drugset
Drugs / V501
last change Mar 2026 re-read 3 minutes ago

V501

also known as Gardasil

Vaccine

Developed for
anogenital human papillomavirus infection · cervical cancer · human papilloma virus infection · cervical intraepithelial neoplasia · adenocarcinoma in situ
Investigated by
Merck Sharp & Dohme LLC

Trials 9

today NCT03493542 · Ph 3 NCT02576054 · Ph 3 NCT01862874 · Ph 3 NCT01544478 · Ph 4 NCT00411749 · Ph 2 NCT00092547 · Ph 3 NCT00092495 · Ph 3 NCT00092482 · Ph 3 NCT00092521 · Ph 3
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial · 1 met primary
Phase 2 NCT00411749 Dec 2006 → Sep 2009 human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 37 trials · 4 met primary
Phase 3 NCT03493542 Aug 2018 → Oct 2023 cervical intraepithelial neoplasia Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT02576054 Nov 2015 → Aug 2018 anogenital human papillomavirus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT01862874 Jun 2013 → Aug 2017 anogenital human papillomavirus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 3 NCT00092547 Oct 2003 → Nov 2005 human papilloma virus infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00092495 Dec 2002 → Sep 2004 anogenital human papillomavirus infection, cervical cancer Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00092482 Jun 2002 → Jun 2004 anogenital human papillomavirus infection, cervical cancer Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00092521 Dec 2001 → Jul 2007 cervical cancer, human papilloma virus infection Merck Sharp & Dohme LLC Completed Met primary
Phase 41 trial
Phase 4 NCT01544478 Nov 2011 → Aug 2016 adenocarcinoma in situ, cervical cancer, cervical intraepithelial neoplasia Merck Sharp & Dohme LLC Completed No outcome recorded

Press releases naming this drug 22 releases

DateIssuerRelease
2026-03-17 Merck Sharp & Dohme LLC Merck to Present New Data Reinforcing Long-Term Efficacy of GARDASIL®9 and GARDASIL® at the EUROGIN International Multidisciplinary HPV Congress 2026 merck.com ↗
2025-05-23 Merck Sharp & Dohme LLC Merck Statement on a Potential Reduced Dosing Recommendation for GARDASIL®9 merck.com ↗
2025-01-08 Merck Sharp & Dohme LLC Merck’s GARDASIL® Receives Expanded Approval for Males in China merck.com ↗
2024-11-12 Merck Sharp & Dohme LLC Merck to Present New Data From GARDASIL®9 Studies Reinforcing the Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at the International Papillomavirus Conference (IPVC) 2024 merck.com ↗
2024-09-11 Merck Sharp & Dohme LLC Merck Announces Positive Top-line Results from Phase 3 Trial Evaluating Efficacy and Safety of GARDASIL®9 in Japanese Males merck.com ↗
2024-03-13 Merck Sharp & Dohme LLC Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9 merck.com ↗
2023-09-05 Merck Sharp & Dohme LLC Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics merck.com ↗
2022-11-07 Merck Sharp & Dohme LLC Reductions in Certain Types of HPV-Related Cervical and Non-Cervical Diseases in Women and Men Observed with Real-World Use of Merck’s GARDASIL® in Systematic Literature Review of 138 Studies merck.com ↗
2020-06-12 Merck Sharp & Dohme LLC FDA Approves Merck’s GARDASIL 9 for the Prevention of Certain HPV-Related Head and Neck Cancers merck.com ↗
2019-06-26 Merck Sharp & Dohme LLC CDC Advisory Committee on Immunization Practices (ACIP) Votes to Provisionally Recommend Shared Clinical Decision-Making for Vaccination of Adults Ages 27-45 with GARDASIL®9 & Harmonization of Catch-up Vaccination for Males and Females Through Age 26 merck.com ↗
2018-06-13 Merck Sharp & Dohme LLC FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases merck.com ↗
2017-10-10 Merck Sharp & Dohme LLC Six-year Efficacy Data for GARDASIL® 9 Presented at EUROGIN 2017 Congress merck.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as V501 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00092547 ↗
8

NCT00092482 ↗

NCT01544478 ↗

NCT01862874 ↗

NCT00092521 ↗

NCT00092495 ↗

NCT03493542 ↗

NCT00411749 ↗

NCT02576054 ↗
Known as Gardasil “The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical...” NCT00092521 ↗
1

“V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years” NCT00092482 ↗
Modality Vaccine “the quadrivalent HPV 6, 11, 16 and 18 L1 VLP vaccine (qHPV)” PMID 21307649 ↗ Feb 2011
Route Intramuscular “0.5 mL intramuscular injection” NCT00092495 ↗