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NNC0442-0344 A

Phase 1

Haemophilia A | Small molecule | Hematology |Novo Nordisk A/S|Last Updated: Apr 24, 2026

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment205
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07238816A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy PeoplePHASE1 RECRUITING 80 — — Nov 18, 2025Apr 29, 2026Dec 31, 20251 United States
NCT07220564A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia APHASE1 RECRUITING 30 — — Oct 23, 2025Feb 5, 2027Apr 24, 202633 United States, Austria +10
NCT06649630A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy MenPHASE1 COMPLETED 95 — — Sep 23, 2024Mar 26, 2026Apr 1, 20262 Germany
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Study Endpoints
Primary Endpoints
AUC0-∞: the area under the plasma Inno8 concentration-time curve from time 0 to infinity after a single oral dose
From baseline (Day 1) to day 17

Measured as nanograms\*day per millilitre (ng\*day/mL).

Number of treatment emergent adverse events
From time of dosing (Day 1) to end of follow-up (Day 46)

Measured as count of events.

SAD: Number of treatment emergent adverse events
From time of dosing (Day 1) to Day 36

Measured as count of events.

MAD: Number of treatment emergent adverse events
From time of dosing (Day 1) to end of follow-up (Day 46)

Measured as count of events.

SSD: Number of treatment emergent adverse events
From time of dosing (Day 1) to Day 36

Measured as count of events.

Secondary Endpoints
Cmax: Maximum observed plasma Inno8 concentration after a single oral dose
From baseline (Day 1) to day 17
Tmax: The time to maximum observed plasma Inno8 concentration after a single oral dose
From baseline (Day 1) to day 17
Number of treatment emergent adverse events
From time of dosing (Day 1) to day 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Group BEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Group CEXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Reference doseACTIVE_COMPARATORParticipants will receive oral dose of NNC0442-0344 A.
Cohort 1EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 2EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 3EXPERIMENTALParticipants will receive oral dose of NNC0442-0344 A.
Cohort 1 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 2 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 3 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 4 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 5 (SAD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A intravenously.
Cohort 1 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 2 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 3 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 4 (MAD): NNC0442-0344 AEXPERIMENTALParticipants will receive a oral daily dose of NNC0442-0344 A for 10 days.
Cohort 1 (SSD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A subcutaneously.
Cohort 2 (SSD): NNC0442-0344 AEXPERIMENTALParticipants will receive single dose of NNC0442-0344 A subcutaneously.
SAD: PlaceboPLACEBO_COMPARATORParticipants will receive single dose of placebo intravenously.
MAD: PlaceboPLACEBO_COMPARATORParticipants will receive a oral daily dose of Placebo for 10 days.
SSD: PlaceboPLACEBO_COMPARATORParticipants will receive single dose of placebo subcutaneously.
Interventions
NameTypeDescription
NNC0442-0344 ADRUGNNC0442-0344 A will be administered orally.
PlaceboDRUGSAD: Placebo will be administered intravenously. MAD: Placebo will be administered orally. SSD: Placebo will be administered subcutaneously.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male. * Age 18-45 years (both inclusive) at the time of signing informed consent. * Body mass index between 18.5 and 29.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. * Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening. * Cons...

Countries:United StatesAustriaBelgiumFranceGermanyItalyPolandPortugalSpainSwedenSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT06649630TRIAL_REMOVED: changed
LOWMay 26, 2026NCT07238816primaryCompletionDate: changed
LOWMay 26, 2026NCT07220564Enrollment: 20 → 30
LOWMay 24, 2026NCT07238816studyFirstPostDate: changed
LOWMay 24, 2026NCT06649630studyFirstPostDate: changed
LOWMay 24, 2026NCT07220564studyFirstPostDate: changed