Regulatory Submission

Cerus nears FDA filing for RedeS red-cell trial after 692-patient enrollment closes

The Phase 3 RedeS trial finished enrollment at 692 patients and is set to complete in mid-2026, positioning Cerus for the final PMA module it has guided toward since 2023.

By AppliedXLJuly 13, 2026Trial NCT03037164

Executive Summary

Cerus has closed enrollment on its second U.S. Phase 3 trial of the INTERCEPT Blood System for Red Blood Cells and is positioned to submit the final module of a modular FDA device application once the trial completes.
The trial's completion date has been pushed back repeatedly over its history, and the current date sits inside the same submission window management first laid out years ago.
No other program shares this pathogen-inactivation mechanism and modality in red-cell transfusion support, leaving the readout without a direct precedent to benchmark against.
The filing itself is procedural; the substantive test is whether the trial's hemoglobin-increment result, once reported, supports the device submission Cerus has guided toward since 2023.

The plan

Cerus Corporation president and chief executive William "Obi" Greenman first laid out the submission plan in an August 2023 earnings release, saying the company would "begin a modular premarket approval (PMA) application submission to FDA in the second half of 2025, with a final PMA module submission planned for the second half of 2026". That guidance has held: the current window for the final module runs from July 1 to December 31, 2026. The submission depends on data from RedeS, a Phase 3 trial testing the INTERCEPT system's pathogen-inactivation treatment of donor red blood cells against Zika virus transfusion-transmission risk, registered as NCT03037164. Cerus+1

Trial status

RedeS moved to Active, not recruiting status on November 10, 2025, when its enrollment count was set at 692 patients, up from an earlier target of 600 and briefly 800. The trial's primary completion date, the point at which the adjusted hemoglobin increment endpoint will be assessed, currently stands at July 31, 2026. That date has moved four times since the trial's 2020-06-30 original target, most recently shifting from October 31, 2025 to July 31, 2026 in the same November 2025 update that closed enrollment. The trial started in May 2017 and runs sites in the United States, Puerto Rico, and Turkey. NCT03037164

Competitive frame

No competitor trial in this dataset shares INTERCEPT's pathogen-inactivation mechanism and cell-therapy modality within red blood cell transfusion support; the nearest listed comparator, amustaline, tested a different small-molecule approach in a separate anemia study and is not eligible as a direct comparator. Cerus's own related Phase 3 program, the cardiac-surgery-focused study behind INTERCEPT RBCs (NCT03459287), completed in September 2024, giving the company one prior same-drug Phase 3 readout in a different surgical population. RedeS is the mechanism's second and larger U.S. registrational test, positioning it as the trial that will determine whether the pathogen-inactivation approach clears the hemoglobin-increment bar in the broader anemia-transfusion setting. NCT03037164

What the filing turns on

A premarket approval submission (the FDA's device-review pathway, distinct from a drug NDA) is a procedural step once a pivotal trial completes; it does not itself carry new efficacy evidence. The substantive event is the RedeS primary completion, now guided for July 31, 2026 shortly ahead of the same-year filing window, and whether the adjusted hemoglobin increment result clears the threshold Cerus needs to complete its modular PMA package alongside the earlier ReCePI cardiac-surgery data. Cerus has an overall trial completion rate of 6 of 8 tracked trials, with 2 terminated, a company-wide execution record that sits apart from RedeS's own repeated completion-date revisions. NCT03037164+1

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.