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Also known as Opemalirsen (AZD2373)
Opemalirsen · 1 trial · 1 indication
Area under the concentration-time curve from zero to infinity
Area under the concentration-time curve from zero to the last measurable concentration
Maximum observed plasma concentration
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Healthy participants will receive a single subcutaneous injection of AZD2373. |
| Group 2 | EXPERIMENTAL | Severe renal impairment participants will receive a single subcutaneous injection of AZD2373. |
| Group 3 | EXPERIMENTAL | Moderate renal impairment participants will receive a single subcutaneous injection of AZD2373 |
| Group 4 | EXPERIMENTAL | Mild renal impairment participants will receive a single subcutaneous injection of AZD2373 |
| Name | Type | Description |
|---|---|---|
| Opemalirsen (AZD2373) | DRUG | Single, subcutaneous injection of AZD2373 |
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, ...
Opemalirsen is an investigational RNA therapy developed by AstraZeneca PLC for renal impairment. It is an antisense oligonucleotide, a class of RNA therapy, and has been studied in a Phase 1 clinical trial. It is not approved for any indication and remains in clinical development.
Opemalirsen is being studied in renal impairment, the condition in which kidney function is reduced. The single completed Phase 1 trial evaluated how renal impairment affects the pharmacokinetics, safety, and tolerability of Opemalirsen. It is investigational and has not been approved for treating renal impairment or any other condition.
Opemalirsen is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 trial studying the drug in renal impairment.
Opemalirsen is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.
Opemalirsen has been studied in one completed Phase 1 trial, NCT07154901, titled Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373). The trial enrolled 35 participants in the United States, included healthy volunteers, and used a controlled design without randomization or double blinding.
Yes, Opemalirsen is also known as AZD2373. Both names refer to the same investigational RNA therapy from AstraZeneca PLC, and the Phase 1 renal impairment trial is listed under the AZD2373 designation.