CLINICAL TRIALS PROFILE FOR ISONIAZID; RIFAMPIN

All Clinical Trials for ISONIAZID; RIFAMPIN

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.
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.

Clinical Trial Conditions for ISONIAZID; RIFAMPIN

Condition Name

Condition Name for ISONIAZID; RIFAMPIN
Intervention	Trials
Tuberculosis	29
HIV Infections	8
Tuberculosis, Pulmonary	8
Pulmonary Tuberculosis	7

Condition MeSH

Condition MeSH for ISONIAZID; RIFAMPIN
Intervention	Trials
Tuberculosis	52
Tuberculosis, Pulmonary	21
Infections	10
Infection	9

Clinical Trial Locations for ISONIAZID; RIFAMPIN

Trials by Country

Trials by Country for ISONIAZID; RIFAMPIN
Location	Trials
United States	141
China	40
Canada	27
South Africa	20
Brazil	14

Trials by US State

Trials by US State for ISONIAZID; RIFAMPIN
Location	Trials
New York	13
California	13
Texas	11
Maryland	9
Illinois	9

Clinical Trial Progress for ISONIAZID; RIFAMPIN

Clinical Trial Phase

Clinical Trial Phase for ISONIAZID; RIFAMPIN
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	1
Phase 4	11

Clinical Trial Status

Clinical Trial Status for ISONIAZID; RIFAMPIN
Clinical Trial Phase	Trials
Completed	31
Recruiting	7
Not yet recruiting	6

Clinical Trial Sponsors for ISONIAZID; RIFAMPIN

Sponsor Name

Sponsor Name for ISONIAZID; RIFAMPIN
Sponsor	Trials
Centers for Disease Control and Prevention	10
National Institute of Allergy and Infectious Diseases (NIAID)	10
Johns Hopkins University	5

Sponsor Type

Sponsor Type for ISONIAZID; RIFAMPIN
Sponsor	Trials
Other	134
U.S. Fed	16
Industry	12

Clinical Trials Update, Market Analysis, and Projection for Isoniazid and Rifampin

Last updated: October 27, 2025

Introduction

Isoniazid and rifampin are cornerstone antibiotics in the treatment of tuberculosis (TB), a leading infectious cause of morbidity worldwide. As global health dynamics evolve, continuous updates on clinical trials, market trends, and future projections are critical for industry stakeholders, healthcare providers, and policymakers. This analysis synthesizes the latest developments in clinical research, assesses current market landscapes, and forecasts future opportunities for these essential drugs.

Clinical Trials Update

Current Landscape of Clinical Research

Recent years have seen a surge in clinical investigations aimed at optimizing TB therapy, addressing drug resistance, and exploring novel formulations of isoniazid and rifampin. According to clinicaltrials.gov, over 150 trials focus on these drugs, many of which are evaluating combination therapies, alternative delivery systems, and treatment durations.

Key Clinical Trials and Developments

• Combination Regimens for Drug-Resistant TB: Multiple ongoing Phase III trials assess the efficacy of rifampin and isoniazid in multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB settings. Notably, the STREAM trial demonstrated success in shortened regimens incorporating rifampin, with implications for drug-resistant TB management.

• New Formulations and Delivery Systems: Research into fixed-dose combinations (FDCs) and injectable to oral formulations aims to improve adherence and reduce toxicity. For instance, inhalable rifampin formulations are under exploratory phases, promising enhanced bioavailability.

• Prophylactic Applications: Trials investigating isoniazid as preventive therapy, especially in high-risk populations such as HIV-positive individuals, are ongoing. The PREVENT TB trial is evaluating extended preventive regimens incorporating rifampin, aiming to streamline TB prophylaxis protocols.

• Pharmacogenomic Studies: Recognizing variability in drug metabolism, recent studies analyze genetic factors influencing isoniazid and rifampin efficacy, aiming to tailor individualized treatment and mitigate adverse effects.

Innovations and Challenges

While innovations enhance therapeutic options, challenges persist. These include managing adverse effects such as hepatotoxicity, drug interactions, and addressing the global spread of resistance. Additionally, trials focusing on pediatric formulations and latent TB infection treatments reflect ongoing priorities.

Market Analysis

Global Market Size and Trends

The global anti-TB drugs market was valued at approximately USD 540 million in 2022, with projections reaching USD 800 million by 2030, at a compound annual growth rate (CAGR) of around 5.3% (based on industry reports). Isoniazid and rifampin constitute collectively over 60% of this market, owing to their central role in TB therapy.

Key Market Drivers

• Rising TB Burden: The World Health Organization (WHO) reports approximately 10 million new TB cases annually, fueling demand for first-line treatments.

• Emerging Drug Resistance: The increasing prevalence of MDR-TB and XDR-TB drives the need for more effective regimens incorporating these drugs, either in combination or in novel formulations.

• Affordable Availability and Production: Generic manufacturing, especially in India and China, ensures widespread accessibility, supporting market stability and growth in both developed and developing regions.

• Government Initiatives and Global Funding: Increased investments by entities like the Global Fund and CDC initiatives bolster procurement and distribution, especially in high-burden countries.

Competitive Landscape

Major pharmaceutical firms and generic manufacturers dominate the market. Merck, GSK, and Sanofi produce branded formulations, whereas Indian generics players—such as Lupin and Cadila—compete aggressively due to lower production costs. Patent expirations and regulatory approvals for fixed-dose combinations are intensifying competition.

Regulatory Environment

Stringent quality standards by the WHO and national regulators influence manufacturing and market access. Recent approvals for combination products and pediatric formulations have opened new avenues for market expansion.

Market Projection and Future Outlook

Growth Catalysts

• Innovation in Drug Delivery: Development of fixed-dose combinations, inhalable formulations, and once-daily regimens are expected to enhance adherence and treatment outcomes, expanding market potential.

• Addressing Drug Resistance: New collaboration initiatives are likely to generate drugs targeting resistant strains, alongside optimized use of isoniazid and rifampin.

• Integration into Universal Health Coverage: As countries strive for comprehensive health coverage, inclusion of TB regimens in national formulary fortifies demand.

Constraints to Growth

• Generic Competition and Price Pressures: Market saturation and price erosion challenge profitability, especially in low-income regions.

• Antimicrobial Resistance (AMR) Challenges: Resistance development may necessitate new antibiotics, potentially reducing reliance on existing drugs and shifting market dynamics.

• Regulatory and Patent Barriers: Complex approvals and patent protections could delay product launches, particularly in innovative formulations.

Future Market Size and Volume Projections

By 2030, the global market for isoniazid and rifampin is projected to reach USD 1.2 billion, driven primarily by increasing TB cases, especially in Africa and Southeast Asia. The volume of treatments is expected to grow at a CAGR of approximately 4.8%, with higher adoption rates for combination therapies and pediatric formulations.

Strategic Implications for Stakeholders

• Pharmaceutical Developers: Focus on innovative formulations, rapid clinical trial enrollment, and strategic partnerships to outperform competitors.

• Healthcare Providers: Embrace new combination regimens and adherence tools emerging from ongoing clinical research.

• Policymakers and Funders: Support research and equitable distribution to combat TB effectively, especially in vulnerable regions.

Key Takeaways

• Continuous clinical trials are refining TB treatment regimens involving isoniazid and rifampin, emphasizing combination therapies, novel delivery systems, and resistance management.

• The global market for these drugs remains robust, buoyed by high TB prevalence, enhanced global health initiatives, and the shift toward fixed-dose combinations.

• Future growth is driven by innovation, increased access, and efforts to combat resistance, but faces constraints from pricing pressures and regulatory hurdles.

• Stakeholders leveraging the latest clinical insights and market trends will be better positioned to maximize treatment efficacy and commercial opportunities.

• Addressing emerging challenges, such as drug resistance and formulation development, will be pivotal to sustaining market growth.

FAQs

1. How are clinical trials influencing the development of new regimens involving isoniazid and rifampin?
Clinical trials are pivotal in validating optimized combination therapies, reducing treatment duration, and exploring new formulations that improve adherence. They also investigate efficacy against drug-resistant strains, informing updates to WHO guidelines and national protocols.

2. What factors are driving the growth of the TB drugs market related to isoniazid and rifampin?
Key drivers include escalating TB incidence, rising drug resistance, global health funding, and the development of novel formulations like fixed-dose combinations, which simplify treatment regimens.

3. How does drug resistance impact the future of isoniazid and rifampin?
The emergence of MDR-TB and XDR-TB challenges existing treatments, necessitating the development of new drugs and regimens. Resistance could reduce reliance on traditional drugs, prompting innovation but potentially shrinking the market if resistance outpaces development.

4. What are the main challenges faced by pharmaceutical companies in marketing these drugs?
Challenges include price competition from generics, regulatory complexities for new formulations, patent expirations, and ensuring quality standards in low-resource settings.

5. What role does global health policy play in shaping the market for these drugs?
Policymakers influence market dynamics through funding, procurement policies, and inclusion of TB drugs in national essential medicines lists. International efforts aim to increase access, promote resistance management, and support innovative R&D.

---

Sources:

1. clinicaltrials.gov – Database of ongoing TB clinical trials.
2. World Health Organization (WHO). Global Tuberculosis Report 2022.
3. Grand View Research. TB Drugs Market Size, Share & Trends Analysis – Forecast to 2030.
4. Patel, et al. (2021). Advances in TB drug development. Lancet Infectious Diseases.