Skip to Main Content

RTI uses cookies to offer you the best experience online. By and clicking “accept” on this website, you opt in and you agree to the use of cookies. If you would like to know more about how RTI uses cookies and how to manage them please view our Privacy Policy here. You can “opt out” or change your mind by visiting: http://optout.aboutads.info/. Click “accept” to agree.

Accept
RTI International
  • About
    • Office Locations
    • Executive Leadership
    • Corporate Governance
    • Partner with Us
      • U.S. Government
      • Clients and Funding Agencies
      • Industry and Commercial Clients
      • Foundations and Associations
      • Bilateral Agencies and Multilateral Banks
      • Universities and Academic Research Institutions
      • Suppliers and Small Businesses
    • Commitment to Quality
      • RTI's Client Listening Program
    • Ethics and Human Research Protection
    • Living Our Mission
    • Open Science Initiative
    • Veteran Opportunities at RTI

    About

  • Practice Areas
    • Health
      • Public Health and Well-Being
      • Health Care Transformation
      • Behavioral Health
      • Health Behavior Change
      • Precision Medicine
      • RTI Health Solutions (RTI-HS)
      • RTI Center for Community Health Evaluation and Economics Research
      • Health Equity
      • RTI Health Advance
    • Transformative Research Unit for Equity​
      • Equity Capacity Building Hub
      • Social and Economic Justice Research Collaborative
      • Narrative Research and Community Engagement Lab
    • Education and Workforce Development
      • Early Childhood
      • K-12 Education
      • Postsecondary Education
      • Career and Adult Education and Workforce Development
      • Education Policy, Systems, and Governance
      • Education Research Methodologies
      • Education Technologies
    • International Development
      • Energy for Development
      • Environment
      • Global Food Security, Agriculture, and Nutrition
      • Global Health
      • International Education
      • Monitoring, Evaluation, Research, Learning, and Adapting (MERLA)
      • Youth and Economic Opportunity
      • Building Resilience Against COVID-19 in Developing Countries
      • Water, Sanitation, and Hygiene (WASH)
      • RTI Center for Governance
    • Climate Change
      • Clean Energy Technology and Renewables
      • Climate Finance
      • Climate Justice and Equity
      • Climate Planning, Preparedness and Resilience
      • Climate Policy
      • Climate Vulnerability, Adaptation, and Mitigation
      • Economic Impacts of Climate Change
    • Water
      • Food-Energy-Water Nexus
      • Water Quality
      • WASH (Water, Sanitation, Hygiene)
      • Water Resources Management
    • Energy Research
      • Carbon Capture and Utilization
      • Biomass Conversion
      • Natural Gas
      • Energy Efficiency
      • Industrial Water
      • Syngas Processing
    • Environmental Sciences
      • Air Quality
      • RTI Center for Water Resources
      • Urban Sustainability
      • Toxics
      • Building Resiliency in the FEW Nexus
      • Climate Change Sciences and Analysis
      • Environmental Policy
      • Environmental Justice
      • Sustainable Materials & Waste Management Solutions
    • Justice Research and Policy
      • RTI Center for Community Safety and Crime Prevention
      • RTI Center for Policing Research and Investigative Science
      • Child Well-Being and Family Strengthening
      • RTI Center for Forensic Sciences
      • Evidence-Based Strategies to Reduce Firearm Violence
    • Food Security and Agriculture
      • Market Systems Strengthening
      • Food Safety
      • Food and Nutrition
      • Global Food Security, Agriculture, and Nutrition
      • Climate-Smart Agriculture
      • Agricultural Innovation
      • Obesity Prevention
    • Innovation Ecosystems
      • Innovation Advising
      • Innovation for Economic Growth
      • Innovation for Emerging and Developing Economies
      • Innovation for Organizations
      • Research, Technology, and Innovation Policy
      • Technology Acceleration
    • Military Support
      • Military Behavioral Health
      • Military Health and Human Performance
      • Military Sexual Assault, Harassment, and Domestic Violence Prevention
      • Wearable Sensor Technologies
      • Military Health System Transformation
      • North Carolina Center for Optimizing Military Performance

    Practice Areas

  • Services + Capabilities
    • Surveys and Data Collection
      • Survey Design
      • Instrument Development
      • Survey Methodologies
      • Data Collection
      • Establishment Surveys
      • Health Registries
      • Data Analysis and Reporting
      • Research Operations Center
    • Statistics and Data Science
      • Survey Statistics
      • Environmental Statistics
      • Coordinating Centers for Multisite Studies
      • Analysis and Design of Complex Data
      • Biostatistics
      • RTI Center for Data Science
    • Evaluation, Assessment and Analysis
      • Evaluation Design and Execution
      • Advanced Qualitative, Quantitative, and Mixed Methods
      • Evaluation, Monitoring, and Assessment
      • Economic Analysis
      • Evaluating Communication Interventions and Campaigns
      • Evidence Synthesis for Policy and Practice
      • Risk Assessment and Prediction
    • Program Design and Implementation
      • Systems Strengthening and Scaling
      • Capacity Assessment and Building
      • Policy Reform Support
      • Curriculum and Teacher Professional Development
      • Interventions and Prevention Programs
      • Implementation Science
    • Digital Solutions for Social Impact
      • Human-Centered Design of Digital Solutions
      • Digital Product Development
      • Digital Communication Campaigns
      • Digital Data Analytics
    • Research Technologies
      • Survey Technologies
      • Data Management and Decision Support Systems
      • Geospatial Science, Technology, and Visualization
      • ICT for Limited-Resource Settings
      • Mobile Applications
      • Web Applications
      • Bioinformatics
      • Interactive Computing
    • Drug Discovery and Development
      • Medicinal Chemistry
      • Molecular Design and Cheminformatics
      • Behavioral Pharmacology
      • Drug Metabolism and Pharmacokinetics (DMPK)
      • In Vitro Pharmacology, Bioassay Development, and High-Throughput Screening (HTS)
      • Isotope Labeling
      • Regulatory Consulting and Support for Medical Products
    • Analytical Laboratory Sciences
      • Bioanalytical and Toxicology Research
      • Forensic Sciences
      • Physicochemical Characterizations
      • Metabolomics
      • Proficiency Testing and Reference Materials
      • Microbiology
      • Analytical Chemistry and Pharmaceutics
    • Engineering & Technology R&D
      • Biomedical Technologies
      • Decarbonization Sciences
      • Environmental Exposure & Protection
      • Materials & Environment
      • Sustainable Energy Solutions

    Services + Capabilities

  • Impact
    • Newsroom
    • Insights Blog
    • Events
    • Publications
    • RTI Press
      • About the RTI Press
      • Instructions for Authors
      • RTI Press Collections
    • Projects
    • Global Reach
      • Asia
      • Eastern Europe and Central Asia
      • RTI International India
      • Africa
      • Middle East and North Africa (MENA)
      • Latin America and the Caribbean (LAC)

    Impact

  • Experts
    • Our Experts
    • In-Depth With Our Experts
    • Related News
    • Experts In the Media
    • RTI Fellow Program

    Experts

  • Emerging Issues
    • COVID-19 Research
    • Artificial Intelligence
    • Global Health Security
    • Cannabis Research
    • Opioid Research
      • Interventions for Opioid Use Disorders
      • Preventing Opioid Misuse and Overdose
      • Treating Opioid Use Disorders
    • Policing Research and Investigative Science
    • Drone Research and Application
    • E-cigarette Research
    • Zika Virus Research
    • Integrated Governance

    Emerging Issues

  • COVID-19 Research + Response
  • Global Reach
  • Insights Blog
  • Newsroom
  • RTI Press
  • Publications
  • Partner With Us
  • Careers
  • Facebook IconTwitter IconInstagram IconYouTube IconLinkedin Icon
  • Home
  • Impact
  • Newsroom
  • FDA Approves Breakthrough Drug to Treat Extensively Drug-Resistant Tuberculosis
Newsroom

FDA Approves Breakthrough Drug to Treat Extensively Drug-Resistant Tuberculosis

August 14, 2019
Share
  • Share on Facebook
  • Share on Twitter
  • Share on Linkedin
  • Email

RESEARCH TRIANGLE PARK, N.C. — Today, the Food and Drug Administration (FDA) announced its approval of pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB. RTI International (RTI) scientist Dr. Doris Rouse and her team have collaborated closely with TB Alliance on the development of pretomanid for almost 20 years. TB Alliance is a non-profit product development partnership that RTI and Dr. Rouse helped to form in 2000. TB Alliance has negotiated license agreements enabling an affordable cost of pretomanid in low resource countries.

“We are seeing an increase in XDR-TB, and we need new weapons to attack it,” Rouse says. “I've been in wards with patients that are so emaciated, they won't eat anything, they have fevers, they can't sleep. But with pretomanid, in a regimen that includes two other drugs, bedaquiline and linezolid, we see improvement within a few weeks. This new treatment will help people who have no other good option for a cure.”

Pretomanid is only the third anti-TB drug approved by FDA in more than 40 years. Prior to the pivotal Nix-TB trial of pretomanid as part of a three-drug regimen with bedaquiline and linezolid (known as the BPaL regimen), treatment for XDR-TB required a two-year regimen and in South Africa, for example, only cured 2 to 22 percent of those receiving treatment. The six-month, all-oral BPaL regimen cured approximately 9 out of 10 participants of the XDR-TB patients in the trials conducted in South Africa.

Tuberculosis kills 1.6 million people a year — more than 4,000 people a day — and kills more people than any other infectious disease. XDR-TB is resistant to four of the main drugs, including injectable agents, currently used to treat drug resistant TB around the world.

With funding from the National Institute of Allergy and Infectious Diseases (NIAID), in 1999 Rouse and a team at RTI headed up the effort to identify potential new compounds for TB treatment. They identified and conducted due diligence on pretomanid, a compound developed by a small biotech, Pathogenesis.

TB Alliance acquired the license to pretomanid, then known as Pa-824, in 2002. RTI assisted TB Alliance in planning and managing the preclinical studies needed for development and preparing the successful Investigational New Drug (IND) application to FDA in 2005, leading to the start of clinical trials that year.

RTI has served as a regulatory contact for TB Alliance since the pretomanid IND was submitted to FDA in 2005.

“We’ve worked on this new drug for 19 years, and it hasn’t always been an easy path,” she added. “But as I’ve always said, ‘One of the main ingredients for successful drug development is blessed stubbornness.’ This public-private partnership is an excellent model for meeting unmet needs, especially those that are in low-resource countries that may not have the commercial attraction of other diseases.”

TB Alliance is now targeting adoption and availability of pretomanid as part of the BPaL regimen in countries with a high unmet need for XDR-TB treatments.  

Highlights

  • Today, the Food and Drug Administration (FDA) announced its approval of pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB.
  • RTI International (RTI) scientist Dr. Doris Rouse and her team have collaborated closely with TB Alliance on the development of pretomanid for almost 20 years.
  • Pretomanid is only the third anti-TB drug approved by FDA in more than 40 years.

Media Info

To request an interview, contact our Media Relations team.

  • +1 919 708 8205
  • news@rti.org
Subscribe to RTI

RTI Logo
Partner With Us
  • US Government
  • Commercial
  • Foundations & Associations
  • Multilateral Donors
  • Universities
  • Suppliers
Site
  • Privacy Policy
  • Security Policy
  • Site Map
  • Terms of Use
  • Accessibility
  • Contact Us
Contact Us
Facebook Icon Twitter Icon Instagram Icon YouTube Icon Linkedin Icon
delivering the promise of science
for global good
RTI Health Solutions RTI Innovation Advisors RTI Health Advance

© 2023 RTI International. RTI International is a trade name of Research Triangle Institute. RTI and the RTI logo are U.S. registered trademarks of Research Triangle Institute.