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
HIV Infections	13
Herpes Simplex	13
Herpes Zoster	10
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

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−

Trials by Country for valacyclovir hydrochloride
Location	Trials
United States	300
Canada	28
India	5
France	4
Netherlands	3

Trials by US State

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−

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
Phase 4	18
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for valacyclovir hydrochloride
Clinical Trial Phase	Trials
Completed	73
Recruiting	16
Terminated	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	134
Industry	75
NIH	17

Valacyclovir Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Valacyclovir Hydrochloride

Valacyclovir hydrochloride, commonly known by its brand name Valtrex, is an antiviral medication widely used to treat infections caused by herpes viruses, including genital herpes, cold sores, and shingles. Here, we will delve into recent clinical trials, market analysis, and projections for this drug.

Clinical Trials Update

Combination Therapy with CAN-2409 in NSCLC

Recent clinical trials have explored the use of valacyclovir in combination with other treatments for non-small cell lung cancer (NSCLC). A phase 2 trial (NCT04495153) presented at the 2024 ASCO Annual Meeting evaluated the combination of CAN-2409, a replication-defective adenovirus, and valacyclovir with continued immune checkpoint inhibitors in patients with stage III/IV NSCLC who were refractory or resistant to anti-PD-1 or PD-L1 therapy.

• Patient Enrollment and Treatment: The trial enrolled 76 patients, with 73 receiving at least one injection of CAN-2409. Patients were divided into two cohorts: those with stable disease (cohort 1) and those with progressive disease (cohort 2) after more than 18 weeks of immune checkpoint inhibitor-based therapy. Both cohorts received two courses of CAN-2409 and valacyclovir, along with continued standard-of-care checkpoint inhibitors with or without chemotherapy[1][4].

• Efficacy and Safety: The results showed that in cohort 2, the overall response rate (ORR) was 8%, and the disease control rate (DCR) was 70%. For cohort 1, the ORR was 40%, and the DCR was 100%. The combination therapy demonstrated favorable tolerability and induced immune responses, with a median overall survival of 22.0 months in patients refractory to anti-PD(L)1 therapy[1][4].

Valacyclovir Oral Suspension

Hyloris Pharmaceuticals SA announced positive results from a pivotal clinical study for its proprietary Valacyclovir Oral Suspension. This study aimed to compare the bioavailability of the oral suspension with Valtrex tablets prepared as an extemporaneous suspension.

• Bioavailability and Patient Compliance: The study found that the Valacyclovir Oral Suspension had comparable relative bioavailability to Valtrex tablets under fasted conditions. This new formulation is expected to enhance stability, storability, and patient compliance, addressing potential dosing inaccuracies associated with crushing tablets[3].

Market Analysis

Current Market Size and Growth

The Valacyclovir Hydrochloride Market has experienced rapid and substantial growth in recent years. As of 2023, the market size was valued in billions of USD, with projections indicating continued significant expansion from 2023 to 2031.

• Market Segmentation: The market is segmented based on type (purity levels such as 97%, 98%, and 99%) and application (medicine, chemical, and others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

• Market Dynamics: The positive momentum in market dynamics, combined with expected sustained expansion, indicates robust growth rates throughout the forecasted period. Key factors influencing the market include product pricing, national GDP, broader market dynamics, and consumer behavior[2][5].

Valacyclovir Hcl API Market

The Valacyclovir Hcl API Market is also experiencing significant growth. This market is categorized based on type (above 98% and above 99% purity) and application (tablets and others).

• Growth Projections: The outlook remains optimistic, with projections indicating continued expansion from 2023 to 2031. The market is expected to see robust growth rates due to favorable market dynamics and increasing demand for valacyclovir hydrochloride[5].

Market Projections

Forecasted Growth

The Valacyclovir Hydrochloride Market and the Valacyclovir Hcl API Market are both poised for significant growth over the next several years.

• Revenue Projections: The market size is expected to increase substantially, measured in USD million, across various segments. The forecasts suggest that the market will continue its upward trend, driven by increasing demand and favorable market conditions[2][5].

• Geographical Expansion: The growth is anticipated to be widespread across different geographical regions, with North America, Europe, and Asia-Pacific expected to be key contributors to the market expansion[2][5].

Key Factors Influencing Market Growth

Drivers

• Increasing Prevalence of Herpes Infections: The rising incidence of herpes infections globally is a significant driver for the valacyclovir hydrochloride market.
• Advancements in Formulations: New formulations like the Valacyclovir Oral Suspension are expected to enhance patient compliance and treatment outcomes.
• Expanding Applications: The use of valacyclovir in combination therapies, such as in NSCLC, is opening up new market opportunities[1][3][4].

Restraints

• Generic Competition: The presence of generic versions of valacyclovir hydrochloride can pose a challenge to branded products.
• Regulatory Hurdles: Navigating regulatory approvals, especially for new formulations, can be a significant restraint.
• Side Effects and Safety Concerns: Any adverse safety profiles or side effects associated with valacyclovir can impact market growth[3][4].

Conclusion

Valacyclovir hydrochloride remains a vital antiviral medication with a strong market presence. Recent clinical trials, particularly the combination therapy with CAN-2409 in NSCLC, and the development of new formulations like the Valacyclovir Oral Suspension, are expected to drive market growth. The positive market dynamics and forecasted expansion indicate a robust future for the valacyclovir hydrochloride market.

Key Takeaways

• Clinical Trials: Valacyclovir is being explored in combination therapies for NSCLC, showing favorable tolerability and immune responses.
• Market Growth: The valacyclovir hydrochloride market is projected to grow significantly from 2023 to 2031.
• New Formulations: The Valacyclovir Oral Suspension is expected to enhance patient compliance and treatment outcomes.
• Geographical Expansion: Growth is anticipated across various geographical regions.

FAQs

What is the primary use of valacyclovir hydrochloride?

Valacyclovir hydrochloride is primarily used to treat infections caused by herpes viruses, including genital herpes, cold sores, and shingles.

What is the significance of the combination therapy with CAN-2409 in NSCLC?

The combination therapy with CAN-2409 and valacyclovir in NSCLC has shown favorable tolerability and induced immune responses, with a median overall survival of 22.0 months in patients refractory to anti-PD(L)1 therapy.

What are the key drivers for the valacyclovir hydrochloride market growth?

Key drivers include the increasing prevalence of herpes infections, advancements in formulations, and expanding applications such as combination therapies in NSCLC.

What are the potential restraints for the valacyclovir hydrochloride market?

Potential restraints include generic competition, regulatory hurdles, and side effects or safety concerns associated with valacyclovir.

What is the expected market size of the valacyclovir hydrochloride market by 2031?

The market size is expected to increase substantially, though exact figures are not specified in the sources, it is anticipated to be in billions of USD.

Sources

1. OncLive: Dr Aggarwal on Data for CAN-2409 Plus Valacyclovir and Continued Immune Checkpoint Inhibitors in Advanced Non–Small Cell Lung Cancer.
2. Market Research Intellect: Global Valacyclovir Hydrochloride Market Size, Scope And Forecast Report.
3. BioSpace: Hyloris Announces Positive Clinical Study Results for Valacyclovir Oral Suspension.
4. OncLive: CAN-2409 Plus Valacyclovir Shows Favorable Tolerability, Induces Immune Responses in NSCLC.
5. Market Research Intellect: Global Valacyclovir Hcl API Market Size, Scope And Forecast Report.