Drug updated on 9/19/2025
Dosage Form | Injection (subcutaneous; 1 mL single-dose vial that contains 5×10¹¹ PU) |
Drug Class | Non-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
- 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 Title | Year | Source |
---|---|---|
Papzimeos (zopapogene imadenovec-drba) Prescribing Information | 2025 | Precigen, Inc., Germantown, MD |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial | Data not availableSubjects F: null% M: null% | 2025 | The Lancet |
Document Title
Sex Distribution:

Year:
2025
Source:The Lancet