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Genital Herpes

11
Pipeline Programs
15
Companies
13
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
2
0
2
5
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1091%
RNA Therapeutic
19%
+ 9 programs with unclassified modality

Competitive Landscape

14 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
3 programs
2
valacyclovirPhase 4Small Molecule
valacyclovirPhase 4Small Molecule
Valaciclovir Hydrochloride.N/A
Sandoz
SandozAustria - Kundl
3 programs
1
2
FamciclovirPhase 4Small Molecule1 trial
FamciclovirPhase 4Small Molecule1 trial
FamciclovirPhase 3Small Molecule1 trial
Active Trials
NCT00306787Completed1,179Est. Feb 2008
NCT00477334Completed463Est. Mar 2009
NCT00129818CompletedEst. Oct 2005
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
1
acyclovirPhase 4Small Molecule1 trial
Active Trials
NCT00495716Terminated72Est. Jun 2010
EMS
EMSBrazil - Hortolândia
1 program
1
FamciclovirPhase 3Small Molecule1 trial
Active Trials
NCT01281007Completed150Est. Mar 2015
Medpace
MedpaceCINCINNATI, OH
1 program
1
AIC316Phase 21 trial
Active Trials
NCT01658826Terminated91Est. Jul 2013
United BioPharma
United BioPharmaTaiwan - Hsinchu
1 program
1
UB-621Phase 21 trial
Active Trials
NCT03595995Unknown80Est. Jun 2024
Agenus
AgenusMA - Lexington
1 program
1
AG-707Phase 11 trial
Active Trials
NCT00231049Completed35
Design Pharmaceuticals
1 program
1
HSV 2 Formulation 1Phase 1
GSK
GSKLONDON, United Kingdom
3 programs
Valaciclovir Hydrochloride.N/A1 trial
valacyclovirPHASE_4Small Molecule1 trial
valacyclovirPHASE_4Small Molecule1 trial
Active Trials
NCT01390805Completed462Est. Mar 2011
NCT00527618Completed28Est. Mar 2011
NCT01346475Completed50Est. Sep 2011
Design Therapeutics
1 program
HSV 2 Formulation 1PHASE_11 trial
Active Trials
NCT04222985Terminated24Est. May 2021
Sanofi
SanofiPARIS, France
1 program
HSV 2 Formulation 1PHASE_1
Merck & Co.
Merck & Co.RAHWAY, NJ
1 program
HSV 2 Formulation 1PHASE_1
Moderna
ModernaCAMBRIDGE, MA
1 program
mRNA-1608PHASE_1_2RNA Therapeutic1 trial
Active Trials
NCT06033261Completed365Est. Apr 2025
Novartis
NovartisBASEL, Switzerland
1 program
FamciclovirPHASE_4Small Molecule

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKvalacyclovir
Allergy Therapeuticsacyclovir
GSKvalacyclovir
SandozFamciclovir
SandozFamciclovir
EMSFamciclovir
SandozFamciclovir
United BioPharmaUB-621
MedpaceAIC316
ModernamRNA-1608
Design TherapeuticsHSV 2 Formulation 1
AgenusAG-707
GSKValaciclovir Hydrochloride.

Clinical Trials (13)

Total enrollment: 2,999 patients across 13 trials

NCT01346475GSKvalacyclovir

Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Start: Nov 2008Est. completion: Sep 201150 patients
Phase 4Completed
NCT00495716Allergy Therapeuticsacyclovir

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Start: Jan 2008Est. completion: Jun 201072 patients
Phase 4Terminated
NCT00527618GSKvalacyclovir

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Start: Dec 2007Est. completion: Mar 201128 patients
Phase 4Completed
NCT00477334SandozFamciclovir

Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

Start: Jun 2007Est. completion: Mar 2009463 patients
Phase 4Completed
NCT00129818SandozFamciclovir

A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Start: Jul 2004Est. completion: Oct 2005
Phase 4Completed
NCT01281007EMSFamciclovir

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Start: Jul 2012Est. completion: Mar 2015150 patients
Phase 3Completed
NCT00306787SandozFamciclovir

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

Start: Mar 2006Est. completion: Feb 20081,179 patients
Phase 3Completed
NCT03595995United BioPharmaUB-621

A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621

Start: Jun 2023Est. completion: Jun 202480 patients
Phase 2Unknown
NCT01658826MedpaceAIC316

Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes

Start: Oct 2012Est. completion: Jul 201391 patients
Phase 2Terminated
NCT06033261ModernamRNA-1608

A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

Start: Sep 2023Est. completion: Apr 2025365 patients
Phase 1/2Completed
NCT04222985Design TherapeuticsHSV 2 Formulation 1

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

Start: Feb 2020Est. completion: May 202124 patients
Phase 1Terminated
NCT00231049AgenusAG-707

Trial Evaluating Safety, Tolerability and Immune Response of AG-707

Start: Mar 200635 patients
Phase 1Completed
NCT01390805GSKValaciclovir Hydrochloride.

Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Start: Nov 2006Est. completion: Mar 2011462 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

2 late-stage (Phase 3) programs, potential near-term approvals
Small Molecule is the dominant modality (91% of programs)
15 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.