Papzimeos FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 17, 2025.

FDA Approved: Yes (First approved August 14, 2025)
Brand name: Papzimeos
Generic name: zopapogene imadenovec-drba
Dosage form: Injection
Company: Precigen, Inc.
Treatment for: Recurrent Respiratory Papillomatosis

Papzimeos (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.

• Recurrent respiratory papillomatosis (RRP) is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract characterized by severe voice disturbance, compromised airway, and recurrent post-obstructive pneumonias. It is caused by chronic human papillomavirus (HPV) 6 or HPV 11 infection.
• Papzimeos works in the treatment of RRP by expressing a fusion antigen comprising of selected regions of HPV 6 and HPV11 infected cells to generate an immune response directed against HPV 6 and HPV 11 proteins.
• FDA approval of Papzimeos was supported by data from the PRGN-2012-201 (NCT04724980) study which demonstrated that 51% (18 out of 35) of study participants achieved Complete Response, requiring no surgeries in the 12 months after treatment. Of the 18 patients with a Complete Response in the ongoing study, 15 patients evaluated at 24 months demonstrated continued Complete Response.
• Papzimeos is administered by subcutaneous injection four times over a 12-week interval (at 0, 2, 6, and 12 weeks).
• Warnings and precautions associated with Papzimeos include injection site reactions and thrombotic events.
• Common adverse reactions (incidence ≥5%) include injection site reactions, fatigue, chills, pyrexia, myalgia, and nausea.

Development timeline for Papzimeos

Further information

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