CLINICAL TRIALS PROFILE FOR PENICILLIN-VK

505(b)(2) Clinical Trials for Penicillin-vk

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT05069974 ↗	Alternative Antibiotics for Syphilis	Recruiting	Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 3	2021-10-01	The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent. It is estimated to include 360 participants.

All Clinical Trials for Penicillin-vk

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000585 ↗	Penicillin Prophylaxis in Sickle Cell Disease (PROPS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-08-01	To determine whether the regular daily administration of oral penicillin would reduce the incidence of documented infection due to Streptococcus pneumoniae in children with sickle cell anemia.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	Hoffmann-La Roche	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00000648 ↗	A Pilot Study Evaluating Penicillin G and Ceftriaxone as Therapies for Presumed Neurosyphilis in HIV Seropositive Individuals	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To provide information on the response of HIV infected, neurosyphilis patients to the currently recommended treatment for neurosyphilis; to determine whether possible co-infection with both HIV and syphilis makes more difficult the diagnosis of syphilis; to explore the usefulness of an alternative treatment which, if effective, would permit outpatient treatment for neurosyphilis that until now required prolonged hospitalization. Studies suggest that syphilis treatment failures may be more common in HIV infected patients than in patients without HIV infection and that treatment failures occur due to and/or are displayed as central nervous system (CNS) involvement. Very little is known about the best treatment course for neurosyphilis in patients who are also infected with HIV.
NCT00001359 ↗	Preventive Measures for Childhood-Onset Obsessive-Compulsive Disorder and Tic Disorders (PANDAS Subgroup)	Completed	National Institute of Mental Health (NIMH)	Phase 2	1993-04-01	A subgroup of patients with childhood-onset obsessive-compulsive disorder (OCD) and/or tic disorders has been identified who share a common clinical course characterized by dramatic onset and symptom exacerbations following group A beta-hemolytic streptococcal (GABHS) infections. This subgroup is designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections). There are five clinical characteristics that define the PANDAS subgroup: presence of OCD and/or tic disorder; prepubertal symptom onset; sudden onset or abrupt exacerbations (relapsing-remitting course); association with neurological abnormalities (presence of adventitious movements or motoric hyperactivity during exacerbations); and temporal association between symptom exacerbations and GABHS infections. In this subgroup, periodic exacerbations appear to be triggered by GABHS infections in a manner similar to that of Sydenham's chorea, the neurological variant of rheumatic fever. Rheumatic fever is a disorder with a presumed post-streptococcal autoimmune etiology. The streptococcal pathogenesis of rheumatic fever is supported by studies that have demonstrated the effectiveness of penicillin prophylaxis in preventing recurrences of this illness. A trial of penicillin prophylaxis in the PANDAS subgroup demonstrated that penicillin was not superior to placebo as prophylaxis against GABHS infections in these children, but this outcome was felt to be secondary to non-compliance with treatment, and there was no decrease in the number of neuropsychiatric symptom exacerbations in this group. In a study comparing azithromycin and penicillin, both drugs were completely effective in preventing streptococcal infections - there were no documented titer elevations during the year-long study period for children taking either penicillin or azithromycin. Comparable reductions in the severity of tics and obsessive-compulsive symptoms were also observed. Thus, penicillin was not performing as an "active placebo" as originally postulated, but rather provided effective prophylaxis against Group A beta-hemolytic streptococcal. Both azithromycin and penicillin appear to be effective in eliminating GABHS infections, and reducing neuropsychiatric symptom severity; thus, between-group differences are negligible. Since increasing the "n" to demonstrate superiority of one prophylactic agent over another would be impractical, we have amended the study design to address two issues: 1. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in prolonging periods of remission among children in the PANDAS subgroup. 2. To determine if antibiotics prophylaxis against GABHS infections is superior to placebo in improving overall symptom severity for obsessive-compulsive symptoms and tics among children in the PANDAS subgroup. Because penicillin has a narrower therapeutic index and is less expensive than azithromycin, it is the preferable prophylactic agent. Further, penicillin (250 mg orally twice a day) has a long history of providing safe and effective prophylaxis for rheumatic fever and is the first line oral therapy recommended by the American Heart Association. Thus, penicillin has been chosen as the prophylactic antibiotic in the present study. Blister packs are used to increase compliance and to allow for easier documentation of missed doses.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.

Clinical Trial Conditions for Penicillin-vk

Condition Name

Condition Name for Penicillin-vk
Intervention	Trials
Penicillin Allergy	10
Syphilis	10
Helicobacter Pylori Infection	8
Infection	7

Condition MeSH

Condition MeSH for Penicillin-vk
Intervention	Trials
Infections	33
Infection	25
Communicable Diseases	24
Pneumonia	13

Clinical Trial Locations for Penicillin-vk

Trials by Country

Trials by Country for Penicillin-vk
Location	Trials
United States	197
Canada	20
China	18
Australia	18
Kenya	11

Trials by US State

Trials by US State for Penicillin-vk
Location	Trials
California	14
Ohio	12
New York	11
Texas	9
North Carolina	9

Clinical Trial Progress for Penicillin-vk

Clinical Trial Phase

Clinical Trial Phase for Penicillin-vk
Clinical Trial Phase	Trials
Phase 4	60
Phase 3	38
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Penicillin-vk
Clinical Trial Phase	Trials
Completed	88
Not yet recruiting	27
Unknown status	26

Clinical Trial Sponsors for Penicillin-vk

Sponsor Name

Sponsor Name for Penicillin-vk
Sponsor	Trials
World Health Organization	7
University of Oxford	5
Shandong University	4

Sponsor Type

Sponsor Type for Penicillin-vk
Sponsor	Trials
Other	351
Industry	25
NIH	9

Penicillin-VK: Clinical Trials, Market Analysis, and Projections

Introduction to Penicillin-VK

Penicillin-VK, also known as phenoxymethylpenicillin, is a narrow-spectrum, beta-lactam antimicrobial widely used for the treatment and prevention of bacterial infections, particularly in community settings. It is effective against encapsulated bacteria such as streptococci, gonococci, and meningococci. Here, we will delve into recent clinical trials, market analysis, and future projections for Penicillin-VK.

Clinical Trials and Pharmacokinetics

Recent Study on Pharmacokinetics

A recent study aimed to explore the pharmacokinetics (PK) of Penicillin-VK in healthy volunteers to support the planning of large dosing studies in adults. The study involved 10 healthy volunteers who were dosed with Penicillin-VK at steady state. The results showed that Penicillin-VK was 77% plasma protein bound and had a free serum half-life of 55 minutes, which is consistent with published product characteristics[1].

The study used a 3-compartment model with an absorptive time lag to describe the PK of Penicillin-VK. This model included linear first-order absorption and elimination to and from the central compartment, as well as linear first-order transfer between bound and unbound drug states. The model demonstrated good correlation between observed and predicted concentrations, providing valuable data for optimizing dosing strategies in adults[1].

Clinical Decision Rules for Penicillin Allergy

Another significant development is the validation of clinical decision rules like PEN-FAST, which enables point-of-care risk assessment for adults reporting penicillin allergies. The PALACE trial demonstrated that PEN-FAST is a reliable tool for assessing the risk of penicillin allergy, allowing for direct oral challenge with penicillin in many cases. This approach can reduce the unnecessary avoidance of penicillin and improve treatment outcomes for patients with suspected penicillin allergies[4].

Market Analysis

Global Penicillin Drug Market

The global penicillin drug market is projected to experience significant growth. As of 2022, the market was valued at $8.4 billion and is expected to reach $12.1 billion by 2032, growing at a CAGR of 3.7% from 2023 to 2032[3].

Market Segmentation

The penicillin market is segmented by penicillin group, route of administration, dosage form, and application. Penicillin-VK falls under the natural penicillins category and is commonly administered orally. It is used for treating various bacterial infections, including pharyngitis, pneumonia, and skin infections[2][3].

Regional Insights

The Asia Pacific region dominates the global antibiotics market, including penicillins, with a revenue share of over 46% in 2023. This is attributed to advanced healthcare infrastructure, government initiatives, and the availability of low-cost generic antibiotics in the region[5].

Market Drivers

The growth of the penicillin market is driven by several factors:

• Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections, such as pneumonia and other respiratory tract infections, drives the demand for effective antibiotics like penicillin[3].
• Advancements in Healthcare Infrastructure: Improved healthcare facilities, especially in developing countries, enhance the diagnosis and management of bacterial infections, increasing the utilization of penicillin[3].
• Expanding Global Population: The growing global population, particularly the aging demographics, increases the susceptibility to infections and thus the demand for penicillin drugs[3].

Market Projections

Growth Forecast

The antibiotics market, which includes penicillins, is expected to reach USD 85.80 billion by 2033, growing at a CAGR of 5.3% from 2024 to 2033. Penicillin is projected to maintain its significant market share due to its efficacy and widespread use[5].

Segment Performance

By drug class, penicillin is expected to continue holding a substantial market share, with over 27% of the market in 2023. The parenteral route of administration is also expected to grow, driven by the demand for intravenous antibiotics in severe infections[5].

Regional Growth

Asia Pacific will likely continue to dominate the market, driven by government initiatives, advanced healthcare infrastructure, and the availability of affordable generic antibiotics. North America and Europe will also remain significant markets due to their well-established healthcare systems and high demand for antibiotics[5].

Key Takeaways

• Pharmacokinetics: Recent studies have provided updated pharmacokinetic data for Penicillin-VK, supporting the optimization of dosing strategies in adults.
• Clinical Decision Rules: Tools like PEN-FAST are being validated to assess penicillin allergy risks, improving treatment outcomes.
• Market Growth: The global penicillin market is projected to grow, driven by increasing bacterial infections, advancements in healthcare, and an expanding global population.
• Regional Dominance: Asia Pacific will continue to lead the market due to its healthcare infrastructure and affordable generic antibiotics.
• Segment Performance: Penicillin will maintain a significant market share, with the parenteral route of administration growing due to its efficacy in severe infections.

FAQs

What is Penicillin-VK used for?

Penicillin-VK is used for the treatment and prevention of bacterial infections, particularly those caused by streptococci, gonococci, and meningococci. It is commonly prescribed for pharyngitis, skin infections, and other community-acquired infections.

How is Penicillin-VK administered?

Penicillin-VK is typically administered orally due to its stability in gastric acid. It can be taken on an empty stomach or 1-2 hours after food.

What are the recent findings on the pharmacokinetics of Penicillin-VK?

A recent study found that Penicillin-VK is 77% plasma protein bound and has a free serum half-life of 55 minutes. The study used a 3-compartment model to describe its pharmacokinetics, which will help in optimizing dosing strategies.

How does the PEN-FAST rule impact the use of Penicillin-VK?

The PEN-FAST rule allows for point-of-care risk assessment for penicillin allergies, enabling direct oral challenge with penicillin in many cases. This reduces unnecessary avoidance of penicillin and improves treatment outcomes.

What are the key drivers of the penicillin market growth?

The key drivers include the increasing prevalence of bacterial infections, advancements in healthcare infrastructure, and the expanding global population, particularly the aging demographics.

Which region dominates the global penicillin market?

The Asia Pacific region dominates the global penicillin market due to its advanced healthcare infrastructure, government initiatives, and the availability of low-cost generic antibiotics.

Sources

1. Exploring the Pharmacokinetics of Phenoxymethylpenicillin (Penicillin-V) in Healthy Volunteers. Open Forum Infectious Diseases, 2021.
2. Penicillin Drug Market Research Report. Market Research Future, 2024.
3. Penicillin Drug Market Size, Share & Growth Report, 2032. Allied Market Research, 2024.
4. Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge with Penicillin. JAMA Internal Medicine, 2023.
5. Antibiotics Market Size to Reach USD 85.80 Billion by 2033. BioSpace, 2024.