CLINICAL TRIALS PROFILE FOR ACYCLOVIR SODIUM

All Clinical Trials for acyclovir sodium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00855309 ↗	Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia	Completed	Wake Forest University Health Sciences	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.
NCT01066624 ↗	Comparative Trial of Cryotherapy Versus Caphosol Versus Saline Solution Mouth Washes for the Prevention of Oral Mucositis in Patients With Multiple Myeloma Undergoing Hematopoietic Stem Cell Transplantation	Completed	South Texas Veterans Health Care System	N/A	2009-08-01	Chemotherapy-induced oral mucositis is the inflammation of the oral mucous membranes, which are tissues that line the mouth. Oral mucositis is caused when chemotherapy attacks and kills the rapidly-dividing cells in the oral mucous membranes. This condition feels like sunburn (or heartburn) on the mucous tissues, and often leads to sores in the mouth or on the tongue. This can cause discomfort, pain, difficulties in eating, and a longer hospital stay. Several therapies appear to either prevent or reduce the severity of mouth ulcers caused by chemotherapy for multiple myeloma. Different strategies are used to try and prevent this condition; a small number of trials found that some of these strategies may be effective. None of the trials had compared head to head the use of saline solution (our standard of care), cryotherapy (ice chips) and Caphosol in patients receiving high-dose melphalan. The goal of this research study to evaluate the effectiveness of saline solution, cryotherapy, Caphosol for the prevention of oral mucositis in patients with multiple myeloma receiving high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation. The researchers hope to learn if there are any differences among saline solution, cryotherapy and Caphosol mouth rinse for the prevention of oral mucositis.

Clinical Trial Conditions for acyclovir sodium

Condition Name

Condition Name for acyclovir sodium
Intervention	Trials
Herpes Simplex	1
Herpes Virus Infection	1
Herpes Zoster	1
Leukemia	1

Condition MeSH

Condition MeSH for acyclovir sodium
Intervention	Trials
Stomatitis	1
Kaposi Varicelliform Eruption	1
Preleukemia	1
Neoplasms, Plasma Cell	1

Clinical Trial Locations for acyclovir sodium

Trials by Country

Trials by Country for acyclovir sodium
Location	Trials
United States	7
China	2
Korea, Republic of	1
Pakistan	1
Egypt	1

Trials by US State

Trials by US State for acyclovir sodium
Location	Trials
Texas	2
North Carolina	1
Washington	1
Utah	1
Nebraska	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	6
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
Fred Hutchinson Cancer Research Center	1
King Edward Medical University	1

Sponsor Type

Sponsor Type for acyclovir sodium
Sponsor	Trials
Other	10
NIH	2
U.S. Fed	1

Acyclovir Sodium: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is acyclovir sodium and how is it positioned commercially?

Acyclovir sodium is the sodium salt of acyclovir, an antiviral nucleoside analog used for herpesviridae infections. Commercial demand is driven by recurring treatment patterns (acute flares and suppression) and by episodic use during outbreaks or hospital care.

Regimen footprint (common clinical use classes)

• HSV: genital herpes, recurrent oral or mucocutaneous HSV
• VZV: varicella and herpes zoster
• Immunocompromised patients: prophylaxis and treatment in institutional settings
• Hospital/IV use: where rapid systemic exposure is needed (common for severe HSV/VZV)

What clinical trial activity exists for “acyclovir sodium” specifically?

A search-quality “clinical trials update” requires a field-level mapping between the query term “acyclovir sodium” and trial records using exact substance naming. In the absence of a source-backed trial table (NCT IDs, phases, dates, enrollment, endpoints, sponsor), a complete and accurate update cannot be produced.

What market does acyclovir sodium serve and what are the pricing dynamics?

Acyclovir is an established off-patent antiviral in most major markets. Acyclovir sodium products (including IV formulations) compete on:

• Formulation and route: oral vs IV vs topical is a major driver of hospital utilization
• Supply reliability: public procurement and hospital formularies prioritize consistent manufacturing
• Generic competition: pricing is constrained by multi-supplier generic markets
• Budget impact: in many payer systems, substitution is routine for off-patent antivirals

Demand drivers

• High baseline prevalence of HSV and HZ: treatment frequency remains stable year to year
• Immunocompromised subpopulation: durable institutional demand for systemic antivirals
• Hospital protocols: IV acyclovir sodium is used when oral administration is not appropriate

Key market risks

• Therapeutic substitution within antivirals: valganciclovir, ganciclovir, and newer HSV agents can shift share for certain indications and patient profiles
• Guideline changes: oral preference, step-down strategies, and formulary management affect IV utilization
• Procurement pressure: public tenders drive unit price downward

How large is the acyclovir sodium opportunity versus the whole acyclovir market?

Acyclovir sodium is best analyzed as a share of the broader acyclovir franchise:

• Oral acyclovir captures outpatient and long-tail chronic use
• IV acyclovir sodium captures inpatient and severe-case volume
• Topicals serve smaller, segment-specific outpatient use

A clean projection requires:

• market sizing by route (IV vs oral),
• branded versus generic splits,
• geography, and
• payer mix. Without source-backed quantitative inputs, any numeric projection would not be complete or accurate.

What is the competitive landscape?

Who competes with acyclovir sodium?

Competition depends on route and indication:

• Other acyclovir formulations (oral, topical) and generic substitution inside the same molecule
• Other antivirals used across HSV/VZV settings, where clinical practice allows substitution based on renal function, dosing convenience, and toxicity profiles

What gives acyclovir sodium an edge?

• Established clinician familiarity
• Extensive manufacturing footprint
• Availability of IV dosing protocols in acute care

What limits upside?

• Off-patent status in most markets
• Generic price compression
• Guideline-driven routing that can reduce IV share

What does a defensible projection require and what can be concluded from available structure?

A defensible market projection for “acyclovir sodium” must be built from:

• baseline market size,
• CAGR by route and geography,
• pricing trend assumptions,
• market share evolution,
• procurement cycles and substitution behaviors.

A complete and accurate numeric projection cannot be produced without the necessary source-backed market inputs.

Given those constraints, the only business-actionable projection statement that can be made without fabricating numbers is structural:

Projection framework (non-numeric, decision-relevant)

• Unit volume: largely stable to modestly growing, tied to HSV/HZ epidemiology and immunocompromised case mix.
• Revenue growth: capped by generics unless a specific region tightens supply or a formulation becomes the procurement standard.
• Share stability: acyclovir sodium likely maintains institutional relevance through established protocols, but share can erode at the margin where alternatives displace IV utilization.

Clinical development outlook: what is most likely?

Acyclovir sodium is an established therapy. New development is typically:

• formulation improvement,
• dosing convenience,
• or expanded use in specific patient populations.

A trial-by-trial update requires source-linked trial data, which is not present in the provided context.

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Key Takeaways

• Acyclovir sodium is an established, off-patent antiviral positioned mainly for systemic HSV/VZV care, including inpatient IV use.
• Market economics are driven by generic competition, procurement behavior, and route-specific utilization (IV vs oral).
• A quantitative clinical trials update and numeric market projection cannot be completed accurately without source-linked trial and market datasets.
• Near-term outlook is structurally stable for volume with revenue growth constrained by pricing and substitution.

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FAQs

1. Is acyclovir sodium still actively developed in clinical trials?
   Clinical trial activity can exist, but a trial-level update requires source-linked records by substance naming.

2. Does acyclovir sodium compete mainly with other antivirals or with other acyclovir products?
   It competes with both, but the strongest direct pressure is generic substitution among acyclovir formulations and route-specific alternatives in clinical protocols.

3. What factors determine acyclovir sodium IV demand?
   Hospital protocols, patient ability to take oral medication, severity of infection, renal dosing practices, and formulary procurement cycles.

4. What drives pricing for acyclovir sodium?
   Generic market supply, tender pricing, and payer or procurement substitution rules.

5. What is the biggest risk to revenue growth?
   Continued downward pricing from generic competition and clinical shifts that reduce IV utilization in favor of oral or alternative agents.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA database. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[3] World Health Organization. (n.d.). ATC/DDD Index. https://www.whocc.no/atc_ddd_index/