CLINICAL TRIALS PROFILE FOR PYRAZINAMIDE

505(b)(2) Clinical Trials for Pyrazinamide

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 Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.
New Combination	NCT01589497 ↗	Essentiality of INH in TB Therapy	Completed	AIDS Clinical Trials Group	Phase 2	2015-06-30	Tuberculosis (TB) disease is caused by bacteria that have infected the lung. TB bacteria are very small living agents that are spread by coughing and can be killed by taking TB drugs. To kill these TB bacteria TB patients have to take a combination of four drugs for 2 months and then two drugs for a further 4 months. During the first 2 months patients take rifampicin, isoniazid, ethambutol, and pyrazinamide. After that patients take only isoniazid and rifampicin for a further 4 months, making a total of 6 months therapy. In A5307 the investigators wanted to test a new combination of drugs to see if the investigators could treat TB faster in the future. Studies in animals have suggested that one of the four drugs, isoniazid, only works for a few days and may not be needed after the first two doses of TB treatment to kill the TB bacteria. After that its effects wear off to the point that it may even interfere with the other drugs. The investigators wanted to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study was the first time that this type of regimen without isoniazid had been tested in humans. If the investigators could show that isoniazid stops working after a few days, the investigators could then try to see if they could possibly make a better tuberculosis treatment in the future.

All Clinical Trials for Pyrazinamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000636 ↗	Prophylaxis Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare the effectiveness of a 2-month regimen of rifampin and pyrazinamide versus a 1-year course of isoniazid (INH) to prevent the development of tuberculosis in patients who are coinfected with HIV and latent Mycobacterium tuberculosis (MTb). Current guidelines recommend 6 to 12 months of treatment with INH for purified protein derivative (PPD)-positive individuals. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to INH-resistant organisms. Studies suggest that two or three months of rifampin and pyrazinamide may be more effective than longer courses of INH. A two-month prevention course should help to increase compliance. In addition, the use of two drugs (rifampin and pyrazinamide) may help overcome problems with drug resistance.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Hoechst Marion Roussel	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.
NCT00000638 ↗	Preventive Treatment Against Tuberculosis (TB) in Patients With Human Immunodeficiency Virus (HIV) Infection and Confirmed Latent Tuberculous Infection	Completed	Lederle Laboratories	N/A	1969-12-31	To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of reactivation tuberculosis in individuals infected with both HIV and latent (inactive) Mycobacterium tuberculosis. Current guidelines from the American Thoracic Society and the Centers for Disease Control recommend 6 to 12 months of INH for PPD (purified protein derivative)-positive individuals. Although the effectiveness of this treatment is not known for HIV-infected individuals, several studies using INH to prevent tuberculosis in presumably normal hosts have shown 60 to 80 percent effectiveness. Problems with this treatment include compliance, adverse reaction, and the possibility of not preventing disease due to tuberculosis organisms being resistant to INH. A two-month preventive treatment plan should help in increasing compliance. In addition, the use of two drugs (rifampin / pyrazinamide) may help overcome problems with drug resistance. If this study shows equal or greater effectiveness of the two-month rifampin / pyrazinamide treatment, it could alter the approach to tuberculosis prevention for both HIV-positive and HIV-negative individuals.

Clinical Trial Conditions for Pyrazinamide

Condition Name

Condition Name for Pyrazinamide
Intervention	Trials
Tuberculosis	55
Pulmonary Tuberculosis	18
Tuberculosis, Pulmonary	18

Condition MeSH

Condition MeSH for Pyrazinamide
Intervention	Trials
Tuberculosis	116
Tuberculosis, Pulmonary	50
HIV Infections	18

Clinical Trial Locations for Pyrazinamide

Trials by Country

Trials by Country for Pyrazinamide
Location	Trials
United States	151
China	95
South Africa	61
Brazil	27
Uganda	22

Trials by US State

Trials by US State for Pyrazinamide
Location	Trials
New York	13
California	13
Texas	10
Illinois	10
Maryland	9

Clinical Trial Progress for Pyrazinamide

Clinical Trial Phase

Clinical Trial Phase for Pyrazinamide
Clinical Trial Phase	Trials
Phase 4	16
Phase 3	26
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Pyrazinamide
Clinical Trial Phase	Trials
Completed	55
Recruiting	23
Not yet recruiting	19

Clinical Trial Sponsors for Pyrazinamide

Sponsor Name

Sponsor Name for Pyrazinamide
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	21
Global Alliance for TB Drug Development	11
Centers for Disease Control and Prevention	8

Sponsor Type

Sponsor Type for Pyrazinamide
Sponsor	Trials
Other	358
NIH	24
Industry	22

Pyrazinamide: Clinical Trials, Market Analysis, and Projections

Introduction to Pyrazinamide

Pyrazinamide is a crucial first-line antibiotic used in the treatment of tuberculosis (TB), a bacterial infection that affects the lungs and can spread to other parts of the body. The drug is often used in combination with other antibiotics to treat TB effectively.

Current Clinical Trials

CRUSH-TB Trial

One of the significant ongoing clinical trials involving pyrazinamide is the CRUSH-TB (Combination Regimens for Shortening Tuberculosis Treatment) trial, launched by the CDC's Tuberculosis Trials Consortium (TBTC). This international trial aims to identify new combinations of drugs to shorten the treatment of TB disease.

• Objective: The trial compares the effectiveness and safety of new four-month regimens based on bedaquiline, moxifloxacin, and pyrazinamide to the standard six-month regimen for patients with drug-susceptible pulmonary TB disease[1].
• Participants: The trial plans to enroll at least 288 participants from international TBTC sites, including children aged 12 and older and individuals with HIV.
• Design: The study uses an adaptive design, allowing researchers to add new study groups to assess additional TB treatment regimens.

This trial is pivotal in potentially reducing the treatment duration for TB, making it more convenient for patients and improving treatment completion rates.

Market Analysis

Global Market Size and Growth

The global pyrazinamide market has been growing steadily due to the increasing prevalence of tuberculosis, particularly in developing nations.

• Current Market Size: The global pyrazinamide market was valued at USD 1.15 billion in 2022[2].
• Projected Growth: It is expected to reach USD 1.89 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2024 to 2030[2].

Key Drivers

Several factors are driving the growth of the pyrazinamide market:

• Increasing Prevalence of TB: The high global burden of tuberculosis, especially in developing countries, is a significant driver[2][5].
• Demand for Effective Treatments: The need for effective anti-tuberculosis drugs, including pyrazinamide, is on the rise[2][5].
• Research and Advancements: Ongoing research and advancements in drug formulations are expanding the therapeutic applications of pyrazinamide[2].
• Government Initiatives: Supportive government initiatives for TB treatment and the development of combination therapies are also boosting the market[2].

Regional Dimensions

The pyrazinamide market is geographically diverse, with different regions showing varying growth potential:

• North America and Asia-Pacific: These regions are expected to dominate the market due to a high prevalence of tuberculosis. North America is anticipated to maintain a dominant streak, while Asia-Pacific, particularly India, is expected to witness rapid growth[5].

Market Segmentation

The pyrazinamide market is segmented based on product types, applications, and distribution channels. This segmentation helps in understanding the unique demands and preferences of different markets.

• Product Types: Various formulations of pyrazinamide, including tablets and combinations with other drugs, cater to different patient needs[2].
• Applications: Pyrazinamide is primarily used for treating TB but is also being explored for other therapeutic applications[5].
• Distribution Channels: The market includes a variety of distribution channels, from pharmacies to hospitals, which are influenced by regional economic conditions, technology adoption rates, and regulatory frameworks[2].

Future Scope and Trends

Forecast and Growth Potential

The future of the pyrazinamide market looks promising, driven by several factors:

• Rising Consumer Demand: Increasing cases of tuberculosis and the need for effective treatments will continue to drive demand[5].
• Technological Advancements: Advancements in drug formulations and the development of combination therapies will expand the market[2].
• Sustainability and Legislative Support: Growing focus on sustainability and legislative backing for TB treatment initiatives will further boost the market[5].

Challenges

Despite the positive outlook, the pyrazinamide market faces some challenges:

• Drug Resistance: The emergence of drug-resistant strains of tuberculosis is a significant challenge[2].
• Toxicity and Safety: Optimizing pyrazinamide dosing to minimize toxicity while maintaining efficacy is an ongoing concern. Studies like the one by the AIDS Clinical Trials Group A5349 aim to determine optimal dosing strategies[3].

Safety, Efficacy, and Dosing

Optimizing the dosing of pyrazinamide is critical for improving treatment efficacy while minimizing toxicity.

• Flat Dosing: Research suggests that flat dosing of pyrazinamide at 1,000 mg/day could be readily implementable and optimize treatment outcomes for drug-susceptible TB[3].
• Pharmacokinetic Parameters: Studies have analyzed pyrazinamide pharmacokinetic parameters to understand the relationship between exposure and efficacy and safety outcomes[3].

Key Takeaways

• Clinical Trials: Ongoing trials like CRUSH-TB are aimed at shortening TB treatment regimens, which could significantly impact patient compliance and treatment outcomes.
• Market Growth: The global pyrazinamide market is expected to grow at a CAGR of 6.5% from 2024 to 2030, driven by increasing TB prevalence and demand for effective treatments.
• Regional Focus: North America and Asia-Pacific are expected to be key regions for market growth.
• Challenges: Despite growth potential, the market faces challenges such as drug resistance and the need for optimized dosing to ensure safety and efficacy.

FAQs

1. What is the current size of the global pyrazinamide market?

The global pyrazinamide market was valued at USD 1.15 billion in 2022[2].

2. What factors are driving the growth of the pyrazinamide market?

The growth is primarily driven by the increasing cases of tuberculosis and the need for effective anti-tuberculosis drugs, along with ongoing research and advancements in drug formulations[2][5].

3. Which regions are dominating the pyrazinamide market?

North America and Asia-Pacific are the leading regions in the pyrazinamide market, due to a high prevalence of tuberculosis[5].

4. What is the expected CAGR for the pyrazinamide market during the forecast period?

The pyrazinamide market is expected to grow at a CAGR of 6.5% from 2024 to 2030[2].

5. What are the key challenges faced by the pyrazinamide market?

One of the key challenges is the emergence of drug-resistant strains of tuberculosis, along with the need to optimize dosing to minimize toxicity while maintaining efficacy[2][3].

Sources

1. CDC: Tuberculosis Trials Consortium Launches New TB Clinical Trial - CDC.
2. GitHub: Pyrazinamide Market Key Drivers and Forecast 2025-2032.md.
3. PubMed: Pyrazinamide Safety, Efficacy, and Dosing for Treating Drug-Susceptible Tuberculosis.
4. GSK: Pipeline assets and clinical trials appendix - Q2 2024.
5. BioSpace: Pyrazinamide Market | Know the Trends which have Potential to Bring Expansive Growth for the Market.