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NNC0365-3769 PPX

Phase 3

Haemophilia A | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Dec 8, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

NNC0365-3769 PPX · 1 trial · 2 indications

Phase 3 1
NCT05878938A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)Haemophilia A
COMPLETED61 Analytics
PHASE3COMPLETED
A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)
Haemophilia A
NCT0587893861
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Study Endpoints

Primary Endpoints

Number of treatment-emergent adverse events
From Visit 2 (week 0) until week 26

Measured as count of events.

Secondary Endpoints

Device handling experience using the Hemophilia Device Handling and Preference Assessment (HDHPA) questionnaire
Visit 8 (after 26 weeks of treatment)
Change in participants' treatment burden using the Hemophilia treatment experience measure (Hemo-TEM) total score
From Visit 2 (week 0) until end of treatment (up to 26 weeks)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC0365-3769 (Mim8) PPXEXPERIMENTALParticipants will receive Mim8 prophylaxis (PPX) subcutaneous (s.c.) injection using a prefilled fixed dose DV3407-C1 pen-injector.

Interventions

NameTypeDescription
NNC0365-3769 (Mim8) PPXDRUGParticipants 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.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites36

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...

Countries:United StatesAustriaBelgiumCanadaFranceGermanyItalyJapanSouth AfricaSouth KoreaSpainUnited Kingdom
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Frequently asked questions about NNC0365-3769 PPX

What is NNC0365-3769 PPX used for?

NNC0365-3769 PPX is an investigational small molecule being developed for the treatment of haemophilia A, including haemophilia A with inhibitors. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes NNC0365-3769 PPX?

NNC0365-3769 PPX is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for haemophilia A.

What phase is NNC0365-3769 PPX in?

NNC0365-3769 PPX is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The Phase 3 trial, known as FRONTIER 5, has been completed, and the results will inform potential regulatory submissions.

What clinical trials is NNC0365-3769 PPX in?

NNC0365-3769 PPX has been studied in one completed Phase 3 clinical trial, identified as NCT05878938, titled "A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)." The trial enrolled 61 participants across multiple countries.

Is NNC0365-3769 PPX the same as Mim8?

Yes, NNC0365-3769 PPX is also known as Mim8. The Phase 3 clinical trial NCT05878938, titled "A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A," evaluates this drug, which is being developed by Novo Nordisk for haemophilia A.