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Quabodepistat-containing regimens for drug-resistant pulmonary tuberculosis

A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Efficacy, Safety, and Tolerability of 4-month and 6-month Quabodepistat-containing Regimens for Rifampicin-resistant/Multidrug-resistant Pulmonary Tuberculosis

Phase 3 Interventional Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT07209761

This will test whether quabodepistat combined with other TB drugs can shorten treatment and be safer for adults and teens with rifampicin-resistant or multidrug-resistant pulmonary TB.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment532 (estimated)
Ages14 Years and up
SexAll
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc. Industry-sponsored
Locations35 sites (Beijing, Beijing Municipality and 34 other locations)
Trial IDNCT07209761 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, open-label, multicenter trial will enroll about 532 participants aged 14 years and older with rifampicin-resistant or multidrug-resistant pulmonary TB. Participants are split into fluoroquinolone-sensitive and fluoroquinolone-resistant cohorts and randomly assigned to receive quabodepistat-containing experimental regimens or standard regimens that include linezolid. The fluoroquinolone-sensitive experimental arm receives a 4-month BPaQM regimen while its control receives a 6-month BPaLM regimen, and the fluoroquinolone-resistant cohort compares a 6-month BPaQ arm to a 6-month BPaL control. The primary endpoint is an unfavorable outcome measured 12 months after randomization, with secondary endpoints including time to unfavorable outcome, time to sputum culture conversion, and safety, and each participant is followed for 16 months.

Who should consider this trial

Good fit: People aged 14 and older with confirmed rifampicin-resistant or multidrug-resistant pulmonary TB who can provide sputum, weigh at least 30 kg, and meet safety and contraception requirements are the intended participants.

Not a fit: Patients with known or suspected resistance to bedaquiline, pretomanid, linezolid, or quabodepistat, or those previously treated with these drugs, are unlikely to benefit from the tested regimens.

Why it matters

Potential benefit: If successful, these regimens could shorten treatment to four months for many patients and reduce the toxicities linked to linezolid.

How similar studies have performed: Bedaquiline–pretomanid–linezolid (BPaL) regimens have shown promising results in drug-resistant TB, but quabodepistat is a newer DprE1 inhibitor being tested in late-phase trials and has not yet been proven at scale.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥14 years
2. Body weight ≥30.0 kg
3. Able to provide written informed consent (if under 18, requires both participant assent and parent/guardian consent)
4. Documented pulmonary TB: Mtb confirmed by Xpert MTB/RIF Ultra (semi-quantitative result of 'low', 'medium', or 'high')
5. Rifampicin resistance confirmed by Xpert MTB/RIF Ultra test
6. Chest radiograph consistent with active TB disease
7. Able to provide sputum sample
8. Participants of childbearing potential must use 2 different approved birth control methods during treatment and for 12 weeks after last dose
9. Willing to have HIV test (unless previous positive result confirmed)
10. For HIV-positive participants: On stable antiretroviral regimen (dolutegravir, lamivudine/emtricitabine, tenofovir) for ≥3 months, Viral load \<200 copies/mL, and CD4 count \>100 cells/mL

Exclusion Criteria:

1. Known/suspected resistance to BDQ, PMD, LZD, or QBS
2. Prior treatment with BDQ, PMD, LZD, DLM, QBS, or DprE1 inhibitors for ≥1 month within past 3 months
3. Severe extrapulmonary TB
4. Abnormal laboratory values: ALT/AST \>2.5×ULN, Total bilirubin \>1.5×ULN, eGFR \<60 mL/min/1.73m², Hemoglobin \<8 g/dL, Platelets \<100,000 cells/mm³, WBC \<2.0×10⁹/L, ANC \<1000 cells/μL, and HbA1c \>9.0%
5. Pre-existing peripheral neuropathy (≥Grade 1), optic neuritis, or visual impairment
6. Co-enrollment in other therapeutic trials
7. QTcF \>450 msec (males) or \>470 msec (females)
8. Clinically significant cardiovascular disorders
9. Bleeding disorders
10. Conditions interfering with X-ray or sputum assessment
11. Drug allergies/hypersensitivity to study medications
12. Pregnancy or breastfeeding
13. Positive drug screen (case-by-case assessment for some substances)
14. Serious mental disorders
15. Karnofsky score \<60
16. BMI \<16.0 kg/m²
17. Significant comorbidities (metabolic, renal, gastrointestinal, neurological, psychiatric, endocrine, liver)
18. Pulmonary conditions other than TB (silicosis, fibrosis)
19. Active SARS-CoV-2 infection
20. Use of prohibited medications
21. Blood/plasma donation within 30 days
22. Current use of herbal remedies or traditional medicines

Where this trial is running

Beijing, Beijing Municipality and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary TuberculosisQuabodepistatBedaquilinePretomanidLinezolidMoxifloxacinFluoroquinolone-sensitive TBFluoroquinolone-resistant TB
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.