Evaluation of the market and availability of vaginal gels with aminopeptide complexes for the treatment of HPV-associated diseases

Authors

DOI:

https://doi.org/10.24959/nphj.26.210

Keywords:

soft dosage forms; pharmaceutical development; aminopeptide complexes; vaginal gels; marketing analysis.

Abstract

The increasing prevalence of papillomavirus infection (HPV) and its role in the development of cervical precancerous and inflammatory diseases cause increased interest in adjunctive and non-invasive approaches to the treatment and prevention of recurrence. Vaginal gels based on aminopeptide complexes occupy a separate segment of the pharmaceutical market and are positioned as agents for the local immunomodulation and stimulation of mucosal regeneration.

Aim. To conduct a comprehensive analysis of the market, regulatory status, and affordability of vaginal gels with amino peptide complexes (in particular, alloferon) in Ukraine.

Materials and methods. The content analysis of official websites of manufacturers, pharmacy network websites, and online pharmacies; the comparative price analysis; the analysis of patient information leaflets, scientific publications, and data from scientific databases were applied.

Results. The market for topical agents for the treatment of HPV-associated pathologies is characterized by high heterogeneity by the composition, mechanisms of action, regulatory status, and evidence level. Dysplagel is the one and only product in the study sample that has an aminopeptide complex (aloferon). The declared mechanism of its action is based on the concept of the local peptide immunomodulation using a liposomal delivery system, but the evidence base for its effectiveness is limited mainly to local studies and does not meet the requirements for medicines in accordance with EMA and FDA standards. The analysis has revealed the high cost and significant interregional variability in the prices and availability of the medicinal product studied, which leads to low economic accessibility and an increased risk of treatment discontinuation.

Conclusions. Amino-peptide vaginal gels, in particular aloferon-based products, have the potential for the local immunomodulation in HPV-associated lesions and can be used as an adjunct to active surveillance strategies for low-grade diseases, provided that the principles of evidence-based medicine are followed and patients are properly informed, which makes further research and development in this scientific field relevant.

References

  1. Milano, G., Guarducci, G., Nante, N., Montomoli, E., & Manini I. (2023). Human Papillomavirus Epidemiology and Prevention: Is There Still a Gender Gap? Vaccines (Basel), 11(6), 1060. http://doi.org/10.3390/vaccines11061060
  2. Nakaz MOZ Ukrainy «Standart medychnoi dopomohy «Rak shyiky matky» № 1075 (2025, Lypen 7). https://www.dec.gov.ua/wp-content/uploads/2025/07/dn_1075_07072025_dod.pdf
  3. Liu, R., He, X., Bao, W., & Li, Z. (2024). Enhancement of HPV therapeutic peptide-based vaccine efficacy through combination therapies and improved delivery strategies: A review. Human Vaccines Immunotherapeutics, 20(1), 2396710. http://doi.org/10.1080/21645515.2024.2396710
  4. Unclear Cervical Smear? Treat your cervical lesions by reducing HPV and precancerous risk factors with DeflaGyn® vaginal gel. https://www.deflagyn.com/
  5. Ozmen, F., Aydin, S. G., Seyfettinoglu, S., & Bas, S. (2025). Vaginal Adsorbent Gel as a Therapeutic Agent: Is a New Era Beginning for HPV? Journal of Clinical Medicine, 14(14), 4826. http://doi.org/10.3390/jcm14144826
  6. Serrano, L., López, A. C., González, S. P., Palacios, S., Dexeus, D., Centeno-Mediavilla, C., Coronado, P., de la Fuente, J., López, J. A., Vanrell, C., & Cortés, J. (2021). Efficacy of a Coriolus versicolor–Based Vaginal Gel in Women With Human Papillomavirus–Dependent Cervical Lesions: The PALOMA Study. Journal of Lower Genital Tract Disease, 25(2), 130–136. http://doi.org/10.1097/LGT.0000000000000596
  7. Gel to prevent and treat cervical lesions caused by HPV. Low-grade cervical lesions (ASCUS/LSIL). https://papilocare.com/en/papilocare-vaginal-gel/
  8. Hel dlia profilaktyky ta likuvannia urazhen shyiky matky, vyklykanykh VPL. Papilocare®. https://papilocare.com.ua/
  9. Rest assured. There is already a solution for HPV. https://papilocare.com/en/home/
  10. Díaz, E. S., Levin, G., Aristizabal, B., Fernandes, A., Noll, F., Cantú, D., Heredia, F., Obermair, H. M., & Pareja, R. (2025). Silicon dioxide, sodium selenite and citric acid vaginal gel, HPV infection, and cervical preinvasive disease: a narrative review. International Journal of Gynecological Cancer, 35(10), 102021. http://doi.org/10.1016/j.ijgc.2025.102021
  11. Kasukawa, H., Howley, P. M., & Benson, J. D. (1998). A fifteen-amino-acid peptide inhibits human papillomavirus E1-E2 interaction and human papillomavirus DNA replication in vitro. Journal of Virology, 72(10), 8166–8173. http://doi.org/10.1128/JVI.72.10.8166-8173.1998
  12. Zhao, C., Yan, S., Song, Y., & Xia, X. (2022). Roles of Antimicrobial Peptides in Gynecological Cancers. International Journal of Molecular Sciences, 23(17), 10104. http://doi.org/10.3390/ijms231710104
  13. Appiah, C., Chen, S., Pori, A. I., Retyunskiy, V., Tzeng, C., & Zhao, Y. (2024). Study of alloferon, a novel immunomodulatory antimicrobial peptide (AMP), and its analogues. Front. Pharmacol., 15, 1359261. http://doi.org/10.3389/fphar.2024.1359261
  14. Bulavenko, О., Lunko, Т., Таtskyy, О., Fomina, Т., Pikul, М., Zdanevych, О., Каzarnovskyy, M., Zadorozhnyy, V., Тurbanist, S., Pysmenna, S., Yamkova-Bodnaruk, O., & Lytvynchuk, L. (2023). The Role of Peptide Immunotherapy in the Treatment of Cervical Dysplasia: Clinical Cases. International Journal of Clinical Oncology and Cancer Research, 8(2), 32–38. http://doi.org/10.11648/j.ijcocr.20230802.13
  15. Vitiuk, A. D. (2025). Papilocare®: novyi pidkhid do likuvannia VPL-asotsiiovanykh staniv. Ukrainskyi medychnyi chasopys, 1(167), 3–5. http://doi.org/10.32471/umj.1680-3051.262996
  16. Kesic, V., Carcopino, X., Preti, M., Vieira-Baptista, P., Bevilacqua, F., Bornstein, J., Chargari, C., Cruickshank, M., Erzeneoglu, E., Gallio, N., Gultekin, M., Heller, D., Joura, E., Kyrgiou, M., Madić, T., Planchamp, F., Regauer, S., Reich, O., Esat, T. B. . . . Stockdale, C. (2023). The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD), and the European Federation for Colposcopy (EFC) consensus statement on the management of vaginal intraepithelial neoplasia. Int. J. Gynecol. Cancer, 33(4), 446–461. http://doi.org/10.1136/ijgc-2022-004213
  17. Walsh, C. J., Friedman, J. C., Piper, C., & Conageski, C. (2024). A Scoping Review of Complementary and Alternative Medicine for Human Papillomavirus Infections and Cervical Dysplasia. J. Low. Genit. Tract. Dis., 28(3), 240–253. http://doi.org/10.1097/LGT.0000000000000806
  18. Głowienka-Stodolak, M., Bagińska-Drabiuk, K., Szubert, S., Hennig, E. E., Horala, A., Dąbrowska, M., Micek, M., Ciebiera, M., & Zeber-Lubecka, N. (2024). Human Papillomavirus Infections and the Role Played by Cervical and Cervico-Vaginal Microbiota-Evidence from Next-Generation Sequencing Studies. Cancers (Basel), 16(2), 399. http://doi.org/10.3390/cancers16020399
  19. Bravo, V., Serrano, M., Duque, A., Ferragud, J., & Coronado, P. J. (2023). Glycyrrhizinic Acid as an Antiviral and Anticancer Agent in the Treatment of Human Papillomavirus. J. Pers. Med., 13(12), 1639. http://doi.org/10.3390/jpm13121639
  20. Borella, F., Gallio, N., Mangherini, L., Cassoni, P., Bertero, L., Benedetto, C., & Preti, M. (2023). Recent advances in treating female genital HPV‐related neoplasms with topical imiquimod. J. Med. Virol., 95(11), e29238. http://doi.org/10.1002/jmv.29238
  21. Voss, F. O., van Beurden, M., & Jordanova, E. S. (2022). Topical imiquimod as first-line treatment for vulvar intraepithelial neoplasia. Lancet, 399(10337), 1755–1757. http://doi.org/10.1016/S0140-6736(22)00624-9
  22. Díaz, E. S., Levin, G., Aristizabal, B., Fernandes, A., Noll, F., Cantú, D., Heredia, F., Obermair, H. M., & Pareja, R. (2025). Silicon dioxide, sodium selenite and citric acid vaginal gel, HPV infection, and cervical preinvasive disease: a narrative review. Int. J. Gynecol. Cancer, 35(10), 102021. http://doi.org/10.1016/j.ijgc.2025.102021
  23. Wang, D. Y., Cui, Y. Y., Zhang, W. W., Fan, M. S., Qiu, K. X., & Yan, L. (2024). Effect of different interventions on the treatment of high-risk human papillomavirus infection: a systematic review and network meta-analysis. Front. Med. (Lausanne), 11, 1274568. http://doi.org/10.3389/fmed.2024.1274568
  24. Alokin-alfa: instruktsiia dlia zastosuvannia. Liky kontrol. https://surl.li/ydykmr
  25. Instruktsiia iz zastosuvannia medychnoho vyrobu «Dyspladzhel». (2024, Lypen 1). https://surl.li/rnprpq
  26. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. https://www.legislation.gov.uk/eur/2017/745/contents
  27. Heli dlia zastosuvannia v hinekolohii. Apteka 9-1-1. https://apteka911.ua/ua/shop/sredstva-dlya-vaginalnogo-ispolzovaniya/gel
  28. Tabletki.ua: ofitsiinyi sait. https://tabletki.ua/

Published

2026-04-08