Regulatory Submission

ImPact's Padeliporfin hits 70% complete-response rate ahead of planned 2026 NDA

ENLIGHTED trial data show a 70% complete-response rate with 24-month durability in low-grade UTUC, as ImPact still targets an NDA submission this year.

By AppliedXLJuly 13, 2026Trial NCT04620239

Executive Summary

ImPact Biotech's Phase 3 trial of Padeliporfin VTP in low-grade upper tract urothelial carcinoma has posted a complete-response rate with durability data extending past a year, giving the company's planned regulatory filing an actual efficacy result to stand on rather than a design promise.
The trial's primary completion date has been pushed repeatedly over its multi-year run, a pattern that raises real questions about whether the company's stated 2026 filing plan will hold even as the clinical data itself has now matured.
No trial in this indication shares Padeliporfin's photodynamic mechanism, leaving the result without a same-mechanism precedent, while an intravesical chemotherapy competitor is running its own late-stage program in the same population.
The open questions are whether the complete-response rate holds as more maintenance-therapy patients cross the 12-month durability mark and whether the company's Type C meeting outcome with the FDA translates into a submission on the stated schedule.

The result

In an update on the ongoing Phase 3 ENLIGHTED trial, ImPact Biotech reported that 50 of 72 response-evaluable patients, 70%, achieved a complete response at the end of primary response evaluation, with an overall response rate of 88%. Among patients who completed maintenance therapy, 85.7% (18 of 21) sustained that complete response at 12 months or beyond, and the median duration of response in the treated area reached 23.9 months. The company described safety as consistent with prior data, citing two Grade 3 serious adverse events that resolved without discontinuations. The trial, registered as NCT04620239 and known as the ENLIGHTED study, is designed as a single-arm registrational study measuring absence of tumor across the entire ipsilateral calyces, renal pelvis, and ureter. ImPact+1

The regulatory path

ImPact Biotech has said it held a Type C meeting with the FDA confirming a registrational pathway for Padeliporfin VTP in low-grade UTUC and expects to submit topline data from ENLIGHTED and an NDA in 2026. That plan places this therapy among a small number of drug-device photodynamic approaches pursuing FDA registration in this indication. The company has said it will pursue partnering to commercialize the program rather than build its own launch infrastructure. ImPact

Timeline history

The trial's primary completion date has changed six times on ClinicalTrials.gov since the study began enrolling in 2021, moving from June 2022 to March 2026, a cumulative shift of 1,389 days. The trial remains in Recruiting status with an anticipated enrollment of 100 patients across sites in the United States, France, Spain, Germany, and Israel. That repeated slippage is the direct counterweight to the 2026 NDA plan: the clinical result has matured, but the trial's own completion-date history shows the company has missed its stated internal timeline before. NCT04620239

The competitive field

No trial identified in this indication shares Padeliporfin's reactive-oxygen-species photodynamic mechanism, leaving the ENLIGHTED result without a same-mechanism precedent to benchmark against. The nearest active competitor is UroGen Pharma's mitomycin-based reverse thermal gel, which is running its own Phase 3 single-arm study in the same low-grade UTUC population with a complete-response-rate primary endpoint. UroGen's UTUC program was flagged with an elevated landscape risk score in the broader competitive set, driven largely by operational signals rather than efficacy data. With no validated disease-modifying mechanism established across this sparse field, a complete-response rate that holds past the 12-month mark already reported, and extends as more patients reach that durability window, is the result that would most clearly separate Padeliporfin from a purely single-arm efficacy signal.

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.