Drugs / Gardasil 9
Gardasil 9
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed human papillomavirus-related squamous cell carcinoma 1 milestone | |||||
| Filed | US (FDA) | GARDASIL 9 | human papillomavirus-related squamous cell carcinoma | 2018-07-27 | “The application is seeking approval for an expanded age indication for GARDASIL 9 for use in women and men ages 27 to 45” merck.com ↗ “Merck announced that the FDA accepted for review a new sBLA for GARDASIL 9” merck.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Gardasil 9 | — | 2015-06-10 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05329961 | Sep 2022 → Jul 2028 expected | human papilloma virus infection | Boston Medical Center | Active not recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05985681 | Jan 2026 → Feb 2028 expected | carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04921111 | Jul 2021 → Jul 2022 | — | Sinocelltech Ltd. | Unknown | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07339163 | Apr 2026 → Apr 2028 expected | recurrent respiratory papillomatosis | Ohio State University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05087849 | Apr 2022 → Jul 2024 | anogenital human papillomavirus infection, skin disorder caused by infection | University of California, San Francisco | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07407569 | Mar 2026 → Jan 2029 expected | human papilloma virus infection | University of Antwerp | Recruiting | No outcome recorded |
| Phase 2 | NCT07806617 | Sep 2025 → Jun 2027 expected | common wart | Rush University Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06793410 | May 2025 → Oct 2029 expected | acute myeloid leukemia, diffuse large B-cell lymphoma, disease related to hematopoietic stem cell transplant, human papilloma virus infection +1 | Vastra Gotaland Region | Recruiting | No outcome recorded |
| Phase 2 | NCT03947775 | Sep 2022 → Mar 2026 | anal carcinoma, epithelial tumor of anal canal, human papilloma virus infection | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2 | NCT05202860 | May 2022 → Jun 2024 overdue | actinic keratosis, basal cell carcinoma, squamous cell carcinoma | Merete Haedersdal | Active not recruiting | Mixed |
| Phase 2 | NCT03519464 | Feb 2019 → Dec 2026 expected | idiopathic CD4-positive T-lymphocytopenia | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02568566 | May 2016 → Feb 2020 overdue | human papillomavirus-related squamous cell carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05580341 | Sep 2022 → Jun 2023 | anogenital human papillomavirus infection, cervical cancer, cervical intraepithelial neoplasia | Shanghai Zerun Biotechnology Co.,Ltd | Unknown | No outcome recorded |
| Phase 3 | NCT03848039 | Dec 2020 → Dec 2022 overdue | cervical intraepithelial neoplasia | Alessandro Ghelardi | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03979014 | Nov 2019 → Sep 2025 | neoplasm | Imperial College London | Completed | No outcome recorded |
| Phase 3 | NCT03431246 | Oct → Nov 2016 | — | Laval University | Completed | No outcome recorded |
| Phase 419 trials · 2 met primary | ||||||
| Phase 4 | NCT06799494 | Aug 2025 → Sep 2028 expected | human papilloma virus infection | Emory University | Recruiting | No outcome recorded |
| Phase 4 | NCT06436274 | Oct 2024 → Dec 2026 expected | HIV infectious disease, human papilloma virus infection | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06588257 | Oct 2024 → May 2026 | human papilloma virus infection | Fundación Huésped | Completed | No outcome recorded |
| Phase 4 | NCT06536855 | Sep 2024 → Mar 2025 overdue | cervical cancer | Rwanda Biomedical Centre | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06052696 | Mar 2024 → Dec 2028 expected | human papilloma virus infection | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05557370 | Jun 2023 → Dec 2028 expected | chronic kidney disease | Medical College of Wisconsin | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05334706 | Sep 2022 → Dec 2026 expected | cervical intraepithelial neoplasia, human papilloma virus infection | Bellvitge Biomedical Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT04982614 | Apr 2022 → Dec 2024 | HIV infectious disease, human papilloma virus infection | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT05031078 | Dec 2021 → Oct 2024 overdue | human papilloma virus infection | Emory University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07314307 | May 2021 → Dec 2027 expected | human papilloma virus infection | Karolinska Institutet | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04910802 | May 2021 → Dec 2025 overdue | cervical cancer, cervical intraepithelial neoplasia grade 2/3, human papilloma virus infection | Miriam Elfström | Recruiting | No outcome recorded |
| Phase 4 | NCT04206813 | Dec 2020 → Apr 2026 overdue | human papilloma virus infection | Boston Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04459221 | Nov 2020 → Jun 2021 | human papilloma virus infection | Centre Hospitalier Universitaire de la Réunion | Completed | No outcome recorded |
| Phase 4 | NCT04274153 | Aug 2020 → Jul 2022 | human papilloma virus infection | Johns Hopkins University | Completed | Met primary |
| Phase 4 | NCT03451071 | Apr 2019 → Jun 2020 | virus associated tumor | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT03675256 | Dec 2018 → Feb 2024 | human papilloma virus infection | Massachusetts General Hospital | Unknown | Met primary |
| Phase 4 | NCT03350698 | Apr 2018 → Dec 2023 | — | Eastern Virginia Medical School | Unknown | No outcome recorded |
| Phase 4 | NCT03391921 | Jan 2018 → May 2023 overdue | HIV infectious disease, anogenital human papillomavirus infection | Centre Hospitalier Universitaire Saint Pierre | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03023631 | Apr 2017 → Sep 2026 overdue | disease related to hematopoietic stem cell transplant, hematopoietic and lymphoid cell neoplasm | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06995157 | Sep 2023 → Sep 2025 overdue | — | University Medical Centre Ljubljana | Recruiting | No outcome recorded |
| Comparator or background therapy15 trials | ||||||
| Phase 1 | NCT06688058 Comparator | Dec 2024 → Nov 2026 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06623409 Comparator | Nov 2024 → May 2028 expected | — | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05496231 Comparator | Aug 2022 → Feb 2024 | cervical intraepithelial neoplasia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT07224477 Comparator | Jul 2026 → Apr 2028 | — | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05060484 Comparator | Oct 2021 → May 2022 | — | Sinocelltech Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04436133 Comparator | Jun 2020 → Mar 2022 | cervical carcinoma, human papilloma virus infection | National Vaccine and Serum Institute, China | Completed | No outcome recorded |
| Phase 3 | NCT06207175 Comparator | Nov 2023 → Nov 2024 | human papilloma virus infection | Beijing Health Guard Biotechnology, Inc | Unknown | No outcome recorded |
| Phase 3 | NCT05662020 Comparator | Mar → Nov 2022 overdue | human papilloma virus infection | Beijing Health Guard Biotechnology, Inc | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04782895 Comparator | Mar 2021 → May 2022 | anogenital human papillomavirus infection, cervical cancer | Xiamen University | Completed | Met primary |
| Phase 3 | NCT05372016 Comparator | Sep 2020 → Jun 2022 | adenocarcinoma in situ, anogenital human papillomavirus infection, cervical cancer, cervical intraepithelial neoplasia grade 2/3 +2 | Shanghai Bovax Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03832049 Comparator | Sep 2019 → Jun 2024 | — | London School of Hygiene and Tropical Medicine | Unknown | No outcome recorded |
| Phase 3 | NCT02834637 Comparator | Feb 2017 → Jan 2020 overdue | human papilloma virus infection | London School of Hygiene and Tropical Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02567955 Comparator | Sep 2015 → Sep 2016 | — | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT05266898 Background | Nov 2022 → Dec 2025 overdue | HIV infectious disease, cervical intraepithelial neoplasia, human papilloma virus infection, intraepithelial neoplasia +1 | Louisiana State University Health Sciences Center in New Orleans | Recruiting | No outcome recorded |
| Phase 4 | NCT01824537 Comparator | Jan 2014 → Nov 2022 | human papilloma virus infection | McGill University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-03-17 | Merck Sharp & Dohme LLC | Results Merck to Present New Data Reinforcing Long-Term Efficacy of GARDASIL®9 and GARDASIL® at the EUROGIN International Multidisciplinary HPV Congress 2026 merck.com ↗
Data show long-term effectiveness of GARDASIL ® 9 and GARDASIL ® 14 years and 18 years, respectively, following vaccination with 3 doses |
| 2024-09-17 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、日本人男性においてGARDASIL®9の有効性と安全性を評価する第3相試験の良好なトップラインの結果を発表 msd.co.jp ↗
この試験における主要評価項目と副次評価項目が達成され、GARDASIL® 9の3回接種により、9種類のHPV型に起因する肛門性器部の持続感染の複合発生率がプラセボと比較して低下することが示されました。 |
| 2024-09-11 | Merck Sharp & Dohme LLC | Results Merck Announces Positive Top-line Results from Phase 3 Trial Evaluating Efficacy and Safety of GARDASIL®9 in Japanese Males merck.com ↗
The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. |
| 2023-09-05 | Merck Sharp & Dohme LLC | Results Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls and boys who received a three-dose regimen of GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at 9-15 years old. |
| 2020-07-31 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Second-Quarter 2020 Financial Results merck.com ↗
Merck announced FDA approval of an expanded indication for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. |
| 2020-06-12 | Merck Sharp & Dohme LLC | Regulatory 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 | Regulatory 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 ↗
The ACIP also voted to expand routine and catch-up recommendations for males through 26 years of age who are not adequately vaccinated. |
| 2018-06-13 | Merck Sharp & Dohme LLC | Regulatory 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 ↗
The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 6, 2018. |
| 2017-10-10 | Merck Sharp & Dohme LLC | Results Six-year Efficacy Data for GARDASIL® 9 Presented at EUROGIN 2017 Congress merck.com ↗
The data, which showed sustained efficacy for up to six years in the per protocol population, were presented during an oral session at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Amsterdam, Netherlands. |
| 2016-10-07 | Merck Sharp & Dohme LLC | Regulatory Merck Statement on FDA Approval of 2-Dose Regimen of GARDASIL® 9 for Girls and Boys 9 through 14 Years of Age merck.com ↗
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a 2-dose vaccination regimen for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), for use in girls and boys 9 through 14 years of age. |
| 2015-12-15 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Expanded Age Indication for GARDASIL® 9 in Males merck.com ↗
GARDASIL 9 Now Approved for Males 16 through 26 Years of Age for the Prevention of Anal Cancers and Genital Warts Caused by Nine HPV types |
| 2015-02-26 | Merck Sharp & Dohme LLC | Regulatory Merck’s 9-Valent HPV Vaccine, GARDASIL®9, Recommended by CDC’s Advisory Committee on Immunization Practices for Females Aged 9-26 and Males Aged 9-21 merck.com ↗
GARDASIL 9 has been added to the routine recommendations for vaccination of 11- and 12- year-old females and males. |
| 2014-12-11 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s HPV Vaccine, GARDASIL®9, to Prevent Cancers and Other Diseases Caused by Nine HPV types – Including Types that Cause About 90% of Cervical Cancer Cases merck.com ↗ |
| 2014-02-20 | Merck Sharp & Dohme LLC | Regulatory FDA Accepts for Review Merck’s Biologics License Application for V503, Investigational 9-valent Human Papillomavirus Vaccine merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Biologics License Application for V503, its investigational 9-valent human papillomavirus (HPV) vaccine, has been accepted for standard review by the U.S. Food and Drug Administration. |
| 2013-11-04 | Merck Sharp & Dohme LLC | Results Merck’s Investigational 9-valent HPV Vaccine, V503, Prevented 97 Percent of Cervical, Vaginal and Vulvar Pre-cancers Caused by Five Additional HPV Types, in Phase III Study merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in the pivotal Phase III efficacy study, its investigational 9-valent HPV vaccine (V503) prevented approximately 97 percent of cervical, vaginal and vulvar pre-cancers caused by HPV types 31, 33, 45, 52, and 58. |
| 2013-10-24 | Merck Sharp & Dohme LLC | Results Merck Provides Update on Investigational 9-valent HPV Vaccine V503 to U.S. Advisory Committee on Immunization Practices merck.com ↗
Merck said that the pivotal efficacy trial is complete, the primary endpoints have been met and the company expects to submit a Biologics License Application for V503 to the U.S. Food and Drug Administration in 2013. |
All press releases naming this drug 16 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 55 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gardasil9 | “METHODS: This is a prospective, single-arm, open-label, non-randomized, Phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose...” PMID 30935375 ↗ Apr 201960“Since 2015, a second-generation vaccine (Gardasil 9, Sanofi Pasteur MSD SNC) has been available that provides protection against 9 HPV types of which 7 types (16, 18, 31, 33,...” NCT04910802 ↗ “All patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized...” NCT03391921 ↗ “This study will evaluate whether Gardasil-9, a vaccine normally used to prevent human papillomavirus (HPV) infection, may be effective for treating recurring warts that have...” NCT07806617 ↗ “Gardasil-9 is a novel, 9-valent HPV recombinant vaccine, which expands the coverage of oncogenic HPV types, with the addition of HPV types 31, 33, 45, 52, and 58 to the...” NCT03947775 ↗ “This study aimed to compare the immunogenicity of the E coli-produced HPV 9-valent vaccine Cecolin 9 (against HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) with Gardasil 9.” PMID 37475116 ↗ Jul 2023 “The three-dose vaccination schedule will be followed with injections at month 0, 2, and 6. Gardasil 9 dosing will be per the recommended and approved labeled guidelines.” NCT03350698 ↗ “930 HIV-negative Tanzanian schoolgirls aged 9-14 years were randomised to receive one, two or three doses of Cervarix® or Gardasil®9 (155 per arm)” PMID 42378813 ↗ Jun 2026 “Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months).” NCT06995157 ↗ “Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).” NCT06588257 ↗ “Gardasil-9 is approved by the Federal Drug Administration to help protect against diseases caused by some types of HPV.” NCT05985681 ↗ |
| Known as | 9-valent HPV vaccine | “9-valent HPV vaccine（Gardasil 9）” NCT04436133 ↗ |
| Known as | 9-valent human papillomavirus vaccine | “9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses” NCT03832049 ↗ |
| Known as | 9vHPV | “The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context” NCT07407569 ↗1“vaccinated with 9vHPV/Gardasil-9™.” NCT05334706 ↗ |
| Known as | GARDASIL 9 -MSD | “Non-infectious adjuvanted recombinant nonavalent HPV vaccine. Three doses (0, 2, 6 months). (Trade name GARDASIL 9 -MSD).” NCT06588257 ↗ |
| Known as | Gardasil(R) 9 | “Commercially available nonavalent HPV vaccine (Gardasil(R) 9) given intramuscularly at baseline, month 2 and month 6” NCT05202860 ↗ |
| Known as | nonavalent human papillomavirus vaccine | “nonavalent human papillomavirus vaccine (Gardasil 9) at 0 and 4 weeks” NCT05087849 ↗ |
| Modality | Vaccine | “The intervention vaccine will be Gardasil 9, a 9-valent vaccine by Merck.” NCT01824537 ↗ |
| Route | Intramuscular | “Given IM” NCT02568566 ↗ |