CLINICAL TRIALS PROFILE FOR PENICILLIN G SODIUM

All Clinical Trials for PENICILLIN G SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00615797 ↗	Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea	Completed	Natal Bioproducts Institute	N/A	2002-05-01	Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also "attack" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which "mop up" the antibodies may reverse or improve affected children. This study hopes to clarify this.

Clinical Trial Conditions for PENICILLIN G SODIUM

Condition Name

Condition Name for PENICILLIN G SODIUM
Intervention	Trials
Breast Cancer	1
Sepsis	1
Colorectal Cancer	1
Steroid Injection	1

Condition MeSH

Condition MeSH for PENICILLIN G SODIUM
Intervention	Trials
Surgical Wound Infection	2
Pulpitis	1
Colorectal Neoplasms	1
Colitis	1

Clinical Trial Locations for PENICILLIN G SODIUM

Trials by Country

Trials by Country for PENICILLIN G SODIUM
Location	Trials
United States	13
Egypt	2
Iraq	1
Brazil	1
South Africa	1

Trials by US State

Trials by US State for PENICILLIN G SODIUM
Location	Trials
Washington	1
Tennessee	1
Oregon	1
Nebraska	1
Missouri	1

Clinical Trial Progress for PENICILLIN G SODIUM

Clinical Trial Phase

Clinical Trial Phase for PENICILLIN G SODIUM
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for PENICILLIN G SODIUM
Clinical Trial Phase	Trials
Completed	6
Terminated	3
Unknown status	2

Clinical Trial Sponsors for PENICILLIN G SODIUM

Sponsor Name

Sponsor Name for PENICILLIN G SODIUM
Sponsor	Trials
The University of Akron	1
Federal University of São Paulo	1
Universidad de Antioquia	1

Sponsor Type

Sponsor Type for PENICILLIN G SODIUM
Sponsor	Trials
Other	20
Industry	1

Penicillin G Sodium Clinical Trials Update, Market Analysis and Exclusivity Outlook

Last updated: July 28, 2026

Penicillin G sodium is an off-patent, widely manufactured β-lactam antibiotic used for hospitalized treatment of susceptible bacterial infections. No meaningful patent or FDA exclusivity “timeline” drives market entry for penicillin G sodium; competitive supply is primarily constrained by manufacturing capacity, sterility/scale-up performance, and contracting dynamics rather than regulatory exclusivity. Clinical-trial activity is limited and tends to center on formulation stability, quality systems, and comparative clinical outcomes in specific infection syndromes rather than new therapeutic classes.

What clinical trials are currently active for penicillin G sodium, and what do they target?

Answer: Active clinical trials for penicillin G sodium are uncommon in large-scale registries. When studies appear, they usually target specific infection categories (for example, streptococcal infections, syphilis-related regimens in historical contexts, aspiration or pneumonia subtypes, endocarditis protocols) or focus on practical endpoints such as microbiologic eradication, safety in complex populations, and pharmacokinetic or dosing comparisons rather than brand-new indications.

What trial types show up most for older antibiotics like penicillin G sodium?

1. Dosing or PK/PD trials
   Typical endpoints include serum concentrations, time above MIC, and microbiologic outcomes in defined organisms (often streptococci and susceptible Gram-positive bacteria).
2. Comparative effectiveness in standard-of-care infection pathways
   Trials may compare penicillin G sodium regimens against other established β-lactams for susceptible pathogens in hospital protocols.
3. Safety and special population studies
   Renal impairment dosing, pediatrics, pregnancy-related safety monitoring, and allergy risk management are common topics for small studies.

How to read a “clinical trials update” for penicillin G sodium

For an off-patent antibiotic, trials do not usually create exclusivity. Use the trial mix to infer:

• Which hospitals keep penicillin G sodium on formulary for current standard regimens.
• Which manufacturers sponsor bioequivalence/quality work that supports uninterrupted supply.
• Where stewardship pressure exists due to resistance patterns, de-escalation guidelines, or formulary preferences for narrower spectrum agents.

How big is the penicillin G sodium market, and what is the revenue outlook by region?

Answer: Penicillin G sodium is part of the broader “injectable penicillin” segment. Revenue is driven by hospital and payer purchasing for acute infections, especially where formulary guidelines favor β-lactams for susceptible organisms. The market outlook is less about growth from new approvals and more about maintaining demand through stewardship and contracting, plus price and availability cycles.

Market drivers

• Hospital utilization for susceptible bacterial infections and empiric-to-targeted therapy pathways.
• Stewardship policies that keep narrow β-lactams in rotation when susceptibility data supports use.
• Formulary conversion between penicillin G sodium and alternative penicillin/cephalosporin options based on procurement cost and supply reliability.

Market constraints

• Global manufacturing capacity for sterile injectable penicillins.
• Quality and sterility compliance risk in bulk production and aseptic filling.
• Price compression from high generic penetration and ongoing tender-based purchasing.

Regional dynamics likely to matter most

• U.S.: Contract and tender pricing, formulary inclusion in inpatient systems, and consistent availability. Growth is mostly volume maintenance rather than premium pricing.
• Europe: Similar hospital contracting dynamics, with strong protocol adherence and procurement standardization.
• Emerging markets: Volume is sensitive to supply stability and procurement costs; penetration depends on distribution reach and inventory management.

When does penicillin G sodium lose exclusivity, and is there any patent tail risk?

Answer: Penicillin G sodium has no relevant modern exclusivity term that would delay generic competition. The compound and core use are long-established and not protected by active, enforceable product exclusivity in the typical sense that governs injectable small molecules.

What this means for commercialization

• Patent tail risk is not the key factor for market access.
• Regulatory pathway risk is low because penicillin G sodium is already represented by numerous ANDA-approved or locally authorized equivalents historically.
• Business risk is supply-side: manufacturing constraints, compliance issues, and batch-to-batch release timelines.

What patents protect penicillin G sodium today, and how strong is the patent estate?

Answer: For penicillin G sodium as a molecule, there is no active, widely recognized patent estate that would block generic entry for conventional injectable penicillin G sodium presentations.

Where patent protection may exist in practice

Even for off-patent actives, patentable elements can still appear around:

• Specific manufacturing methods or crystallization/purification refinements.
• Specific formulations tied to stability or reconstitution characteristics for a particular branded presentation.
• Method-of-use protocols in narrow disease settings, though these are less common for penicillin G sodium compared with newer classes.

Actionable interpretation for investors and licensees

• Treat penicillin G sodium as a manufacturing and supply-chain opportunity, not a new-IP licensing opportunity.
• Evaluate competitors primarily on capacity, fill-finish capabilities, sterility release performance, and cost structure, not on “freedom to operate” for the active itself.

What is the Orange Book status of penicillin G sodium, and how does it affect generic entry?

Answer: Penicillin G sodium is generally expected to have an Orange Book footprint dominated by older listings or multiple generic approvals. For market access, the key effect is that generic competition is already established, so new entry focuses on manufacturing approval, label conformance, and pricing/tender readiness rather than exclusivity leverage.

Commercial implications of Orange Book saturation

• Entry barriers are low from an IP perspective.
• Differentiation is operational: lead times, availability guarantees, and contract compliance (such as preferred distributor relationships).

What generic entry risks exist for penicillin G sodium?

Answer: For penicillin G sodium, the main “entry risk” is operational and regulatory-quality related rather than IP. The dominant risks include:

• Sterile injectable manufacturing disruptions
• Batch rejection risk
• Reconstitution/stability documentation requirements
• Cold-chain or storage compliance at distribution level where relevant to specific labeled presentations

What to monitor

• Manufacturer inspection outcomes and warning letter history affecting sterile penicillin production.
• Supplier concentration within hospital procurement networks.
• Tender price resets that can destabilize supply economics for marginal producers.

How does penicillin G sodium compare with other injectable penicillins and β-lactams?

Answer: Penicillin G sodium is typically compared within hospital protocols against:

• Penicillin VK (oral) for non-severe or outpatient sequences
• Other penicillins (such as nafcillin in some settings, where applicable)
• Cephalosporins (often used for broader Gram-negative coverage needs)
• Anti-staphylococcal agents where resistance patterns change empiric therapy

Competitive positioning in formularies

Penicillin G sodium stays relevant when:

• The organism spectrum is favorable.
• Stewardship policies support narrow β-lactams for susceptible infections.
• Procurement cost and reliability are competitive.

What patent litigation affects penicillin G sodium?

Answer: Patent litigation is not a prominent feature for penicillin G sodium commercialization. The market structure is dominated by generic supply rather than infringement battles over active-molecule patents.

Where litigation could still arise

• Disputes over specific formulation manufacturing claims
• Contested labeling or bioequivalence documentation disputes
• Procedural litigation in limited scenarios

What is the FDA regulatory status of penicillin G sodium?

Answer: Penicillin G sodium is an established FDA-regulated prescription antibiotic with multiple authorized generic products. FDA oversight is primarily about:

• Sterility assurance in injectable manufacturing
• Labeling accuracy for indication, dosing, and reconstitution/stability

How regulatory status translates into market access

• If a product is already FDA-approved or within the established generic ecosystem, the practical bottleneck is not “approval exclusivity.” It is sustained compliance and consistent batch release.

Market projection for penicillin G sodium: base case, down case, and up case

Answer: The projection profile is supply-driven with price compression. The base case assumes stable volume at hospitals with modest real growth constrained by generic pricing pressure; the down case assumes intermittent supply disruptions or manufacturing compliance issues; the up case assumes stronger substitution into protocols due to procurement economics or resistance-guided β-lactam preference.

Base case (most likely)

• Stable demand from inpatient acute infection treatment pathways.
• Flat-to-low net revenue growth from price decreases offset partly by volume stability.
• No IP-driven step-function change in market structure.

Down case

• Supply interruptions from sterile manufacturing disruptions.
• Higher batch rejection rates or prolonged quality remediation at key suppliers.
• Contracting shifts to alternative β-lactams, reducing penicillin G sodium utilization.

Up case

• Improved supply reliability from expanded sterile capacity.
• Procurement-driven substitution where penicillin G sodium clears tender pricing.
• Greater protocol adherence in susceptible infection pathways.

Which companies supply penicillin G sodium, and what is the competitive landscape?

Answer: Supply is typically concentrated among major sterile injectable manufacturers and multiple generic firms with penicillin capacity. The competitive landscape behaves like a commodity hospital injectable: pricing is tender-led, differentiation is reliability and release performance.

How to benchmark suppliers

• Historical availability (stockout frequency and lead times)
• Inspection and compliance history for sterile injectable production lines
• Distribution footprint to support hospital system procurement
• Portfolio adjacency (ability to flex production between penicillin products)

Key takeaways

• Penicillin G sodium operates as an off-patent, high-generic-penetration injectable antibiotic where clinical trial activity is limited and exclusivity is not a commercialization lever.
• Market outlook is primarily supply-chain and contracting driven, not IP-driven.
• Revenue growth is constrained by price compression and stabilized by volume continuity in hospital protocols.
• Primary business risks cluster around sterile manufacturing reliability, quality compliance, and batch release continuity.

FAQs

1. Why does penicillin G sodium market pricing move sharply in tender cycles?
2. Which infection guidelines most influence penicillin G sodium hospital demand?
3. How do manufacturing and sterility compliance requirements affect availability of injectable penicillin G products?
4. What are the most common microbiology and safety endpoints used in small penicillin G sodium clinical studies?
5. How do stewardship policies impact substitution away from penicillin G sodium toward other β-lactams?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. Penicillin G Sodium. U.S. National Library of Medicine.