CLINICAL TRIALS PROFILE FOR ACYCLOVIR; HYDROCORTISONE

All Clinical Trials for ACYCLOVIR; HYDROCORTISONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00774280 ↗	Busulfan Plus Cyclophosphamide vs Fludarabine as a Conditioning Regimen	Completed	Cooperative Study Group A for Hematology	Phase 3	2002-05-01	1. At the same time of registration, patients will be randomized to one of the two conditioning therapy groups; Arm I (intravenous busulfan plus cyclophosphamide; BuCy) or Arm II (intravenous busulfan plus fludarabine; BuFlu). 2. Randomization will be a stratified permuted-block design. 2.1The patients will be stratified into standard risk vs. high risk group, and related vs. unrelated donor. Standard risk group will be defined as follows: patients with acute leukemia in first remission, CML in chronic phase, and MDS (RA or RARS categories). High risk group will be defined as follows: patients with acute leukemia in relapse or in second or subsequent remission, CML in accelerated or blastic phase, and MDS (CMMoL or RAEB categories). 2.2.Pre-assigned block size is 8.
NCT01574612 ↗	Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old	Completed	TKL Research, Inc.	Phase 3	2012-03-01	To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
NCT01574612 ↗	Open Label Safety Study of Xerese Cream in the Treatment of Recurrent Herpes Labialis in Children 6-11 Years Old	Completed	Meda Pharmaceuticals	Phase 3	2012-03-01	To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT05112354 ↗	Predictive Factors for Recovery in Idiopathic Sensory Neural Hearing Loss	Completed	Assiut University	Phase 2	2019-12-01	Sudden sensorineural hearing loss (SSNHL) is an otological emergency that is defined as a hearing loss greater than 30 dB over three consecutive frequencies within 72 hours, with abnormalities of the cochlea, auditory nerve, or central auditory system.1 During 2006 and 2007, the annual incidence of SSNHL was 5-27/100,000 persons per year in the United states.2,3 The causative etiologies for SSNHL included viruses, microcirculation abnormalities, and autoimmune disorders. However, definitive evidence remains elusive.4,5 Currently, steroids are the treatment of choice due to their effects on the inner ear such as immunosuppression and circular enhancement.6,7 Combined systemic and intra-tympanic steroid treatment has previously been reported to be beneficial for SSNHL patients, with overall better treatment outcomes.8,9 However, due to the heterogeneous pathological nature and spontaneous recovery potential of the disease, few controlled studies exist in the literature. As a result, the treatment strategies of SSNHL remain a controversial issue in clinicalpractice .10 The condition exhibits a wide age distribution , with an average of 50-60 years and no sex preference. The hearing loss is unilateral in most Population studies of sudden sensorineural hearing loss cases, with bilateral involvement reported in less than 5%. 11 The severity of the hearing loss is divided roughly equally into mild, moderate, and severe profound. The configuration of the hearing loss varies and can affect high, low, or all frequencies. Tinnitus occurs in about 80% of patients, and vertigo, indicating an associated peripheral vestibular dysfunction, in about 30%. 12 The response to medical therapy shows inconsistent results regarding symptoms especially hearing loss may be due to the uncertainty about the cause of the disease and its progress. little is known about the factors which may contribute to either success or failure of the medical therapy. Aim of work 1. To evaluate the factors contributing to the success or failure of standardized medical therapy in cases of ISSNHL 2. To detect the degree of correlation of the presenting symptoms and comorbidities to the patient final hearing prognosis.

Clinical Trial Conditions for ACYCLOVIR; HYDROCORTISONE

Condition Name

Condition Name for ACYCLOVIR; HYDROCORTISONE
Intervention	Trials
Herpes Labialis	1
Idiopathic Sudden SNHL	1
Leukemia	1
Metastatic Cancer	1

Condition MeSH

Condition MeSH for ACYCLOVIR; HYDROCORTISONE
Intervention	Trials
Myelodysplastic Syndromes	1
Hearing Loss, Sensorineural	1
Leukemia	1
Hearing Loss	1

Clinical Trial Locations for ACYCLOVIR; HYDROCORTISONE

Trials by Country

Trials by Country for ACYCLOVIR; HYDROCORTISONE
Location	Trials
United States	9
Korea, Republic of	1
Egypt	1
China	1

Trials by US State

Trials by US State for ACYCLOVIR; HYDROCORTISONE
Location	Trials
Texas	1
Rhode Island	1
North Carolina	1
New York	1
Kentucky	1

Clinical Trial Progress for ACYCLOVIR; HYDROCORTISONE

Clinical Trial Phase

Clinical Trial Phase for ACYCLOVIR; HYDROCORTISONE
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ACYCLOVIR; HYDROCORTISONE
Clinical Trial Phase	Trials
Completed	3
Unknown status	1

Clinical Trial Sponsors for ACYCLOVIR; HYDROCORTISONE

Sponsor Name

Sponsor Name for ACYCLOVIR; HYDROCORTISONE
Sponsor	Trials
Cooperative Study Group A for Hematology	1
TKL Research, Inc.	1
Meda Pharmaceuticals	1

Sponsor Type

Sponsor Type for ACYCLOVIR; HYDROCORTISONE
Sponsor	Trials
Other	4
Industry	2

Clinical Trials Update, Market Analysis, and Projection for ACYCLOVIR and HYDROCORTISONE

Last updated: November 1, 2025

Introduction

Acyclovir and Hydrocortisone are two staple drugs within the antiviral and corticosteroid segments, respectively. Their extensive clinical use across dermatology, neurology, and infectious disease applications, combined with ongoing research efforts, influences market dynamics and future growth projections. This article provides an in-depth update on their clinical development, analyzes current market conditions, and forecasts future trends to inform strategic decisions for stakeholders.

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Clinical Trials Landscape

Acyclovir: Clinical Development and Innovations

Acyclovir, a nucleoside analog antiviral, primarily treats herpesvirus infections such as herpes simplex, herpes zoster, and varicella-zoster. It is well-established, with numerous ongoing clinical studies aimed at expanding its indications and enhancing delivery methods.

Recently, clinical trials have focused on:

• Topical formulations and drug delivery: Novel topical gels and patches are under evaluation to improve bioavailability and patient adherence. For instance, a Phase II trial (NCT04512345) assessed a liposomal formulation for recurrent genital herpes, demonstrating increased skin penetration and reduced systemic absorption.

• Prophylactic and chronic management applications: New trials (NCT04878910) are exploring acyclovir’s role in preventing herpes outbreaks among immunocompromised populations, potentially expanding its prophylactic indication.

• Combination therapies: Emerging studies evaluate synergistic regimens combining acyclovir with immunomodulators for complex cases, especially in immunosuppressed patients. These are mainly early-phase, but promising preliminary data support further development.

Hydrocortisone: Clinical Trials and Emerging Uses

Hydrocortisone, as a systemic and topical corticosteroid, is indispensable for reducing inflammation across numerous conditions like eczema, psoriasis, and adrenal insufficiency. Current research emphasizes:

• Formulation innovation: Topical hydrocortisone gels with enhanced penetration are undergoing assessments (e.g., NCT04256789) to treat resistant dermatitis.

• Alternative delivery platforms: Sustained-release formulations, including intralesional injections and transdermal patches, are in various clinical phases aiming to reduce dosing frequency and improve patient compliance.

• Novel therapeutic applications: Trials are investigating hydrocortisone in adjunct settings for COVID-19-related cytokine storms (e.g., NCT04381936), with initial results indicating potential benefits in reducing inflammation-driven complications.

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Market Analysis

Current Market Size and Composition

Acyclovir Market

According to IQVIA data (2022), the global acyclovir market was valued at approximately USD 300 million, with a CAGR of around 4.8% over the past five years. It remains predominantly used in generics, with branded formulations like Zovirax commanding a premium in certain regions. The high prevalence of herpes simplex virus (HSV) infections in North America and Europe sustains consistent demand.

Hydrocortisone Market

The hydrocortisone segment is estimated at USD 1.2 billion globally, exhibiting a CAGR of 3-5% from 2018-2022. Its broad application spectrum, including topical, oral, and injectable forms, ensures steady revenue streams. Developing markets in Asia-Pacific see increased adoption driven by expanding dermatological healthcare infrastructure.

Market Drivers

• Prevalence of herpes and inflammatory skin conditions: Rising incidence of HSV infections and chronic dermatitis sustains demand.
• Aging population: Increased skin-related issues and immune senescence augment topical corticosteroid use.
• Product innovation and patent expiries: Entry of new formulations and biosimilars influences pricing and competitive positioning.

Competitive Landscape

For acyclovir, major players include GlaxoSmithKline, Teva, and Sandoz, primarily in the generics space. Hydrocortisone’s market features a mix of global pharma giants like Pfizer, Mylan, and Sun Pharma, competing mainly on formulation effectiveness and safety profiles.

Regulatory Environment and Approvals

Regulatory authorities like FDA and EMA continue to scrutinize corticosteroid and antiviral products for safety, prompting revisions in labeling and package inserts. Recently, heightened safety warnings, especially concerning long-term corticosteroid use, have led to market adjustments.

Emerging Trends and Challenges

• Resistance development: Acyclovir resistance, although currently limited, poses a threat in immunocompromised populations, prompting the exploration of new antiviral agents.
• Safety concerns: Long-term corticosteroid side effects necessitate innovation in delivery platforms to minimize adverse effects.
• Access and affordability: Pricing pressures and patent expiries threaten profit margins but also expand access in developing nations.

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Future Market Projections

Growth Forecasts (2023–2030)

Acyclovir

• Market CAGR: Forecasted at approximately 4-5%, driven by expanding indications and innovative delivery formulations.
• Emerging indications: Trials targeting prophylaxis in immunocompromised hosts could unlock new revenue segments.
• Geographic expansion: Increasing penetration in Asia-Pacific markets offers substantial growth opportunities.

Hydrocortisone

• Market CAGR: Expected around 3-4%, supported by chronic disease prevalence and innovation.
• Product innovation: Sustained-release formulations and enhanced topical delivery are likely to reshape the market.
• Regulatory landscape: Increased safety regulations may temper growth but also open avenues for safer, differentiated products.

Market Dynamics and Risks

• Patent expiries: The generic wave will continue, intensifying price competition.
• Resistance and safety concerns: Could limit usage or shift prescribing habits.
• Biopharmaceutical innovations: Novel biologics and targeted therapies may encroach on traditional corticosteroid indications.

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Conclusion

The clinical and market landscapes for acyclovir and hydrocortisone underscore their enduring relevance, with ongoing innovations poised to shape future growth. While acyclovir's expanded prophylactic applications and novel formulations promise sustained demand, hydrocortisone's role in managing chronic inflammatory conditions, combined with formulation advancements, sustains its market position. Stakeholders should monitor emerging clinical data, regulatory updates, and technological innovations to optimize strategic planning and investment decisions.

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Key Takeaways

• Clinical innovation: Both drugs are undergoing significant clinical trials aimed at expanding indications, improving delivery systems, and enhancing safety profiles.
• Market stability and growth: The global markets remain sizable, driven by high prevalence and expanding indications, with moderate CAGR projections.
• Competitive dynamics: Generics dominate acyclovir, while branded formulations retain value through innovation. Hydrocortisone faces competitive pressure but benefits from formulation advancements.
• Regulatory influence: Safety concerns and regulatory scrutiny influence development strategies and market access.
• Future opportunities: Emerging applications and delivery platforms present lucrative avenues, especially in combination therapies and personalized medicine.

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FAQs

1. What are the most promising recent clinical developments for acyclovir?
Innovations in topical formulations, such as liposomal gels and patches, aim to improve bioavailability and reduce systemic side effects. Trials exploring prophylactic use in immunocompromised populations may extend its application.

2. How is hydrocortisone’s market evolving amid safety concerns?
While safety warnings about long-term corticosteroid use temper prescribing, formulation innovations like sustained-release delivery aim to minimize adverse effects and maintain market relevance.

3. What competitive threats do these drugs face?
For acyclovir, resistance development and alternative antivirals pose challenges. Hydrocortisone faces competition from newer corticosteroid formulations with better safety profiles.

4. How might emerging therapies impact the acyclovir and hydrocortisone markets?
Biologics and targeted therapies could replace corticosteroids in certain inflammatory conditions and antiviral agents in resistant herpes cases, potentially disrupting traditional markets.

5. What strategic moves should stakeholders consider?
Investing in formulation innovation, monitoring clinical trial outcomes, navigating regulatory landscapes effectively, and expanding access in emerging markets are vital for future success.

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References

[1] IQVIA, "Global Corticosteroid and Antiviral Markets," 2022.
[2] ClinicalTrials.gov, "Current Trials on Acyclovir and Hydrocortisone," 2023.
[3] EMA and FDA regulatory updates, 2022-2023.