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Biological/Vaccine

Phase 3

Type 1 Diabetes | Monoclonal antibody | Metabolic |Vertex Pharmaceuticals Incorporated|Last Updated: Mar 23, 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
UNCONTROLLED
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06832410An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney TransplantPHASE3 RECRUITING 10Mar 31, 2025Sep 17, 2027Mar 23, 20267 United States, Canada +1
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Study Endpoints
Primary Endpoints
Proportion of Participants who are Insulin Independent
At 1 year After VX-880 infusion
Secondary Endpoints
Proportion of participants who achieve insulin independence and are insulin independent 12 months later
1 year after achieving insulin independence
Change from Baseline in glycosylated hemoglobin (HbA1c)
Baseline, At 1 year After VX-880 infusion
Proportion of Participants who Maintain Insulin Independence for at least 1 year
From VX-880 infusion to End of Study (up to 2 years)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VX-880EXPERIMENTAL -
Interventions
NameTypeDescription
Biological/VaccineBIOLOGICALInfused into the hepatic portal vein.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Key Inclusion Criteria: * Clinical history of T1D with greater than or equal to (≥)5 years of insulin dependence * Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks * Consistent use of continuous glucose monito...

Countries:United StatesCanadaSaudi Arabia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06832410primaryCompletionDate: changed
LOWMay 24, 2026NCT06832410studyFirstPostDate: changed