On August 14, TB Alliance became the first nonprofit organisation to receive FDA regulatory approval for its drug, pretomanid, for the treatment of tuberculosis.

This approval followed the successful Nix-TB trial, which took place at three sites in South Africa. With this in mind, a further analysis of the current clinical trial space for tuberculosis can be completed in the Clinical Trials Database of GlobalData’s Pharma Intelligence Center. In this article, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively. 

Results of the analysis

Looking at all of the tuberculosis clinical trials in the database, most trials (37.8%) are in Phase II, as seen in Figure 1. Additionally, 28.5% are in Phase I, 18.6% are in Phase III, and 15.1% in Phase IV. Based on trial status, most trials were completed (66.3%). This was followed by ongoing, recruiting (13.1%); suspended, terminated, and withdrawn (S/T/W) (9.0%); planned (7.9%); ongoing, not recruiting (3.1%); and ongoing, recruiting by invitation (0.5%) (Figure 2).

As stated earlier, the pivotal Nix-TB trial took place in three sites. This is consistent with the majority of the clinical trials in the database. A total of 82.7% of the clinical trials took place at 1–10 sites, 6.3% took place in 11–25 sites, 1.3% took place in 26–50 sites, and only 0.5% took place in more than 50 sites. This can be seen in Figure 3.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.