CLINICAL TRIALS PROFILE FOR PENICILLIN G POTASSIUM

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.
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.

Clinical Trial Conditions for penicillin g potassium

Condition Name

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

Condition MeSH

Condition MeSH for penicillin g potassium
Intervention	Trials
Sepsis	1
Leishmaniasis, Cutaneous	1
Leishmaniasis	1
Stomatitis, Aphthous	1

Clinical Trial Locations for penicillin g potassium

Trials by Country

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

Trials by US State

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

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

Clinical Trial Status

Clinical Trial Status for penicillin g potassium
Clinical Trial Phase	Trials
Terminated	1
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for penicillin g potassium

Sponsor Name

Sponsor Name for penicillin g potassium
Sponsor	Trials
The University of Akron	1
Universidad de Antioquia	1
Universidad de Santander	1

Sponsor Type

Sponsor Type for penicillin g potassium
Sponsor	Trials
Other	10

Penicillin g potassium Market Analysis and Financial Projection

Last updated: April 28, 2026

Penicillin G Potassium: Clinical-Stage Update, Market Read, and Projection

What is the current clinical trial landscape for penicillin G potassium?

Penicillin G potassium (benzylpenicillin potassium) is an older, widely used antibiotic with long-established clinical use. Public, drug-level clinical trial tracking for “penicillin G potassium” specifically is limited because trials are typically conducted under older INNs/brands, combination products, or in contexts that do not list the active as “penicillin G potassium” as a stand-alone entry.

What can be stated from available public registries:

• Ongoing interventional studies for “penicillin G potassium” specifically are not consistently identifiable at a level that supports a complete, drug-only clinical update.
• Most modern clinical research activity involving benzylpenicillin occurs under broader “benzylpenicillin” or “penicillin” entries, or focuses on resistance surveillance, stewardship, pharmacokinetics, or special populations, rather than new registrational trials for the potassium salt as a standalone product.

Practical implication for R&D and investment: penicillin G potassium is not being advanced through a recognizable, active “registrational” pipeline under that exact product name in standard trial registries. Commercial activity is therefore driven primarily by generic supply, distribution, and hospital formulary dynamics rather than by new clinical development milestones.

What does the market look like today for penicillin G potassium?

Penicillin G potassium is a mature generic antibiotic used largely in hospital settings and in specific clinical indications where benzylpenicillin remains preferred or guideline-directed. The market behaves like other older injectable antibiotics: demand is steady but price is volatile, and supply is shaped by manufacturing capacity and regulatory/quality events.

Demand drivers

• Hospital and institutional procurement (injection administration).
• Targeted clinical use tied to organism susceptibility and guideline recommendations.
• Use in targeted settings (for example, streptococcal and select other susceptible infections) where benzylpenicillin retains clinical fit.

Supply dynamics

• Many products are generic and substitutable by molecule rather than brand.
• Manufacturing scale and sterility/quality compliance drive availability.
• Global supply can be influenced by API production concentration and batch release constraints, leading to periodic shortfalls.

Pricing and payer pressure

• Generic antibiotics face sustained pricing pressure in most markets.
• Formularies and group purchasing organizations drive contracted procurement volumes.
• Substitution policies and therapeutic equivalence reduce price dispersion across suppliers.

Regulatory positioning

• Penicillin G potassium is a known active ingredient with long product histories and established labeling pathways through generic review.
• Entry barriers are mostly manufacturing-quality and regulatory compliance, not R&D risk.

Net market characterization

• Mature, procurement-led, institution-driven market.
• Volume is tied to stewardship and susceptibility patterns.
• Growth is constrained; change comes mostly from price, access, and supply stability rather than new clinical adoption.

How large is the opportunity and how should it be projected?

A rigorous, investment-ready forecast requires product-level sales data by geography, dosage form, and strength, plus clear visibility on generic entry and supply continuity. In the absence of those product-granular inputs, the only defensible projection approach is a scenario built from high-level market behavior of older generic injectables (pricing erosion, steady demand, episodic supply).

Because no product-level baseline sales for “penicillin G potassium” is provided here, the most actionable projection is a directional model grounded in generic antibiotic market structure:

Projection framework (directional, decision-useful)

• Base year: steady-to-mildly declining unit economics due to generic competition.
• Volume: stable to modestly up/down depending on infection epidemiology and stewardship.
• Net revenue: typically declines faster than units because pricing compresses.
• Upside: supply constraints or quality issues reduce competition temporarily and lift contracted pricing.
• Downside: increased generic supply or payer tender pressure pushes pricing down.

What this means for a 3-to-5-year outlook

• Penicillin G potassium is likely to remain a “steady demand, low growth” asset class within hospital antibiotics.
• Revenue growth, if any, is more likely to come from supply-driven pricing and contracting than from expanding clinical use.

Competitive and substitution reality

• The substitution threat is high because multiple benzylpenicillin formulations exist.
• Differentiation comes from reliability of supply, stability of pricing in tenders, and product quality records.

Where are the practical clinical-use boundaries today?

For mature antibiotics, “clinical trial updates” translate into “clinical practice updates”:

• Treatment depends on pathogen susceptibility and local resistance patterns.
• Hospital protocols often prioritize narrow-spectrum penicillins when indicated to reduce broader-spectrum antibiotic use.
• PK/PD considerations continue to matter for dosing schedules, but they usually do not translate into new drug development for the potassium salt.

Resistance and stewardship

• Resistance trends for penicillin-susceptible organisms drive usage patterns and can shift prescribing behavior.
• Stewardship efforts in hospitals can both reduce unnecessary use and reinforce guideline-directed use where benzylpenicillin is appropriate.

Regulatory and patent position: what does this mean for exclusivity?

Penicillin G potassium is not positioned for meaningful patent-driven exclusivity in most markets. It behaves as a classic generic antibiotic: companies compete on manufacturing, regulatory status, and contract procurement.

Implication

• If you underwrite this asset, the key variable is not a trial endpoint. It is supply reliability and cost structure across manufacturing and QA/QC.

Business takeaways for R&D, manufacturing, and commercial strategy

Even without an active registrational pipeline under the exact product name, penicillin G potassium can still be strategically relevant:

• Manufacturing advantage matters. Batch consistency, sterility assurance, and regulatory track record often determine procurement awards.
• Tender readiness wins. Hospital contracts prioritize delivery reliability and compliance history.
• Portfolio fit matters. As an older injectable antibiotic, it often functions as part of an institutional antibiogram and stewardship pathway.
• Operational risk is the swing factor. Quality events and supply outages can temporarily reprice the market.

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Key Takeaways

1. Penicillin G potassium is a mature antibiotic with limited evidence of ongoing registrational-stage clinical development under that specific product naming.
2. The market is procurement-driven, generic/substitutable, and sensitive to pricing tenders and supply stability.
3. Forecasting should treat growth as low and revenue changes as supply and pricing driven rather than trial-driven.
4. Competitive differentiation is operational: manufacturing reliability, regulatory standing, and contracting performance.

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FAQs

1) Is penicillin G potassium currently in late-stage clinical trials?

No clear, drug-only evidence indicates a late-stage, registrational pipeline specifically for penicillin G potassium under that exact product naming in standard public trial listings.

2) What primarily drives market demand for penicillin G potassium?

Hospital and institutional procurement for guideline-directed use in susceptible infections, with stewardship and antibiogram changes shaping volume.

3) How do prices typically behave for mature generic injectables like penicillin G potassium?

Prices usually erode over time under generic competition, with temporary repricing possible during supply constraints or tender cycles.

4) What are the main competitive risks?

Supply expansions by other generics, tender-based pricing pressure, and manufacturing or quality disruptions.

5) What is the most important commercial KPI?

On-time delivery and batch availability through tenders, tied to regulatory compliance and manufacturing throughput.

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References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. https://clinicaltrials.gov/
[2] European Medicines Agency. Medicines. https://www.ema.europa.eu/en/medicines
[3] World Health Organization. Antimicrobial resistance and stewardship resources. https://www.who.int/health-topics/antimicrobial-resistance