Phase 2 trial will evaluate new investigational “pan-TB” regimen that includes three new compounds, in pursuit of a shorter, simpler TB treatment
CAMBRIDGE, Mass. (NOVEMBER 10, 2026) — The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) Collaboration today announced plans to launch a Phase 2 clinical trial evaluating a novel four-drug regimen designed to shorten treatment for drug-sensitive tuberculosis (DS-TB) from six months to four. Enrollment is expected to begin in the third quarter of 2027 at trial sites across Africa and Asia.
The trial will include two new investigational compounds, TBD09 and TBD11, initially advanced through the TB Drug Accelerator and now being developed by the Gates Medical Research Institute (Gates MRI). The regimen also includes two compounds from TB Alliance: sorfequiline, an investigational compound currently in Phase 2 for the treatment of drug-sensitive TB and pretomanid, which is recommended by the World Health Organization (WHO) to treat rifampicin-resistant (RR)/multi-drug resistant (MDR)-TB as part of the bedaquiline, pretomanid and linezolid (BPaL)1 regimen, except in certain circumstances. Together, the four compounds combine different mechanisms of action which could potentially shorten the treatment course.
Sponsored by Gates MRI on behalf of the PAN-TB Collaboration, the trial will compare three, four-month, all-oral treatment arms against isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE), the current first-line, six-month standard of care for DS-TB:
- TBD09, pretomanid, and sorfequiline
- TBD09, pretomanid, sorfequiline, and a low dose of TBD11
- TBD09, pretomanid, sorfequiline, and a higher dose of TBD11
“The current first-line treatment regimen is decades old, and drug-resistant strains have developed. To address this urgent need, we’re developing new investigational compounds that build on recent advances. A substantially shorter regimen with a more favorable safety profile for treating TB would be a major benefit for health systems and patients,” said Dr. Charles Wells, Chief Medical Officer of Gates MRI. “Emerging evidence from a related ongoing clinical trial could also help inform whether treatment duration can be shortened further, potentially to just three months.”
The need for new TB treatments remains urgent. TB is the world’s leading cause of death from a single infectious agent, affecting an estimated 10.7 million people and killing 1.2 million in 2024 according to the WHO. DS-TB is the most common form of the disease, yet its standard first-line treatment still requires people to take multiple medicines every day for at least six months.
“This trial builds on 20 years of advances in TB research, including a fundamental shift in how we develop treatments: evaluating new drugs together as regimens, rather than one at a time. By focusing clinical trials on promising regimens, we can make better use of precious time and resources. Our goal is to bring better treatments to the patients who need them as quickly and safely as possible,” said Dr. Mel Spigelman, President and CEO of TB Alliance.
Building on evidence from the first PAN-TB trial
This will be the second clinical trial conducted by the PAN-TB Collaboration. The first, launched in 2023, evaluated two four-drug regimens and was discontinued in 2025 after data showed that neither was potent enough to achieve the trial’s goal of shortening treatment to three months.
Those findings helped inform the selection and development of the next-generation regimen in this new trial, which has proven to have greater treatment shortening potential in pre-clinical studies. To support research across the broader TB drug development field, clinical data from the first trial is also available on request through the C-Path data platform at pan-tb.org.
“We need to bring the same pace of innovation we’re seeing in other areas of drug development to TB. PAN-TB brings partners together to advance research that traditional market incentives alone are unlikely to support—sharing evidence, identifying the right drug combinations and moving promising regimens forward faster to improve treatment for people with TB. This trial moves us closer to our ultimate goal: dramatically shorter, simpler treatments that can work across all forms of active TB,” said Dr. Raj Gupta, Deputy Director of TB Drugs and Diagnostics Research & Development at the Gates Foundation and a member of the PAN-TB Collaboration.
Toward shorter, simpler TB treatment
Months of daily treatment can place significant demands on people with TB and their households, including lost income and the cost of traveling to clinics for care and monitoring. Shortening treatment could ease those burdens, help more people complete treatment, and reduce demands on health systems.
If the Phase 2 trial succeeds in shortening DS-TB treatment, the regimen would next be evaluated in a Phase 3 clinical trial with the goal of developing a “pan-TB” regimen that could treat both DS- and DR-TB in three months or less, simplifying how TB treatment is delivered and reducing the need to determine drug resistance before treatment begins. An estimated 390,000 people developed DR-TB globally in 2024, underscoring the need for treatment options that can work across DS- and DR-TB.
Looking further ahead, PAN-TB partners aim to make treatment simpler still. One possibility is a long-acting injectable (LAI) formulation of a future pan-TB regimen that could reduce months of daily medicines to just one month or a small number of doses over the full course of treatment.
Learn more about the PAN-TB Collaboration at pan-tb.org.
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1 BPaL refers to the WHO-recommended regimen of bedaquiline, pretomanid and linezolid. It was the first TB regimen to reduce treatment time for drug-resistant TB to six months.
Notes to Editors
About the Project to Accelerate New Treatments for Tuberculosis (PAN-TB)
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is a first-of-its-kind collaboration among philanthropic, non-profit, and private sectors that aims to accelerate the development of an investigational drug regimen capable of treating all forms of tuberculosis.
The PAN-TB collaboration leverages members’ collective assets, resources and scientific expertise to identify and evaluate new drug regimens with an acceptable safety profile that have the potential to treat both drug-sensitive and drug-resistant TB, and are better-tolerated, shorter in duration and simpler to use than existing options. The collaboration focuses on advancing research through Phase 2 clinical efficacy trials in order to identify promising regimens for further development.
Launched in 2020, the current members of the PAN-TB collaboration include Evotec, GSK, Johnson & Johnson, Otsuka Pharmaceutical Co., Ltd., TB Alliance, the Gates Medical Research Institute, and the Gates Foundation.
About the Gates Medical Research Institute (Gates MRI)
The Gates Medical Research Institute is a non-profit medical research organization dedicated to
the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited.
For further information please visit www.gatesmri.org.
About the Investigational Compounds
TBD11
TBD11 is an investigational agent under clinical development by Gates MRI, with a potentially novel mechanism of action that could shorten TB treatment time of existing TB regimens. TBD11 was identified and its potential ascertained by Cornell University and the nonprofit drug development division of Scripps Research, Calibr-Skaggs Institute for Innovative Medicines (Calibr-Skaggs), through the TB Drug Accelerator (TBDA), a collaboration among biopharmaceutical companies, research organizations and universities established with support and leadership from the Gates Foundation to accelerate the discovery and development of novel therapeutic candidates against TB. Following preclinical evaluation, TBDA facilitated the licensing of TBD11 from Calibr-Skaggs to Gates MRI for clinical trial research.
TBD09
TBD09 (also known as MK-7762) is an investigational agent under development by Gates MRI with a mechanism of action (protein synthesis inhibition) similar to linezolid. Linezolid is a cornerstone agent/anchor for SOC regimens for drug-resistant TB and was instrumental in shortening duration of treatment for those indications. Both belong to the oxazolidinone class of compounds. The potentially improved safety profile of TBD09 allows inclusion of an oxazolidinone in regimens for treating drug sensitive Mtb. Scientists at Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the United States and Canada), working with the US National Institutes of Health under the guidance of the TBDA, discovered TBD09. Merck & Co., Inc., Rahway, NJ, USA licensed TBD09 to Gates MRI for evaluation in preclinical and clinical trials.
Sorfequiline
Sorfequiline (previously known as TBAJ-876) is an investigational agent under development by TB Alliance with a mechanism of action similar to bedaquiline, both belonging to the diarylquinoline class of compounds.
Pretomanid
Pretomanid, developed by TB Alliance, is a nitroimidazole recommended by the WHO as part of a combination regimen with bedaquiline and linezolid, with or without moxifloxacin, for the treatment of MDR-TB or rifampicin-resistant TB (RR-TB) in people ages 14 and older. It is included on the WHO List of Essential Medicines for MDR-TB and received its first regulatory approval from the US FDA in 2019, followed by EMA approval in 2020. It is not currently approved for use in treating DS-TB.