Zopapogene imadenovec-drba

(Papzimeos®)

Papzimeos®

Drug updated on 9/19/2025

Dosage FormInjection (subcutaneous; 1 mL single-dose vial that contains 5×10¹¹ PU)
Drug ClassNon-replicating adenoviral vectors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adults with recurrent respiratory papillomatosis

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Papzimeos (zopapogene imadenovec-drba) is indicated for the treatment of adults with recurrent respiratory papillomatosis (RRP).
  • Among 35 adults (≥18 years) with RRP requiring ≥3 interventions in the prior year, 18 patients (51%) treated at the recommended phase 2 dose of 5×10¹¹ particle units achieved a complete response, defined as no intervention required for 12 months after treatment.
  • The median duration of complete response was not reached at the time of reporting, indicating sustained responses.
  • In adults aged ≥18 years with RRP requiring ≥3 interventions in the prior year, treatment-related adverse events were primarily mild, with injection site reaction in 34/35 patients (97%), fatigue in 28/35 (80%), chills in 25/35 (71%), and fever in 24/35 (69%). No significant safety concerns or severe adverse effects were reported; adverse events were grades 1–2.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Papzimeos (zopapogene imadenovec-drba) Prescribing Information2025Precigen, Inc., Germantown, MD

Randomized Controlled Trials

Document TitleSex DistributionYearSource
PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial
Data not availableSubjects
F: null%
M: null%
2025The Lancet