Does Selepressin work?
Partly: some human trials, with gaps: one 868-adult trial found no benefit.
One large randomized, double-blind, placebo-controlled trial (SEPSIS-ACT, 868 adults with septic shock) tested selepressin and found no benefit on its primary endpoint or on mortality. A controlled trial exists, but it was negative, so there is no evidence supporting the use for which the drug was designed. Earlier phase 2a data were small and dose-finding. 12
SEPSIS-ACT was an adaptive phase 2b/3 trial. It enrolled 868 adults with septic shock who needed norepinephrine. It ran at 63 hospitals in several countries. Patients got one of several selepressin infusion rates or placebo, on top of standard care. The primary endpoint was days alive and free of both mechanical ventilation and vasopressors through day 30. Selepressin patients averaged about 15 such days. Patients on placebo also averaged about 15. There was no difference. Mortality at 90 days was around 40 percent in both groups. A planned interim analysis led to stopping the trial for futility. 1
Selepressin did cut the dose of norepinephrine needed. It also cut the amount of intravenous fluid given. This showed it was active as a vasoconstrictor. That effect on the body did not lead to any benefit patients would notice. 1
Evidence checklist
- Randomised controlled trial SEPSIS-ACT, double-blind, placebo-controlled
- Human study over 100 people SEPSIS-ACT 868 adults
- More than one research group One trial by one sponsor
- Clinical outcomes, not surrogate markers Ventilator-free days and 90-day mortality
- Human safety data beyond case reports Adverse events similar to placebo
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Reference information only, not medical advice. Drawn from the Selepressin article, fact-checked against the cited sources. No dosing anywhere on this site.