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Giapreza

Phase 1

Septic Shock | Small molecule | Gastrointestinal |Innoviva, Inc.|Last Updated: May 5, 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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07568275Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial ElastanceEARLY_PHASE1 ACTIVE NOT_RECRUITING 30Nov 15, 2024Jan 1, 2028May 5, 20261 United States
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Study Endpoints
Primary Endpoints
Change in arterial elastance
6 hours

Change in arterial elastance will be measure by echocardiography at baseline, 6 hours and 24 hours. Dynamic arterial elastance will be calculated as the ratio between pulse pressure variation and stroke volume variation obtained from arterial line waveform.

Secondary Endpoints
Change in arterial ventricular coupling
6 hours
Change in norepinephrine equivalent dose
6 hours
Change in renal perfusion index
6 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Angiotensin IIACTIVE_COMPARATORAngiotensin II will be continued for 24 hours and then discontinued, and SOC vasopressors resumed according to institutional practices.
Standard of CareNO_INTERVENTIONFixed-dose vasopressin and standard of care vasopressors increased as per institutional guidelines according to MAP targets.
Interventions
NameTypeDescription
GiaprezaDRUG2.5 mg/mL
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age ≥ 18 years at the time of enrollment * Septic shock as defined by Sepsis-3 criteria (highly suspected or confirmed infection, requiring norepinephrine to maintain a MAP ≥ 65 mmHg, and serum lactate \> 2 mmol/L after adequate fluid resuscitation) within a 48 hour window pri...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07568275studyFirstPostDate: changed
LOWMay 21, 2026NCT07568275NEW_TRIAL: changed
LOWMay 21, 2026NCT07568275NEW_TRIAL: changed