Papillomavirus Infections

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine

17100%

+ 30 programs with unclassified modality

Competitive Landscape

9 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Sharp TherapeuticsPA - Pittsburgh

18 programs

9vHPV VaccinePhase 3Vaccine

9vHPV vaccinePhase 3Vaccine

+13 more programs

MSDIreland - Ballydine

18 programs

9vHPV VaccinePhase 3Vaccine1 trial

9vHPV vaccinePhase 3Vaccine1 trial

+13 more programs

Active Trials

NCT01355003Terminated1,080Est. Jun 2010

NCT00549250Completed114Est. May 2010

NCT00365716Completed1,158Est. Sep 2009

+15 more trials

2A PharmaSweden - Malmö

1 program

HPV-L2 vaccinePhase 1Vaccine1 trial

Active Trials

NCT03929172Completed20Est. May 2020

Inovio PharmaceuticalsCA - San Diego

1 program

VGX-3100Phase 11 trial

Active Trials

NCT00685412Completed18Est. Mar 2011

Merck & Co.RAHWAY, NJ

3 programs

GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)N/A

Human Papillomavirus 6/11 in the Lower Airway of NeonatesN/A

Quadrivalent Human PapillomavirusPHASE_3

Allergy TherapeuticsUK - West Sussex

2 programs

HPV Infections in Older WomenN/A1 trial

High-Risk HPV Infections in Women Aged 25 to 65N/A1 trial

Active Trials

NCT00743392Completed503Est. May 2011

NCT00461877Completed303Est. Dec 2008

TakedaTOKYO, Japan

2 programs

851BPHASE_21 trial

Active Trials

NCT00312286Terminated538Est. Jun 2008

NCT00117884Terminated240Est. Jun 2008

Autonomous TherapeuticsMD - Rockville

1 program

16S rRNA gene sequencing of cervical secretionsN/A1 trial

Active Trials

NCT04694495Completed7,500Est. Dec 2024

UNION therapeuticsDenmark - Hellerup

1 program

Human PapillomavirusN/A1 trial

Active Trials

NCT03548740Unknown151Est. May 2020

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

2028

2029

MSD9vHPV vaccine

MSD9vHPV Vaccine

MSD9vHPV vaccine

MSD9vHPV Vaccine

MSDV503

MSD9vHPV vaccine

MSDQuadrivalent Human Papillomavirus

MSDV503

MSDV503 Vaccine

MSDQuadrivalent Human Papillomavirus

MSDGardasil™

Showing 15 of 26 trials with date data

Clinical Trials (26)

Total enrollment: 38,918 patients across 26 trials

NCT05450705 MSD9vHPV vaccine

V503 in Chinese Girls 9-14 Years Old Versus Chinese Women 20-26 Years Old (V503-071)

Start: Jul 2022Est. completion: Aug 20291,500 patients

Phase 3Active Not Recruiting

NCT05119855 MSD9vHPV Vaccine

Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)

Start: Mar 2022Est. completion: Dec 2023165 patients

Phase 3Completed

NCT05285826 MSD9vHPV Vaccine

Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052)

Start: Feb 2022Est. completion: May 20298,100 patients

Phase 3Active Not Recruiting

NCT04772534 MSD9vHPV vaccine

Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

Start: May 2021Est. completion: Apr 2024314 patients

Phase 3Completed

NCT04708041 MSD9vHPV vaccine

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

Start: Mar 2021Est. completion: Oct 2029700 patients

Phase 3Active Not Recruiting

NCT04199689 MSD9vHPV Vaccine

Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)

Start: Feb 2020Est. completion: Aug 20286,033 patients

Phase 3Active Not Recruiting

NCT03998254 MSDV503

Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)

Start: Jun 2019Est. completion: Mar 20286,000 patients

Phase 3Active Not Recruiting

NCT03903562 MSDV503

Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024)

Start: Apr 2019Est. completion: Feb 20251,990 patients

Phase 3Completed

NCT03546842 MSD9vHPV vaccine

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)

Start: Jun 2018Est. completion: Jan 2019201 patients

Phase 3Completed

NCT01245764 MSDQuadrivalent Human Papillomavirus

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)

Start: Mar 2011Est. completion: Apr 2013250 patients

Phase 3Completed

NCT01254643 MSDV503

A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).

Start: Jan 2011Est. completion: Aug 2013100 patients

Phase 3Completed

NCT01073293 MSDV503 Vaccine

A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

Start: Apr 2010Est. completion: Jun 20111,054 patients

Phase 3Completed

NCT00496626 MSDQuadrivalent Human Papillomavirus

An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)

Start: Jul 2008Est. completion: Feb 2009600 patients

Phase 3Completed

NCT00380367 MSDQuadrivalent Human Papillomavirus

Safety, Tolerability and Immunogenicity of HPV (Human Papilloma Virus) Vaccine in Healthy Females 9 to 15 Years of Age in India (V501-029)

Start: May 2007Est. completion: Feb 2008110 patients

Phase 3Completed

NCT00157950 MSDGardasil™

Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)

Start: Oct 2005Est. completion: Jun 2006176 patients

Phase 3Completed

NCT00312286 Takeda851B

Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.

Start: Apr 2006Est. completion: Jun 2008538 patients

Phase 2Terminated

NCT00117884 Takeda851B

Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.

Start: Apr 2006Est. completion: Jun 2008240 patients

Phase 2Terminated

NCT00365716 MSDQuadrivalent HPV

Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)

Start: May 2000Est. completion: Sep 20091,158 patients

Phase 2Completed

NCT03929172 2A PharmaHPV-L2 vaccine

A Study of Safety, Tolerability and Immunogenicity of HPV-L2 Vaccine in Healthy Adult Male and Female Subjects

Start: Feb 2019Est. completion: May 202020 patients

Phase 1Completed

NCT00685412 Inovio PharmaceuticalsVGX-3100

Phase I of Human Papillomavirus (HPV) DNA Plasmid (VGX-3100) + Electroporation for CIN 2 or 3

Start: May 2008Est. completion: Mar 201118 patients

Phase 1Completed

NCT04694495 Autonomous Therapeutics16S rRNA gene sequencing of cervical secretions

HPV Infection and Genital Microecology of Childbearing-age Female in China: A Cohort and Multicenter Study

Start: Nov 2020Est. completion: Dec 20247,500 patients

N/ACompleted

NCT03548740 UNION therapeuticsHuman Papillomavirus

Diversity Analysis of Vaginal Microbiota on Women With High-risk Human Papillomavirus Infection

Start: Sep 2018Est. completion: May 2020151 patients

N/AUnknown

NCT00743392 Allergy TherapeuticsHPV Infections in Older Women

HPV Infections in Older Women

Start: Jul 2008Est. completion: May 2011503 patients

N/ACompleted

NCT01355003 MSDGARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

GARDASIL™ Post Marketing Surveillance in the Philippines (V501-077)

Start: Feb 2008Est. completion: Jun 20101,080 patients

N/ATerminated

NCT00549250 MSDHuman Papillomavirus 6/11 in the Lower Airway of Neonates

Human Papillomavirus 6/11 in the Lower Airway of Neonates

Start: Nov 2007Est. completion: May 2010114 patients

N/ACompleted

NCT00461877 Allergy TherapeuticsHigh-Risk HPV Infections in Women Aged 25 to 65

High-Risk HPV Infections in Women Aged 25 to 65

Start: Mar 2007Est. completion: Dec 2008303 patients

N/ACompleted

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

30 late-stage (Phase 3) programs, potential near-term approvals

9 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.