What the FDA decided on INO-3107 for Recurrent respiratory papillomatosis
The FDA approved INO-3107 for recurrent respiratory papillomatosis (RRP).
The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), INOVIO's INO-3107, on October 30, 2026 for adults with recurrent respiratory papillomatosis. It is the first plasmid DNA-based immunotherapy approved in the US and the second RRP treatment after Papzimeos (August 2025). The approval rests on fewer surgeries after treatment.
In the 32-patient trial, 7 of the 26 patients who had at least 3 surgeries in the prior year needed none in the year after treatment (27%), and INOVIO must run further trials to confirm the benefit. Voceryq is injected into muscle with the CELLECTRA 5PSP device, whose brief electrical pulses help the DNA enter cells.
The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. INOVIO expects it to be available to order in about 60 days, with a full launch in the first quarter of 2027.
Who the INO-3107 decision matters to
Recurrent respiratory papillomatosis (RRP) is a rare disease in which wart-like growths caused by HPV types 6 and 11 grow in the airway, most often on the voice box. The growths are not cancer, but they keep coming back after they are removed, so many patients need surgery again and again.
The FDA approved the first drug for adults with RRP, Papzimeos, in August 2025, and on October 30, 2026 it granted accelerated approval to a second, INOVIO's Voceryq (INO-3107).
Prevalence: In the US, CDC estimates put new cases at 2 or fewer per 100,000 children and 2 to 3 per 100,000 adults (NIDCD), and the FDA counts about 1,000 new cases a year. See our full Recurrent Respiratory Papillomatosis page for current treatments, recruiting trials, and community resources.
How INO-3107 works
INO-3107: DNA plasmid immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with electroporation to generate T cells against infected cells. Our full INO-3107 profile covers how it works, side effects in plain language, and its trial history.
Where Recurrent Respiratory Papillomatosis treatment stands today
Read our full Recurrent Respiratory Papillomatosis treatment summary
Adults with RRP now have an FDA-approved option, Papzimeos, given as 4 injections under the skin over 12 weeks after the growths are removed. A second immunotherapy, INOVIO's Voceryq (INO-3107), a DNA medicine given as 4 injections into a muscle, usually the upper arm, received FDA accelerated approval for adults on October 30, 2026.
Children do not yet have an approved drug; trials and off-label options such as bevacizumab are managed by specialist airway centers.
The NIH Clinical Center in Bethesda runs RRP research, and the Recurrent Respiratory Papillomatosis Foundation is the main US patient organization. Ask whether a trial requires surgery before or during dosing, since that changes how many procedures you should expect.
The Recurrent Respiratory Papillomatosis page has every treatment and trial →Meanwhile, 9 Recurrent Respiratory Papillomatosis studies are open or about to open
The FDA's decision does not end research on Recurrent Respiratory Papillomatosis. Of these, 6 test a treatment; the others follow patients over time. The most recently updated:
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Frequently asked questions
Has the FDA decided on INO-3107?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: FDA press release, Oct 30 2026
What was INO-3107 approved for?
The FDA approved INOVIO's BLA for INO-3107 in Recurrent respiratory papillomatosis (RRP).
What to know: The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), INOVIO's INO-3107, on October 30, 2026 for adults with recurrent respiratory papillomatosis. It is the first plasmid DNA-based immunotherapy approved in the US and the second RRP treatment after Papzimeos (August 2025). The approval rests on fewer surgeries after treatment. In the 32-patient trial, 7 of the 26 patients who had at least 3 surgeries in the prior year needed none in the year after treatment (27%), and INOVIO must run further trials to confirm the benefit. Voceryq is injected into muscle with the CELLECTRA 5PSP device, whose brief electrical pulses help the DNA enter cells. The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. INOVIO expects it to be available to order in about 60 days, with a full launch in the first quarter of 2027.
How it works: DNA plasmid immunotherapy encoding HPV 6 and HPV 11 antigens, delivered into muscle with electroporation to generate T cells against infected cells.
More: the INO-3107 drug page explains it in plain language.
Is there already an FDA-approved treatment for Recurrent Respiratory Papillomatosis?
Yes. Trial Friend's drug list includes 2 FDA-approved drugs for Recurrent Respiratory Papillomatosis.
Approved: Voceryq (ino-3107), Papzimeos (zopapogene imadenovec).
Check: the Recurrent Respiratory Papillomatosis page also searches FDA drug labels for approved treatments.
What did the INO-3107 trials show?
The Phase 1/2 trial (NCT04398433) enrolled 32 adults who had needed at least 2 surgeries in the prior year (a median of 4). In the year after treatment, 81% (26 of 32) needed fewer surgeries, 28% needed none, and the median reduction was 3 surgeries.
More: the INO-3107 drug page has the full trial history and sources.
What are the side effects of INO-3107?
The most common side effects reported by the FDA were injection site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The electrical pulse can cause brief muscle contractions, minor bleeding, redness or pain where it is given, anxiety, and lightheadedness or fainting.
More: the INO-3107 drug page has the label's warnings in full.
How much will INO-3107 cost?
Trial Friend does not list a price for INO-3107. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the INO-3107 decision?
The FDA approved INO-3107 for Recurrent respiratory papillomatosis (RRP) on October 30, 2026.
Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
Where this outcome comes from
The outcome on this page comes from FDA press release, Oct 30 2026. This page rechecks against our calendar, which is re-verified daily.