CLINICAL TRIALS PROFILE FOR ISONIAZID

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	2015-06-30	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.

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.

Clinical Trial Conditions for Isoniazid

Condition Name

Condition Name for Isoniazid
Intervention	Trials
Tuberculosis	110
HIV Infections	29
Tuberculosis, Pulmonary	23
Pulmonary Tuberculosis	19

Condition MeSH

Condition MeSH for Isoniazid
Intervention	Trials
Tuberculosis	201
Tuberculosis, Pulmonary	58
HIV Infections	41
Latent Tuberculosis	32

Clinical Trial Locations for Isoniazid

Trials by Country

Trials by Country for Isoniazid
Location	Trials
United States	313
South Africa	76
China	75
Canada	45
Brazil	39

Trials by US State

Trials by US State for Isoniazid
Location	Trials
California	28
New York	26
Texas	24
Illinois	20
Colorado	20

Clinical Trial Progress for Isoniazid

Clinical Trial Phase

Clinical Trial Phase for Isoniazid
Clinical Trial Phase	Trials
Phase 4	40
Phase 3	51
Phase 2/Phase 3	11

Clinical Trial Status

Clinical Trial Status for Isoniazid
Clinical Trial Phase	Trials
Completed	106
Recruiting	34
Not yet recruiting	30

Clinical Trial Sponsors for Isoniazid

Sponsor Name

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

Sponsor Type

Sponsor Type for Isoniazid
Sponsor	Trials
Other	516
NIH	55
U.S. Fed	47

Clinical Trials, Market Analysis, and Projections for Isoniazid

Introduction to Isoniazid

Isoniazid is a first-line antitubercular agent used in the treatment and prevention of tuberculosis (TB). It has been a cornerstone in TB therapy for decades, but its effectiveness and safety are continually being evaluated through clinical trials and market analyses.

Clinical Trials Update

Early Bactericidal Activity of High-Dose Isoniazid

A recent phase IIa clinical trial (A5312) investigated the early bactericidal activity (EBA) of high-dose isoniazid in patients with tuberculosis caused by katG-mutated Mycobacterium tuberculosis (M.tb), which typically confers high-level resistance to isoniazid. The trial randomized participants to receive either 15 or 20 mg/kg of isoniazid daily for 7 days. The results showed negligible bactericidal activity of high-dose isoniazid in the majority of participants, except for a subset of slow NAT2 acetylators who experienced higher concentrations of the drug. This study highlights the limited efficacy of high-dose isoniazid against katG-mutated M.tb[1].

Short-Course Treatment Regimens

Another significant clinical study compared the effectiveness of short-course treatment regimens involving isoniazid and rifampin to the traditional 9-month course of isoniazid monotherapy for the treatment of latent tuberculosis infection (LTBI). The study found that short-course treatment with isoniazid and rifampin for 3-4 months was safe and superior to the 9-month isoniazid monotherapy in terms of compliance and outcomes. No patients developed clinical disease during the follow-up period, and serious drug-related adverse effects were not detected[3].

Adverse Events in Routine Settings

A pragmatic implementation trial in Uganda assessed the incidence and management of adverse events (AEs) associated with the 12-week isoniazid and rifapentine (3HP) regimen for TB prevention. The study found that while the 3HP regimen was generally safe and well-tolerated, real-world data on AEs were crucial for health systems to anticipate resource needs for AE management. The trial emphasized the importance of monitoring AEs in routine care settings to ensure the successful scale-up of TB preventive treatment programs[4].

Market Analysis

Global Market Overview

The global isoniazid market is anticipated to grow significantly over the next few years. As of 2023, the market was valued at a substantial amount, and it is projected to reach even higher values by 2030, witnessing a notable compound annual growth rate (CAGR). This growth is driven by increasing demand for effective TB treatments, especially in high-burden countries[5].

Key Players

The isoniazid market is dominated by several key players, including:

• AMSAL CHEM
• Resonance Specialties
• Calyx Pharma & Chem
• Camus pharma
• Titan Pharma (India)
• Taizhou Tianrui Pharmaceutical
• Zhejiang Second Pharma

These companies are involved in the production and distribution of isoniazid, contributing to the market's competitive landscape[5].

Market Segmentation

The isoniazid market is segmented by type and application. The primary applications include:

• Hospital
• Clinic
• Other healthcare settings

Understanding these segments is crucial for market players to tailor their strategies and meet specific demand needs[5].

Regional Analysis

The market analysis also includes a regional breakdown, highlighting the revenue and volume share, forecast, and CAGR for different regions. This regional analysis helps in identifying high-growth areas and opportunities for market expansion[2][5].

Market Projections

Forecast and Growth Trends

The global isoniazid market is expected to continue its growth trajectory from 2025 to 2031. The forecast includes detailed revenue and volume projections, as well as an analysis of the competitive landscape, growth factors, and trends. The market is driven by the increasing incidence of TB, particularly in regions with high disease burdens, and the need for effective and safe treatment regimens[2][5].

Drivers and Opportunities

Key drivers of the isoniazid market include:

• The global effort to eliminate TB by 2030, which necessitates the scale-up of TB preventive treatment programs.
• The efficacy and safety of short-course treatment regimens involving isoniazid.
• Increasing investment in healthcare infrastructure in developing countries.

Opportunities for market growth also lie in the development of new formulations and the expansion of distribution channels to reach more patients[2][5].

Challenges and Restraints

Despite the growth potential, the isoniazid market faces several challenges, including:

• Resistance to isoniazid, particularly in cases of katG-mutated M.tb.
• Adverse events associated with isoniazid use, which require careful management.
• Regulatory hurdles and patent issues that can affect market dynamics.

Addressing these challenges is crucial for sustaining market growth and ensuring the continued availability of effective TB treatments[1][4][5].

Key Takeaways

• Clinical Efficacy: High-dose isoniazid shows limited efficacy against katG-mutated M.tb, while short-course regimens with isoniazid and rifampin are superior to traditional monotherapy.
• Market Growth: The global isoniazid market is projected to grow significantly, driven by increasing demand for TB treatments.
• Key Players: Several companies dominate the market, including AMSAL CHEM, Resonance Specialties, and others.
• Regional Analysis: The market is segmented by region, with high-growth areas identified in high-burden countries.
• Challenges: Resistance and adverse events are significant challenges that need to be addressed.

FAQs

What is the current status of high-dose isoniazid in treating TB caused by katG-mutated M.tb?

High-dose isoniazid (15-20 mg/kg) has been found to have negligible bactericidal activity against katG-mutated M.tb in the majority of participants, except for a subset of slow NAT2 acetylators[1].

Which treatment regimen is recommended for latent tuberculosis infection (LTBI)?

Short-course treatment with isoniazid and rifampin for 3-4 months is recommended over the traditional 9-month isoniazid monotherapy due to better compliance and outcomes[3].

What are the common adverse events associated with the 3HP regimen?

The 3HP regimen (12 weeks of isoniazid and rifapentine) is generally safe, but real-world data show that adverse events can occur, necessitating careful monitoring and management in routine care settings[4].

Who are the key players in the global isoniazid market?

Key players include AMSAL CHEM, Resonance Specialties, Calyx Pharma & Chem, Camus pharma, Titan Pharma (India), Taizhou Tianrui Pharmaceutical, and Zhejiang Second Pharma[5].

What is the projected growth of the global isoniazid market?

The global isoniazid market is anticipated to grow significantly from 2025 to 2031, driven by increasing demand for effective TB treatments and preventive measures[2][5].

Sources

1. High-Dose Isoniazid Lacks EARLY Bactericidal Activity against ... - PubMed
2. Isoniazid Market Report 2024 (Global Edition) - Cognitivemarketresearch
3. Effectiveness of a 9-Month Regimen of Isoniazid Alone versus 3 ... - Oxford Academic
4. Adverse Events Reported During Weekly Isoniazid-Rifapentine ... - Oxford Academic
5. Global Isoniazid Market Research Report 2024 - Valuates Reports - Valuates Reports

Last updated: 2025-01-02