Herpes Simplex

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

Small Molecule

1579%

Vaccine

421%

+ 12 programs with unclassified modality

Competitive Landscape

8 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

ViiV HealthcareNC - Durham

10 programs

valacyclovirPhase 4Small Molecule

GSK208141Phase 3

GSK208141 vaccinePhase 3Vaccine

Herpes simplex candidate vaccine- adjuvanted GSK208141Phase 3Vaccine

VACV tabletsPhase 3

+5 more programs

Allergy TherapeuticsUK - West Sussex

7 programs

ValaciclovirPhase 3Small Molecule1 trial

FialuridinePhase 21 trial

acyclovirPhase 1/2Small Molecule1 trial

ValacyclovirPhase 1Small Molecule1 trial

AcyclovirN/ASmall Molecule1 trial

+2 more programs

Active Trials

NCT00001115Completed75Est. Jun 2005

NCT00138320Terminated6Est. May 2007

NCT00000985Completed26Est. Oct 1990

+4 more trials

SandozAustria - Kundl

2 programs

FamciclovirPhase 3Small Molecule

famciclovirPhase 2Small Molecule

MaruhoJapan - Osaka

2 programs

ASP2151Phase 31 trial

Active Trials

NCT02209324Completed275Est. Aug 2015

NCT01959295Completed468Est. Apr 2015

Kite PharmaCA - El Segundo

2 programs

CidofovirPhase 1Small Molecule

CidofovirN/ASmall Molecule

GSKLONDON, United Kingdom

4 programs

Herpes simplex candidatePHASE_11 trial

ValaciclovirPHASE_1Small Molecule1 trial

GSK208141 vaccinePHASE_3Vaccine1 trial

VACV tabletsPHASE_31 trial

Active Trials

NCT00698893Completed16Est. Jul 1992

NCT00297206Completed36Est. Feb 2007

NCT00224471Completed671Est. Jan 2006

+1 more trials

Gilead SciencesFOSTER CITY, CA

2 programs

CidofovirN/ASmall Molecule1 trial

CidofovirPHASE_1Small Molecule1 trial

Active Trials

NCT00002181Completed

NCT00002116Completed30

NovartisBASEL, Switzerland

2 programs

famciclovirPHASE_2Small Molecule2 trials

FamciclovirPHASE_3Small Molecule1 trial

Active Trials

NCT00448227Completed18

NCT00248144CompletedEst. Jul 2007

NCT00098059Completed74Est. Dec 2007

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Novartisfamciclovir

Allergy TherapeuticsVidarabine

MaruhoASP2151

GSKVACV tablets

NovartisFamciclovir

GSKGSK208141 vaccine

Allergy TherapeuticsValaciclovir

Allergy TherapeuticsFialuridine

Novartisfamciclovir

Allergy Therapeuticsacyclovir

Allergy TherapeuticsValacyclovir

GSKValaciclovir

GSKHerpes simplex candidate

Allergy TherapeuticsAcyclovir

Showing 15 of 16 trials with date data

Clinical Trials (18)

Total enrollment: 2,035 patients across 18 trials

NCT00248144 Novartisfamciclovir

A Study to Evaluate the Safety and Efficacy of Single Day or Single Dose Famciclovir for the Treatment of Recurrent Herpes Labialis

Start: Oct 2003Est. completion: Jul 2007

Phase 4Completed

NCT00000985 Allergy TherapeuticsVidarabine

Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With AIDS Who Have Not Had Success With Acyclovir

Est. completion: Oct 199026 patients

Phase 3Completed

NCT02209324 MaruhoASP2151

Open-label Study of ASP2151 in Herpes Simplex Patients

Start: Nov 2013Est. completion: Aug 2015275 patients

Phase 3Completed

NCT01959295 MaruhoASP2151

Phase III Study of ASP2151 in Herpes Simplex Patients

Start: Aug 2013Est. completion: Apr 2015468 patients

Phase 3Completed

NCT01602562 GSKVACV tablets

Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

Start: May 2012Est. completion: May 201340 patients

Phase 3Completed

NCT00098059 NovartisFamciclovir

Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Start: Feb 2005Est. completion: Dec 200774 patients

Phase 3Completed

NCT00224471 GSKGSK208141 vaccine

Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine

Start: Dec 2003Est. completion: Jan 2006671 patients

Phase 3Completed

NCT00001649 Allergy TherapeuticsValaciclovir

Valaciclovir to Prevent Transmission of Herpes Simplex Virus

Start: Aug 1997Est. completion: Aug 2003180 patients

Phase 3Completed

NCT00000654 Allergy TherapeuticsFialuridine

The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU

Est. completion: Feb 199378 patients

Phase 2Completed

NCT00448227 Novartisfamciclovir

Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Start: Oct 200718 patients

Phase 2Completed

NCT00004644 Allergy Therapeuticsacyclovir

Phase I/II Study of High-Dose Acyclovir for Central Nervous System or Disseminated Neonatal Herpes Simplex Virus Infection

Start: Feb 199525 patients

Phase 1/2Completed

NCT00002116 Gilead SciencesCidofovir

A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

30 patients

Phase 1Completed

NCT05468619 Allergy TherapeuticsValacyclovir

Neonatal Phase 1 Valacyclovir Study

Start: Aug 2023Est. completion: Jul 202517 patients

Phase 1Completed

NCT00297206 GSKValaciclovir

A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Start: Jan 2003Est. completion: Feb 200736 patients

Phase 1Completed

NCT00698893 GSKHerpes simplex candidate

Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

Start: May 1992Est. completion: Jul 199216 patients

Phase 1Completed

NCT00002181 Gilead SciencesCidofovir

Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

N/ACompleted

NCT00001115 Allergy TherapeuticsAcyclovir

The Effect of Acyclovir Treatment of the Herpes Simplex Virus (HSV) Infection on HIV Levels in the Blood

Est. completion: Jun 200575 patients

N/ACompleted

NCT00138320 Allergy TherapeuticsHerpevac Neonatal Substudy

Herpevac Neonatal Substudy

Start: Aug 2005Est. completion: May 20076 patients

N/ATerminated

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

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

Small Molecule is the dominant modality (79% of programs)

8 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.