Papzimeos (zopapogene imadenovec)
An approved treatment for Recurrent Respiratory Papillomatosis.
The same compound appears under different names depending on the context. Here is how to identify Zopapogene imadenovec wherever you encounter it, plus the key facts at a glance.
- Generic name
- Zopapogene imadenovec
- Brand name
- Papzimeos
- Development code
- PRGN-2012
- Drug class
- Gene-based immunotherapy (adenoviral vector)
- Manufacturer
- Precigen
- How it's taken
- 4 injections under the skin, each 5 x 10^11 particle units, on days 1, 15, 43 and 85.
The first FDA-approved treatment for recurrent respiratory papillomatosis, approved on August 14, 2025 for adults. It is given as 4 injections under the skin over 12 weeks, after the airway growths are surgically removed.
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Where Zopapogene imadenovec fits
Before August 2025, RRP had no approved drug and was managed with repeated surgery, sometimes with off-label cidofovir or bevacizumab. Papzimeos is approved for adults only. INOVIO's INO-3107, a DNA immunotherapy for adults with RRP, has an FDA decision due October 30, 2026.
How Zopapogene imadenovec works
RRP growths are driven by HPV types 6 and 11, which the immune system often fails to clear from the airway. Papzimeos uses a modified adenovirus that cannot replicate to deliver pieces of HPV 6 and 11 proteins into the body, prompting T cells to recognize and attack the cells that carry the virus. The goal is to stop the papillomas from growing back after surgery rather than to remove them directly.
Mechanism: Non-replicating adenoviral vector immunotherapy that carries HPV 6 and HPV 11 antigens and trains T cells to attack infected airway cells
Side effects and safety
The most common side effects on the FDA label include injection site reactions, fatigue, chills, fever, muscle aches, nausea, headache, a fast heart rate, diarrhea, vomiting and heavy sweating. The label also warns that blood clots may occur after adenoviral vector treatments like Papzimeos. Get medical help for shortness of breath, chest pain, leg swelling, lasting belly pain, or a severe or lasting headache or blurred vision. You will be watched for at least 30 minutes after the first dose. In the pivotal trial there were no dose-limiting toxicities and no treatment-related side effects above grade 2, meaning none were rated severe. The full list is in the FDA prescribing information.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Zopapogene imadenovec
4 injections under the skin, each 5 x 10^11 particle units, on days 1, 15, 43 and 85. The papillomas are surgically removed before the first dose, and any visible growth is removed again before doses 3 and 4.
Availability and cost
Only available as the brand-name product.
MedCity News reported in August 2025 that Precigen set a list price of $115,000 per vial, or about $460,000 for the 4-dose course.
Help paying for Papzimeos
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Eligible commercially insured patients enrolled in the Copay Program may pay as little as $0 out of pocket. No income requirement.
For: private insurance · source - Insurance and case manager help
Papzimeos SUPPORT helps with understanding coverage, the insurance process, and financial assistance resources; tracks enrollment status.
The official page does not say who qualifies. Ask the program. · source
Good to know: Patients with high copays are automatically considered for the copay program after enrolling. Official page says PAPZIMEOS is covered by Medicare and Medicaid. No free-drug program is described.
Clinical trial results
In a single-arm pivotal trial of adults who needed at least 3 surgeries a year, 51.4% (18 of 35) had a complete response, meaning no surgery in the 12 months after treatment. 15 of those 18 were still in complete response at 24 months. Precigen reported in May 2026 that 15 of the 18 remained in complete response at an April 30, 2026 data cutoff, when every responder had at least 36 months of follow-up and 5 had passed 4 years[5]. The results were published in The Lancet Respiratory Medicine in January 2025 by NIH investigators.
Development history
Developed by Precigen as PRGN-2012 with investigators at the NIH. The FDA granted Breakthrough Therapy and Orphan Drug designations and priority review, and approved it on August 14, 2025 as the first therapy of any kind for RRP. Precigen filed under the accelerated approval pathway, but the FDA granted full approval with no confirmatory trial required. Precigen said in May 2026 that the FDA had granted Papzimeos 7 years of orphan drug exclusivity[5], and a European marketing application submitted in November 2025 is under review at the European Medicines Agency[6].
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Common questions about Zopapogene imadenovec
▸What is Zopapogene imadenovec (Papzimeos)?
The first FDA-approved treatment for recurrent respiratory papillomatosis, approved on August 14, 2025 for adults. It is given as 4 injections under the skin over 12 weeks, after the airway growths are surgically removed.
▸How does Zopapogene imadenovec work?
RRP growths are driven by HPV types 6 and 11, which the immune system often fails to clear from the airway. Papzimeos uses a modified adenovirus that cannot replicate to deliver pieces of HPV 6 and 11 proteins into the body, prompting T cells to recognize and attack the cells that carry the virus. The goal is to stop the papillomas from growing back after surgery rather than to remove them directly.
▸What are the side effects of Zopapogene imadenovec?
The most common side effects on the FDA label include injection site reactions, fatigue, chills, fever, muscle aches, nausea, headache, a fast heart rate, diarrhea, vomiting and heavy sweating. The label also warns that blood clots may occur after adenoviral vector treatments like Papzimeos. Get medical help for shortness of breath, chest pain, leg swelling, lasting belly pain, or a severe or lasting headache or blurred vision. You will be watched for at least 30 minutes after the first dose. In the pivotal trial there were no dose-limiting toxicities and no treatment-related side effects above grade 2, meaning none were rated severe. The full list is in the FDA prescribing information.
▸How is Zopapogene imadenovec taken?
4 injections under the skin, each 5 x 10^11 particle units, on days 1, 15, 43 and 85. The papillomas are surgically removed before the first dose, and any visible growth is removed again before doses 3 and 4.
▸Is Zopapogene imadenovec FDA approved?
Yes, Zopapogene imadenovec (Papzimeos) is FDA approved (2025) for the treatment of Recurrent Respiratory Papillomatosis.
▸Is Papzimeos FDA approved for recurrent respiratory papillomatosis?
▸How well does Papzimeos work?
In its pivotal trial, 51.4% of adults (18 of 35) treated with Papzimeos needed no surgery for 12 months after treatment, and most of those complete responses have lasted. Precigen reported in May 2026 that 15 of the 18 responders remained in complete response with at least 36 months of follow-up, and 5 had passed 4 years. [5]
▸What are the side effects of Papzimeos?
The most common side effects of Papzimeos on the FDA label are injection site reactions, fatigue, chills, fever, muscle aches, nausea, headache, a fast heart rate, diarrhea, vomiting and heavy sweating. The label also warns that blood clots may occur after adenoviral vector treatments, so get medical help for shortness of breath, chest pain, leg swelling, lasting belly pain, or a severe or lasting headache or blurred vision. You will be watched for at least 30 minutes after the first dose, and in the pivotal trial there were no treatment-related side effects above grade 2. [2]
▸How much does Papzimeos cost?
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration · 2025-08-14. FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis
- DailyMed. Papzimeos (zopapogene imadenovec-drba) prescribing information. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103db7f1-8540-4bea-935e-217d69e7aa01
- Precigen · 2025-08-15. Precigen Announces Full FDA Approval of PAPZIMEOS. https://investors.precigen.com/news-releases/news-release-details/precigen-announces-full-fda-approval-papzimeos-zopapogene
- Precigen · 2025-10-13. Precigen Announces Long-Term Follow-Up Results. https://investors.precigen.com/news-releases/news-release-details/precigen-announces-long-term-follow-results-highlighting-ongoing
- Precigen · 2026-05-30. Precigen Presents New Long-Term Durability Data for PAPZIMEOS, Recently Granted Seven-Year Market Exclusivity, Demonstrating Complete Responses Beyond 4 Years. https://investors.precigen.com/news-releases/news-release-details/precigen-presents-new-long-term-durability-data-papzimeos
- Precigen · 2026-08. Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth. https://investors.precigen.com/news-releases/news-release-details/precigen-reports-second-quarter-2026-financial-results
- MedCity News · 2025-08. First Therapy for Rare Tumor Is a Blockbuster Prospect, But Does Precigen Have the Cash to Make It Happen?. https://medcitynews.com/2025/08/precigen-papzimeos-rare-disease-recurrent-respiratory-papillomatosis-fda-approval-pgen/