Zopapogene imadenovec
| Clinical data | |
|---|---|
| Trade names | Papzimeos |
| Other names | PRGN-2012, zopapogene imadenovec-drba |
| AHFS/Drugs.com | Papzimeos |
| License data | |
| Routes of administration | Subcutaneous |
| ATC code |
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| Legal status | |
| Legal status | |
| Identifiers | |
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Zopapogene imadenovec, sold under the brand name Papzimeos, is a medication used for the treatment of recurrent respiratory papillomatosis.[1][3] Zopapogene imadenovec is a first-of-its-kind non-replicating adenoviral vector-based immunotherapy.[1][3] It is given by injection under the skin (subcutaneous).[1]
Zopapogene imadenovec was approved for medical use in the United States in August 2025.[3]
Medical uses
Zopapogene imadenovec is indicated for the treatment of adults with recurrent respiratory papillomatosis.[1][3]
Recurrent respiratory papillomatosis is a rare, chronic disease caused by persistent human papillomavirus (HPV) 6 or 11 infection, leading to the growth of benign tumors in the respiratory tract, most commonly the larynx.[3] The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction.[3]
History
The US Food and Drug Administration (FDA) approved zopapogene imadenovec based on results from a single-arm, open-label trial evaluating zopapogene imadenovec in adults with recurrent respiratory papillomatosis who required three or more surgeries per year.[3] Participants received four subcutaneous injections of zopapogene imadenovec over twelve weeks following surgical debulking (reduction) procedures.[3] In the pivotal portion of the study, 51.4% of participants (18/35) achieved a complete response—defined as no need for surgical intervention in the twelve months following treatment.[3] Follow-up data showed that durable responses were maintained in most participants through two years, with a strong correlation between clinical benefit and the induction of HPV 6/11-specific T cells.[3]
The FDA granted the application for zopapogene imadenovec priority review, orphan drug, and breakthrough therapy designations.[3] The FDA granted approval of Papzimeos to Precigen.[3]
Society and culture
Legal status
Zopapogene imadenovec was approved for medical use in the United States in August 2025.[3][4]
Name
Zopapogene imadenovec is the international nonproprietary name.[5]
Zopapogene imadenovec is sold under the brand name Papzimeos.[3]
References
- ^ a b c d e https://www.fda.gov/media/188264/download
- ^ "Papzimeos". U.S. Food and Drug Administration (FDA). 14 August 2025. Retrieved 31 August 2025.
- ^ a b c d e f g h i j k l m n "FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis". U.S. Food and Drug Administration (FDA) (Press release). 14 August 2025. Retrieved 25 August 2025. This article incorporates text from this source, which is in the public domain.
- ^ "Precigen Announces Full FDA Approval of Papzimeos (zopapogene imadenovec-drba), the First and Only Approved Therapy for the Treatment of Adults with Recurrent Respiratory Papillomatosis" (Press release). Precigen. 15 August 2025. Retrieved 25 August 2025 – via PR Newswire.
- ^ World Health Organization (2024). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 92". WHO Drug Information. 38 (3). hdl:10665/379650.
Further reading
- Norberg SM, Valdez J, Napier S, Kenyon M, Ferraro E, Wheatley M, et al. (April 2025). "PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial". The Lancet. Respiratory Medicine. 13 (4): 318–326. doi:10.1016/S2213-2600(24)00368-0. PMID 39855244.
External links
- "Zopapogene Imadenovec ( Code - C207022 )". EVS Explore.
- Clinical trial number NCT04724980 for "Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis" at ClinicalTrials.gov