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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05878938A Research Study Looking at How Safe it is to Switch From Emicizumab to Mim8 in People With Haemophilia A (FRONTIER 5)PHASE3 COMPLETED 61Jun 26, 2023Jul 19, 2024Dec 8, 202536 United States, Austria +10
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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 — 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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