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Last Updated: December 12, 2019

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CLINICAL TRIALS PROFILE FOR ISONIAZID

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505(b)(2) Clinical Trials for 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 2015-06-01 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. The investigators want to test a new combination of drugs to see if the investigators can treat TB faster in the future. By being in this study, you will not have a shorter course of anti-TB treatment; you must still take anti-TB medications for about 6 months. 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 want to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study will be the first time that this type of regimen without isoniazid has been tested in humans. If the investigators can show that isoniazid stops working after a few days, the investigators could then try to see if they can 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 2015-06-01 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. The investigators want to test a new combination of drugs to see if the investigators can treat TB faster in the future. By being in this study, you will not have a shorter course of anti-TB treatment; you must still take anti-TB medications for about 6 months. 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 want to see if stopping isoniazid early, or using moxifloxacin, a different drug, instead could treat TB faster. This study will be the first time that this type of regimen without isoniazid has been tested in humans. If the investigators can show that isoniazid stops working after a few days, the investigators could then try to see if they can 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 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 Isoniazid

Condition Name

Condition Name for Isoniazid
Intervention Trials
Tuberculosis 92
HIV Infections 26
Tuberculosis, Pulmonary 14
Pulmonary Tuberculosis 10
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Condition MeSH

Condition MeSH for Isoniazid
Intervention Trials
Tuberculosis 153
Tuberculosis, Pulmonary 38
HIV Infections 33
Infection 21
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Clinical Trial Locations for Isoniazid

Trials by Country

Trials by Country for Isoniazid
Location Trials
United States 268
Canada 44
South Africa 41
China 32
Brazil 26
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Trials by US State

Trials by US State for Isoniazid
Location Trials
California 24
New York 22
Texas 20
Maryland 18
Illinois 18
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Clinical Trial Progress for Isoniazid

Clinical Trial Phase

Clinical Trial Phase for Isoniazid
Clinical Trial Phase Trials
Phase 4 31
Phase 3 46
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Isoniazid
Clinical Trial Phase Trials
Completed 74
Not yet recruiting 36
Recruiting 26
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Clinical Trial Sponsors for Isoniazid

Sponsor Name

Sponsor Name for Isoniazid
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 29
Centers for Disease Control and Prevention 20
Johns Hopkins University 10
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Sponsor Type

Sponsor Type for Isoniazid
Sponsor Trials
Other 343
NIH 39
U.S. Fed 36
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