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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis

A Phase 2, Open-Label, Multi-Group, Controlled, Randomized Trial of the Safety, Bactericidal Activity, and Pharmacokinetics of TBD09 in Combination With Other Active Agents in Adults With Drug-Sensitive Pulmonary Tuberculosis

Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary Tuberculosis (NCT07525427) is a Phase 2 interventional studying Drug Susceptible Pulmonary Tuberculosis, sponsored by Gates Medical Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Drug Susceptible Pulmonary Tuberculosis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 150 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Drug Susceptible Pulmonary Tuberculosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 18-65 years at consent - Body weight 35-100 kg at screening - Written willing to sign a consent form obtained - Newly diagnosed rifampicin-sensitive pulmonary TB - Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra - ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result - Rifampicin sensitivity on molecular test - Chest X-ray consistent with TB (Investigator assessment) - Able to spontaneously produce sputum - Reproductive requirements met - Women of childbearing potential: 2 approved contraceptive methods or abstinence - Males: contraception or abstinence through 90 days post-dose Who Should NOT Join This Trial: - Prior anti-TB treatment for the current TB episode within 60 days - Prior medication active against Mtb within 3 months - Evidence of extra-thoracic TB, per investigator judgement - Prior treatment completion for TB within 3 years - 2 or more prior episodes of TB - Clinically significant history of or current medical condition posing safety risk - If HIV positive: - Not on ARVs or taking ARVs for \<3 months prior to screening OR - CD4+ count \<200cells/uL at screening OR - HIV viral load \>200 copies /mL at screening OR - AIDS infection or malignancies - Meets any of the following laboratory values during screening: - AST, ALT, or ALP ≥2.5× ULN - Total bilirubin ≥1.2× ULN - eGFR \<60 mL/min/1.73 m² - Hemoglobin \<9.0 g/dL (male) or \<8.5 g/dL (female) - White blood cell count \<2,000/mm³ - Absolute neutrophil count \<800/mm³ - Platelet count ≤100,000/mm³ - Positive hepatitis B surface antigen - Positive hepatitis C antibody - HbA1c ≥8.0% - Current or recent systemic immunosuppressive therapy, including corticosteroids - Significant drug or alcohol abuse affecting compliance or safety - Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 18-65 years at consent * Body weight 35-100 kg at screening * Written informed consent obtained * Newly diagnosed rifampicin-sensitive pulmonary TB * Molecular confirmation of M. tuberculosis on Xpert MTB/RIF Ultra * ≥1+ AFB smear or Xpert Ultra low, medium, or high semi-quantitative result * Rifampicin sensitivity on molecular test * Chest X-ray consistent with TB (Investigator assessment) * Able to spontaneously produce sputum * Reproductive requirements met * Women of childbearing potential: 2 approved contraceptive methods or abstinence * Males: contraception or abstinence through 90 days post-dose Exclusion Criteria: * Prior anti-TB treatment for the current TB episode within 60 days * Prior medication active against Mtb within 3 months * Evidence of extra-thoracic TB, per investigator judgement * Prior treatment completion for TB within 3 years * 2 or more prior episodes of TB * Clinically significant history of or current medical condition posing safety risk * If HIV positive: * Not on ARVs or taking ARVs for \<3 months prior to screening OR * CD4+ count \<200cells/uL at screening OR * HIV viral load \>200 copies /mL at screening OR * AIDS infection or malignancies * Meets any of the following laboratory values during screening: * AST, ALT, or ALP ≥2.5× ULN * Total bilirubin ≥1.2× ULN * eGFR \<60 mL/min/1.73 m² * Hemoglobin \<9.0 g/dL (male) or \<8.5 g/dL (female) * White blood cell count \<2,000/mm³ * Absolute neutrophil count \<800/mm³ * Platelet count ≤100,000/mm³ * Positive hepatitis B surface antigen * Positive hepatitis C antibody * HbA1c ≥8.0% * Current or recent systemic immunosuppressive therapy, including corticosteroids * Significant drug or alcohol abuse affecting compliance or safety * Pregnant or breastfeeding, positive pregnancy test, or planning pregnancy shortly after treatment

Treatments Being Tested

DRUG

Bedaquiline, pretomanid and TBD09

Group 1 (30 participants): The combination of TBD09 (100 mg three times weekly, TIW), bedaquiline (200 mg daily, QD), and pretomanid (200 mg QD), 28 days

DRUG

Bedaquiline, pretomanid and TBD09

Group 2 (30 participants): The combination of TBD09 (100 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUG

Bedaquiline, pretomanid and TBD09

Group 3 (30 participants): The combination of TBD09 (300 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUG

Bedaquiline, pretomanid and TBD09

Group 4 (30 participants): The combination of TBD09 (500 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

DRUG

Bedaquiline, pretomanid and linezolid

Group 5 (30 participants): The combination of linezolid (600 mg QD), bedaquiline (200 mg QD), and pretomanid (200 mg QD), 28 days

Locations (13)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Enhancing Care Foundation at Wentworth Hospital
Durban, Bluff, South Africa
TASK Applied Science - Eden
George, Central, South Africa
Clinical Research and HIV Research Unit (CHRU) @ Helen Joseph Hospital
Johannesburg, Gauteng, South Africa
The Aurum Institute Tembisa
Tembisa, Gauteng, South Africa
CHRU @ Isango Lethemba
Bethelsdorp, Gqeberha, South Africa
Madibeng Centre for Research
Brits, North West, South Africa
Setshaba Research Center
Pretoria, Soshangue, South Africa
ONE MRI
Cape Town, Western Cape, South Africa
TASK Applied Science - Brookylyn Chest Hospital
Cape Town, Western Cape, South Africa
BioMedical Research Institute - Stellenbosch University @ Tygerberg Hospital
Cape Town, Western Cape, South Africa
UCT Lung Institute
Cape Town, Western Cape, South Africa
Desmond Tutu Health Foundation
Cape Town, Western Cape, South Africa
Synergy Biomedical Research Institute (SBRI)
East London, South Africa

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07525427), the sponsor (Gates Medical Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07525427 clinical trial studying?

The purpose of this study is to evaluate if TBD09 in combination with other active agents in adults with drug sensitive pulmonary tuberculosis has potential to be safe and effective. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07525427?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07525427?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07525427. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07525427. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.