Launch of the Critical Path to TB Drug Regimens

Today marks the launch of an exciting new initiative in TB R&D. The US Food and Drug Administration (FDA) has supported the Critical Path to TB Drug Regimens (CPTR). The CPTR comprises a broad collaborative network of partners including pharmaceutical companies, government, academia, and advocates, and NGOs with the focus to accelerate the development of new, safe, and highly effective shorter length TB treatment regimens.

Why is this initiative so important?

TB and Drug-Resistant TB remain major growing threats to global health. No new TB drugs have been registered in more than 40 years, and current treatments are burdensome to and take too long to cure. The continuing growth of drug-reistant TB epidemic emphasizes the urgent need for new, faster-acting TB drug regimens.

To fully realize the potential of the global TB drug portfolio, a new and innovative model for TB drug development strategy is also needed to expedite the time it takes for regimen development process, particularly where the emergence of drug resistance is a key concern.

Under CPTR, drug companies and other product developers will work together to test promising combinations of individual TB drug candidates as early as possible and identify the best new combinations, and subsequently test combinations of new drugs together in the clinical phases of development. This is in contrast to the traditional model, which substitutes (or adds) new compounds into the existing regimen individually and sequentially; each the process of each substitution traditionally takes roughly six years.

At the same time, CPTR partners will work with regulators to develop new pathways to evaluate and register these safe, effective combination TB therapies in record time.

By testing promising new drug combinations together, the CPTR initiative has the potential to reduce the timeline for developing novel TB drug regimens to as little as six years—cutting time needed to approve a fully novel regimen by up to 75 percent. The institution of CPTR and its support by the FDA is truly an innovative step in TB drug discovery.

To read more about the CPTR:

TB Alliance CPTR page:
C-Path CPTR page:

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