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Also known as NNC0365-3769 (Mim8) PPX
NNC0365-3769 PPX · 1 trial · 2 indications
Measured as count of events.
| Arm | Type | Description |
|---|---|---|
| NNC0365-3769 (Mim8) PPX | EXPERIMENTAL | Participants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector. |
| Name | Type | Description |
|---|---|---|
| NNC0365-3769 (Mim8) PPX | DRUG | Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks. |
Inclusion Criteria: 1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. Male or female with diagnosis of congenital haemophilia A of a...
NNC0365-3769 PPX is an investigational small molecule being developed by Novo Nordisk for the treatment of haemophilia A, including haemophilia A with inhibitors. It is in Phase 3 clinical development and has been studied in a trial evaluating patients who switch from emicizumab to this therapy.
NNC0365-3769 PPX is being developed for haemophilia A, a bleeding disorder. The Phase 3 FRONTIER 5 study enrolled people with haemophilia A and haemophilia A with inhibitors, including those transitioning from prior emicizumab treatment. It is investigational and has not been approved for commercial use.
NNC0365-3769 PPX is developed by Novo Nordisk A/S, which trades under the ticker NVO. Novo Nordisk is the sponsor of the clinical program studying this small molecule in haemophilia A, including the completed Phase 3 FRONTIER 5 trial.
NNC0365-3769 PPX is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. The drug remains investigational and has not been approved by the FDA or other regulators.
NNC0365-3769 PPX has been studied in NCT05878938, the Phase 3 FRONTIER 5 trial titled a research study looking at how safe it is to switch from emicizumab to Mim8 in people with haemophilia A. The trial enrolled 61 participants across the United States, Europe, Canada, Japan, South Korea, South Africa, and other countries, and is completed.
Yes, NNC0365-3769 PPX is also known as NNC0365-3769 (Mim8) PPX. The Mim8 designation appears in the Phase 3 FRONTIER 5 trial title, which studied switching from emicizumab to Mim8 in people with haemophilia A. Both names refer to the same Novo Nordisk investigational asset.