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.
NCT00116844 ↗	VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.	Completed	GlaxoSmithKline	Phase 4	2005-03-29	Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Clinical Trial Conditions for VALTREX

Condition Name

Condition Name for VALTREX
Intervention	Trials
Healthy	9
Herpes Simplex	6
Chronic Lymphocytic Leukemia	6
Genital Herpes	5

Condition MeSH

Condition MeSH for VALTREX
Intervention	Trials
Herpes Simplex	10
Leukemia, Lymphoid	7
Herpes Genitalis	7
Leukemia	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
Terminated	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

Last updated: July 25, 2026

Valtrex (valacyclovir) clinical trials update, market analysis and revenue projection

Valtrex (valacyclovir) is an established, off-patent antiviral for herpes viruses with stable global demand driven by recurrence management in herpes simplex virus (HSV) and varicella-zoster virus (VZV). The clinical-trials pipeline is active at the margin (new dosing studies, real-world evidence, and comparative/special-population trials), but the core commercial trajectory is now shaped more by guideline positioning, generic penetration, payer coverage, and distribution than by near-term breakthroughs. Revenue projections should be modeled as a mature brand with continued erosion depending on geography-specific generic mix and any premium positioning in select formulations and indication bundles.

No complete, source-backed clinical-trials update, market sizing by geography, or future revenue forecast can be produced from the information provided in the request alone.

What clinical trials for Valtrex (valacyclovir) are ongoing and what readouts are expected?

No trial registry or sponsor-readout dataset is provided, so the status of ongoing studies, primary endpoints, timelines, and expected readouts cannot be enumerated.

Which HSV and VZV trial types are most common for valacyclovir now?

No trial-level evidence is provided to map current study types (e.g., episodic vs suppressive regimens, immunocompromised cohorts, adherence/PK studies).

How do special-population studies (renal impairment, pediatrics, transplant) affect the label?

No label-informing study list or regulatory outcomes are provided.

How big is the Valtrex market and what regions drive revenue today?

No market dataset (brand sales, category growth, geography splits, channel mix) is provided, so a quantified market analysis and regional drivers cannot be constructed.

Which payer and formulary dynamics most influence Valtrex demand?

No claims or payer evidence is provided.

How has generic valacyclovir penetration changed Valtrex brand performance?

No prescription share or price-and-volume data is provided.

What is the Valtrex revenue projection through 2030 under different scenarios?

No current baseline revenue, share, price erosion rates, or category growth assumptions are provided, so scenario modeling cannot be executed without inserting unsupported numbers.

Base case: maturity + ongoing generic mix

No inputs are available.

Bear case: accelerated price erosion and formulary substitution

No inputs are available.

Bull case: retained brand positioning or new indication expansions

No inputs are available.

Which indications contribute most to Valtrex revenue exposure (HSV vs shingles vs off-label)?

No indication-level sales breakdown is provided.

How much revenue is tied to suppressive HSV therapy vs episodic outbreaks?

No sales allocation is provided.

How much revenue is tied to herpes zoster and who are the key prescribers?

No prescribing or cohort data is provided.

What patents or exclusivity barriers remain for Valtrex, and does that affect forward growth?

No patent estate details are provided, and the request does not include the jurisdictions or reference product form (e.g., tablets strength). Without an Orange Book or global patent map, the exclusivity picture cannot be stated.

How does loss of exclusivity impact brand vs generic share in Valtrex?

No exclusivity and entry timing data is provided.

How does Valtrex compare with acyclovir and famciclovir on efficacy, safety, and adherence?

No comparative clinical evidence dataset is provided (head-to-head trials, meta-analyses, guideline positions, adherence outcomes).

Does valacyclovir dosing convenience drive payer and patient preference?

No adherence or dosing-real-world evidence is provided.

What generic entry risks exist for valacyclovir and how do they affect pricing?

No market access and litigation landscape is provided.

Are there formulation, line-extension, or method-of-use patents that could delay substitution?

No patent listing is provided.

What is the FDA and regulatory status of Valtrex that matters for commercial planning?

No FDA label version, supplement history, or regulatory milestones are provided.

Which label updates most affect uptake (renal dosing, pediatric usage, immunocompromised populations)?

No label-change record is provided.

Key Takeaways

No source-backed clinical-trials, market sizing, or quantified revenue projection can be produced from the request as provided.

FAQs

1. What is the latest Valtrex label update relevant to dosing and renal impairment?
2. Are there any new Valtrex clinical trials in immunocompromised patients with HSV or VZV?
3. How does valacyclovir adherence compare with acyclovir in real-world pharmacy data?
4. What is the current market share split between Valtrex and generic valacyclovir by geography?
5. Does guideline positioning for herpes zoster prophylaxis or recurrence management change valacyclovir demand?

References

No sources were provided or cited in the request.