Last Updated: May 11, 2026

CLINICAL TRIALS PROFILE FOR PENICILLIN V POTASSIUM


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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
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Condition MeSH

Condition MeSH for PENICILLIN V POTASSIUM
Intervention Trials
Stomatitis, Aphthous 1
Stomatitis 1
Neoplasm Metastasis 1
Sepsis 1
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Clinical Trial Locations for PENICILLIN V POTASSIUM

Trials by Country

Trials by Country for PENICILLIN V 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 V POTASSIUM
Location Trials
New York 1
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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
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Clinical Trial Status

Clinical Trial Status for PENICILLIN V POTASSIUM
Clinical Trial Phase Trials
Withdrawn 1
Completed 1
Terminated 1
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Clinical Trial Sponsors for PENICILLIN V POTASSIUM

Sponsor Name

Sponsor Name for PENICILLIN V 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 V POTASSIUM
Sponsor Trials
Other 10
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PENICILLIN V POTASSIUM Market Analysis and Financial Projection

Last updated: May 6, 2026

PENICILLIN V POTASSIUM: Clinical Trials Update, Market Analysis, and Projection

What does the clinical-trials record show for Penicillin V potassium?

Penicillin V potassium is an established, off-patent antibacterial (oral phenoxymethyl penicillin) used for infections where penicillin is appropriate, including streptococcal pharyngitis and selected odontogenic/dental infections. It is not being developed in the modern “new molecular entity” pipeline style that produces large, drug-specific randomized trials with ongoing registrational datasets.

Clinical-trials activity (public registries):

  • There is no credible basis to describe a current, drug-specific late-stage (Phase 2-3) development program for “Penicillin V potassium” that would support a forward-looking “clinical trials update” in the sense used for pipeline assets.
  • Clinical activity around penicillin-class antibiotics in recent years is dominated by:
    • stewardship and comparative effectiveness studies,
    • narrow sub-questions such as dosing regimens or adherence,
    • and resistance surveillance, rather than development of a new formulation intended for regulatory expansion.

Bottom line: the clinical-trials “update” for Penicillin V potassium is best characterized as low-noise, registry-infrequent incremental studies rather than a pipeline with measurable, near-term regulatory catalysts.


What is the market structure for Penicillin V potassium?

Penicillin V potassium sits in a mature, generics-led segment of the oral penicillin market. Demand is driven by:

  • guideline-based use for susceptible organisms,
  • outpatient treatment patterns,
  • and payer preference for low-cost generics.

Because it is a widely available antibiotic:

  • Pricing is constrained by competitive generic supply,
  • Formularies typically list multiple interchangeable products,
  • and volume is sensitive to prescribing behavior, antimicrobial stewardship policies, and resistance dynamics.

How do regulatory and stewardship forces shape demand?

Demand for penicillin-class antibiotics is structurally influenced by:

  • stewardship programs that reduce unnecessary broad-spectrum prescribing,
  • local resistance patterns that shift prescribers toward alternatives when penicillin susceptibility declines,
  • and acute-care prescribing protocols for conditions like pharyngitis and dental infections.

This makes the market less about “launch momentum” and more about:

  • sustained formulary presence,
  • reliable supply (generic manufacturing continuity),
  • and competitive price discipline.

What market sizing is supportable for Penicillin V potassium?

No verifiable, product-specific market sizing dataset can be stated here for Penicillin V potassium as a standalone branded/generic SKU with a reliable methodology, since most public market sources report by broader antibiotic classes or by formulation groups without isolating this exact salt.

Actionable alternative: business analysis should treat Penicillin V potassium as part of the oral penicillin V / phenoxymethylpenicillin generic basket and evaluate:

  • total oral beta-lactam volume trends,
  • competitive pricing indices for generics,
  • and formulary share for “penicillin V” under outpatient formularies.

Given the requirement for hard data, a product-specific numeric market size and share projection is not deliverable in this format.


How should you project Penicillin V potassium’s outlook?

A credible projection for this asset uses scenario drivers tied to utilization, not “clinical catalysts.”

Key projection drivers (directional):

  • Prescribing volume: stabilizes at a baseline under stewardship with episodic variation by season and outbreak patterns in upper respiratory infections.
  • Resistance environment: shifts within regional susceptibility can cause substitution to other beta-lactams or non-penicillin antibiotics.
  • Generic pricing: tends to compress over time with entrants and manufacturing capacity; upside is limited unless supply disruptions tighten availability.
  • Switching risk: formulary substitutions are common within generics when pricing changes.

Projection implication: Penicillin V potassium is expected to follow a mature generic trajectory:

  • steady but not expanding growth,
  • revenue mostly influenced by price and formulary share rather than new indication uptake.

Competitive landscape: what matters in the real market

Because Penicillin V potassium is a generics product, competition is driven by:

  • unit cost,
  • availability (manufacturing continuity),
  • packaging/strength formats,
  • and payer/formulary listing.

Where to focus for investment or R&D decisions:

  • Supply-chain reliability and manufacturing scale for consistent market presence.
  • Formulation and compliance improvements (e.g., palatability and adherence) if pursued commercially.
  • Market access execution in outpatient formularies.
  • Quality and regulatory inspection outcomes for generic manufacturers.

Patent and exclusivity context (why “clinical trials update” is low-signal)

Penicillin V potassium is not an exclusivity-led asset; it is historical antibiotic chemistry with no practical pathway to incremental exclusivity that would resemble modern NDA/505(b)(2) development dynamics. As a result:

  • “Clinical trials update” does not typically map to patent term extension,
  • and there is no clear late-stage regulatory pipeline to anticipate.

Key Takeaways

  1. Penicillin V potassium has no credible current development pathway that would justify a Phase 2-3 “clinical trials update” with meaningful near-term regulatory catalysts.
  2. The market is generics-led and stewardship-sensitive, so revenue outlook tracks prescribing behavior, regional susceptibility, and price competition.
  3. Forward projections should be built on mature generic drivers (unit pricing, formulary share, supply continuity), not on new clinical milestones.

FAQs

1) Is Penicillin V potassium currently in Phase 2 or Phase 3 development?
No drug-specific late-stage development program with a definable timeline and registrational endpoints is supported by the accessible public trial record for the exact product.

2) What are the main clinical use cases?
Oral treatment of susceptible infections, commonly including streptococcal pharyngitis and selected dental/odontogenic infections where penicillin V is appropriate.

3) What most affects demand: resistance or stewardship?
Stewardship affects prescribing decisions; resistance affects whether penicillin remains the preferred option once clinicians select an empiric or targeted therapy.

4) How do generics shape pricing for Penicillin V potassium?
Generic competition typically compresses price over time; revenue variability is more driven by formulation availability and formulary placement than by product differentiation.

5) What is the most actionable growth lever for this asset class?
Maintain supply reliability and formulary access; incremental value comes from competitive unit cost and dependable market presence rather than clinical expansion.


References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
[2] World Health Organization. (2018). The WHO model list of essential medicines: 20th list. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2018-06
[3] Centers for Disease Control and Prevention. (n.d.). Antibiotic use and stewardship resources. https://www.cdc.gov/antibiotic-use/index.html

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