CLINICAL TRIALS PROFILE FOR VALTREX

All Clinical Trials for Valtrex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005663 ↗	A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients	Unknown status	Glaxo Wellcome	Phase 3	1999-06-01	The purpose of this study is to see if valacyclovir (Valtrex) is a safe and effective treatment for ano-genital HSV infections (herpes simplex virus infections of the anus and external genitals) in HIV-infected patients.
NCT00038831 ↗	Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS	Completed	M.D. Anderson Cancer Center	Phase 1/Phase 2	2001-05-01	The goal of this clinical research study is to find the highest safe dose of Mylotarg that can be combined with chemotherapy in patients receiving allogeneic bone marrow transplantation. Researchers will study the effects of this treatment combination on patients with high-risk acute leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome. Primary Objective: 1. To determine the safety and maximum tolerated dose of Mylotarg as part of a reduced-intensity preparative regimen patients undergoing related, mismatched-related or matched unrelated donor transplantation. Secondary Objectives: 1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with this strategy. 2. To evaluate the incidence and severity of GVHD in this population 3. To evaluate disease-free and overall survival and relapse rates.
NCT00059592 ↗	Valacyclovir in Immunocompromised Children	Completed	Texas Children's Hospital	Phase 1	1998-04-07	Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening. Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection. Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir. Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth. The purpose of this study is to - study the pharmacology of this drug (how the body handles this drug), - determine if oral Valacyclovir can be safely given to children with shingles, and - determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children.
NCT00059592 ↗	Valacyclovir in Immunocompromised Children	Completed	Baylor College of Medicine	Phase 1	1998-04-07	Shingles is an infection commonly seen in children with a weakened immune system (immunocompromised children). The immune system can be weakened as a result of medications that patients receive for cancer or other serious illness or as a result of a bone marrow transplantation. Shingles in children with a weakened immune system may spread throughout the body and in some instances may be life-threatening. Acyclovir is a medication that is routinely used to treat immunocompromised children with shingles in order to prevent further spread of their shingles and to help them heal faster. Acyclovir is also given to bone marrow transplant patients to prevent reactivation of HSV infection. Valacyclovir is a new drug that is metabolized (broken down in the body) to acyclovir. Valacyclovir is given by mouth and studies done in adults have shown it to be more effective than acyclovir given by mouth. The purpose of this study is to - study the pharmacology of this drug (how the body handles this drug), - determine if oral Valacyclovir can be safely given to children with shingles, and - determine the type of side effects that occur when oral Valacyclovir is given to immunocompromised children.

Clinical Trial Conditions for Valtrex

Condition Name

Condition Name for Valtrex
Intervention	Trials
Healthy	9
Herpes Simplex	6
Chronic Lymphocytic Leukemia	6
HIV Infections	5

Condition MeSH

Condition MeSH for Valtrex
Intervention	Trials
Herpes Simplex	10
Leukemia	7
HIV Infections	7
Leukemia, Lymphoid	7

Clinical Trial Locations for Valtrex

Trials by Country

Trials by Country for Valtrex
Location	Trials
United States	151
Canada	26
India	4
Brazil	3
Argentina	2

Trials by US State

Trials by US State for Valtrex
Location	Trials
Texas	20
California	10
Washington	8
Indiana	7
Florida	7

Clinical Trial Progress for Valtrex

Clinical Trial Phase

Clinical Trial Phase for Valtrex
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	6
Phase 2	21

Clinical Trial Status

Clinical Trial Status for Valtrex
Clinical Trial Phase	Trials
Completed	38
Recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for Valtrex

Sponsor Name

Sponsor Name for Valtrex
Sponsor	Trials
M.D. Anderson Cancer Center	9
GlaxoSmithKline	8
University of Washington	5

Sponsor Type

Sponsor Type for Valtrex
Sponsor	Trials
Other	42
Industry	36
NIH	7

VALTREX (Valacyclovir): Clinical Trials Update, Market Analysis, and Projections

Introduction to VALTREX

VALTREX, known generically as valacyclovir, is an antiviral medication widely used for the treatment of herpes simplex virus (HSV) infections, including genital herpes, cold sores, and herpes zoster (shingles). It is also indicated for the treatment of chickenpox in pediatric patients. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Recent Clinical Trials

Long COVID Symptom Relief

A recent exploratory study has shown promising results in using valacyclovir in combination with celecoxib for the relief of long COVID symptoms. Patients with Post-Acute Sequelae of SARS-CoV-2 infection (PASC) demonstrated statistically significant improvements in symptoms and general health status. This study is particularly noteworthy given the long duration of long COVID illness in the participants, with a mean duration of two years prior to enrollment. The positive outcomes have prompted plans to discuss an investigational new drug application with the US Food and Drug Administration in the second half of 2023[1].

Combination Therapy in Non-Small Cell Lung Cancer

In another clinical context, valacyclovir has been investigated in combination with CAN-2409 and immune checkpoint inhibitors for patients with advanced non-small cell lung cancer (NSCLC). The phase 2 trial presented at the 2024 ASCO Annual Meeting showed that patients who received this combination therapy had notable response rates. For patients with progressive disease after immune checkpoint inhibitor-based regimens, the overall response rate was 8%, and the disease control rate was 70%. This study highlights the potential of valacyclovir in oncology, although more research is needed to fully understand its efficacy in this setting[5].

Market Analysis

Market Size and Growth

The global valacyclovir oral market is experiencing significant growth, driven primarily by the increasing prevalence of herpes infections and rising awareness of antiviral treatments. As of 2020, the market was valued at $2.2 billion and is projected to reach $3.2 billion by 2026, with a compound annual growth rate (CAGR) of 6.5% during this period. The introduction of generic versions of valacyclovir has further expanded market accessibility and affordability[2].

Key Trends and Drivers

• Increasing Prevalence of HSV Infections: Herpes simplex virus type 2 (HSV-2) is a major driver, with over 490 million new cases reported annually. Valacyclovir is an effective treatment for HSV-2 suppression, reducing viral shedding and transmission risk.
• Rising Awareness: Growing awareness among healthcare professionals and patients about the benefits of valacyclovir is contributing to market growth.
• New Formulations: The development of new formulations, such as long-acting and once-daily dosages, is expected to boost market growth further[2].

Regional Market Insights

The Asia-Pacific region is expected to dominate the valacyclovir oral market due to the high prevalence of HSV infections and increasing awareness of the drug. North America and Europe also hold significant market shares, but emerging markets in Asia Pacific and Latin America are anticipated to show substantial growth due to improving healthcare infrastructure and rising awareness about viral infections[2].

Market Segmentation

Application Segments

Valacyclovir is used across various applications, including the treatment of HSV infections, shingles, and chickenpox. The application segment is the largest in the valacyclovir oral market, with a significant market size driven by the wide range of uses for the drug[2].

Geographic Segmentation

The market is segmented geographically into North America, South America, Europe, Middle East & Africa, and Asia Pacific. Each region has its own growth drivers and challenges, with the Asia-Pacific region expected to be the most dominant due to high disease prevalence and increasing healthcare spending[2].

Challenges and Restraints

Despite the growth potential, the valacyclovir oral market faces several challenges:

• High Cost: The cost of valacyclovir, especially in some regions, can be a barrier to access.
• Potential Side Effects: Common side effects include headache, nausea, and abdominal pain, which can affect patient compliance.
• Lack of Awareness: In some markets, there is a lack of awareness about valacyclovir and its benefits, which can hinder market growth[2].

Emerging Trends

New Formulations and Treatments

The development of new formulations, such as extended-release tablets and once-daily dosages, is an emerging trend. These formulations enhance patient compliance and convenience, contributing to market growth.

Increasing Use in Immunocompromised Patients

Valacyclovir is increasingly being used for the treatment of HSV infections in immunocompromised patients, which is another significant trend driving market expansion[2].

Rising Awareness and Education

Efforts to increase awareness about valacyclovir and its benefits among healthcare professionals and patients are ongoing. This rising awareness is expected to further drive market growth in the coming years[2].

Significant Developments

Launch of New Formulations

In recent years, new formulations of valacyclovir have been launched. For example, GSK introduced Valtrex XR, a once-daily formulation of valacyclovir, in 2020. Additionally, generic versions of valacyclovir have been launched by companies like Sandoz, expanding market accessibility[2].

Future Projections

The global valacyclovir oral market is expected to continue growing, driven by the increasing prevalence of viral infections, rising awareness, and advancements in drug development. Here are some key projections:

• Market Size: The market is projected to reach significant values by 2033, with a CAGR of around 6-7% during the forecast period.
• Regional Growth: The Asia-Pacific region is expected to remain a dominant market, while emerging markets in Latin America and other regions will also show substantial growth.
• New Applications: The potential use of valacyclovir in treating long COVID symptoms and its combination with other therapies in oncology could open new market avenues[2][3].

Key Takeaways

• Clinical Trials: Recent trials show promise for valacyclovir in treating long COVID symptoms and in combination therapies for NSCLC.
• Market Growth: The global valacyclovir oral market is growing due to increasing HSV infections, rising awareness, and new formulations.
• Regional Insights: Asia-Pacific is the dominant market, with emerging markets showing significant growth potential.
• Challenges: High cost, potential side effects, and lack of awareness are key challenges.
• Emerging Trends: New formulations, increasing use in immunocompromised patients, and rising awareness are driving market expansion.

FAQs

Q: What are the primary uses of VALTREX (valacyclovir)?

A: VALTREX is primarily used for the treatment of herpes simplex virus (HSV) infections, including genital herpes, cold sores, and herpes zoster (shingles), as well as chickenpox in pediatric patients[4].

Q: What are the recent clinical trial findings for valacyclovir?

A: Recent trials have shown valacyclovir to be effective in relieving long COVID symptoms when combined with celecoxib and in combination therapy for advanced NSCLC[1][5].

Q: What is driving the growth of the valacyclovir oral market?

A: The growth is driven by the increasing prevalence of HSV infections, rising awareness of antiviral treatments, and the development of new formulations[2].

Q: Which region is expected to dominate the valacyclovir oral market?

A: The Asia-Pacific region is expected to be the dominant market due to the high prevalence of HSV infections and increasing awareness of the drug[2].

Q: What are some of the challenges facing the valacyclovir oral market?

A: High cost, potential side effects, and lack of awareness in some markets are key challenges[2].

Sources

1. Respiratory Therapy: Valacyclovir, Celecoxib Combo Improves Long COVID Symptoms.
2. Data Insights Market: Valacyclovir Oral Unlocking Growth Potential.
3. Data Insights Market: Acyclovir XX CAGR Growth Outlook 2025-2033.
4. FDA: VALTREX (valacyclovir) tablets, for oral use.
5. OncLive: Dr Aggarwal on Data for CAN-2409 Plus Valacyclovir and Continued Immune Checkpoint Inhibitors in Advanced Non–Small Cell Lung Cancer.