CLINICAL TRIALS PROFILE FOR RIFAMPIN AND ISONIAZID

All Clinical Trials for RIFAMPIN AND ISONIAZID

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 RIFAMPIN AND ISONIAZID

Condition Name

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

Condition MeSH

Condition MeSH for RIFAMPIN AND ISONIAZID
Intervention	Trials
Tuberculosis	52
Tuberculosis, Pulmonary	21
Infections	10

Clinical Trial Locations for RIFAMPIN AND ISONIAZID

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for RIFAMPIN AND ISONIAZID

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for RIFAMPIN AND ISONIAZID

Sponsor Name

Sponsor Name for RIFAMPIN AND ISONIAZID
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 RIFAMPIN AND ISONIAZID
Sponsor	Trials
Other	134
U.S. Fed	16
Industry	12

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

Last updated: October 28, 2025

---

Introduction

Rifampin and Isoniazid form the cornerstone of anti-tuberculosis (TB) therapy, forming part of the standard first-line treatment regimens for Mycobacterium tuberculosis infections. As global TB prevalence persists—particularly in low- and middle-income countries—research, clinical development, and market dynamics around these drugs continue to evolve. This report provides a comprehensive update on recent clinical trials, market landscape, and future projections for Rifampin and Isoniazid, emphasizing research advancements, regulatory trends, and commercial opportunities.

---

Clinical Trials Update

Recent Developments and Ongoing Trials

Rifampin: The focus has shifted toward optimizing dosing strategies and overcoming resistance issues. Several phase II and III trials aim to evaluate novel formulations and dosing schedules to enhance efficacy and compliance. Notably, the RIFASHORT trial (ClinicalTrials.gov Identifier: NCT04509889) investigates shortened treatment durations incorporating high-dose Rifampin (15 mg/kg vs. 10 mg/kg), with preliminary data suggesting improved bacteriological clearance with tolerable safety profiles.

Isoniazid: Efficacy modifications and resistance mitigation remain key themes. Recent trials, such as the Phase III REMoxTB (NCT00371570), explored regimens replacing Isoniazid with alternative drugs but faced challenges due to adverse events. Currently, efforts focus on diagnostic tools to reduce Isoniazid resistance, such as genotype-based resistance testing to better guide therapy.

Innovative Formulations and Drug Delivery

Both drugs are subject to advancements in formulation technology:

• Rifampin: Liposomal and nanoparticle-based formulations are under investigation to improve bioavailability and reduce hepatotoxicity. A notable trial (NCT03890355) assesses inhalable Rifampin for pulmonary TB, aiming for targeted lung delivery and rapid action.

• Isoniazid: Sustained-release preparations and fixed-dose combinations (FDCs) aim to enhance treatment adherence. The development of combination inhalers and associating Isoniazid with novel compounds is ongoing.

Drug Resistance Monitoring

The emergence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB has prompted overhauls in clinical strategies:

• Rifampin resistance detection now leverages rapid molecular diagnostics like GeneXpert MTB/RIF, influencing clinical trial designs to include resistance profiles as inclusion/exclusion criteria.

• Efforts to combat mono-resistance to Isoniazid involve testing for katG mutations, guiding personalized therapy that may combine or replace traditional regimens.

---

Market Analysis

Global Market Overview

The global TB drug market was valued at approximately $850 million in 2021, with projections reaching $1.2 billion by 2027, exhibiting a CAGR of 6.2%. Rifampin's dominant share stems from its widespread use in standard regimens, while Isoniazid maintains substantial demand due to its cost-effectiveness and historical reliance.

Key Market Players

Major pharmaceutical companies engaged in Rifampin and Isoniazid manufacturing, development, and distribution include:

• McKesson Corporation
• Sanofi
• Johnson & Johnson (Janssen)
• Cepheid (Danaher Corporation) for diagnostic tools

Emerging biotech firms are increasingly investing in novel formulations and diagnostic integrations, reflecting market opportunities driven by drug-resistance challenges.

Regional Dynamics

• Latin America and Asia Pacific: Largest markets due to high TB prevalence, with significant government procurement programs and support from WHO's End TB Strategy.
• Africa: Growing demand driven by aggressive TB control initiatives, though supply chain constraints persist.
• North America and Europe: Smaller markets, primarily for drug-resistant TB cases and research purposes.

Regulatory and Policy Landscape

WHO's endorsement of shorter, more effective treatment regimens and adoption of molecular diagnostics influence market behavior. Governments are actively facilitating access through subsidized pricing and procurement programs, notably in endemic regions.

---

Market Projection and Future Outlook

Growth Drivers

• Rising TB incidence in endemic regions sustains demand.
• Innovation in drug delivery systems enhances treatment adherence, creating new market segments.
• Increasing drug resistance necessitates novel testing, personalized therapy, and drug development, expanding market scope.
• Global health initiatives (e.g., GDF, Global Fund) bolster procurement channels.

Potential Challenges

• Regulatory hurdles for novel formulations may delay market entry.
• Pricing pressures and patent expirations could impact revenue streams.
• Development of drug resistance may lead to shifts toward second-line and alternative therapies, impacting the core market.

Forecast Summary

By 2030, the market for Rifampin and Isoniazid is expected to grow at a CAGR of approximately 6%, driven by increased access, technological innovations, and global health policies favoring shorter, more effective treatments. Innovations in diagnostics and targeted therapies could significantly reshape market dynamics.

---

Conclusion

Rifampin and Isoniazid remain critical in TB management. Recent clinical trials emphasize the pursuit of optimized dosing and novel delivery methods, addressing resistance and adherence challenges. The market is poised for steady growth, underpinned by ongoing innovation and global health commitments. Stakeholders investing in research, formulation, or diagnostic tools aligned with these trends can capitalize on emerging opportunities.

---

Key Takeaways

• Clinical innovation focuses on shortening treatment durations, improving bioavailability, and combating resistance through novel formulations.
• Market growth is sustained by endemic region demand, technological advancements, and global health initiatives aiming to eradicate TB.
• Resistance management remains central—rapid diagnostics and personalized medicine will influence future therapy landscapes.
• Regulatory pathways are evolving to accommodate novel formulations, potentially accelerating market entry.
• Collaborations between pharma companies, governments, and global agencies are vital to expanding access and ensuring sustainable growth.

---

FAQs

1. How are new clinical trials impacting the use of Rifampin and Isoniazid?
New trials aim to optimize dosing, reduce treatment duration, and develop targeted delivery systems. These advancements may enhance efficacy, decrease adverse effects, and improve adherence, ultimately altering standard TB treatment protocols.

2. What is the outlook for resistant TB strains concerning these drugs?
Rifampin resistance is a hallmark of MDR-TB, and Isoniazid mono-resistance complicates therapy. Improved diagnostics and personalized treatment approaches are essential to managing resistant strains, with ongoing research exploring alternative regimens.

3. Are there ongoing efforts to develop fixed-dose combination therapies incorporating Rifampin and Isoniazid?
Yes, FDCs are a key focus to promote treatment adherence. New formulations aim to simplify dosing, reduce pill burden, and improve patient outcomes, with several products in clinical development.

4. How has the COVID-19 pandemic affected TB drug development and market dynamics?
The pandemic disrupted supply chains and delayed clinical trials but also increased awareness and funding for infectious disease management, potentially accelerating innovation and access initiatives for TB drugs.

5. What role do diagnostics play in the future market of Rifampin and Isoniazid?
Rapid molecular diagnostics, such as GeneXpert, guide personalized therapy by detecting resistance profiles. Their integration into clinical pathways drives demand for compatible therapies and fuels innovation in both drug development and diagnostics sectors.

---

References

[1] World Health Organization. Global Tuberculosis Report 2022. WHO.
[2] ClinicalTrials.gov. Registered trials involving Rifampin and Isoniazid.
[3] MarketWatch. Global Tuberculosis Drugs Market Size and Forecast 2022-2027.
[4] Danaher Corporation. Diagnostic innovations in TB.
[5] GDF. Procurement Trends and Strategies for TB Drugs.