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Denecimig

Phase 3

Haemophilia A | Biologics | Hematology |Novo Nordisk A/S|Trials Updated: Oct 28, 2026

Denecimig development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Denecimig clinical trials

Denecimig · 1 trial · 1 indication

Phase 3 1
NCT07830732A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia AHaemophilia A
RECRUITING84 Analytics
PHASE3RECRUITING
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia AUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of treated bleeds
From treatment initiation (week 0) until end of main part (week 12)

Measured as count of treated bleeds.

Secondary Endpoints

Number of treated bleeds
From initiation of extension part (week 13) up until end of treatment (week 52)
Number of clinically relevant new bleeds
From treatment initiation (week 0) up until end of treatment (week 52)
Days of treatment with bypassing agent (BPAs) or coagulation factor VIII (FVIII) products for management of bleeding episodes
From treatment initiation (week 0) up until end of treatment (week 52)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DenecimigEXPERIMENTALDenecimig will be administered subcutaneously.

Interventions

NameTypeDescription
DenecimigDRUGParticipants will receive subcutaneous (s.c.) injections of denecimig.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites83

Inclusion Criteria: * 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. * Male or female participants (sex assigned at birth, inclusive of...

Countries:United StatesArgentinaAustraliaBrazilCanadaDenmarkFranceGermanyGreeceIndiaItalyJapanMalaysiaPolandSouth AfricaSpainTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

LOWOct 28, 2026NCT07830732Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 28, 2026NCT07830732Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 21, 2026NCT07830732NEW_TRIAL: changed
LOWSep 21, 2026NCT07830732NEW_TRIAL: changed

Frequently asked questions about Denecimig

What is Denecimig used for?

Denecimig is being developed for the treatment of haemophilia A, including acquired haemophilia A in adults. It is an investigational therapy being studied in a Phase 3 clinical trial in adults aged 18 years and older. It has not been established as an approved treatment.

Who is developing Denecimig?

Denecimig is being developed by Novo Nordisk A/S, which trades under the ticker NVO. The company is sponsoring the Phase 3 clinical program evaluating Denecimig in adults with acquired haemophilia A across multiple countries including the United States, United Kingdom, Germany, France, Japan, and others.

What phase is Denecimig in?

Denecimig is in Phase 3 clinical development. It is an investigational therapy and is not approved for commercial use. The ongoing Phase 3 study is currently recruiting participants and has an planned enrollment of 84 adults with acquired haemophilia A.

What clinical trial is Denecimig being studied in?

Denecimig is being evaluated in the Phase 3 trial NCT07830732, titled A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A. The trial is recruiting, has a planned enrollment of 84 participants, and is an uncontrolled study enrolling adults aged 18 years and older across 18 countries.

Is Denecimig the same as Mim8?

Yes, Denecimig is also known as Mim8. The Phase 3 trial NCT07830732 refers to the investigational therapy as Denecimig (Mim8), confirming that both names refer to the same Novo Nordisk development compound being studied in adults with acquired haemophilia A.