Co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance and launched in March 2010, CPTR members include the world’s leading pharmaceutical developers, global regulatory agencies, and civil society organizations, which are working together to overcome obstacles and speed new TB drug regimens to the patients who most urgently need them.

Since the 1950s, researchers have known that TB treatment must be delivered in multi-drug regimens to prevent resistance from developing. However, the conventional paradigm for TB drug development meant that individual drug candidates were developed and registered separately and substituted or added, one at a time, into existing combination therapies. Each substitution studied in clinical trials takes approximately six years to complete. That means, all told, a novel four-drug regimen would have required a quarter century of development. With more than 9 million new cases of TB each year, this is an unacceptably long wait for those suffering from the disease.



CPTR has the potential to shorten development time to as short as 6 years. 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. 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.

Organizations like the United States FDA support CPTR as a major public health imperative.

Prior to the inception of the TB Alliance, there was no pipeline of TB drugs. Today, the global portfolio includes 9 new TB drug candidates in clinical stages of development, three of which are part of the TB Alliance's portfolio. What’s more, the TB Alliance is developing more than 20 pre-clinical projects. These projects will feed the CPTR trials of tomorrow—and beyond. The time has finally come that novel TB regimens can be realistically conceived and realized. CPTR will allow them to make a difference in the lives of the millions in need as soon as possible.

The TB Alliance coordinates the clinical combination drug development component of this initiative and manages a preclinical combination drug study program that continues to feed the CPTR combination pipeline.