Regulatory Submission

Cerus's ReCePI trial met its AKI non-inferiority bar ahead of 2026 FDA filing

Cerus already showed INTERCEPT RBCs match conventional red cells on kidney injury risk; the open question is whether the RedeS trial's safety data holds before the H2 2026 PMA module goes in.

By AppliedXLJuly 13, 2026Trial NCT03459287

Executive Summary

The trial that anchors this filing already reported a positive primary result: INTERCEPT-treated red cells matched conventional red cells on kidney injury risk, the efficacy question the trial was designed to answer.
A safety signal on treatment-related adverse events ran higher for the pathogen-reduced cells, and it did not reach statistical significance, but Cerus is folding it into a second Phase 3 trial's safety analysis before finalizing the FDA submission.
Cerus is submitting to the FDA in stages rather than all at once, and the final piece depends on a second, still-running trial finishing on schedule.
No other program in cardiac surgery complications uses a comparable red-cell pathogen-reduction approach, leaving this filing to stand on its own trial data rather than against a rival readout.

The filing plan

Cerus plans to submit the final module of a modular premarket approval (PMA) application to the FDA in the second half of 2026, contingent on completing its ongoing RedeS trial and folding integrated safety data from both RedeS and the completed ReCePI trial into the package. The submission covers INTERCEPT RBCs, a pathogen and leukocyte inactivation system for donated red blood cells, in a Phase 3 study registered as NCT03459287 and known by the acronym ReCePI. Cerus had earlier planned to initiate the modular PMA in the second half of 2025, meaning the final module is the second of at least two staged FDA filings for this asset. Cerus+1

What ReCePI already showed

ReCePI enrolled complex cardiac surgery patients and tested whether INTERCEPT RBCs produce acute kidney injury (AKI) at rates comparable to conventional red cells, using AKI as a marker of transfusion efficacy tied to tissue oxygen delivery. In the modified intent-to-treat population, AKI incidence was 29.3% (46 of 157) with INTERCEPT RBCs versus 28.0% (45 of 161) with conventional cells, and the 95% confidence interval's upper bound of 10.4% cleared the trial's prespecified non-inferiority margin of 14.0% (p=0.001). That result, disclosed in March 2024, already settled the trial's primary efficacy question well before this filing catalyst. Cerus

The open safety thread

A secondary safety measure showed related treatment-emergent adverse events in 2.5% of INTERCEPT recipients versus 0.6% of conventional-cell recipients, a difference the trial did not find statistically significant (p=0.130). Cerus' chief medical officer and ReCePI principal investigator, Richard Benjamin, called the trial "a pioneering trial in the field of transfusion medicine". The company is carrying this same safety question into its ongoing RedeS Phase 3 trial, which enrolls a broader population needing red-cell transfusion for acute and chronic anemia, and plans to combine both trials' safety data into one integrated analysis for the PMA package. Cerus

Registry history

ReCePI's own registry record shows a trial that took longer to reach this point than initially planned: its primary completion date moved six times between 2021 and 2024, from January 2021 to September 2024, and enrollment was revised from 600 to 292 participants in 2022 before the registry later reflected 581 enrolled at the time results were first posted in September 2025. The trial moved to Active, not recruiting status in February 2024 and to Completed in May 2025. That pattern reflects a trial whose guided completion window shifted repeatedly over six years rather than one that stalled or was abandoned; it finished and posted results. NCT03459287

Competitive and regulatory context

No comparator identified in this trial's competitive field shares INTERCEPT's target mechanism or modality; the closest trials in cardiac surgery complications test antithrombin, nitric oxide, ferric derisomaltose, or postoperative pericardial flushing, none of which address pathogen reduction in transfused red cells. Cerus already markets INTERCEPT systems for platelets, plasma, and fibrinogen concentrate, and frames red cells as the next component in that same commercial system. The FDA submission carries no Breakthrough, Priority Review, or Fast Track designation on record for this program. Cerus

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