Drugs / Denecimig
Denecimig
also known as
Mim8 · NNC0365-3769 · Factor VIIIa-mimetic · FVIII Mimetic · NN-7769 · NNC0365-0005-3769
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | hemophilia B leyden | — | “In September 2025, Novo Nordisk submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA).” novonordisk.com ↗ “In September 2025, Novo submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA).” novonordisk.com ↗ “Novo submitted a BLA for denecimig for the treatment of haemophilia A in adult and paediatric patients to the US FDA for review” novonordisk.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05681845 | Jan → Oct 2023 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT05127473 | Jul 2021 → May 2022 | hemophilia | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04204408 | Jan 2020 → Oct 2023 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT05878938 | Jun 2023 → Jul 2024 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05685238 | Feb 2023 → Jun 2028 expected | hemophilia A | Novo Nordisk A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05306418 | Apr 2022 → Nov 2024 | hemophilia A | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT05053139 | Dec 2021 → Mar 2024 | hemophilia A | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-07-11 | Novo Nordisk A/S | Results Novo Nordisk’s denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026 novonordisk.com ↗
Presented interim FRONTIER4 data evaluate the long-term safety and efficacy of investigational denecimig across once-weekly, once-every-two-weeks, and once-monthly dosing in hemophilia A participants of all ages and disease severities 1,2 |
| 2026-07-11 | Novonordisk Us | Results Novo Nordisk's denecimig (Mim8) demonstrated positive results in long term safety and efficacy in phase 3 hemophilia A FRONTIER extension study at ISTH 2026 novonordisk-us.com ↗
Presented interim FRONTIER4 data evaluate the long-term safety and efficacy of investigational denecimig across once-weekly, once-every-two-weeks, and once-monthly dosing in hemophilia A participants of all ages and disease severities1,2 |
| 2026-04-29 | Novo Nordisk A/S | Results Novo Nordisk A/S: Denecimig (Mim8) significantly reduced annualised bleeding rate in people with haemophilia A, regardless of inhibitor status, in phase 3 data published in NEJM novonordisk.com ↗
Published pivotal FRONTIER2 study showed investigational denecimig significantly reduced annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment in people with haemophilia A, with or without inhibitors1 |
| 2026-04-29 | Novonordisk Us | Results Denecimig (Mim8) significantly reduced annualized bleeding rate in people with hemophilia A, regardless of inhibitor status, in phase 3 data published in NEJM novonordisk-us.com ↗
Today, the New England Journal of Medicine (NEJM) published 26-week results from the phase 3 FRONTIER2 trial evaluating the efficacy and safety of once-monthly and once-weekly denecimig (Mim8) in adults and adolescents 12 years of age and older with hemophilia A (congenital Factor VIII (FVIII) deficiency), with or without FVIII inhibitors. |
| 2025-11-05 | Novo Nordisk A/S | Regulatory Novo Nordisk's sales increased by 12% in Danish kroner and by 15% at CER in the first nine months of 2025; R&D pipeline progress continues novonordisk.com ↗
Also within Rare disease, Novo Nordisk submitted Mim8 for regulatory approval in the EU and in the US. |
| 2024-05-13 | Novo Nordisk A/S | Results Novo Nordisk A/S: Once-weekly and once-monthly Mim8 demonstrate superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A in the Frontier 2 trial novonordisk.com ↗
The trial achieved its co-primary endpoints by demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment. |
All press releases naming this drug 12 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Denecimig | “Denecimig (Mim8) is a next-generation, activated factor VIII mimetic, fully human bispecific IgG4 antibody in development for subcutaneous prophylaxis in bleeding episodes for...” PMID 42469164 ↗ Jul 2026 |
| Known as | Factor VIIIa-mimetic | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314670 ↗ |
| Known as | FVIII Mimetic | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314670 ↗ |
| Known as | Mim8 | “Denecimig (Mim8) is a next-generation, activated factor VIII mimetic, fully human bispecific IgG4 antibody in development for subcutaneous prophylaxis in bleeding episodes for...” PMID 42469164 ↗ Jul 2026 |
| Known as | NN-7769 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314670 ↗ |
| Known as | NNC0365-0005-3769 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314670 ↗ |
| Known as | NNC0365-3769 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05878938 ↗ |
| Action | Restore | “Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).” NCT05685238 ↗ |
| Modality | Monoclonal antibody | “fully human bispecific IgG4 antibody” PMID 42469164 ↗ Jul 2026 |
| Route | Subcutaneous | “All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin)” NCT05127473 ↗ |