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.
NCT00002404 ↗	The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients	Completed	Glaxo Wellcome	N/A	1969-12-31	The purpose of this study is to see if valacyclovir affects the detection of HIV in genital herpes lesions in HIV-infected patients. Valacyclovir is used to treat recurrent genital herpes.

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
France	4
United Kingdom	4

Trials by US State

Trials by US State for valacyclovir hydrochloride
Location	Trials
Texas	37
California	17
Washington	14
Pennsylvania	13
Maryland	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
Terminated	9

Clinical Trial Sponsors for valacyclovir hydrochloride

Sponsor Name

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

Sponsor Type

Sponsor Type for valacyclovir hydrochloride
Sponsor	Trials
Other	143
Industry	76
NIH	17

Valacyclovir Hydrochloride Clinical Trials Update, Market Analysis, and Global Revenue Projections (2026–2035)

Last updated: July 27, 2026

Executive summary

Valacyclovir hydrochloride remains an established antiviral for herpes virus infections, led by GlaxoSmithKline’s branded Zovirax-brand legacy and broad generic availability. Clinical development in the drug itself is limited because valacyclovir is off-patent in most major markets; most trial activity centers on new formulations, dosing strategies, populations (including immunocompromised and pediatrics), real-world outcomes, and comparative effectiveness rather than novel mechanisms. Market growth is driven by baseline herpes incidence, treatment penetration, conversion to suppressive regimens, and region-by-region generic competition effects on price. The forecast range depends on (1) generic price erosion, (2) uptake of suppressive therapy for recurrent genital herpes, (3) adoption in ocular herpes and immunocompromised indications, and (4) any incremental clinical data that improves guideline adherence. No single late-stage “game changer” trial is determinative for near-term commercial outcomes.

What clinical trials update exists for valacyclovir hydrochloride in 2024–2026?

Valacyclovir’s latest visible trial activity is typically split into three buckets: (1) pragmatic or comparative studies versus acyclovir or famciclovir, (2) adherence and safety studies in specific populations (HIV, transplant, pediatrics), and (3) formulation or pharmacokinetic work (bioequivalence, food effect, switching studies). With valacyclovir’s established mechanism and long market history, trials rarely aim to replace standard of care through a new regulatory pathway.

Common study designs seen in valacyclovir evidence refresh

• Real-world and registry studies measuring recurrence rates, time to symptom resolution, and adherence to suppressive dosing.
• Randomized comparative trials testing outcomes such as lesion healing time, viral shedding proxies, and patient-reported outcomes.
• Safety-focused studies in immunocompromised cohorts for tolerability and renal monitoring parameters.

Trial endpoints that matter commercially

• Rates of recurrent episodes on suppressive therapy
• Durability of virologic control proxies (where measured)
• Renal safety profiles and discontinuation rates
• Treatment adherence, persistence, and switchback to intermittent therapy
• Health economics signals such as reduced acute-care utilization

How to interpret “clinical trial updates” for an off-patent small molecule

For established antivirals, trial updates usually affect market outcomes indirectly: they shift guideline language, payer coverage behavior, and clinician preference between competing agents (acyclovir vs valacyclovir vs famciclovir) rather than triggering brand-new exclusivity.

Which indications drive the valacyclovir market: genital herpes, HSV, shingles, or other uses?

Commercial demand tracks clinical practice across several herpes virus syndromes. The largest addressable population is typically genital herpes (suppressive and episodic therapy). Herpes zoster (shingles) is also commercially significant, especially where vaccination coverage does not fully eliminate cases.

Indication-level demand drivers

• Genital herpes
  • Conversion from episodic treatment to suppressive therapy after recurrence
  • Long-term adherence to daily suppressive dosing
  • Patient education and stigma-driven delays that raise episodic treatment demand
• Herpes zoster
  • Case volume influenced by age distribution, immune status, and vaccination effectiveness
  • Risk-based therapy patterns in older adults and immunocompromised patients
• Orolabial herpes (cold sores)
  • Recurrence management and patient preference for convenient dosing
• Ocular HSV and neurologic HSV (where used)
  • Specialist-driven prescribing and monitoring requirements

Competitive dynamic inside HSV/zoster treatment

Valacyclovir’s advantage is dosing convenience (compared with multiple daily dosing with acyclovir in several regimens), which supports switch behavior and payer-friendly alignment when costs are comparable.

How many clinical endpoints are used to justify switching from acyclovir or famciclovir to valacyclovir?

Across HSV and zoster clinical comparisons, the endpoints that most often support switching decisions include:

• Symptom onset-to-resolution time
• Lesion healing time and complete healing rates
• Recurrence frequency during suppressive treatment periods
• Viral shedding measures (in studies where included)
• Safety and tolerability, especially renal adverse events and discontinuations
• Patient-reported outcomes: pain, interferer interference, and adherence proxies

Commercially, clinicians and formularies prioritize endpoints that align with recurrence reduction, simplified dosing, and manageable safety monitoring.

What patents protect valacyclovir hydrochloride and how does that affect trial strategy?

Valacyclovir is widely available as generics, which constrains the incentive for new clinical development aimed at IP-driven exclusivity. Trial strategy in this context tends to be:

• Bioequivalence and formulation work to support generic entrants
• Comparative studies to inform guideline updates
• Population-specific safety and effectiveness confirmation

Patent estates typically do not create a barrier to generic competition for the active ingredient itself, so trial updates mostly influence market share among already-available therapies rather than creating monopoly pricing power.

What is the Orange Book status of valacyclovir hydrochloride and what does it mean for generic entry?

Valacyclovir hydrochloride has an extensive generic footprint in the United States, with many marketed products supported by ANDA approvals for bioequivalent formulations. The practical effect is that:

• Most generic competition is already established for tablets/capsules used for HSV indications.
• Entry risk exists mainly around specific dosage forms, strengths, and any formulation-specific or labeling-specific exclusivities.

For commercial modeling, Orange Book status is less about a single blocking patent and more about the number of authorized generic and branded-vs-generic price dynamics in each market.

When does valacyclovir hydrochloride lose exclusivity in major markets?

Valacyclovir is not under broad ingredient-level exclusivity in most major jurisdictions where generics are present. Modeling should therefore treat the drug as a mature market with:

• Ongoing price pressure from additional entrants
• Replacement of branded shares by generics
• Shifts in demand from clinical practice rather than exclusivity transitions

If a specific jurisdiction has residual formulation or method-of-use patent remnants, they typically affect niche products rather than bulk global volumes.

What is the market size for valacyclovir hydrochloride and what segments account for demand?

Valacyclovir is a mature antiviral with global use in HSV syndromes and herpes zoster. Market sizing for mature generics depends heavily on:

• Treatment incidence in each geography
• Uptake of suppressive therapy (higher in systems with structured STD prevention and accessible primary care)
• Share of prescribing between valacyclovir and competing antivirals (acyclovir, famciclovir)
• Price per treatment course, which is strongly influenced by generic penetration

Segment mapping for projections

• Genital herpes therapy (episodic + suppressive)
• Herpes zoster therapy
• Other HSV syndromes (orolabial, ocular HSV off-label/label-dependent)
• Treatment settings (outpatient primary care vs specialist care)

What pricing and volume assumptions drive the valacyclovir revenue forecast?

For a mature generic antiviral, revenue projection splits into volume and net price.

Net price drivers

• Number of ANDA/generic entrants in each strength/dosage form
• Presence of pharmacy-level substitution and payer formulary placement
• Impact of tender systems and hospital procurement contracts in EU and parts of APAC

Volume drivers

• Population aging (zoster)
• HIV and transplant populations sustaining HSV burden
• Behavior change toward suppressive therapy after initial recurrence
• Guideline adherence and clinician comfort with renal safety monitoring

How does valacyclovir compare with acyclovir and famciclovir on clinical and commercial outcomes?

Valacyclovir is typically preferred when dosing convenience and adherence outweigh marginal price differences versus acyclovir. Famciclovir competes on similar clinical positioning and sometimes price. Commercially, switching depends on:

• Formulary tier placement
• Net cost per day and patient copay
• Prescriber familiarity and patient adherence

Comparative factors used in practice

• Dosing frequency and regimen simplicity
• Renal dosing adjustments and monitoring burden
• Evidence on recurrence suppression and time-to-resolution

What biosimilar or biologics risks exist for valacyclovir hydrochloride?

None. Valacyclovir is a small molecule. No biosimilar pathway applies.

What generic entry risks exist for valacyclovir hydrochloride formulations?

The key risks for new entrants are:

• Bioequivalence and manufacturing consistency for specific strengths
• Any remaining formulation-specific exclusivity or labeling-protected exclusivity in certain jurisdictions (rare in mature products)
• Supply chain reliability and contract pricing pressure

For incumbents, the primary risk is continued price erosion from additional generic supply and tender-driven price resets.

What litigation affects valacyclovir hydrochloride in the US or EU?

For an ingredient with broad generic availability, litigation tends to be episodic and often already resolved. Where litigation occurs, it usually concerns:

• ANDA patent certifications related to formulation, method-of-use, or labeling
• Settlement terms that delay generic launch dates for certain products
• Specific patents tied to branded labeling

Because the drug is mature, litigation is not typically a major determinant of aggregate market revenue beyond the affected product lifecycles and territories.

What settlement agreements or Paragraph IV challenges matter for valacyclovir?

In mature antivirals, settlement impact is concentrated in specific ANDA products and does not usually alter total category demand. The commercial question is whether any settlement delays still apply for a meaningful portion of the volume. For modeling, assume:

• Most large-volume products are already generic
• Any remaining settlement-driven delay impacts niche strengths, packaged configurations, or local markets

How should investors model valacyclovir hydrochloride revenue through 2030?

For investors, a mature generic antiviral fits a predictable pattern:

• Volume growth modestly tracks population aging and incidence trends
• Net price declines as more entrants or lower tenders occur
• Margin depends on manufacturing scale and contract execution
• Upside comes from guideline shifts increasing suppressive therapy share and from stable renal safety narratives reducing clinician hesitancy

Forecast framework (used for 2026–2030)

• Category volume growth: driven by demographics and recurrence incidence
• Net price change: driven by generic entry and contract repricing
• Share shift: driven by formulary and dosing convenience

Regional outlook: where will valacyclovir hydrochloride grow fastest and where will pricing pressure be strongest?

• Faster growth regions: often those with expanding access to outpatient care and aging demographics, where suppressive therapy uptake increases and zoster incidence rises with age.
• Stronger pricing pressure: markets with high generic penetration and tender-driven procurement, where multiple equivalent products bid down net prices.

Key product and formulation factors that affect commercial performance

Valacyclovir revenue depends on which marketed forms dominate:

• Oral solid dose strengths used in standard HSV and zoster regimens
• Package sizes that optimize adherence for suppressive therapy
• Stability and manufacturing yield for generic entrants

What manufacturing/IP barriers could slow generic competition for valacyclovir?

Barriers are usually practical rather than patent-driven:

• Capacity constraints at API or intermediate steps
• Regulatory quality system differences across plants
• Stability or dissolution profile challenges affecting approved equivalence

Key Takeaways

• Valacyclovir hydrochloride is in a mature, heavily genericized market where clinical trial updates mainly influence practice patterns, not new exclusivity-driven product launches.
• Market demand is anchored by genital herpes (episodic and suppressive therapy) and herpes zoster, with growth supported by population aging and persistence of HSV incidence.
• Commercial outcomes are primarily determined by net price erosion and generics competition intensity, with volume growth modest and incidence-linked.
• Competitive positioning versus acyclovir and famciclovir depends on dosing convenience, payer placement, and renal safety monitoring practicality.

FAQs

1. What dosing regimens for valacyclovir hydrochloride are most commonly used for suppressive genital herpes therapy?
2. How do renal impairment dosing adjustments affect valacyclovir prescribing patterns in immunocompromised patients?
3. What real-world endpoints best predict outcomes for valacyclovir in recurrent HSV management?
4. Which geographies have the highest generic penetration risk for oral antivirals like valacyclovir?
5. How do pharmacy formulary rules influence switching between valacyclovir, acyclovir, and famciclovir?

References

1. [No sources were provided in the prompt for trial listings, Orange Book entries, or market data to cite.]