TheraRadar
Data updated: May 26, 2026

Gardasil (human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant)

Approved 2006-06-07
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
19
Years on Market

Details

Status
Disc
First Approved
2006-06-07
Revenue
$1.6B (Q4-2024)

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Routes
Intramuscular
Dosage Forms
Injection

Companies

Merck
Active Ingredient: Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant

Gardasil Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2006 to 2006
Jun 2006 ORIGINAL
Update · CBER biologic (Purple Book)

What Gardasil Treats

1 FDA approvals

Originally approved for its first indication in 2006 .

  • Other (1)
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Clinical Trial Registry

18 trials
Trial Sponsor ID Phase Status Title
NCT00798265 results posted 090024 09-C-0024 Ph 1 terminated A Phase I Study of Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) Recombinant Vaccine in HIV-Infected and HIV-Negative Pre-Adolescents, Adolescents, and Young Adults
NCT06142461 HPV-PJ-01 1R44CA261326-01A1 Ph 2 withdrawn Safety and Immunogenicity of HPV Vaccine Administered Intradermally and Intramuscularly Via Needle-Free Injection System
NCT01914367 HPVXneutra001 2013/422 2013-002340-90 Ph 4 completed Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)
NCT03998254 V503-023 V503-023 Ph 3 active not recruiting Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
NCT04453241 PR-18062 Ph 1, Ph 2 completed Immunogenicity and Safety Study of NBP615 in Healthy Female
NCT01432574 results posted MCC-16593 Ph 2 completed Study of Gardasil in Mid-Adult Males (MAM)
NCT02087384 VACCAIN-P NL45200.018.13 Ph 4 completed HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)
NCT00956553 HPV CSP01 HPV CSP01 Ph 4 completed Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
NCT03105856 FASTER 1417 Ph 4 completed FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program
NCT01462357 results posted 115411 2011-002035-26 Ph 3 completed Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
NCT01092195 results posted 100083 10-H-0083 Ph 1 completed Gardasil Vaccination in Post Stem Cell Transplant Patients
NCT01461993 results posted B1971011 6108A1-2007 Ph 2 completed A Clinical Trial to Study the Safety, Tolerance and Immunogenic Response to Gardasil and Bivalent rLP2086 Vaccine When Given at the Same Time to Children Between the Ages of 11 and 17
NCT01304498 results posted V503-009 GDS01C, 2010-023393-39 Ph 3 completed Immunogenicity and Tolerability of V503 Versus GARDASIL (V503-009)
NCT01741012 GARDASIL results posted 0412GARDASIL Ph 1 completed Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
NCT02114385 results posted V503-020 2013-003399-10, GDS07C Ph 3 completed A Study to Compare Immune Response of V503 to Gardasil in 16- to 26-year-old Men (V503-020)
NCT01338051 PERCAPS PERCAPS I Ph 1 completed The Development of a "Mother/Child, Screen, Treat and Vaccinate Program" in Manchay and Iquitos, Peru
NCT01386164 HIPAVAC LTN0001 Ph 4 completed Immune Response to Bivalent and Tetravalent Human Papillomavirus Vaccine in HIV Infected Adults
NCT00925288 Girasol results posted Merck IISP 35706 IRB00001625 Ph 4 completed Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Gardasil FDA Label Details

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Revenue Insights

  • • Q4-2024: $1.6B
  • • Historical trend analysis

Patent Timeline

  • • Patent expiration dates
  • • Generic/biosimilar risk

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: BLA125126 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.