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Opemalirsen

Phase 1

Renal Impairment | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: May 22, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07154901Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)PHASE1 ACTIVE NOT_RECRUITING 34Aug 18, 2025Jun 15, 2026May 22, 20262 United States
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Study Endpoints
Primary Endpoints
AUCinf
Pre-dose to 3 weeks post dose

Area under the concentration-time curve from zero to infinity

AUClast
Pre-dose to 3 weeks post-dose

Area under the concentration-time curve from zero to the last measurable concentration

Cmax
Pre-dose to 3 weeks post-dose

Maximum observed plasma concentration

Secondary Endpoints
Tmax
Pre-dose to 3 weeks post-dose
t1/2λz
Pre-dose to 3 weeks post-dose
CL/F
Pre-dose to 3 weeks post-dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALHealthy participants will receive a single subcutaneous injection of AZD2373.
Group 2EXPERIMENTALSevere renal impairment participants will receive a single subcutaneous injection of AZD2373.
Group 3EXPERIMENTALModerate renal impairment participants will receive a single subcutaneous injection of AZD2373
Group 4EXPERIMENTALMild renal impairment participants will receive a single subcutaneous injection of AZD2373
Interventions
NameTypeDescription
Opemalirsen (AZD2373)DRUGSingle, subcutaneous injection of AZD2373
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participant must be 18 to 80 years of age, inclusive, at the time of signing the informed consent. Type of Participant and Disease Characteristics For all participants, ...

Countries:United States
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT07154901Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07154901studyFirstPostDate: changed