CLINICAL TRIALS PROFILE FOR ACYCLOVIR SODIUM

All Clinical Trials for ACYCLOVIR SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00855309 ↗	Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia	Completed	National Cancer Institute (NCI)	Phase 3	2008-11-01	RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
NCT00855309 ↗	Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia	Completed	Comprehensive Cancer Center of Wake Forest University	Phase 3	2008-11-01	RATIONALE: Acyclovir may be effective in preventing herpes simplex virus infection in patients with neutropenia. PURPOSE: This randomized phase III trial is studying the side effects of acyclovir and is comparing two doses of acyclovir in preventing herpes simplex virus infection in patients with neutropenia.
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.
NCT00045292 ↗	Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation	Completed	National Cancer Institute (NCI)	Phase 3	2002-04-01	RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.
NCT00045292 ↗	Valacyclovir in Preventing Cytomegalovirus Infection in Patients Who Are Undergoing Donor Stem Cell Transplantation	Completed	Fred Hutchinson Cancer Research Center	Phase 3	2002-04-01	RATIONALE: Antivirals such as valacyclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valacyclovir is effective in preventing cytomegalovirus in patients undergoing stem cell transplantation. PURPOSE: Randomized phase III trial to determine the effectiveness of valacyclovir in preventing cytomegalovirus in patients who are undergoing donor stem cell transplantation.

Clinical Trial Conditions for ACYCLOVIR SODIUM

Condition Name

Condition Name for ACYCLOVIR SODIUM
Intervention	Trials
Herpes Simplex	1
Herpes Zoster	1
Leukemia	1
Metastatic Cancer	1

Condition MeSH

Condition MeSH for ACYCLOVIR SODIUM
Intervention	Trials
Herpes Simplex	1
Herpes Zoster	1
Cytomegalovirus Infections	1
Syndrome	1

Clinical Trial Locations for ACYCLOVIR SODIUM

Trials by Country

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Trials by Country for ACYCLOVIR SODIUM
Location	Trials
United States	7
China	2
Egypt	1
Korea, Republic of	1

Trials by US State

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−

Trials by US State for ACYCLOVIR SODIUM
Location	Trials
Texas	2
Utah	1
Nebraska	1
California	1
North Carolina	1

Clinical Trial Progress for ACYCLOVIR SODIUM

Clinical Trial Phase

Clinical Trial Phase for ACYCLOVIR SODIUM
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ACYCLOVIR SODIUM
Clinical Trial Phase	Trials
Completed	5
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for ACYCLOVIR SODIUM

Sponsor Name

Sponsor Name for ACYCLOVIR SODIUM
Sponsor	Trials
National Cancer Institute (NCI)	2
Haining Health-Coming Biotech Co., Ltd.	1
Sohag University	1

Sponsor Type

Sponsor Type for ACYCLOVIR SODIUM
Sponsor	Trials
Other	9
NIH	2
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Acyclovir Sodium

Introduction to Acyclovir Sodium

Acyclovir sodium is a widely used antiviral medication, particularly for the treatment of herpes simplex virus (HSV) infections. It is marketed under various brand names, including Zovirax and Sitavig. Here, we will delve into the current clinical trials, market analysis, and future projections for acyclovir sodium.

Clinical Trials and Emerging Alternatives

Current Clinical Trials on Acyclovir Resistance

For patients with acyclovir-resistant HSV infections, especially those who are immunocompromised, alternative treatments are being explored. One notable clinical trial involves the use of pritelivir, a novel oral antiviral agent.

• Pritelivir Trials: A multi-center, comparative trial is assessing the efficacy and safety of pritelivir in subjects with acyclovir-resistant mucocutaneous HSV infections. The trial includes several phases, with Part A and Part B (Phase 2) already finalized. Part C (Phase 3) aims to show the superiority of pritelivir over investigator's choice treatments, such as foscarnet or cidofovir, in achieving clinical cure rates within 28 days[1][4].

Efficacy and Safety of Pritelivir

• Clinical Outcomes: Studies have shown that pritelivir is well-tolerated and effective, with 83% of participants in a phase 2 study experiencing complete resolution of HSV lesions by 28 days[4].
• Exclusion Criteria: The trials exclude patients with known resistance or intolerance to pritelivir, significant cardiovascular or other diseases, and those undergoing hemodialysis or with end-stage renal disease[1].

Market Analysis of Acyclovir Sodium

Global Market Size and Growth

• Current Market Value: The global acyclovir sodium injection market was valued at US$ 1290 million in 2023. It is projected to reach US$ 2117.9 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% during the forecast period of 2024-2030[2].
• Market Segmentation: The market is segmented by type (10ml, 20ml, 50ml, etc.), application (herpes simplex, genital herpes, herpes simplex encephalitis, etc.), and region. Key players include AuroMedics, Hari Pharma, Fresenius Kabi, and SteriMax[2].

Herpes Simplex Virus Treatment Market

• Overall Market Size: The global herpes simplex virus treatment market was valued at US$ 2246.7 million in 2022 and is expected to reach US$ 3503.7 million by 2030, with a CAGR of 5.70% during the forecast period[3].
• Drug Type Segmentation: The market is dominated by acyclovir, followed by valacyclovir and famciclovir. Acyclovir remains a preferred anti-viral agent for treating oral herpes and herpes simplex encephalitis[3].

Market Projections and Trends

Growth Drivers

• Increasing Awareness: Greater awareness about HSV and available therapeutics is expected to drive market growth. This includes the use of acyclovir for treating and preventing recurrent genital herpes infections[3].
• Oral Route Dominance: The oral route of administration is expected to dominate the market due to its ease of use and high patient compliance[3].

Challenges and Restraints

• Social Stigma: Social stigma associated with sexually transmitted diseases (STDs) can hinder market growth by reducing the number of patients seeking treatment[3].
• Product Recalls: Rising product recalls can also hamper market growth by eroding consumer trust in antiviral medications[3].

Key Players in the Acyclovir Market

• Major Manufacturers: Key players in the acyclovir market include GSK, Mylan, TEVA, Zydus Pharmaceuticals, Bausch Health, and Fresenius Kabi. These companies are driving innovation and competition in the market[5].

Future Outlook

Emerging Therapies

• Pritelivir and Beyond: The development of new antiviral agents like pritelivir is expected to offer alternative treatment options for patients with acyclovir-resistant HSV infections. This could potentially shift market dynamics and provide better outcomes for immunocompromised patients[1][4].

Market Expansion

• Geographical Growth: The market is expected to expand across various regions, driven by increasing demand for effective antiviral treatments. This growth will be fueled by rising healthcare expenditures and improved access to healthcare services[2].

"The global acyclovir sodium injection market is anticipated to reach US$ 2117.9 million by 2030, witnessing a CAGR of 7.4% during the forecast period 2024-2030"[2].

Key Takeaways

• Clinical Trials: Ongoing clinical trials are evaluating the efficacy and safety of pritelivir as an alternative to acyclovir for treating acyclovir-resistant HSV infections.
• Market Growth: The global acyclovir sodium injection market is projected to grow at a CAGR of 7.4% from 2024 to 2030.
• Market Segmentation: The market is segmented by type, application, and region, with key players driving innovation.
• Challenges: Social stigma and product recalls are potential restraints to market growth.
• Future Outlook: Emerging therapies like pritelivir are expected to offer better treatment options and potentially alter market dynamics.

FAQs

What is the current market size of the global acyclovir sodium injection market?

The global acyclovir sodium injection market was valued at US$ 1290 million in 2023[2].

What is the projected growth rate of the acyclovir sodium injection market?

The market is expected to grow at a CAGR of 7.4% from 2024 to 2030[2].

Who are the key players in the acyclovir market?

Key players include GSK, Mylan, TEVA, Zydus Pharmaceuticals, Bausch Health, and Fresenius Kabi[5].

What are the main applications of acyclovir sodium?

Acyclovir sodium is used to treat herpes simplex, genital herpes, herpes simplex encephalitis, and other related infections[2].

What are the challenges facing the herpes simplex virus treatment market?

Social stigma associated with STDs and rising product recalls are significant challenges[3].

Sources

1. CenterWatch: Trial on Efficacy and Safety of Pritelivir Tablets for Treatment of Acyclovir-Resistant Mucocutaneous HSV Infections in Immunocompromised Subjects.
2. Valuates Reports: Global Acyclovir Sodium Injection Market Research Report 2024.
3. Coherent Market Insights: Herpes Simplex Virus Treatment Market - Price, Size, Share & Growth.
4. Oxford Academic: Multicenter Assessment of the Outcomes and Toxicities of Foscarnet and Pritelivir for Acyclovir-Refractory HSV Infection.
5. Valuates Reports: Acyclovir Market, Report Size, Worth, Revenue, Growth, Industry.