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Herpes Labialis

11
Pipeline Programs
10
Companies
17
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
1
5
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
4100%
+ 14 programs with unclassified modality

Competitive Landscape

10 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
4 programs
2
1
1
valacyclovirPhase 4Small Molecule
valacyclovir+clobetasol gelPhase 2
Acyclovir patchPhase 1
New formulationPhase 1
Medivir
MedivirSweden - Huddinge
4 programs
1
3
ME-609Phase 31 trial
ME-609Phase 31 trial
ME-609Phase 31 trial
ME-609Phase 21 trial
Active Trials
NCT00736437Completed417Est. Aug 2000
NCT00735761Completed201Est. Sep 2007
NCT00375570Completed254Est. Sep 2007
+1 more trials
EMS
EMSBrazil - Hortolândia
1 program
1
Acyclovir 50mg/gPhase 31 trial
Active Trials
NCT01257074Completed76Est. Oct 2012
Valerio Therapeutics
Valerio TherapeuticsFrance - Paris
1 program
1
Acyclovir LauriadPhase 31 trial
Active Trials
NCT00769314Completed1,727Est. Aug 2009
Sandoz
SandozAustria - Kundl
1 program
1
FamciclovirPhase 2/3Small Molecule1 trial
Active Trials
NCT00878072Completed53Est. Jun 2010
GSK
GSKLONDON, United Kingdom
3 programs
New formulationPHASE_11 trial
valacyclovir+clobetasol gelPHASE_21 trial
valacyclovirPHASE_4Small Molecule1 trial
Active Trials
NCT00711776Completed27Est. Aug 2008
NCT00297011Completed300Est. Jan 2008
NCT00306293Completed70Est. Nov 2006
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
onabotulinumtoxinAN/A1 trial
Active Trials
NCT01225341Terminated20Est. Jun 2012
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
GlutaminePHASE_24 trials
Active Trials
NCT04019769Withdrawn0Est. Jan 2021
NCT00913692Terminated11Est. Dec 2011
NCT00133562Withdrawn108Est. May 2006
+1 more trials
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
HDIT101PHASE_22 trials
Active Trials
NCT04539483Terminated761Est. May 2023
NCT04165122Completed122Est. Nov 2021
Novartis
NovartisBASEL, Switzerland
1 program
FamciclovirPHASE_2_3Small Molecule

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKvalacyclovir
EMSAcyclovir 50mg/g
Valerio TherapeuticsAcyclovir Lauriad
MedivirME-609
MedivirME-609
MedivirME-609
Allergy TherapeuticsGlutamine
Allergy TherapeuticsGlutamine
SandozFamciclovir
Heidelberg PharmaHDIT101
Heidelberg PharmaHDIT101
Allergy TherapeuticsGlutamine
GSKvalacyclovir+clobetasol gel
MedivirME-609
Allergy TherapeuticsGlutamine

Showing 15 of 17 trials with date data

Clinical Trials (17)

Total enrollment: 5,698 patients across 17 trials

NCT00306293GSKvalacyclovir

VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2

Start: Feb 2006Est. completion: Nov 200670 patients
Phase 4Completed
NCT01257074EMSAcyclovir 50mg/g

Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

Start: Feb 2012Est. completion: Oct 201276 patients
Phase 3Completed
NCT00769314Valerio TherapeuticsAcyclovir Lauriad

Phase 3 Clinical Study for the Treatment of Cold Sore

Start: May 2007Est. completion: Aug 20091,727 patients
Phase 3Completed
NCT00735761MedivirME-609

Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis in Immunocompromised Patients

Start: Dec 2006Est. completion: Sep 2007201 patients
Phase 3Completed
NCT00375570MedivirME-609

Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents

Start: Oct 2006Est. completion: Sep 2007254 patients
Phase 3Completed
NCT00361881MedivirME-609

Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

Start: Jul 2006Est. completion: Dec 20071,443 patients
Phase 3Completed
NCT00338221Allergy TherapeuticsGlutamine

Clinical Trial of Alanyl-Glutamine or Glycine in Children With Persistent Diarrhea or Malnutrition

Start: Aug 2004Est. completion: Apr 2005108 patients
Phase 3Withdrawn
NCT00133562Allergy TherapeuticsGlutamine

HIAS II - Study of Nutritional Supplementation in Hospitalized Children With Persistent Diarrhea or Malnutrition

Start: Aug 2004Est. completion: May 2006108 patients
Phase 3Withdrawn
NCT00878072SandozFamciclovir

Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

Start: Mar 2009Est. completion: Jun 201053 patients
Phase 2/3Completed
NCT04539483Heidelberg PharmaHDIT101

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 1 Infection

Start: Oct 2020Est. completion: May 2023761 patients
Phase 2Terminated
NCT04165122Heidelberg PharmaHDIT101

Monoclonal Antibody Therapy Against Chronic Herpes Simplex Virus 2 Infection

Start: Nov 2019Est. completion: Nov 2021122 patients
Phase 2Completed
NCT00913692Allergy TherapeuticsGlutamine

A Randomized Double-Blind Control-Comparison Crossover Trial of Oral Glutamine to Suppress Frequently Recurrent Herpes Labialis

Start: Jun 2009Est. completion: Dec 201111 patients
Phase 2Terminated
NCT00297011GSKvalacyclovir+clobetasol gel

Valacyclovir+Temovate Gel for the Treatment of Herpes Labialis

Start: Sep 2004Est. completion: Jan 2008300 patients
Phase 2Completed
NCT00736437MedivirME-609

Efficacy of Acyclovir in Combination With a Glucocorticosteroid on UV-Induced Herpes Labialis

Start: Aug 1999Est. completion: Aug 2000417 patients
Phase 2Completed
NCT04019769Allergy TherapeuticsGlutamine

Glutamine Supplementation in People With Immune Dysregulation

Start: Mar 2020Est. completion: Jan 20210
Phase 1Withdrawn
NCT00711776GSKNew formulation

Bioequivalence Study of Aciclovir 5% Cream in Japanese Healthy Volunteers

Start: Apr 2008Est. completion: Aug 200827 patients
Phase 1Completed
NCT01225341AbbVieonabotulinumtoxinA

Botulinum Toxin A for Herpes Labialis

Start: Aug 2010Est. completion: Jun 201220 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

5 late-stage (Phase 3) programs, potential near-term approvals
10 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.