CLINICAL TRIALS PROFILE FOR PENICILLIN V

505(b)(2) Clinical Trials for Penicillin V

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 V

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.

Clinical Trial Conditions for Penicillin V

Condition Name

Condition Name for Penicillin V
Intervention	Trials
Syphilis	10
Penicillin Allergy	10
Helicobacter Pylori Infection	8
Pneumonia	7

Condition MeSH

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

Clinical Trial Locations for Penicillin V

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Penicillin V

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Penicillin V

Sponsor Name

Sponsor Name for Penicillin V
Sponsor	Trials
World Health Organization	7
University of Oxford	5
Sanofi	4

Sponsor Type

Sponsor Type for Penicillin V
Sponsor	Trials
Other	351
Industry	25
NIH	9

Penicillin V: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to Penicillin V

Penicillin V, a member of the penicillin class of antibiotics, is widely used to treat various bacterial infections, including those of the ear, throat, skin, and to prevent rheumatic fever. Here, we will delve into recent clinical trials, market analysis, and future projections for Penicillin V.

Clinical Trials: Efficacy and Safety

Recent Study on Pharyngotonsillitis

A significant clinical trial published in the BMJ in 2019 compared the efficacy of two different dosing regimens of Penicillin V in treating pharyngotonsillitis caused by group A streptococci. The study involved patients aged 6 years and over, treated with either 800 mg of Penicillin V four times daily for five days or 1000 mg three times daily for 10 days. The results showed that the five-day regimen was non-inferior to the 10-day regimen in terms of clinical outcomes, with no significant difference in the number of relapses and complications. However, the five-day regimen had a lower incidence and shorter duration of adverse events such as diarrhea, nausea, and vulvovaginal disorders[1].

Comparison with Amoxicillin in Pediatric Pneumonia

A more recent study published in 2024 compared the clinical efficacy of Penicillin V and amoxicillin in treating pediatric pneumonia. The findings indicated that amoxicillin outperformed Penicillin V, showing a lower risk of treatment failure. Despite Penicillin V's narrower antimicrobial range, the risk of severe complications was statistically identical between the two antibiotics. This study challenges the traditional use of Penicillin V in Scandinavian practices and highlights the global trend towards using amoxicillin for pediatric pneumonia[4].

Market Analysis

Market Size and Growth

The global penicillin drug market, which includes Penicillin V, was valued at $8.4 billion in 2022 and is projected to reach $12.1 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.7% from 2023 to 2032. Penicillin, including Penicillin V, holds a significant share of the antibiotics market due to its widespread use and efficacy against various bacterial infections[5].

Market Segmentation

• By Source: The semisynthetic penicillin segment dominated the market in 2022, expected to grow at the fastest rate during the forecast period. Semisynthetic penicillins offer an expanded spectrum of activity compared to natural penicillins, targeting both gram-positive and some gram-negative organisms[5].
• By Route of Administration: The parenteral segment dominated the market in terms of revenue in 2022, primarily due to the use of penicillin injections for severe bacterial infections and syphilis. However, the oral segment is anticipated to grow at the fastest rate due to its cost-effectiveness and convenience[5].
• By Spectrum of Activity: The broad-spectrum penicillin segment, which includes amoxicillin, dominated the market in 2022, driven by the increasing demand for effective treatments against a wide range of bacterial infections[5].

Distribution Channels and Regional Analysis

The market is segmented into hospital pharmacies, drug stores, retail pharmacies, and online providers. Geographically, the market is analyzed across North America, Europe, Asia-Pacific, and Latin America, Middle East, and Africa (LAMEA). Improved healthcare infrastructure, especially in developing regions, has enhanced access to diagnosis and treatment, contributing to the growing demand for penicillin[5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections, both in community and healthcare settings, drives the demand for penicillin and other antibiotics[5].
• Advancements in Healthcare Infrastructure: Improved healthcare facilities, particularly in developing countries, have led to better diagnosis and management of bacterial infections, increasing the demand for penicillin[5].
• Expanding Global Population: The growing global population, especially the aging demographics, increases the susceptibility to infections, thereby driving the demand for penicillin drugs[5].

Challenges

• Antimicrobial Resistance: The increasing threat of antimicrobial resistance poses a significant challenge to the penicillin market. Continuous monitoring and development of new antibiotics are crucial to address this issue[3].
• Competition from Other Antibiotics: The market faces competition from other antibiotics, such as amoxicillin, which have shown superior efficacy in certain infections, as seen in the pediatric pneumonia study[4].

Projections and Future Outlook

Market Growth

The penicillin drug market, including Penicillin V, is expected to continue growing driven by the increasing prevalence of bacterial infections and advancements in healthcare infrastructure. The market is projected to reach $12.1 billion by 2032, with a CAGR of 3.7% from 2023 to 2032[5].

Innovations and Developments

Future growth will be influenced by innovations in drug formulation, manufacturing, and delivery systems. The development of new semisynthetic penicillins with broader spectra of activity will continue to drive the market. Additionally, improvements in oral formulations will make penicillin more accessible and convenient, further boosting market growth[5].

Key Takeaways

• Clinical Efficacy: Penicillin V has been shown to be non-inferior to traditional dosing regimens in treating pharyngotonsillitis and may offer a shorter treatment duration with fewer adverse events.
• Market Dominance: Penicillin, including Penicillin V, holds a significant share of the antibiotics market due to its efficacy and widespread use.
• Growth Drivers: The market is driven by the increasing prevalence of bacterial infections, advancements in healthcare infrastructure, and the expanding global population.
• Challenges: The market faces challenges from antimicrobial resistance and competition from other antibiotics.

FAQs

What is the current recommended dosage of Penicillin V for treating pharyngotonsillitis?

The current recommended dosage is 1000 mg three times daily for 10 days, but a recent study suggests that 800 mg four times daily for five days could be a non-inferior alternative[1].

How does Penicillin V compare to amoxicillin in treating pediatric pneumonia?

Amoxicillin has been shown to outperform Penicillin V in treating pediatric pneumonia, with a lower risk of treatment failure, although the risk of severe complications is statistically identical between the two[4].

What is the projected market size of the penicillin drug market by 2032?

The global penicillin drug market is projected to reach $12.1 billion by 2032, growing at a CAGR of 3.7% from 2023 to 2032[5].

What are the main drivers of the penicillin drug market?

The main drivers include the increasing prevalence of bacterial infections, advancements in healthcare infrastructure, and the expanding global population[5].

What challenges does the penicillin market face?

The market faces challenges from antimicrobial resistance and competition from other antibiotics, such as amoxicillin[3][4].

Sources

1. BMJ: Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study. Published 04 October 2019.
2. Biospace: Antibiotics Market Size to Reach USD 85.80 Billion by 2033. Published 24 May 2024.
3. The Lancet Microbe: Antimicrobial resistance: a concise update. Published 18 September 2024.
4. News-Medical: Amoxicillin outperforms penicillin V in treating pediatric pneumonia, study finds. Published 18 June 2024.
5. Allied Market Research: Penicillin Drug Market Size, Share & Growth Report, 2032.