Cervical Intraepithelial Neoplasia

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

1083%

Monoclonal Antibody

217%

+ 31 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

InnovaxChina - Haicang District

10 programs

Recombinant Human Papillomavirus BivalentPhase 41 trial

3 doses of HPV 16/18 bivalent vaccinePhase 3Vaccine1 trial

HPV VaccinePhase 3Vaccine1 trial

Nonavalent HPV vaccinePhase 3Vaccine1 trial

30μg HPVPhase 21 trial

+5 more programs

Active Trials

NCT03206255Completed940Est. Aug 2018

NCT04969445Unknown647Est. Jan 2024

NCT06243666Active Not Recruiting2,188Est. Dec 2026

+7 more trials

ViiV HealthcareNC - Durham

6 programs

HPVPhase 41 trial

GSK Biologicals' HPV-16/18 VaccinePhase 3Vaccine1 trial

HPV9 High formulationPhase 1/21 trial

Safety data collectionN/A1 trial

cisplatinN/A1 trial

+1 more programs

Active Trials

NCT03438006Completed3,016Est. Dec 2020

NCT01345279Completed1Est. Jul 2009

NCT01160185Completed1Est. Jul 2009

+3 more trials

Enterprise TherapeuticsUK - Brighton

8 programs

3 doses of HPV 16/18 bivalent vaccinePhase 3Vaccine

HPV VaccinePhase 3Vaccine

Nonavalent HPV vaccinePhase 3Vaccine

30μg HPVPhase 2

3 doses of HPV 16/18 bivalent vaccineN/AVaccine

+3 more programs

MSDIreland - Ballydine

2 programs

PembrolizumabPhase 2Monoclonal Antibody

GardasilPhase 1

Sharp TherapeuticsPA - Pittsburgh

2 programs

PembrolizumabPhase 2Monoclonal Antibody

GardasilPhase 1

GenexineKorea - Seoul

2 programs

GX-188EPhase 21 trial

Active Trials

NCT02596243Unknown134Est. Aug 2018

NCT02139267Completed72Est. Mar 2016

BiocorpFrance - Issoire

1 program

Aminolaevulinic acidPhase 21 trial

Active Trials

NCT02631863Completed60Est. Nov 2018

Prevail TherapeuticsNY - New York

1 program

PemetrexedPhase 21 trial

Active Trials

NCT00190983Completed29Est. Oct 2007

Inovio PharmaceuticalsCA - San Diego

1 program

VGX 3100Phase 21 trial

Active Trials

NCT01304524Completed167Est. Apr 2015

Antiva BiosciencesCA - Redwood City

1 program

ABI-2280 Vaginal Tablet/InsertPhase 1/21 trial

Active Trials

NCT05502367Terminated44Est. Oct 2025

GSKLONDON, United Kingdom

6 programs

Safety data collectionN/A

cisplatinN/A

paclitaxelN/A

HPV9 High formulationPHASE_1_2

GSK Biologicals' HPV-16/18 VaccinePHASE_3Vaccine

+1 more programs

City TherapeuticsMA - Cambridge

1 program

Recombinant Human Papillomavirus BivalentN/A

Eli Lilly and CompanyINDIANAPOLIS, IN

1 program

PemetrexedPHASE_2

Biotest PharmaceuticalsGermany - Dreieich

1 program

SOR007PHASE_21 trial

Active Trials

NCT03143491Withdrawn0Est. Mar 2019

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

2027

InnovaxRecombinant Human Papillomavirus Bivalent

ViiV HealthcareHPV

InnovaxNonavalent HPV vaccine

Innovax3 doses of HPV 16/18 bivalent vaccine

InnovaxHPV Vaccine

ViiV HealthcareGSK Biologicals' HPV-16/18 Vaccine

Biotest PharmaceuticalsSOR007

BiocorpAminolaevulinic acid

GenexineGX-188E

Inovio PharmaceuticalsVGX 3100

Innovax30μg HPV

Prevail TherapeuticsPemetrexed

Antiva BiosciencesABI-2280 Vaginal Tablet/Insert

ViiV HealthcareHPV9 High formulation

Showing 15 of 23 trials with date data

Clinical Trials (23)

Total enrollment: 37,811 patients across 23 trials

NCT05426148 InnovaxRecombinant Human Papillomavirus Bivalent

Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female

Start: May 2020Est. completion: Apr 2021540 patients

Phase 4Completed

NCT03629886 ViiV HealthcareHPV

Safety and Protective Effect Study of GSK Biologicals' Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed (GSK580299) in Healthy Female Subjects From the HPV-039 Study

Start: Aug 2018Est. completion: Feb 20206,051 patients

Phase 4Completed

NCT04537156 InnovaxNonavalent HPV vaccine

Efficacy, Immunogenicity and Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Start: Sep 2020Est. completion: Dec 20279,327 patients

Phase 3Active Not Recruiting

NCT02562508 Innovax3 doses of HPV 16/18 bivalent vaccine

A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Start: Dec 2015Est. completion: Aug 2016979 patients

Phase 3Completed

NCT01735006 InnovaxHPV Vaccine

Efficacy and Immunogenicity Study of Recombinant Human Papillomavirus Bivalent（Type 16/18 ）Vaccine

Start: Nov 2012Est. completion: Oct 20197,372 patients

Phase 3Completed

NCT00316706 ViiV HealthcareGSK Biologicals' HPV-16/18 Vaccine

Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine

Start: Oct 2005Est. completion: Jan 20091,245 patients

Phase 3Completed

NCT03143491 Biotest PharmaceuticalsSOR007

Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)

Start: Oct 2017Est. completion: Mar 20190

Phase 2Withdrawn

NCT02631863 BiocorpAminolaevulinic acid

Aminolaevulinic Acid Photodynamic Therapy for HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)

Start: Mar 2016Est. completion: Nov 201860 patients

Phase 2Completed

NCT02596243 GenexineGX-188E

Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Plasmid DNA Therapeutic Vaccine(GX-188E)

Start: Aug 2015Est. completion: Aug 2018134 patients

Phase 2Unknown

NCT02139267 GenexineGX-188E

Dose-finding, Safety Study of Plasmid DNA Therapeutic Vaccine to Treat Cervical Intraepithelial Neoplasia

Start: Jul 2014Est. completion: Mar 201672 patients

Phase 2Completed

NCT01304524 Inovio PharmaceuticalsVGX 3100

A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3

Start: Apr 2011Est. completion: Apr 2015167 patients

Phase 2Completed

NCT01356823 Innovax30μg HPV

Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Start: Mar 2011Est. completion: Oct 20131,600 patients

Phase 2Completed

NCT00190983 Prevail TherapeuticsPemetrexed

A Trial for Patients With Advanced/Recurrent Cervical Cancer

Start: Feb 2005Est. completion: Oct 200729 patients

Phase 2Completed

NCT05502367 Antiva BiosciencesABI-2280 Vaginal Tablet/Insert

A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia

Start: Sep 2022Est. completion: Oct 202544 patients

Phase 1/2Terminated

NCT05496231 ViiV HealthcareHPV9 High formulation

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

Start: Aug 2022Est. completion: Feb 20241,080 patients

Phase 1/2Completed

NCT06243666 InnovaxRecombinant Human Papillomavirus Bivalent

Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls

Start: Feb 2024Est. completion: Dec 20262,188 patients

N/AActive Not Recruiting

NCT05045755 InnovaxRecombinant Human Papillomavirus Bivalent

The Durability of Protection and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

Start: Apr 2021Est. completion: Jan 20241,339 patients

N/AUnknown

NCT04969445 InnovaxRecombinant Human Papillomavirus Bivalent

The Durability of Protection Study of a Recombinant HPV 16/18 Bivalent Vaccine in Female

Start: Mar 2021Est. completion: Jan 2024647 patients

N/AUnknown

NCT04704908 InnovaxRecombinant Human Papillomavirus Bivalent

Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)

Start: Feb 2021Est. completion: Dec 2023979 patients

N/AUnknown

NCT03438006 ViiV HealthcareSafety data collection

A Post Marketing Surveillance (PMS) Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Female Chinese Subjects

Start: May 2018Est. completion: Dec 20203,016 patients

N/ACompleted

NCT03206255 Innovax3 doses of HPV 16/18 bivalent vaccine

Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Start: Jul 2017Est. completion: Aug 2018940 patients

N/ACompleted

NCT01160185 ViiV Healthcarepaclitaxel

Meta-analysis of Efficacy of Topotecan

Start: Jun 2009Est. completion: Jul 20091 patients

N/ACompleted

NCT01345279 ViiV Healthcarecisplatin

Indirect Comparison Topotecan Cervical Carcinoma

Start: Jun 2009Est. completion: Jul 20091 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

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

14 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.