Trial Profile

A Phase 3 Trial of PRGN-2012 for the Treatment of Recurrent Respiratory Papillomatosis in Adult Patients

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 Aug 2025

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At a glance

15 Aug 2025 According to a Precigen Inc media release, company announced that the US Food and Drug Administration (FDA) has approved PAPZIMEOS™ (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP). Precigen completed submission of the rolling Biologics License Application (BLA) in December 2024 under an accelerated approval pathway; however, the FDA has granted PAPZIMEOS full approval, which does not require a confirmatory clinical trial.
06 Aug 2024 Status changed from planning to recruiting.
06 Aug 2024 According to a Precigen Inc media release, PRGN-2012 is on track for a rolling BLA submission under an accelerated approval pathway anticipated in the second half of 2024; patient enrollment initiated in the confirmatory clinical trial.

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