The Critical Path to TB Drug Regimens (CPTR) initiative

The Partnership aims to bring together leaders from global regulatory agencies, civil society organizations, and pharmaceutical and other drug developers to support advances in regulatory science and the development of infrastructure to facilitate the development and availability of new TB drug treatments.

The Critical Path to TB Drug Regimens (CPTR) initiative

The Critical Path to TB Drug Regimens (CPTR) initiative, co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance, is a multi-sectoral effort to overcome the challenges associated with TB drug development and to dramatically accelerate the development of new and impactful TB drug regimens. This innovative partnership brings together the world’s leading pharmaceutical and other drug developers, global regulatory agencies, and civil society organizations to support advances in regulatory science, the development of infrastructure, and other progress needed to facilitate the development and availability of new TB drug treatments.

The regimen development paradigm promoted by the TB Alliance is championed through the CPTR initiative partners. Under this initiative's umbrella, a diverse group of drug developers will allow their compounds to be tested in combination to find the best regimen, regardless of sponsor(s). This collaboration is a testament to a "patient-first" commitment from all parties and the realization that it will take many organizations working in partnership to stop TB’s devastating global effect.

The CPTR initiative also seeks to advance the regulatory science that will allow for the most efficient, accurate, and robust evaluation and application of these new testing models as well as address issues related to the lack of clinical trial capacity and funding. The TB Alliance coordinates the clinical combination drug development component of this initiative and, in partnership with Johns Hopkins University manages a preclinical combination drug study program that continues to feed the CPTR combination pipeline.


  • Bill & Melinda Gates Foundation (B&MGF)

    United States | Staff size: Unknown
    They are focused on the areas of greatest need, on the ways in which they can do the most good.


  • Critical Path Institute

    United States | Staff size: 26-50

    Critical Path Institute (C-Path) is a nonprofit, public-private partnership with the Food and Drug Administration (FDA) created under the auspices of the FDA’s Critical Path Initiative...

  • TB Alliance

    Implementing NGO
    United States | Staff size: 26-50

    Established in 2000 to address an urgent health need, TB Alliance relentlessly pursues its mission of discovering and developing improved TB treatments. Today, the organization and its partners...

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Key Information

  • Start Date 2010