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Vortosiran

Phase 2

Venous Thromboembolism (VTE) | RNA therapy | Other |Fortrea Holdings Inc.|Trials Updated: Sep 30, 2026

Vortosiran development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Vortosiran clinical trials

Vortosiran · 1 trial · 3 indications

Phase 2 1
NCT07850453Vortosiran for VTE PreventionVenous Thromboembolism (VTE)
NOT YET_RECRUITING150 Analytics
PHASE2NOT YET_RECRUITING
Vortosiran for VTE Prevention
Venous Thromboembolism (VTE)
NCT07850453150
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Study Endpoints

Primary Endpoints

Primary objective
At Week 8

To evaluate the effect of two dose levels of vortosiran on coagulation Factor XI (FXI) activity.

Primary endpoint
Baseline to Week 8.

Percentage change from baseline in FXI activity, compared with placebo.

Secondary Endpoints

Secondary objective
Up to week 56
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low-dose groupACTIVE_COMPARATOR -
High-dose groupACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
VortosiranDRUGVortosiran, active drug.
PlaceboDRUGPlacebo that is identical in appearance of active IMP.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites30

Key Inclusion Criteria: Cohort A 1. Adult male and female participants (≥18 years) meeting the specified below criteria for Cohort A. 2. Postmenopausal women are eligible without additional contraceptive measures. Postmenopausal status is defined as: * Age ≥55 years with ≥12 months of spont...

Countries:BulgariaFrancePolandRomania
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