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The “new generation” of tuberculosis drugs includes two very different things: shorter, all-oral combinations already recommended by the World Health Organization (WHO) for eligible people with particular forms of drug-resistant TB, and investigational compounds still being studied. The newer regimens are not universal treatments for TB; the right option depends on drug resistance, eligibility, and clinical guidance.
Which newer TB regimens are recommended?
WHO’s 2025 guideline table suggests two six-month, all-oral options for defined groups with multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB). The recommendations are distinct, and eligibility should be assessed under applicable WHO and national guidance.
| Regimen | WHO 2025 recommendation | Duration | Medicines |
|---|---|---|---|
| BPaLM | Suggested for eligible people with MDR/RR-TB and pre-extensively drug-resistant TB (pre-XDR-TB). | Six months | Bedaquiline, pretomanid, linezolid, and moxifloxacin. |
| BDLLfxC | Suggested for MDR/RR-TB with or without fluoroquinolone resistance. | Six months | Bedaquiline, delamanid, linezolid, levofloxacin, and clofazimine. |
What changes when fluoroquinolone resistance is found?
In its August 2024 rapid communication, WHO said to drop moxifloxacin from BPaLM when fluoroquinolone resistance is documented. The resulting regimen is called BPaL: bedaquiline, pretomanid, and linezolid. WHO described BPaLM/BPaL as the prioritized treatment choice for eligible patients with drug-resistant TB at that time. This is not a direction to alter treatment without a clinician; regimen choice and resistance assessment belong in clinical care.
How widely have BPaLM and BPaL been used?
WHO’s Global Tuberculosis Report 2024 recorded use of BPaLM/BPaL in 58 countries by the end of 2023, up from 41 countries by the end of 2022. The report counted 5,646 people starting these regimens in 2023, compared with 1,744 in 2022. These are adoption and treatment-start figures, not measures of cure or treatment success.
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What drugs are still in clinical trials?
WHO’s Global Tuberculosis Report 2024 counted 29 drugs for TB disease in phase I, II, or III trials in its August 2024 pipeline snapshot. Eighteen were new chemical entities, three were already approved drugs being studied in trials, and eight were repurposed drugs. The approved medicines in the trial count were bedaquiline, delamanid, and pretomanid.
The named new chemical entities included 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 size of this pipeline does not mean these drugs are available as standard treatment.
Examples from the August 2024 pipeline snapshot
| Candidate | What the cited pipeline reported | How to interpret the status |
|---|---|---|
| BTZ-043 | Phase I/II work. | Investigational; the snapshot does not establish routine use or clinical benefit. |
| Ganfeborole (GSK-3036656) | Phase II work. | Investigational; trial phase is not a treatment recommendation. |
| Quabodepistat (OPC-167832) | Early studies in WHO’s August 2024 snapshot. | TAG’s 2025 pipeline report later described it as approaching phase III. |
| Sutezolid | Phase II combinations. | Investigational; the cited material does not establish it as standard treatment. |
| Telacebec (Q203) | Phase II work. | Investigational; phase alone does not show that a regimen is effective or recommended. |
| Sudapyridine (WX-081) | Phase II work. | Investigational; the snapshot is dated August 2024. |
What is notable about the newer pipeline developments?
TAG’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 bedaquiline formulation had entered clinical development—the first long-acting formulation of a TB medicine to do so. These are development milestones, not evidence of approval, routine availability, or a WHO treatment recommendation.
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Repair common Windows errors and clear accumulated junk for a smoother, more stable PC - no reinstall needed.Free scan · no reinstallDoes product prequalification mean a drug is approved for use?
No. 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 is a product-quality status used in procurement contexts; it is not the same as national marketing authorization or a clinical recommendation for a particular patient.
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How should readers interpret claims about a “new TB drug”?
- Recommended regimen: Check the specific form of drug resistance and eligibility named in WHO and national guidance. A recommendation for MDR/RR-TB or pre-XDR-TB does not apply automatically to every TB diagnosis.
- Investigational candidate: A phase I, II, or III label describes where a medicine is being studied, not whether it is approved, routinely available, or proven to cure TB.
- Changing status: WHO’s pipeline numbers describe an August 2024 snapshot; TAG’s pipeline observations are from 2025. Those dated reports do not establish the live status of every trial or candidate.
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