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Freedom251 › Blog › BPaLM

A New Generation of Tuberculosis Drugs: What’s Available and What’s Still in Trials

By Freedom251 Team · · 3 min read

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Newer tuberculosis treatment is already changing care for some people with drug-resistant TB: WHO’s 2025 guidance suggests six-month all-oral regimens including BPaLM and BDLLfxC for specific eligible patients. A much larger group of candidate drugs remains in clinical development. A medicine being tested is not the same as a recommended or routinely available treatment.

Which newer TB medicines are used in treatment now?

The clearest change is the use of shorter, all-oral combinations for particular forms of drug-resistant tuberculosis. These regimens are not universal treatments for every form of TB. WHO’s 2025 recommendation table suggests six-month BPaLM for eligible people with multidrug- or rifampicin-resistant TB (MDR/RR-TB) and pre-extensively drug-resistant TB (pre-XDR-TB). It also suggests six-month BDLLfxC for MDR/RR-TB, with or without fluoroquinolone resistance. These are separate recommendations, and eligibility depends on the individual clinical situation.

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Regimen Medicines WHO guidance and population stated Duration
BPaLM Bedaquiline, pretomanid, linezolid, moxifloxacin WHO’s 2025 table suggests it for eligible people with MDR/RR-TB and pre-XDR-TB. Six months
BDLLfxC Bedaquiline, delamanid, linezolid, levofloxacin, clofazimine WHO’s 2025 table suggests it for MDR/RR-TB with or without fluoroquinolone resistance. Six months

These recommendations do not determine which regimen is right for a particular person. Treatment choices, eligibility, testing, monitoring, and access should be handled by a qualified TB-care team using applicable WHO and national clinical guidance.

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When BPaLM becomes BPaL

BPaLM’s final letter stands for moxifloxacin. In its August 2024 rapid communication, WHO said to drop moxifloxacin when fluoroquinolone resistance is documented, leaving BPaL: bedaquiline, pretomanid, and linezolid. WHO described BPaLM/BPaL as the prioritized treatment of choice for eligible patients with drug-resistant TB at that time. This does not make either combination suitable for every patient or every form of TB.

What adoption figures show—and what they do not

WHO’s Global Tuberculosis Report 2024 recorded broader country use of BPaLM/BPaL: 58 countries had used the regimens by the end of 2023, up from 41 by the end of 2022. The report counted 5,646 people starting them in 2023, compared with 1,744 in 2022. These figures describe reported rollout and treatment starts; they are not trial efficacy results or a measure of treatment success.

How many TB drugs are still in development?

WHO’s Global Tuberculosis Report 2024 counted 29 drugs for TB disease in phase I, II, or III trials in its August 2024 snapshot. Of these, 18 were new chemical entities, three were already-approved medicines being studied in trials, and eight were repurposed drugs. The count describes a clinical-development pipeline, not 29 new treatments available to patients.

Examples of new chemical entities

The WHO snapshot listed candidates including alpibectir (BVL-GSK098), BTZ-043, delpazolid, ganfeborole (GSK-3036656), quabodepistat (OPC-167832), TBAJ-587, TBAJ-876, TBI-223, pyrifazimine (TBI-166), TBA-7371, telacebec (Q203), sanfetrinem, SQ109, sutezolid, and sudapyridine (WX-081), among others. The report separately counted bedaquiline, delamanid, and pretomanid as approved medicines under study in trials, as well as eight repurposed drugs.

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What the trial phases mean

The August 2024 WHO pipeline table described study stages and purposes, not established clinical benefit. Its examples included phase I/II work on BTZ-043, phase II work on ganfeborole, early studies of quabodepistat, phase II sutezolid combinations, and phase II studies of telacebec and sudapyridine. A phase label alone does not show that a drug is approved, recommended, or proven to cure TB. Trial status can change, and the cited snapshot does not establish each candidate’s current enrollment or results.

What changed in the pipeline in 2025?

Treatment Action Group’s 2025 pipeline report described quabodepistat as the first drug from a new class since bedaquiline and delamanid to approach phase III. It also reported that a long-acting formulation of bedaquiline had entered clinical development, described as the first long-acting formulation of a TB medicine to do so. Both are development milestones, not evidence that the formulation or candidate is approved or routinely available.

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What prequalification says about a medicine

WHO’s prequalification list recorded a Lupin pretomanid 200 mg tablet as fully prequalified on 9 September 2025 and a Lupin linezolid dispersible 150 mg tablet on 5 July 2025. Prequalification concerns product quality for procurement; it is distinct from national marketing authorization and from clinical guidance about which regimen a patient should receive.

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