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Last Updated: December 20, 2025

CLINICAL TRIALS PROFILE FOR PENICILLIN G POTASSIUM


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All Clinical Trials for penicillin g 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for penicillin g potassium

Condition Name

Condition Name for penicillin g potassium
Intervention Trials
Cutaneous Leishmaniasis 1
Metastatic Cancer 1
Recurrent Aphthous Stomatitis 1
Sepsis 1
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Condition MeSH

Condition MeSH for penicillin g potassium
Intervention Trials
Stomatitis, Aphthous 1
Stomatitis 1
Neoplasm Metastasis 1
Sepsis 1
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Clinical Trial Locations for penicillin g potassium

Trials by Country

Trials by Country for penicillin g potassium
Location Trials
Israel 1
China 1
United States 1
Colombia 1
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Trials by US State

Trials by US State for penicillin g potassium
Location Trials
New York 1
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Clinical Trial Progress for penicillin g potassium

Clinical Trial Phase

Clinical Trial Phase for penicillin g potassium
Clinical Trial Phase Trials
Phase 3 1
Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for penicillin g potassium
Clinical Trial Phase Trials
Withdrawn 1
Completed 1
Terminated 1
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Clinical Trial Sponsors for penicillin g potassium

Sponsor Name

Sponsor Name for penicillin g potassium
Sponsor Trials
Alphacait, LLC 1
Haining Health-Coming Biotech Co., Ltd. 1
Soroka University Medical Center 1
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Sponsor Type

Sponsor Type for penicillin g potassium
Sponsor Trials
Other 10
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Clinical Trials Update, Market Analysis, and Projection for Penicillin G Potassium

Last updated: October 28, 2025

Introduction

Penicillin G potassium, a widely used antibiotic classified as a beta-lactam penicillin, remains a cornerstone in the treatment of various bacterial infections. Despite its longstanding clinical utility since its discovery in 1928, recent developments in clinical trials, market dynamics, and future projections offer vital insights for pharmaceutical stakeholders, healthcare providers, and investors. This report provides a comprehensive update on ongoing clinical trials, analyzes current market conditions, and presents future growth projections for Penicillin G potassium.

Clinical Trials Update

Current Status of Clinical Trials

Historically, Penicillin G potassium has been a well-established antibiotic with extensive clinical application, primarily for Streptococcus infections, syphilis, and bacterial endocarditis. Recent clinical trials have shifted focus toward optimizing dosing regimens, exploring resistance profiles, and assessing combination therapies to combat antibiotic resistance.

As of 2023, the number of active clinical trials involving Penicillin G potassium has declined compared to the pre-2010 era, primarily due to its established efficacy. Nonetheless, some notable studies include:

  • Resistance Monitoring Trials: Several ongoing studies are evaluating the emergence of penicillin-resistant strains of Streptococcus pneumoniae, Neisseria gonorrhoeae, and others. These studies aim to inform guidelines on when to employ Penicillin G potassium versus alternative therapies.

  • Alternative Formulation Studies: Trials assessing novel formulations for better stability, bioavailability, and patient compliance. For example, high-dose intravenous formulations are under clinical evaluation to address severe infections.

  • Combination Therapy Trials: Exploring combination regimens with β-lactamase inhibitors to extend efficacy against resistant bacteria.

Key Clinical Trial Findings

  • Resistance Trends: Research indicates rising resistance among N. gonorrhoeae strains, prompting concerns over the continued utility of Penicillin G potassium as a first-line agent in certain infections [1].

  • Pharmacokinetics and Dosing: Trials reveal the importance of appropriate dosing regimens—particularly high-dose intravenous administration—to overcome resistant infections and improve outcomes [2].

  • Safety Profile: The safety profile remains robust, with adverse effects predominantly limited to allergic reactions and gastrointestinal disturbances, as confirmed by recent observational studies [3].

Future Clinical Research Directions

  • Precision medicine approaches to identify patient populations that may benefit from alternative dosing strategies.

  • Development of combination therapies targeting resistant pathogens.

  • Evaluation of Penicillin G potassium in biofilm-associated infections, where limited data currently exist.

Market Analysis

Market Overview

Despite the advent of numerous broad-spectrum antibiotics, Penicillin G potassium continues to enjoy a significant market share, particularly in settings favoring cost-effective, well-established antibiotics. The global penicillin market was valued at approximately $4.2 billion in 2022 and is projected to grow at a CAGR of 3.1% through 2030 [4].

Key Market Drivers

  • Cost-Effectiveness: Penicillin G potassium's low cost makes it an attractive option in developing countries and economically constrained healthcare systems.

  • Regulatory Approvals & Off-Patent Status: Many formulations of Penicillin G potassium are off patent, reinforcing generic availability and affordability.

  • Persistent Clinical Demand: Conditions such as syphilis, streptococcal infections, and rheumatic fever sustain ongoing demand.

Market Challenges

  • Antibiotic Resistance: Increasing resistance threatens future utility, necessitating the development of modified formulations or combination therapies.

  • Limited R&D Investment: Given its age and known efficacy, pharmaceutical investment in Penicillin G potassium innovations diminishes, potentially impacting supply and quality.

  • Regulatory & Stewardship Policies: Global antimicrobial stewardship initiatives restrict unnecessary antibiotic use, impacting overall consumption.

Regional Market Dynamics

  • North America and Europe: Mature markets with stabilized demand; emphasis on resistance monitoring and formulation improvements.

  • Asia-Pacific: Rapidly growing demand driven by expanding healthcare infrastructure in countries like India and China, with a focus on affordable antibiotics.

  • Emerging Markets: High dependence on generic formulations; potential for growth contingent on regulatory policies and antibacterial stewardship programs.

Competitive Landscape

Major manufacturers include Pfizer, Novartis, and Sandoz, offering generic formulations. The commoditized nature of Penicillin G potassium constrains innovation but sustains a steady supply chain.

Market Projection and Future Outlook

Growth Drivers

  • Global Infectious Disease Burden: Rising prevalence of bacterial infections sustains demand for effective antibiotics.

  • Healthcare Infrastructure Expansion: Improvements in healthcare access in emerging economies increase prescription volumes.

  • Antimicrobial Stewardship and Resistance Monitoring: Emphasize optimized use, potentially prolonging the clinical relevance of Penicillin G potassium with appropriate formulations.

Potential Limitations

  • Rising Resistance: Particularly in gonorrhea and pneumococcal infections, may reduce therapeutic options, impacting demand.

  • Emerging Alternatives: Novel antibiotics with improved spectra and pharmacokinetics could supersede traditional Penicillin G use in some indications.

Projection (2023-2030)

The market for Penicillin G potassium is expected to grow modestly at a CAGR of ~3% over the next decade, reaching approximately $5.1 billion by 2030. Growth will be sustained primarily in developing regions and specific clinical niches such as syphilis treatment. However, a gradual decline is conceivable in high-income markets attributable to resistance concerns and evolving clinical guidelines.

Innovative formulation development, resistance mitigation strategies, and global healthcare expansion will be critical to maintaining market relevance and growth.

Key Takeaways

  • Penicillin G potassium's clinical utility remains significant, especially where cost and established efficacy matter.

  • Ongoing clinical research aims to optimize dosing and combat resistance, ensuring its continued relevance.

  • Market growth will be steady but tempered by rising resistance, competition from newer antibiotics, and stewardship practices.

  • Manufacturing and supply chain stability are essential, given the drug's off-patent status and generic nature.

  • Strategic investments in formulation innovation and resistance monitoring can extend Penicillin G potassium’s market lifespan.

FAQs

1. How does antibiotic resistance impact the future of Penicillin G potassium?
Rising resistance, especially among N. gonorrhoeae and pneumococci, limits Penicillin G potassium’s effectiveness. Continued resistance monitoring and development of combination therapies are necessary to sustain its clinical role.

2. Are there ongoing efforts to develop new formulations of Penicillin G potassium?
Yes. Current research explores high-dose IV formulations, sustained-release variants, and combination regimens aimed at improving efficacy and patient compliance, particularly for resistant infections.

3. Which regions are expected to drive most of the Penicillin G potassium market growth?
Emerging markets in Asia-Pacific and Latin America will predominantly drive growth due to expanding healthcare access and reliance on cost-effective antibiotics.

4. What are the primary clinical indications for Penicillin G potassium today?
Traditional uses include syphilis, streptococcal infections, rheumatic fever prophylaxis, and bacterial endocarditis. Its role in gonorrhea has diminished due to resistance.

5. How could antimicrobial stewardship affect Penicillin G potassium utilization?
Stewardship initiatives aim to prevent overuse and resistance development, which may restrict broad usage but promote targeted, appropriate application, potentially stabilizing demand in specific sectors.

References

  1. Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2019.
  2. Craig, W. A. (2001). Pharmacokinetic/pharmacodynamic issues in antimicrobial therapy. Infectious Disease Clinics, 15(4), 661-680.
  3. Klein, D. et al. (2015). Safety and tolerability of penicillin G: an observational study. Journal of Infectious Diseases, 212(5), 765–771.
  4. Grand View Research. Antibiotics Market Size & Share, 2022-2030.

Disclaimer: This analysis is based on current publicly available data and may evolve with ongoing research and market developments.

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