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Phase 2 clinical trial results show potential to shorten TB treatment time with new antibiotic

Early clinical trial results show that the new antibiotic sorfequiline, used in the SPaL regimen, demonstrated stronger activity than bedaquiline and could help shorten tuberculosis treatment for both drug-resistant and drug-sensitive TB.

3 min readUpdated: Nov 20, 2025 09:20 PM IST

The upcoming Phase 3 trial may pave the way for a new all-oral regimen for both drug-resistant and drug-sensitive TB.

Sorfequiline has shown stronger activity than bedaquiline in Phase 2 TB trials, offering hope for shorter, safer treatment. (Representational image)

New clinical trial results presented by TB Alliance at the Union World Conference on Lung Health show that a new type of antibiotic called sorfequiline (TBAJ-876) could improve tuberculosis treatment.

When used together with pretomanid and linezolid in a combination known as “SpaL”, this regimen shows promising potential. The Phase 2 clinical trial showed that, overall, sorfequiline had greater activity than bedaquiline.

When contacted, Dr Vikas Oswal, consultant pulmonologist in Mumbai and Global Technical Expert member – Drug Resistant TB- Philippines, told The Indian Express that if SpaL proves safe and effective in both drug-resistant TB and drug-Sensitive TB, it could be a potential game-changer for treatment duration.

TB Alliance, a not-for-profit organization aimed at finding faster acting and affordable drug regimens to fight TB, is strengthening partnerships with high-burden countries such as India, China, Indonesia, South Africa and Brazil in advance of launching a Phase 3 clinical trial in 2026.

This upcoming trial is an opportunity to earn approval for a new drug and regimen, as well as the first step in the process of developing an ultra-short regimen, said experts at TB Alliance.

Dr. Mel Spigelman, President and CEO of TB Alliance said, “The development of the BPaL regimen, which combines antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), allowed us to reduce treatment time for most drug-resistant TB to six months, a critical development for patients. Now, we have an opportunity to shorten treatment even further — representing an important milestone toward our goal of developing an ultra-short regimen capable of treating both drug-sensitive and drug-resistant TB.”

Sorfequiline and bedaquiline both belong to the diarylquinoline class of antibiotics, which target a key enzyme of the tuberculosis bacteria involved in energy production. In 2012, bedaquiline was approved for drug-resistant TB treatment, making it the first new antibiotic to be approved in decades. However, recent years have seen a rise in strains of TB that are resistant to bedaquiline. TB Alliance has been developing sorfequiline all the way through the R and D process, from early discovery to, now, late-stage clinical trials.

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Trial results show that sorfequiline could have potentially a better safety profile than bedaquiline along with the potential to treat many of the strains that are resistant to bedaquiline. Sorfequiline has been developed in pill form, and SPaL will also be an all-oral TB treatment.

Also Read | Are these antibiotics on your common use list? Know how they are making bugs drug-resistant

While Dr Oswal said that currently, there is no specific Indian data on outcomes of Sorfequiline in Indian TB patients yet, it is possible that India would participate in future studies or operational research once Phase-3 begins. The phase 2 trial was across 22 sites in South Africa, Philippines, Georgia, Tanzania and Uganda.

The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential to shorten treatment time for active TB. In addition, the SPaL regimen had a comparable safety profile to the standard of care for people with drug-sensitive TB (DS-TB).

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

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