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Early Vasopressin

Phase 3

Septic Shock | Small molecule | Other |Precision BioSciences, Inc.|Last Updated: Jan 30, 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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment2,800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06464510Norepinephrine and Vasopressin for Rescue Versus Early Vasopressin for Vasopressor Dependent SepsisPHASE3 RECRUITING 2,800Nov 21, 2024Sep 1, 2027Jan 30, 20268 Brazil
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Study Endpoints
Primary Endpoints
All-cause mortality or renal replacement therapy
28 days

Composite of all-cause mortality or renal replacement therapy within 28 days after randomization.

Secondary Endpoints
All-cause mortality
28 days
Renal replacement-therapy
28 days
Renal replacement-free days
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Early VasopressinEXPERIMENTALAfter randomization, vasopressin will be initiated and titrated up to 0.04U/min to maintain the target mean arterial pressure (MAP). Concurrently, norepinephrine will be reduced, with the goal of using the maximum dose of vasopressin and minimizing or eliminating the use of norepinephrine, while still maintaining the target MAP.
Norepinephrine plus vasopressin for rescueACTIVE_COMPARATORAfter randomization, norepinephrine will be titrated to maintain the target MAP. Vasopressin will be introduced as a rescue strategy only if the norepinephrine dose exceeds 0.5 μg/kg/min. Once vasopressin is initiated, it can be titrated up to 0.04U/min to help maintain the target MAP if the norepinephrine dose remains above 0.5 μg/kg/min.
Interventions
NameTypeDescription
Early VasopressinDRUGEarly Vasopressin group: Vasopressin up to 0.04U/min initiated after randomization.
Norepinephrine and Vasopressin for RescueDRUGNorepinephrine and Vasopressin for Rescue group: Vasopressin up to 0.04U/min initiated only if norepinephrine dose exceeds 0.5 μg/kg/min.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration or laboratory confirmed viral infection, plus hypotension with the need of vasopressors for at least one hour; * Admitted or expected to be admitted to the ICU in the next ...

Countries:Brazil
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06464510studyFirstPostDate: changed