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Opemalirsen

Phase 1

Renal Impairment | Small molecule | Nephrology |AstraZeneca PLC|Last Updated: Jun 26, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Opemalirsen · 1 trial · 1 indication

Phase 1 1
NCT07154901Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)Renal Impairment
COMPLETED35 Analytics
PHASE1COMPLETED
Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)
Renal ImpairmentUnlock trial analytics

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 to 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)

MEDIUMJul 27, 2026NCT07154901TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT07154901TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT07154901TRIAL_REMOVED: changed
MEDIUMJul 27, 2026NCT07154901TRIAL_REMOVED: changed
HIGHJun 26, 2026NCT07154901Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 26, 2026NCT07154901Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about Opemalirsen

What is Opemalirsen used for?

Opemalirsen is an investigational small molecule being studied for use in renal impairment. It is being evaluated for its effects on the pharmacokinetics, safety, and tolerability in patients with renal impairment. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes Opemalirsen?

Opemalirsen is being developed by AstraZeneca PLC, a multinational pharmaceutical company. AstraZeneca is listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with renal impairment.

What phase is Opemalirsen in?

Opemalirsen is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for its safety, tolerability, and pharmacokinetics in patients with renal impairment.

What clinical trials is Opemalirsen in?

Opemalirsen has one completed clinical trial registered under NCT07154901. This Phase 1 study investigated the effects of renal impairment on the pharmacokinetics, safety, and tolerability of Opemalirsen (AZD2373). The trial enrolled 35 participants in the United States and included healthy volunteers.

Is Opemalirsen the same as AZD2373?

Yes, Opemalirsen is also known as AZD2373. The clinical trial NCT07154901 refers to the drug as Opemalirsen (AZD2373), confirming that these names refer to the same investigational compound being developed by AstraZeneca.