Brand Name
Papzimeos
Generic Name
Zopapogene imadenovec
View Brand Information FDA approval date: August 12, 2025
Form: Injection
What is Papzimeos (Zopapogene imadenovec)?
PAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis. PAPZIMEOS™ is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis.
Approved To Treat
Top Global Experts
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Open-Label Study of Zopapogene Imadenovec Retreatment and Vector Shedding Evaluation in Adult Patients With Recurrent Respiratory Papillomatosis
Summary: 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 shedding in urine, feces, skin, and nasal tissue; Cohort 2 to assess the complete response rate following retreatment.
Related Latest Advances
Brand Information
PAPZIMEOS (zopapogene imadenovec)
1INDICATIONS AND USAGE
PAPZIMEOS is indicated for the treatment of adults with recurrent respiratory papillomatosis.
2DOSAGE FORMS AND STRENGTHS
PAPZIMEOS is supplied as a slightly opalescent to opalescent, colorless suspension for subcutaneous injection with a concentration of 5×10
3CONTRAINDICATIONS
None.
4DESCRIPTION
PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of human papillomavirus (HPV) types 6 and 11 proteins.
PAPZIMEOS has a concentration of 5×10
PAPZIMEOS is a sterile, slightly opalescent to opalescent colorless suspension.
The product contains no preservatives.
5CLINICAL STUDIES
The efficacy of PAPZIMEOS was evaluated in an open-label, single-arm study in adults with recurrent respiratory papillomatosis (PRGN-2012-201; NCT04724980). The study enrolled adults who had histological and clinically diagnosed recurrent respiratory papillomatosis and had 3 or more debulking procedures to remove laryngotracheal papillomas in the 12 months prior to treatment with PAPZIMEOS.
A total of 38 patients received subcutaneous injections of PAPZIMEOS on days 1, 15, 43, and 85. Prior to initiation of treatment with PAPZIMEOS (Day 1), patients underwent a standard-of-care surgical debulking procedure to remove laryngotracheal papillomas. Physicians also had the option to remove any visible papillomas during the treatment interval. Of the 38 patients, 3 patients were treated with PAPZIMEOS at a dose of 1×10
The demographic characteristics of the population were as follows: the median age was 50 years (range 20 to 88 years), 15 patients (39%) were female, 33 patients (87%) were White, 1 patient (3%) was Asian, 1 patient (3%) was African American, 1 patient (3%) was of “other” race, 2 patients (5%) were of unknown race, and 32 patients (84%) were non-Hispanic or Latino. The mean (SD) BMI was 28 (6) kg/m
The primary efficacy endpoint was the percentage of patients with a complete response to PAPZIMEOS treatment, defined as no requirement for surgical intervention in the 12 months after treatment.
At a dose of 5×10
At a dose of 1×10
6PATIENT COUNSELING INFORMATION
Discuss following with the patients.
- Injection Site Reactions: Inform patients injection site reactions have occurred after PAPZIMEOS injection. Signs and Symptoms may include reactions such as redness, pain, swelling, itching, or warmth at the injection site. Advise patients to manage symptoms with cold compresses, over the counter pain relievers or antihistamines, if needed. Seek medical care if symptoms worsen or are accompanied by signs of a systemic allergic reaction (difficulty breathing, widespread rash, facial swelling) or infection [see Warnings and Precautions (
- Thrombotic Events: Inform patients that thrombotic events may occur after PAPZIMEOS injection. Signs and Symptoms may include shortness of breath, chest pain, leg swelling, persistent abdominal pain, or neurological symptoms (including severe or persistent headaches or blurred vision). Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice [see Warnings and Precautions (
Manufactured by:
Precigen, Inc.
20358 Seneca Meadows Parkway
Germantown, MD 20876 USA
U.S. License No. 2364