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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR DOW-ISONIAZID


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505(b)(2) Clinical Trials for Dow-isoniazid

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.
New Formulation NCT02043314 ↗ A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers Completed Oswaldo Cruz Foundation Phase 1 2008-10-01 The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested the development of a new 300mg isoniazid formulation. The aim of the study is to compare the bioavailability of the isoniazid 300mg new formulation and three 100mg tablets of the reference formulation. The study is a randomized, single dose, open label, fasting, two-phase crossover bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human volunteers. For the determination of isoniazid in human plasma, the investigators developed and validated a sensitive, simple and rapid HPLC-MS/MS method. This will support the strategy adopted by the Brazilian National Program for Tuberculosis for the treatment of latent tuberculosis. The new formulation will increase patients' adherence to the treatment and quality of life. Medical doctors in Brazil should become aware of the new formulation and the new treatment strategy in order to prescribe the right medication and avoid errors that could result in a high frequency of adverse events. Future research studies should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact on the cure rate.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dow-isoniazid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000588 ↗ Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1989-06-01 To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
NCT00000588 ↗ Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone Completed Case Western Reserve University Phase 2 1989-06-01 To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
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.
NCT00000638 ↗ Preventive Treatment 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 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dow-isoniazid

Condition Name

Condition Name for Dow-isoniazid
Intervention Trials
Tuberculosis 110
HIV Infections 29
Tuberculosis, Pulmonary 23
Pulmonary Tuberculosis 19
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Condition MeSH

Condition MeSH for Dow-isoniazid
Intervention Trials
Tuberculosis 201
Tuberculosis, Pulmonary 58
HIV Infections 41
Latent Tuberculosis 32
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Clinical Trial Locations for Dow-isoniazid

Trials by Country

Trials by Country for Dow-isoniazid
Location Trials
United States 313
South Africa 76
China 75
Canada 45
Brazil 39
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Trials by US State

Trials by US State for Dow-isoniazid
Location Trials
California 28
New York 26
Texas 24
Colorado 20
Illinois 20
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Clinical Trial Progress for Dow-isoniazid

Clinical Trial Phase

Clinical Trial Phase for Dow-isoniazid
Clinical Trial Phase Trials
Phase 4 40
Phase 3 51
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Dow-isoniazid
Clinical Trial Phase Trials
Completed 106
Recruiting 34
Not yet recruiting 30
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Clinical Trial Sponsors for Dow-isoniazid

Sponsor Name

Sponsor Name for Dow-isoniazid
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 41
Centers for Disease Control and Prevention 22
Johns Hopkins University 14
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Sponsor Type

Sponsor Type for Dow-isoniazid
Sponsor Trials
Other 516
NIH 55
U.S. Fed 47
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Clinical Trials, Market Analysis, and Projections for Isoniazid

Introduction to Isoniazid

Isoniazid is a crucial first-line antitubercular agent used in the treatment of tuberculosis (TB), including both active and latent forms of the disease. Its efficacy and widespread use make it a cornerstone in global TB control efforts.

Clinical Trials Update

endTB Clinical Trials

Recent clinical trials, such as those conducted under the endTB initiative, have introduced significant advancements in TB treatment regimens. These trials have focused on developing shorter, more patient-friendly treatments for multidrug-resistant tuberculosis (MDR-TB). The endTB trials have shown promising results, offering regimens that reduce treatment duration from up to 24 months to 6 or 9 months, with fewer side effects and no daily injections. These regimens have demonstrated non-inferiority to the current standard treatments, providing strong evidence for their efficacy, especially for difficult-to-treat patients, including those with comorbidities like HIV, diabetes, and hepatitis B and C[1].

TB Alliance Trials

The TB Alliance has also been at the forefront of clinical trials aimed at improving TB treatment. The SimpliciTB trial, for example, is evaluating a novel regimen known as BPaMZ (bedaquiline, pretomanid, moxifloxacin, and pyrazinamide) for patients with drug-sensitive and drug-resistant TB. This regimen is administered for four months for drug-sensitive TB and six months for MDR-TB, showing high efficacy and safety profiles[3].

Other notable trials include the Nix-TB trial, which tested the BPaL regimen (bedaquiline, pretomanid, and linezolid) for extensively drug-resistant TB (XDR-TB) and treatment-intolerant or non-responsive MDR-TB, achieving a 90% favorable outcome rate at six months post-treatment[3].

LTBI Treatment Trials

For latent TB infection (LTBI), clinical trials are focusing on improving treatment adherence and efficacy. A pragmatic, randomized clinical trial in Brazil is comparing the safety, adherence, and completion rates of LTBI treatment using a 300 mg isoniazid tablet versus the standard 100 mg tablets. This study aims to enhance patient compliance by reducing the pill burden, which is a critical factor in LTBI treatment success[4].

Market Analysis

Market Size and Growth

The global isoniazid market is experiencing steady growth due to the ongoing global burden of tuberculosis. As of 2023, the market size was valued at USD 0.792 billion and is projected to reach USD 1.13 billion by 2031, growing at a CAGR of 5.9% from 2024 to 2031[5].

Market Segmentation

The isoniazid market is segmented based on type (above 98% isoniazid and below 98% isoniazid) and application/end user (hospital, clinic, and others). Geographically, the market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2][5].

Drivers and Trends

Key drivers of the isoniazid market include the high demand for effective TB treatments, especially in developing countries where TB remains a significant public health concern. Technological advancements in pharmaceutical formulations and diagnostic tools, along with government-funded TB control programs and partnerships between pharmaceutical companies and healthcare organizations, are also propelling market growth[5].

Competitive Landscape

The competitive landscape of the isoniazid market is characterized by a mix of established pharmaceutical companies and emerging players. The market dynamics are influenced by factors such as buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition. A Porter’s Five Forces analysis highlights these factors, providing insights into the market ecosystem[5].

Projections and Future Outlook

Growing Demand

The demand for isoniazid is expected to continue growing as TB remains a major global health issue. Improvements in healthcare infrastructure and the increasing prevalence of TB diagnosis will drive the market forward. Additionally, the need for effective treatments for multidrug-resistant TB will keep isoniazid in high demand[5].

Innovations and Research

Ongoing research into innovative drug delivery methods and personalized medicine techniques is expected to enhance the treatment effects of isoniazid. New formulations and regimens, such as those being tested in clinical trials, will further improve treatment outcomes and patient compliance[3][5].

Global Health Initiatives

International organizations and government initiatives aimed at controlling TB will continue to support the growth of the isoniazid market. These efforts include funding for TB control programs, public health campaigns, and collaborations between healthcare providers and pharmaceutical companies[5].

Key Takeaways

  • Clinical Trials: Recent trials have introduced shorter, more patient-friendly regimens for TB treatment, reducing treatment duration and side effects.
  • Market Growth: The global isoniazid market is projected to grow at a CAGR of 5.9% from 2024 to 2031, driven by high demand for effective TB treatments.
  • Market Segmentation: The market is segmented by type and application, with a strong presence in hospitals and clinics.
  • Drivers: Technological advancements, government initiatives, and partnerships between pharmaceutical companies and healthcare organizations are key drivers.
  • Future Outlook: The market is expected to grow due to ongoing global health initiatives and the need for effective treatments for multidrug-resistant TB.

FAQs

What are the recent advancements in TB treatment regimens?

Recent clinical trials, such as the endTB and TB Alliance trials, have introduced new regimens that reduce treatment duration and side effects, offering more patient-friendly options for both drug-sensitive and drug-resistant TB.

How is the isoniazid market segmented?

The isoniazid market is segmented based on type (above 98% isoniazid and below 98% isoniazid) and application/end user (hospital, clinic, and others), with geographical analysis across various regions.

What are the key drivers of the isoniazid market?

Key drivers include high demand for effective TB treatments, technological advancements, government-funded TB control programs, and partnerships between pharmaceutical companies and healthcare organizations.

How is the competitive landscape of the isoniazid market characterized?

The competitive landscape is influenced by factors such as buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition, as analyzed through a Porter’s Five Forces framework.

What is the projected growth of the isoniazid market?

The global isoniazid market is projected to grow at a CAGR of 5.9% from 2024 to 2031, reaching USD 1.13 billion by 2031.

Sources

  1. endTB Clinical Trial Results: "endTB clinical trial results" - endTB.org
  2. Isoniazid Market Dynamics: "Isoniazid Market Dynamics 2021-2031" - The Insight Partners
  3. TB Alliance Trials: "Trials - TB Alliance" - TB Alliance
  4. LTBI Treatment Trial: "Protocol for pragmatic randomized clinical trial to evaluate the completion of treatment of LTBI with the drug Isoniazid" - PMC
  5. Isoniazid Market Size and Projections: "Isoniazid Market Size and Projections" - Market Research Intellect

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