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Pulmonary & Respiratory

Recurrent Respiratory Papillomatosis (RRP) Clinical Trials

Also called RRP, Laryngeal Papillomatosis, Respiratory Papillomatosis, Juvenile-Onset Recurrent Respiratory Papillomatosis, JoRRP, Adult-Onset Recurrent Respiratory Papillomatosis, AoRRP

RRP is caused by 2 low-risk types of human papillomavirus, HPV 6 and HPV 11, the same types that cause genital warts. The virus infects the lining of the airway and produces benign growths called papillomas, most often on the vocal cords.

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About Recurrent Respiratory Papillomatosis

RRP is caused by 2 low-risk types of human papillomavirus, HPV 6 and HPV 11, the same types that cause genital warts. The virus infects the lining of the airway and produces benign growths called papillomas, most often on the vocal cords. They can spread down the windpipe and, rarely, into the lungs, and in a small number of patients they turn cancerous.

The growths are removed with surgery, using a laser or a microdebrider, but the virus stays in the surrounding tissue and the papillomas grow back. Some patients need surgery every few weeks, and some have had dozens or even hundreds of procedures over their lifetime. In severe cases a tracheostomy keeps the airway open. Doctors have added drugs such as cidofovir and, for severe or lung disease, the cancer drug bevacizumab, with mixed results.

In August 2025 the FDA approved Papzimeos (zopapogene imadenovec), an immunotherapy that trains the immune system to attack HPV 6 and 11 infected cells, as the first treatment for adults with RRP. In its pivotal trial, 51% of adults needed no surgery for 12 months after treatment.

Common Symptoms of Recurrent Respiratory Papillomatosis

Recognizing the signs of Recurrent Respiratory Papillomatosis early can lead to faster diagnosis and better outcomes. Symptoms may vary in severity from person to person. If you or a loved one are experiencing any of the following, consider speaking with a specialist.

  • Hoarseness or a changing voice, the most common symptom
  • Noisy breathing, especially when breathing in
  • Shortness of breath or trouble breathing as growths narrow the airway
  • Chronic cough
  • Trouble swallowing
  • In children, symptoms that are often mistaken for asthma or chronic bronchitis

Who Recurrent Respiratory Papillomatosis Affects

RRP has 2 forms. Juvenile-onset RRP usually appears in early childhood; in a CDC study of 576 US children born 2004 to 2013, the median age at diagnosis was 3.4 years, and the virus is thought to pass from mother to baby during birth. Adult-onset RRP usually starts in adulthood and is thought to spread through sexual contact. Symptoms tend to be more severe in children.

The childhood form is becoming rarer as HPV vaccination spreads. In the US, the number of new cases per 100,000 births fell from 2.0 among children born in 2004 to 2005 to 0.5 among those born in 2012 to 2013, and Australia recorded a similar drop after starting school-based HPV vaccination.

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FDA-Approved Treatments for Recurrent Respiratory Papillomatosis

There is currently 1 FDA-approved medication for Recurrent Respiratory Papillomatosis. These therapies represent the current standard of care and may be used alongside or compared against investigational treatments in active clinical trials.

zopapogene imadenovec
Precigen
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Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.

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Side Effect Explorer

Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.

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Diagnosis and Testing

Caused by infection with HPV types 6 and 11, not by an inherited gene change.

Trusted Recurrent Respiratory Papillomatosis Resources

Reputable organizations and medical references for learning more about Recurrent Respiratory Papillomatosis, including disease registries, foundation resources, and clinical guidelines.

FDA decision ahead
The FDA is due to decide on INO-3107 (INOVIO) for Recurrent respiratory papillomatosis (RRP) by October 30, 2026. DNA immunotherapy for adults with recurrent respiratory papillomatosis, given as 4 injections into muscle with INOVIO's CELLECTRA device. INOVIO seeks accelerated approval; the FDA accepted the application under standard review and flagged a preliminary view that eligibility for accelerated approval had not been justified. Would be the second RRP treatment after Papzimeos (August 2025).
See all upcoming rare disease FDA decisions →

Active Clinical Trials for Recurrent Respiratory Papillomatosis

Use this Recurrent Respiratory Papillomatosis clinical trial finder to see the 6 studies recruiting patients and 2 opening soon in the United States and worldwide, with eligibility criteria in plain English. These studies play a critical role in advancing care for pulmonary & respiratory conditions and may offer access to treatments not yet widely available. Each trial below is sourced directly from ClinicalTrials.gov, with eligibility criteria translated into plain English to help patients and caregivers evaluate whether a study may be a fit.

TrialsSite mapPipeline timeline

Note: Trial recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator before making plans.

8 active trials worldwide
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NOT YET RECRUITINGPHASE2Recently updatedNCT07756840

Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)

Intervention: PRGN-2012, Bevacizumab

Sponsor: National Cancer Institute (NCI)

Background:

Ages 18 Years – 120 Years1 location
Started Oct 2026Updated todayEst. Jul 2029 (~2y 9m)
RECRUITINGPHASE1Recently updatedNCT07317154

Autologous Dendritic Cell Vaccine For Recurrent Respiratory Papillomatosis (RRP) Patients

Intervention: Autologous HPV6 E6-and E7-derived peptide-loaded dendritic cell

Sponsor: Mayo Clinic

The purpose of this study is to evaluate the safety and immunogenicity of autologous DC vaccine in recurrent respiratory papillomatosis patients

Ages 18 Years+1 location
Started Sep 2026Updated 2 months agoEst. Jun 2027 (~9 months)
RECRUITINGPHASE2Recently updatedNCT04645602

Merck IIT: RRP Pembro and Lenvatinib

Intervention: Lenvatinib, Pembrolizumab

Sponsor: Yale University · Eisai Inc. + 1 more

This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP).

The names of the study drugs involved in this study are:

* Pembrolizumab

* Lenvatinib

Ages 18 Years+1 location
Started Jul 2025Updated 2 months agoEst. Dec 2027 (~1y 3m)
NOT YET RECRUITINGPHASE1, PHASE2No updates in a whileNCT07339163

Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*

Intervention: GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)

Sponsor: Ohio State University · Merck Sharp & Dohme LLC

The investigators propose the study titled "Efficacy of booster injection with Gardasil-9 vaccine on intersurgical interval (ISI) for adults with recurrent respiratory papillomatosis (RRP)".

Ages 18 Years+1 location
Started Apr 2026Updated 8 months agoEst. Apr 2028 (~1y 6m)
RECRUITINGPHASE4No updates in a whileNCT06538480

Zopa Retreatment and Vector Shedding in Adults With RRP

Intervention: Zopapogene imadenovec (Zopa)

Sponsor: Precigen, Inc

This open-label study evaluates safety, vector shedding, and retreatment efficacy of Zopapogene imadenovec (Zopa) in adults with recurrent respiratory papillomatosis (RRP). Two cohorts will be enrolled (n=30): Cohort 1 to assess the magnitude and duration of adenoviral vector she...

Ages 18 Years+3 locations
Started Jul 2024Updated 9 months agoEst. Dec 2027 (~1y 2m)
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Active trial locations7 cities in the US

Trial Pipeline

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Data from ClinicalTrials.gov, U.S. National Library of Medicine.
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Related Pulmonary & Respiratory Conditions

Other rare diseases in the pulmonary & respiratory category. Patients with Recurrent Respiratory Papillomatosis may find relevant research, shared treatment pathways, or overlapping clinical trials among these related conditions.

Recurrent Respiratory Papillomatosis News and Analysis

Trial Friend articles about Recurrent Respiratory Papillomatosis, newest first

Companies Developing Recurrent Respiratory Papillomatosis Treatments

1 pharmaceutical company has Recurrent Respiratory Papillomatosis in their rare disease portfolio

Frequently Asked Questions About Recurrent Respiratory Papillomatosis