Recent Updates
Recently added Catalysts

Sutacimig

Phase 2

Congenital Factor VII Deficiency | Small molecule | Rare Disease |Hemab Therapeutics Holdings, Inc.|Last Updated: Jul 22, 2026

Target and mechanism

Molecular targetFactor VIIa/TLT-1
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

BREAKTHROUGH_THERAPYFAST_TRACKORPHAN_DRUG

Clinical trial landscape

Sutacimig · 1 trial · 1 indication

Phase 2 1
NCT07347249A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII DeficiencyCongenital Factor VII Deficiency
RECRUITING18 Analytics
PHASE2RECRUITING
A Clinical Study to Assess Sutacimig in Participants With Congenital Factor VII Deficiency
Congenital Factor VII DeficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events (TEAEs)
Day 1 through Day 57

Secondary Endpoints

Pharmacokinetic Parameter: Maximum observed plasma concentration (Cmax) of sutacimig
Day 1 through Day 57
Pharmacokinetic Parameter: Time to reach maximum observed plasma concentration (Tmax)
Baseline through Day 57
Pharmacokinetic Parameter: Area under the plasma concentration-time curve from time zero to last quantifiable concentration (AUClast)
Day 1 through Day 57
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants with a FVII(a) level of < 10%EXPERIMENTAL -
Participants with a FVII(a) level of ≥10%EXPERIMENTAL -

Interventions

NameTypeDescription
SutacimigDRUGSutacimig is a subcutaneously administered, bispecific antibody being developed as a prophylactic treatment option for congenital bleeding disorders.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age 18 to 60 years, inclusive, at the time of signing informed consent. 2. Diagnosis of FVIID defined by Factor VII:C activity \< 10% documented on ≥ 2 different laboratory measurements by local laboratory assessment. 3. Severe bleeding history characterized by history of a m...

Countries:United Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMJul 26, 2026NCT07347249primaryCompletionDate: changed
MEDIUMJul 26, 2026NCT07347249primaryCompletionDate: changed
MEDIUMJul 26, 2026NCT07347249primaryCompletionDate: changed

Frequently asked questions about Sutacimig

What is Sutacimig used for?

Sutacimig is an investigational small molecule being developed for the treatment of congenital Factor VII deficiency, a rare bleeding disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does Sutacimig target?

Sutacimig targets Factor VIIa/TLT-1, a molecular complex involved in blood coagulation. By modulating this target, the drug aims to address the underlying clotting defect in patients with congenital Factor VII deficiency.

Who is developing Sutacimig?

Sutacimig is being developed by Hemab Therapeutics Holdings, Inc., a biopharmaceutical company. The company's stock is listed under the ticker symbol COAG.

What phase is Sutacimig in?

Sutacimig is currently in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The drug has been granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA.

What clinical trials is Sutacimig in?

Sutacimig is being evaluated in a Phase 2 clinical trial with the identifier NCT07347249. This study is recruiting participants with congenital Factor VII deficiency in the United Kingdom and aims to enroll 18 adults aged 18 years and older.

Is Sutacimig the same as any other drug?

No alternative names for Sutacimig have been reported. It is identified solely by its investigational name and is not known to be marketed under any other brand or generic designation.