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AZD4144

Phase 2

Sepsis | Small molecule | Infectious Disease |AstraZeneca PLC|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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07215702A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.PHASE2 RECRUITING 124Feb 10, 2026Feb 11, 2027May 5, 202671 United States, Argentina +12
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Study Endpoints
Primary Endpoints
Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl).
During the treatment period.

The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.

Secondary Endpoints
Days alive and free of KRT.
Through study completion, an average of 30 days.
Days alive and free of modified KDIGO AKI Stage 2 or 3.
Through study completion, an average of 30 days
AUC: SCr
During the treatment period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 (AZD4144)EXPERIMENTALAZD4144 solution for IV infusion
Arm 2 (Placebo)PLACEBO_COMPARATORPlacebo concentrate for solution for infusion
Interventions
NameTypeDescription
AZD4144DRUGIntravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.
PlaceboDRUGIntravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites71

Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-...

Countries:United StatesArgentinaBelgiumCanadaCzechiaDenmarkFranceGermanyGreeceHungaryItalySpainTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07215702primaryCompletionDate: changed
LOWMay 24, 2026NCT07215702studyFirstPostDate: changed