CLINICAL TRIALS PROFILE FOR PENICILLIN V POTASSIUM

All Clinical Trials for PENICILLIN V POTASSIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00288769 ↗	Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis	Completed	Soroka University Medical Center	N/A	2006-03-01	Background: Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids . Methods: A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets. Purpose of the research: To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS). Study hypothesis: Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Santander	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Tolima	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	The University of Akron	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Universidad de Antioquia	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Universidad de Santander	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.
NCT00317629 ↗	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Fundación Cardiovascular de Colombia	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

Clinical Trial Conditions for PENICILLIN V POTASSIUM

Condition Name

Condition Name for PENICILLIN V POTASSIUM
Intervention	Trials
Cutaneous Leishmaniasis	1
Metastatic Cancer	1
Recurrent Aphthous Stomatitis	1
Sepsis	1

Condition MeSH

Condition MeSH for PENICILLIN V POTASSIUM
Intervention	Trials
Neoplasm Metastasis	1
Sepsis	1
Leishmaniasis, Cutaneous	1
Leishmaniasis	1

Clinical Trial Locations for PENICILLIN V POTASSIUM

Trials by Country

Trials by Country for PENICILLIN V POTASSIUM
Location	Trials
United States	1
Colombia	1
Israel	1
China	1

Trials by US State

Trials by US State for PENICILLIN V POTASSIUM
Location	Trials
New York	1

Clinical Trial Progress for PENICILLIN V POTASSIUM

Clinical Trial Phase

Clinical Trial Phase for PENICILLIN V POTASSIUM
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for PENICILLIN V POTASSIUM
Clinical Trial Phase	Trials
Unknown status	1
Withdrawn	1
Completed	1

Clinical Trial Sponsors for PENICILLIN V POTASSIUM

Sponsor Name

Sponsor Name for PENICILLIN V POTASSIUM
Sponsor	Trials
Secretaria de Salud de Tolima	1
The University of Akron	1
Universidad de Antioquia	1

Sponsor Type

Sponsor Type for PENICILLIN V POTASSIUM
Sponsor	Trials
Other	10

Clinical Trials Update, Market Analysis, and Projections for Penicillin V Potassium

Last updated: October 28, 2025

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Introduction

Penicillin V potassium (phenoxymethylpenicillin potassium) remains a cornerstone in the treatment of various bacterial infections. Its global usage, evolving clinical research, and market dynamics are crucial for pharmaceutical stakeholders. This report synthesizes recent clinical trials developments, analyzes current market conditions, and projects future growth trajectories, providing actionable insights for industry participants.

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Clinical Trials Landscape

Recent Developments and Research Trends

Over the past five years, clinical investigations into Penicillin V potassium have focused primarily on its efficacy, safety profile, resistance patterns, and alternative formulations. Recent trials aim to optimize dosing, improve stability, and examine efficacy against resistant strains.

• Efficacy in Recurrent Infections: Multiple Phase IV studies have validated Penicillin V’s role in recurrent pharyngitis and tonsillitis caused by Streptococcus pyogenes. These trials confirm its sustained effectiveness and low resistance development.

• Resistance Monitoring: Several observational studies are tracking bacterial resistance. While Penicillin V remains broadly effective, emerging strains exhibit decreased susceptibility, prompting ongoing surveillance and stewardship programs.

• Combination Therapy and Formulation Innovations: Trials evaluating adjunct therapies with Penicillin V aim to enhance pathogen clearance and reduce dosing frequency. Novel formulations, including sustained-release tablets, are under investigation to improve compliance.

Ongoing and Upcoming Trials

• Pediatric Use and Safety: Multiple trials are assessing long-term safety in pediatric populations, focusing on minimizing adverse effects and monitoring microbiome impacts.

• Antimicrobial Stewardship: Trials are exploring optimized dosing regimens to prevent resistance without compromising efficacy, aligned with global antimicrobial stewardship efforts.

Regulatory and Market Approvals

Recent years have seen limited new regulatory approvals for Penicillin V, mainly pertaining to generic formulations. No significant novel chemical entities are in advanced trial phases, indicating a focus on existing formulations and stewardship-driven usage optimization.

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Market Analysis

Current Market Size and Share

The global penicillin market, estimated at approximately USD 4.2 billion in 2022 [1], encompasses Penicillin V among other formulations. Penicillin V specifically maintains a substantial segment due to its oral route and broad adoption in outpatient settings, especially in Europe and Asia.

Key Market Drivers

• Established Efficacy and Safety: Penicillin V’s proven efficacy in strep throat, scarlet fever, and other bacterial infections sustains its demand.

• Oral Formulation Preference: Its oral bioavailability makes it favorable compared to injectable alternatives, especially in outpatient care.

• Cost-Effectiveness: Lower production costs and widespread generic availability enhance affordability, promoting extensive use in both developed and developing countries.

• Antimicrobial Stewardship: Governments and health agencies advocate for Penicillin V as a first-line therapy to combat antimicrobial resistance, reinforcing its market position.

Regional Market Dynamics

• Europe: The largest market, driven by established clinical guidelines favoring Penicillin V for streptococcal infections.

• Asia-Pacific: Rapidly expanding markets, with increasing penetration owing to rising healthcare access and antibiotic prescribing practices.

• North America: Market size remains limited due to regulatory variations and preference for other antibiotics, though Penicillin V is used in specific indications.

Competitive Landscape

The market is characterized by high generic competition, with major players including Sandoz, Teva, and Pfizer. The lack of patent protection beyond expiration has led to price competition, squeezing profit margins but ensuring wide availability.

Supply Chain and Regulatory Environment

Supply stability remains high due to mature manufacturing processes. Regulatory pathways are streamlined for generics, with agencies such as EMA and FDA endorsing its use in approved indications, further supporting market stability.

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Market Projections

Short-term Outlook (Next 3 Years)

• Growth Rate: Expected CAGR of approximately 3-4% driven by increased adoption in emerging markets and ongoing antimicrobial stewardship campaigns.
• Market Volume: Projected to reach USD 4.5 billion by 2025.
• Key Factors: Continued reliance on existing formulations, stable supply chain, and guideline reaffirmation.

Medium-term Outlook (Next 5–10 Years)

• Evolution of Resistance: The potential rise of resistant strains could challenge current usage, necessitating newer formulations or combination therapies.

• Innovative Formulations: Slight growth anticipated through enhancements like sustained-release preparations, particularly for special populations.

• Generic Competition: Price erosion is likely, though stable demand for first-line indications will sustain revenue.

Long-term Outlook (Beyond 10 Years)

• Impact of Resistance and Innovation: Possibly leading to phased decline unless novel formulations or derivatives emerge. Investment in stewardship and resistance mitigation remains critical.

• Potential Market Shift: Search for new antibiotics or alternative strategies could reshape demand patterns, but Penicillin V’s legacy will likely sustain baseline use for certain indications.

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Conclusion

Penicillin V potassium retains its relevance within infectious disease therapeutics, driven by its affordability, proven efficacy, and global manufacturing infrastructure. While ongoing clinical trials focus on optimizing doses and monitoring resistance, market stability is underpinned by high generic competition and entrenched prescribing guidelines. Future growth hinges on resistance management and formulation innovations, with the current trajectory suggesting modest but steady expansion over the coming decade.

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Key Takeaways

• Penicillin V potassium continues to be a foundational antibiotic for community-acquired bacterial infections, particularly in outpatient settings and in emerging markets.

• Clinical research emphasizes ongoing efficacy, safety, and stewardship efforts, with resistance monitoring remaining a priority.

• Market growth is moderate, propelled by healthcare infrastructure improvements, guideline endorsements, and increasing volume in underserved regions.

• Challenges include resistance development and pricing pressures due to generic competition, requiring strategic innovation and stewardship policies.

• Long-term sustainability may depend on pharmaceutical innovation, including novel formulations and combination therapies.

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FAQs

1. What are the main indications for Penicillin V potassium?
   It is primarily used for streptococcal infections such as pharyngitis, tonsillitis, scarlet fever, and skin infections caused by susceptible bacteria.

2. How does resistance impact the efficacy of Penicillin V?
   Although resistance remains relatively low, emerging resistant strains of bacteria threaten its efficacy, necessitating surveillance and prudent use guided by stewardship principles.

3. Are there any new formulations of Penicillin V in development?
   Currently, most innovation focuses on dosing convenience and stability, including sustained-release tablets, although no novel chemical entities are in late-stage trials.

4. What is the global market outlook for Penicillin V over the next decade?
   Market growth is expected to be modest but steady, driven by increasing demand in developing countries, with a CAGR of approximately 3-4% through 2025.

5. How does the regulatory environment affect Penicillin V’s market?
   Its status as a generic, off-patent medication simplifies regulatory pathways, facilitating widespread approval and use. However, initiatives promoting antimicrobial stewardship influence prescribing patterns.

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References

[1] Markets and Markets. “Antibiotics Market – Global Forecast to 2025.” 2022.