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Last Updated: January 15, 2025

CLINICAL TRIALS PROFILE FOR PENICILLIN G BENZATHINE


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505(b)(2) Clinical Trials for Penicillin G Benzathine

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

All Clinical Trials for Penicillin G Benzathine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00031499 ↗ Azithromycin/Bicillin Syphilis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2000-06-01 The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed Cairo University N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
NCT01156740 ↗ Treatment of Group A Beta Hemolytic Streptococcal Pharyngitis in Children in Low Resource Settings Completed United States Agency for International Development (USAID) N/A 2001-08-01 The purpose of this study was to compare the microbiological effects of two different treatments: a single dose of intramuscular benzathine penicillin G (IM BPG) vs. a 10-day daily dose of amoxicillin for the treatment of GABHS pharyngitis in children in low resource settings. This study was a prospective multi-center randomized active control treatment trial. The trial is a non-inferiority equivalence trial, to determine if amoxicillin treatment is at least as effective as the currently given IM BPG treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Penicillin G Benzathine

Condition Name

Condition Name for Penicillin G Benzathine
Intervention Trials
Syphilis 8
Yaws 2
Pandas 1
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Condition MeSH

Condition MeSH for Penicillin G Benzathine
Intervention Trials
Syphilis 11
HIV Infections 2
Acquired Immunodeficiency Syndrome 2
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Clinical Trial Locations for Penicillin G Benzathine

Trials by Country

Trials by Country for Penicillin G Benzathine
Location Trials
United States 15
Brazil 3
Madagascar 3
China 3
Papua New Guinea 2
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Trials by US State

Trials by US State for Penicillin G Benzathine
Location Trials
North Carolina 2
Maryland 2
Louisiana 2
Indiana 2
Alabama 2
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Clinical Trial Progress for Penicillin G Benzathine

Clinical Trial Phase

Clinical Trial Phase for Penicillin G Benzathine
Clinical Trial Phase Trials
Phase 4 6
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Penicillin G Benzathine
Clinical Trial Phase Trials
Completed 7
Unknown status 5
Recruiting 4
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Clinical Trial Sponsors for Penicillin G Benzathine

Sponsor Name

Sponsor Name for Penicillin G Benzathine
Sponsor Trials
World Health Organization 3
Universidad Peruana Cayetano Heredia 2
University of Southern California 2
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Sponsor Type

Sponsor Type for Penicillin G Benzathine
Sponsor Trials
Other 54
NIH 2
U.S. Fed 1
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Penicillin G Benzathine: Clinical Trials, Market Analysis, and Projections

Introduction to Penicillin G Benzathine

Penicillin G Benzathine, commonly known as Benzathine Penicillin G (BPG), is a long-acting form of penicillin used to treat various bacterial infections, including syphilis, rheumatic fever, and diphtheria. This antibiotic is characterized by its slow release from intramuscular injection sites, providing prolonged therapeutic levels in the blood.

Clinical Trials Update

Pain Reduction with Lidocaine

A significant clinical trial currently underway focuses on the addition of lidocaine to BPG injections to reduce pain. This randomized, double-blinded, placebo-controlled trial aims to quantify the pain reduction achieved by adding 0.5 ml of 1% lidocaine to prepackaged BPG syringes compared to using normal saline solution.

  • Methodology: Participants receive two injections of BPG (1.2 million units each) into the gluteal muscles, with one injection containing lidocaine and the other containing normal saline. The side of each injection is randomized, and both the injecting medical assistant and the participant are blinded to the contents[1][3].
  • Objectives: The primary aim is to assess the pain reduction at 10 minutes and 24 hours after injection. Secondary objectives include evaluating any adverse effects of adding lidocaine to BPG[1][3].
  • Significance: This study addresses the common adverse effect of injection site pain associated with BPG, which could improve patient compliance and comfort during treatment.

Market Analysis

Market Trends

The Benzathine Penicillin G market is experiencing significant trends driven by several factors:

  • Increasing Antibiotic Resistance: With rising levels of resistance to newer antibiotics, there is a renewed interest in traditional antibiotics like BPG, especially against sensitive bacterial strains[2].
  • Cost-Effectiveness: BPG is cost-effective compared to newer antibiotics, making it a preferred choice in many clinical settings[2].
  • Growing Prevalence of Bacterial Infections: The increasing incidence of bacterial infections such as syphilis and rheumatic fever is driving the demand for BPG. For example, in the US, 27,814 cases of syphilis were reported in 2016[2].

Market Size and Projections

  • Current Market Size: The global Benzathine Penicillin G market was valued at a significant amount in 2019 and is expected to grow at a CAGR of 3.3% from 2020 to 2027[5].
  • Projected Market Size: By 2032, the market is projected to reach USD 3.60 billion at a CAGR of 7.2% during the forecast period 2023-2032[2].
  • Regional Segmentation: The market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East and Africa. North America, particularly the US and Canada, dominates the market due to high cases of syphilis and bacterial infections. Europe is the second largest market, driven by cases of rheumatic fever. The Asia-Pacific region is expected to be the fastest-growing due to rising prevalence of bacterial infections and changing lifestyles[2][5].

Key Players

The market is dominated by several key players, including Pfizer Inc, Alembic IT Department, ECPlaza Network Inc, Abcam plc, Sandoz International GmbH, Merck KGaA, Triveni Interchem Private Limited, and CSC Pharmaceuticals. These companies are involved in the production, distribution, and research and development of BPG[2].

Clinical Pharmacology of Penicillin G Benzathine

Mechanism of Action

Penicillin G Benzathine exerts a bactericidal action by inhibiting the biosynthesis of cell-wall peptidoglycan, making the bacterial cell wall osmotically unstable. It is effective against penicillin-susceptible microorganisms during the stage of active multiplication[4].

Pharmacokinetics

  • Absorption and Distribution: BPG has an extremely low solubility, leading to slow release from intramuscular injection sites. It is hydrolyzed to penicillin G, resulting in prolonged blood serum levels. For example, administration of 1,200,000 units can maintain detectable blood levels for up to 4 weeks[4].
  • Excretion: The drug is excreted rapidly by tubular excretion in individuals with normal kidney function. However, excretion is delayed in neonates, young infants, and individuals with impaired kidney function[4].

Market Dynamics and Challenges

Driving Factors

  • Increasing Bacterial Infections: The high prevalence of bacterial infections, including antibiotic-resistant infections, drives the demand for BPG. In the US, about 2 million people suffer from antibiotic-resistant infections each year[5].
  • Cost-Effectiveness and Efficacy: BPG's cost-effectiveness and efficacy against certain bacterial strains make it a preferred treatment option[2].

Challenges

  • Supply Chain Disruptions: The market is experiencing shortages of BPG due to disruptions in the supply chain, which complicates the treatment of syphilis and other bacterial infections[5].
  • Low Health Expenditure in Some Regions: Regions like the Middle East and Africa have low health expenditure and low awareness of therapeutic treatments, which hampers market growth in these areas[2][5].

Regional Market Summary

  • North America: Dominates the market due to increasing cases of syphilis and bacterial infections, as well as advancements in clinical practices and access to treatments[2][5].
  • Europe: The second largest market, driven by cases of rheumatic fever and other infectious diseases[2].
  • Asia-Pacific: Expected to be the fastest-growing region due to rising prevalence of bacterial infections and changing lifestyles[2][5].
  • Middle East and Africa: Holds the least share due to low health expenditure and low awareness, but is expected to grow with increasing healthcare programs and investments in research and development[2][5].

Key Takeaways

  • Clinical Trials: Ongoing trials focus on reducing pain associated with BPG injections by adding lidocaine.
  • Market Growth: The Benzathine Penicillin G market is projected to grow significantly due to increasing bacterial infections and the cost-effectiveness of the drug.
  • Regional Variations: Market growth varies by region, with North America and Europe being the largest markets, and Asia-Pacific showing the fastest growth.
  • Challenges: Supply chain disruptions and low health expenditure in some regions are key challenges facing the market.

FAQs

What is the primary aim of the current clinical trial involving Penicillin G Benzathine and lidocaine?

The primary aim is to assess whether adding 0.5 ml of 1% lidocaine to prepackaged BPG syringes reduces pain at 10 minutes and 24 hours after injection compared to using normal saline solution[1][3].

What is the projected market size of Benzathine Penicillin G by 2032?

The market is projected to reach USD 3.60 billion by 2032 at a CAGR of 7.2% during the forecast period 2023-2032[2].

Which regions dominate the Benzathine Penicillin G market?

North America, particularly the US and Canada, dominates the market, followed by Europe. The Asia-Pacific region is expected to be the fastest-growing[2][5].

What are the main challenges facing the Benzathine Penicillin G market?

Key challenges include supply chain disruptions leading to shortages and low health expenditure in regions like the Middle East and Africa[5].

How does Penicillin G Benzathine work?

It exerts a bactericidal action by inhibiting the biosynthesis of cell-wall peptidoglycan, making the bacterial cell wall osmotically unstable[4].

Sources

  1. CTV Veeva: "Lidocaine With Intramuscular Injection of Benzathine Penicillin G for Treponema pallidum Infections"
  2. Market Research Future: "Benzathine Penicillin G Market Trends | Market Research Future"
  3. ClinicalTrials.gov: "Lidocaine with Intramuscular Injection of Benzathine Penicillin G for Treponema pallidum Infections"
  4. Pfizer Medical Information: "BICILLIN® L-A (penicillin G benzathine) Clinical Pharmacology"
  5. Maximize Market Research: "Global Benzathine Penicillin G Market: Industry Analysis 2019 - 2027"

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