NNC0365-3769 (Mim8)

DRUG3 trials

Sponsors

Novo Nordisk A/S

Conditions

Haemophilia AHaemophilia A With InhibitorsHaemophilia A With or Without InhibitorsHealthy Volunteers

Phase 1

A Study to Compare the Blood Levels of Mim8 in Healthy Men When Administered With the DV3407-C1 Pen Injector or a Syringe and Cartridge

CompletedNCT05681845

Novo Nordisk A/SHaemophilia A

Start: 2023-01-02End: 2023-10-13Updated: 2025-10-14

Phase 2

A Research Study Investigating Mim8 in People With Haemophilia A

CompletedNCT04204408

Novo Nordisk A/SHaemophilia A With or Without Inhibitors, Healthy Volunteers

Start: 2020-01-10End: 2023-10-06Updated: 2025-12-19

Phase 3

A Research Study Investigating Mim8 in Adults and Adolescents With Haemophilia A With or Without Inhibitors

CompletedNCT05053139

Novo Nordisk A/SHaemophilia A, Haemophilia A With Inhibitors

Start: 2021-12-02End: 2024-12-17Updated: 2025-12-08

Related Papers

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

PubMed2026-04-30

Mim8 prophylaxis in adults and adolescents with hemophilia A: 52-week efficacy and safety outcomes from the phase 3 FRONTIER2 study

Blood2025-11-03

From efficacy to experience: 52-week patient-reported outcomes with Mim8 in adolescents and adults with hemophilia A with or without inhibitors (FRONTIER2)

Blood2025-11-03

Comparative <i>ex vivo</i> analysis of Mim8 in thrombin generation assays triggered by activated factor XI or tissue factor.

2025-10-10

FRONTIER1 multiple ascending dose extension: a safety, tolerability, pharmacokinetics, and pharmacodynamics study of Mim8 in people with hemophilia A.

2025-10-08

Model-informed drug development of Mim8 - a next-generation bispecific antibody for treatment of haemophilia A.

2025-06-07

Mim8 Prophylaxis Beyond Bleeding: Investigating Multifaceted, Patient-Reported Outcomes for Hemophilia A in the FRONTIER2 Study

Blood2024-11-05

Safety and Efficacy of Mim8 Prophylaxis Administered Once Every Two Weeks for Patients with Hemophilia A with or without Inhibitors: Interim Analysis of the FRONTIER4 Open-Label Extension Study

Blood2024-11-05

FRONTIER1: a partially randomized phase 2 study assessing the safety, pharmacokinetics, and pharmacodynamics of Mim8, a factor VIIIa mimetic.

2023-12-2218 citations

Mim8, a novel factor VIIIa mimetic bispecific antibody, shows favorable safety and pharmacokinetics in healthy adults.

2023-08-2318 citations

Mim8 Clinical Development Program: An Overview of the Frontier Studies

Blood2022-11-156 citations

A Multiple Ascending Dose Study of Mim8 in Patients with Severe Hemophilia a with or without Factor VIII Inhibitors

Blood2022-11-151 citations