CLINICAL TRIALS PROFILE FOR VALACYCLOVIR HYDROCHLORIDE

505(b)(2) Clinical Trials for Valacyclovir Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01689285 ↗	Bioequivalence Study in Healthy Volunteers of a New Paediatric Formulation of Valacyclovir	Completed	Radboud University	Phase 1	2013-12-01	A new paediatric formulation (oral liquid) has been developed for flexible and accurate dosing of valacyclovir in children. To establish the bioavailability of this new formulation, healthy volunteers will be exposed to the new formulation and to valacyclovir tablets. The concentration of valacyclovir in their blood after exposure to the oral liquid will be measured and compared to the tablet.

All Clinical Trials for Valacyclovir Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001038 ↗	A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 3	1969-12-31	PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
NCT00001038 ↗	A Study of Valacyclovir Hydrochloride in the Prevention of Life-Threatening Cytomegalovirus Disease in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival. SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV. Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.
NCT00001054 ↗	The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children	Withdrawn	Glaxo Wellcome	Phase 1	1969-12-31	To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ). Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
NCT00001054 ↗	The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children	Withdrawn	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ). Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
NCT00002000 ↗	A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients	Completed	Glaxo Wellcome	N/A	1969-12-31	To evaluate the safety and efficacy of oral valacyclovir hydrochloride (256U87) vs. acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients (CD4 greater than or equal to 100).
NCT00002084 ↗	A Comparative Trial of Valacyclovir Hydrochloride ( 256U87 ) and Acyclovir for the Suppression of Anogenital Herpes Infections in HIV-Infected Patients	Completed	Glaxo Wellcome	N/A	1969-12-31	To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or > 100 cells/mm3.

Clinical Trial Conditions for Valacyclovir Hydrochloride

Condition Name

Condition Name for Valacyclovir Hydrochloride
Intervention	Trials
Herpes Simplex	13
HIV Infections	13
Herpes Zoster	11
Healthy	9

Condition MeSH

Condition MeSH for Valacyclovir Hydrochloride
Intervention	Trials
Herpes Simplex	31
Infection	20
Infections	19
HIV Infections	18

Clinical Trial Locations for Valacyclovir Hydrochloride

Trials by Country

Trials by Country for Valacyclovir Hydrochloride
Location	Trials
United States	304
Canada	28
India	5
United Kingdom	4
Taiwan	4

Trials by US State

Trials by US State for Valacyclovir Hydrochloride
Location	Trials
Texas	37
California	17
Washington	14
Maryland	13
Pennsylvania	13

Clinical Trial Progress for Valacyclovir Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Valacyclovir Hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Valacyclovir Hydrochloride
Clinical Trial Phase	Trials
Completed	75
Recruiting	19
Not yet recruiting	9

Clinical Trial Sponsors for Valacyclovir Hydrochloride

Sponsor Name

Sponsor Name for Valacyclovir Hydrochloride
Sponsor	Trials
GlaxoSmithKline	11
M.D. Anderson Cancer Center	11
University of Washington	10

Sponsor Type

Sponsor Type for Valacyclovir Hydrochloride
Sponsor	Trials
Other	143
Industry	76
NIH	17

Last updated: April 27, 2026

Valacyclovir Hydrochloride: Clinical-Trials Update, Market Analysis, and Forecast

What is the current clinical-trials and evidence landscape for valacyclovir hydrochloride?

Valacyclovir hydrochloride is an orally administered prodrug of acyclovir used in virology indications including herpes simplex virus (HSV) and varicella-zoster virus (VZV). The current “clinical trials” picture for valacyclovir is largely dominated by post-approval studies rather than novel mechanism development. Most active or recent trial activity is concentrated in:

• Indication refinements (dose timing, treatment duration, and patient-subgroup outcomes)
• Comparative or supportive studies (health outcomes, tolerability, and adherence)
• Safety and effectiveness in specific populations (e.g., renal impairment settings, immunocompromised cohorts)

Publicly tracked registries do not consistently show a large pipeline of pivotal, first-in-class programs for valacyclovir because the drug is established and widely genericized. The commercial opportunity therefore depends more on endpoint optimization, guideline alignment, and market access than on breakthrough efficacy claims.

Clinical development pattern (typical for an established small molecule):

• Earlier lifecycle: label expansion and comparator trials
• Mid-to-late lifecycle: supportive pharmacokinetic, adherence, and real-world outcome studies
• Maturity: reduced probability of new mechanism-changing efficacy differentiation

Operational takeaway: The value of new studies is mostly in payer and guideline positioning (duration, regimen simplification, and outcomes in high-need subgroups) rather than in creating a new patent-protected “next drug.”

What does the market for valacyclovir look like and how is it segmented?

Valacyclovir is used across three principal commercial demand centers:

1. Herpes simplex infections (HSV)
   • Episodic treatment (cold sores)
   • Suppressive therapy to reduce recurrence and transmission
2. Genital herpes (HSV-2)
   • Episodic and chronic suppressive use
3. Herpes zoster and related VZV infections (shingles)
   • Treatment to reduce duration/severity, particularly early after rash onset

Market structure

• High volume, low unit differentiation: A well-known branded origin product competes against multiple generics.
• Price compression: As patents expire and generics enter, pricing converges quickly.
• Channel dependence: Primary care and urgent care prescribing drives short-cycle demand for episodic therapy; long-term suppressive therapy is influenced by primary care follow-up and guideline adoption.

Segmentation by use pattern

• Episodic treatment demand tracks with acute presentation of symptoms (seasonality and healthcare access influence volumes).
• Suppressive therapy demand is more stable but still exposed to payer controls and generic penetration.

How do guidelines and payer dynamics typically affect demand for valacyclovir?

Valacyclovir prescribing is strongly shaped by clinical guideline recommendations and payer formularies because its differentiator is not novelty but administration convenience (oral dosing with known efficacy) relative to alternatives.

Key dynamics that influence demand:

• Early initiation requirement: Clinical benefit is time-dependent, affecting real-world outcomes and prescriber behavior.
• Renal dosing management: Safety depends on correct dose adjustment in renal impairment; this can both limit overuse and create monitoring-driven adherence opportunities.
• Formulary placement: Generics generally secure broad formulary status, but utilization management can still shape which dose regimens are preferred.

Commercial implication: Forecasts should model demand at the regimen level (episodic vs suppressive; HSV vs VZV) and apply substitution and payer rules as generics expand.

What are the major growth and risk factors for market projection?

Given valacyclovir’s maturity and genericized competition, the market outlook hinges on volume elasticity and substitution rather than patent-driven protection.

Growth drivers

• Rising diagnosis and healthcare utilization for HSV and shingles
• Persisting preventive intent via suppressive regimens (where clinically indicated)
• Inclusion in clinical pathways that standardize dosing and early treatment

Downside risks

• Generic price erosion: Ongoing reductions limit revenue even if volumes hold
• Shingles vaccine substitution: Uptake of VZV vaccines can reduce incident shingles requiring antiviral therapy, even as population age grows
• Safety-driven prescribing caution in renal impairment settings
• Competitive substitution to other antivirals for HSV or VZV depending on local formulary preferences

Market projection framework for valacyclovir (how to translate trial and utilization trends into revenue outlook)

For an established generic-dominant antiviral, market projection should be built on three layers:

1. Diagnosed prevalence and treatment rates
   • HSV episodic and suppressive uptake
   • VZV incidence and time-to-therapy compliance
2. Regimen mix
   • Daily suppressive dose vs episodic course dosing
   • Dose frequency changes and adherence effects
3. Net pricing
   • Generic AWP-to-NET compression
   • Contracting cycles in hospital and payer channels

Projection logic used in institutional forecasting (applied to valacyclovir):

• Assume volume stability or modest growth tied to population aging and diagnostic rates
• Assume revenue growth lags volume due to pricing compression
• Apply shingles vaccine uptake as a partial offset to VZV treatment volumes
• Monitor renally adjusted dosing and tolerability as drivers of utilization persistence

How does a clinical-trials update translate to business decisions?

Because new trials for mature valacyclovir tend to be supportive rather than transformative, the decision-use of a trials update is practical:

• Regimen validation: Do studies support simplified dosing or improved outcomes that can be reflected in payer policies or guideline updates?
• Population focus: Are there signals in subgroups that payers treat differently (renal impairment, immunocompromised patients, adherence barriers)?
• Endpoint durability: Do trials strengthen specific endpoints relevant to coverage decisions (time to lesion healing, symptom resolution, recurrence reduction, or transmission risk metrics)?

Business implication: In valacyclovir, the biggest return usually comes from utilization capture (preferred regimen selection, guideline alignment, and formulary persistence) more than from claims that require new clinical differentiation.

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Key Market Snapshot: Valacyclovir Hydrochloride (high-level)

Dimension	Current commercial reality	What it means for projections
Competitive landscape	Generic-dominant	Pricing pressure drives revenue risk
Clinical positioning	Established efficacy and known safety	Trials influence regimen/payer policy more than differentiation
Indication breadth	HSV episodic, suppressive HSV, VZV shingles treatment	Forecast should be built by indication and regimen mix
Demand variability	Episodic demand tied to acute care access	Utilization management and diagnostic rates matter

(No additional quantified market size, unit volumes, or revenue forecasts are provided here because they require registry-by-registry trial extraction and market databases that are not supplied in this prompt.)

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Key Takeaways

• Valacyclovir’s clinical development is primarily supportive and label-adjacent, with limited evidence of a large, mechanism-changing pipeline typical of newer antivirals.
• Market performance depends more on diagnosis, regimen mix (episodic vs suppressive), and net pricing than on breakthrough clinical differentiation.
• Shingles vaccine uptake can dampen VZV antiviral treatment volumes even as age-related incidence rises.
• For forecasting and R&D prioritization, focus on utilization capture: dosing simplification, early treatment pathways, and subgroup outcomes that affect payer and prescriber behavior.

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FAQs

1) Is valacyclovir hydrochloride still seeing meaningful clinical-trial activity?

Yes, but it is mostly post-approval and supportive (optimization, safety, and population-specific studies) rather than a large pipeline of pivotal novelty.

2) What indications drive most real-world use?

HSV episodic and suppressive therapy and VZV (shingles) treatment are the primary commercial demand centers.

3) How does the shingles vaccine affect valacyclovir demand?

Higher vaccine uptake can reduce shingles incidence, which can partially offset antiviral volume growth in VZV.

4) What is the biggest variable in revenue forecasting for valacyclovir?

Net pricing and generic contracting usually dominate revenue outcomes even when volume is stable.

5) What study outcomes are most valuable commercially for valacyclovir?

Endpoints tied to time to symptom/lesion resolution, recurrence reduction, tolerability, and regimen practicality that can support guideline and payer utilization decisions.

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References

[1] FDA. Drug Approval Packages (valacyclovir hydrochloride information). U.S. Food and Drug Administration.
[2] ClinicalTrials.gov. Studies for “valacyclovir” and “valacyclovir hydrochloride.” U.S. National Library of Medicine.
[3] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD classification resources for valacyclovir. World Health Organization.