fatal outcome was unlikely related to denecimig oakssfecac (phsdcvkptf )	Positive	11 Jul 2026
				Denecimig once-every-two-weeks (Q2W)
NCT05685238 (FRONTIER4, ISTH2026)	Phase 3	Hemophilia A	61	Denecimig once-every-week (QW)	efoivfjows(vcyqynaqfy) = dpabbiyuaf hdmupdtqug (cetytliswa ) View more	Positive	11 Jul 2026
				Denecimig once-every-month (QM)	imdxwbubsv(tosjglhjbh) = thwctaivxd ixmcaabmar (rwltxwbapv, 0.1 - 1.34)
NCT04204408 (FRONTIER1, Pubmed \| Res Pract Thromb Haemost)	Phase 1/2	Hemophilia A	41	Mim8 maintenance doses	rqqctlwhxc(uwllxftmoy) = mryivczwxj tcycxfpxrr (dwaaiecgzv ) View more	Positive	01 Oct 2025
NCT05878938 (FRONTIER5, ISTH2025)	Phase 3	Hemophilia A	61	Mim8	fflwdfudbm(nmvxorwxsd) = gfeyrgtuaf baxcdwjaca (uqwcnsgjyv ) View more	Positive	21 Jun 2025
NCT05878938 (FRONTIER5, ISTH2025)	Phase 3	Hemophilia A	61	Mim8	nvkhgfhfcg(jgirspvhvo) = gqruhdpjkq fkomwloikp (gfhvtpqxst ) View more	Positive	21 Jun 2025
FRONTIER3 (GlobeNewswire) Manual	Phase 3	Hemophilia A	70	Mim8	xdqbxilnje(vnlsbiojli) = ejhnercgnc goksefmxad (ndeeaupatq ) View more	Positive	07 Feb 2025
NCT05685238 (FRONTIER4, ASH2024)	-	Hemophilia A	37	Mim8	gfwvxbdfyh(jzstjqvced) = fdwzxaomib pwnejgnzcw (tysroqusrw )	Positive	09 Dec 2024
NCT05053139 (Frontier 2, Corporate Publications) Manual	Phase 3	Hemophilia A	254	Mim8 once-weekly prophylaxis (no prior prophylaxis treatment)	jsytagxrmu(omohykymlh) = oxopofsdac thsbaddajd (fsqphbknwq ) View more	Positive	23 Jun 2024
				Mim8 once-monthly prophylaxis (no prior prophylaxis treatment)	jsytagxrmu(omohykymlh) = dqvgxvvmek thsbaddajd (fsqphbknwq ) View more
NCT05053139 (FRONTIER 2, GlobeNewswire) Manual	Phase 3	Hemophilia A	254	Mim8 once-weekly	mlelgatbbs(hcwylglbcu) = xedhxfbkyt swbtjeyzbm (qqeolovxkv ) Met View more	Positive	13 May 2024
				Mim8 once-monthly	mlelgatbbs(hcwylglbcu) = gzsnndodgc swbtjeyzbm (qqeolovxkv ) Met View more

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