TheraRadar
Data updated: May 26, 2026

Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)

Approved 2014-12-09
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-12-09
Routes
Intramuscular
Dosage Forms
Injection

Companies

Merck
Active Ingredient: Human Papillomavirus 9-valent Vaccine, Recombinant , Human Papillomavirus 9-valent Vaccine, Recombinant

Gardasil 9 Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Dec 2014 ORIGINAL
Update · CBER biologic (Purple Book)

What Gardasil 9 Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT03519464 180092 18-I-0092 Ph 2 active not recruiting Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia
NCT06658405 HPV2 HPV2-2303 2024-513081-19-00 Ph 2 recruiting Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions
NCT05266898 AGO-Gard 2070 MISP61476 Ph 4 recruiting Immunogenicity of Gardasil-9 HPV Vaccine in People Living With HIV
NCT05496231 results posted 213749 2022-000090-15 Ph 1, Ph 2 completed A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age
NCT06681636 HPV9vxFSW HPV9-VINIF2427 Ph 2 not yet recruiting Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure
NCT06536855 FasterHPV01 Ph 4 not yet recruiting Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda
NCT04270773 9-VPH-MVIH 9-VPH-MVIH Ph 4 active not recruiting Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women
NCT05625633 IRB_00152954 Ph 2, Ph 3 recruiting Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
NCT02968420 Merck08 results posted H16-00700 Ph 4 completed Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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 9 FDA Label Details

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Data Sources

FDA Approval: BLA125508 → Trials: ClinicalTrials.gov →

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