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Home › Conditions › Herpes Simplex

Herpes Simplex

Part of Herpesviridae Infections

4 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Herpes Simplex

14 trials tracked for Herpes Simplex: 8 in phase 3 or 4 and 1 with published results. The most-cited published study has 19 citations.

14Trials tracked
8Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 3 8 Phase 2 2 Phase 1 2 Other / NA 2
  1. Phase 3 Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old Completed · 19 cited
  2. Phase 3 Open-label Study of ASP2151 in Herpes Simplex Patients Completed
  3. Phase 3 Phase III Study of ASP2151 in Herpes Simplex Patients Completed
  4. Phase 3 Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients Completed
  5. Phase 3 Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection Completed
  6. Phase 3 Acyclovir for Herpes Infections Involving the Central Nervous System in Neonates Completed
Show 8 more trials
  1. Phase 3 Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia Completed
  2. Phase 3 Acyclovir Herpes Simplex Virus (HSV) Skin, Eye, and Mouth Completed
  3. Phase 2 HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding Completed
  4. Phase 2 Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection Completed
  5. Phase 1 A Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants (PTN_Acyclo) Completed
  6. Phase 1 A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years Completed
  7. N/A Identification of Herpes Simplex Virus (HSV) Shedding in the Female Genital Tract of Pregnant and Nonpregnant Women by GeneXpert PCR, Routine PCR, and Culture Completed
  8. N/A Clinical Evaluation of the Sentosa SA HSV1/2 Qualitative PCR Test Completed

Showing the 14 most-cited and recently-updated of 14 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Herpes Simplex: what the trials found

Several trials evaluated the safety and efficacy of various antiviral treatments for herpes simplex virus (HSV) infections. Acyclovir was assessed in multiple studies, including investigations into neurologic impairment at 12 months as measured by Bayley's Neuro-developmental Assessment [6, 7] and in a Phase 1 study 12. Other established interventions included famciclovir [8, 10], the experimental agent ASP2151 [2, 3], and GSK208141 1.

Clinical outcomes for these treatments varied. In studies involving Acyclovir, motor and mental scores were recorded at 12 months [6, 7], and cutaneous recurrence rates were monitored 7. For ASP2151, the percentage of participants with healing by day 8 was reported as 66.4% and 69.5% (p=0.5086) in one cohort 2, while a different study reported a value of 194 3. Additionally, VACV tablets or granules were evaluated for changes in blood pressure and heart rate over a 35-day period 4.

Recent results — preliminary, needs further review

  • valacyclovir showed a mean change in HIV-1 levels in plasma between 34 and 38 weeks gestation of -0.53 and 0.03 9. HSVTI Formulation 1 was evaluated for the seropositivity rate of anti-HSVTI antibodies, showing rates ranging from 20.0% to 100% 11. Genexpert assay demonstrated a positive percent agreement of 80% and a negative percent agreement of 99.2% for detecting HSV DNA in the genital tract of pregnant women compared to routine PCR 13. A Vela Sentosa SA HSV1/2 Qualitative PCR Test was evaluated in a large cohort 14.

For the clinician treating this condition

  • Acyclovir and famciclovir are established interventions for managing HSV-related conditions, with Acyclovir specifically studied regarding neurodevelopmental outcomes and cutaneous recurrence [6, 7, 8, 10].
  • ASP2151 was evaluated for healing rates by day 8, though results showed no statistically significant difference between groups (p=0.5086) in the primary study reported 2.

AI synthesis of 10 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
TORCH seroprevalence 32.5% in Malaysia; CMV highest, screening urged
Pediatrics Meta-analysis
TORCH seroprevalence 32.5% in Malaysia; CMV highest, screening urged TORCH infections found in 32.5% of Malaysian pregnant women and infants
This meta-analysis of 19 reports estimates a 32.5% overall seroprevalence of TORCH infections among pregnant women and infants in Malaysia, …
A meta-analysis finds 32.5% of pregnant women and infants in Malaysia have been exposed to TORCH infections, with CMV most common.
Aug 24, 2026
Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital
Pediatrics Cohort
Acyclovir treatment for HSV in febrile hospitalized children at Jinan Children's Hospital The hidden troublemaker
This retrospective cohort study evaluated 100 febrile hospitalized children at Jinan Children's Hospital.
Finding a second germ alongside Herpes Simplex Virus in sick children explains why some stay hospitalized longer than expected.
Frontiers Apr 16, 2026
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir
Infectious Disease Meta-analysis
Meta-analysis finds topical propolis/honey associated with faster herpes lesion resolution than acyclovir Topical propolis and honey may help heal herpes lesions faster than acyclovir cream
A meta-analysis of 7 studies compared topical propolis and/or honey to 5% topical acyclovir for labial and genital herpes lesions.
Using natural propolis or honey on herpes sores healed lesions nearly two days faster and cut pain compared to standard acyclovir cream.
Apr 6, 2026
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing
Pediatrics Meta-analysis
Global neonatal HSV incidence 8.2 per 100k births, rising 3.5% annually; nHSV-1 proportion increasing A dangerous virus is affecting more newborns worldwide, with cases rising each year
A systematic review and meta-analysis found the global pooled incidence of neonatal herpes simplex virus (nHSV) is 8.2 per 100,000 live birt…
A dangerous newborn infection is rising worldwide, with cases increasing by 3.5% each year and highest rates now seen in the Americas.
Mar 30, 2026

Research across Herpesviridae Infections

Related studies from across the Herpesviridae Infections family.

FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms
Dermatology FDA Approval
FDA Approves Abreva () for cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms The FDA has approved a new non-prescription drug called Abreva for treating cold sores
The FDA approved Abreva for treating cold sores/fever blisters on the face or lips to shorten healing time and duration of symptoms such as …
FDA approves new over-the-counter drug Abreva to shorten cold sore healing time and ease painful symptoms like tingling and itching.
FDA Apr 17, 2026

Questions about Herpes Simplex

What is the incidence of neonatal Herpes Simplex in newborns worldwide?

The global incidence of neonatal herpes simplex virus (nHSV) is approximately 8.2 cases per 100,000 live births.

Full answer →