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New TB drug cocktail aims to shorten treatment

NCT ID NCT06058299

Disease control Sponsor: Global Alliance for TB Drug Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether a new drug called TBAJ-876, or the existing drug bedaquiline, combined with pretomanid and linezolid, can treat drug-sensitive tuberculosis faster and more effectively than the standard 6-month regimen. About 309 adults with newly diagnosed TB are taking part. The study compares how quickly the bacteria clear from sputum and checks safety over 26 weeks of treatment plus 52 weeks of follow-up.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TBAJ-876 (also called sorfequiline), bedaquiline, pretomanid, linezolid, and standard TB drugs (isoniazid, rifampicin, pyrazinamide, ethambutol)
What this could lead to
If successful, this could lead to a shorter, simpler treatment regimen for drug-sensitive tuberculosis, potentially replacing the current standard of care.
What could go wrong
This is a Phase 2 trial with only 309 participants, so results may not apply to everyone. The new drug combinations may cause side effects like nerve damage or heart rhythm issues, and they might not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

309 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed informed consent * DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB * Of non-childbearing potential OR using effective birth control methods * Body weight ≥ 35 kg Exclusion Criteria: * Karnofsky score \< 60 at screening * Any evidence of extrapulmonary TB * Cardiovascular or QT prolongation risk factors * Pregnant or breast-feeding Any of the following lab toxicities: * Platelets \<100,000/mm³ * Creatinine \>1.3 x ULN * Haemoglobin \<9.5 g/dL or \<95 g/L * Absolute neutrophil count \<800/mm³ * Serum potassium less than the lower limit of normal for the laboratory. * ALT and/or AST ≥2.5 x ULN * Total bilirubin ≥1.6 x ULN * Direct bilirubin \>1 x ULN * Haemoglobin A1c ≥8.0% * Total lipase ≥1.5 x ULN * Total amylase ≥1.5 x ULN * CPK \>3 x ULN (if \>3 x ULN, enquire about the participant's recent strenuous activity and consider repeating the test within the screening window) * TSH \>1 x ULN * Positive results at screening for HBsAg, HAV IgM, or hepatitis C antibodies For participants living with HIV only: * CD4+ count\<200 cells/μL. * WHO Clinical Stage 4 HIV disease * Participant does not agree to use DTG/TFV/3TC during trial if ARV therapy is indicated, and randomised to the TBAJ876 or the B-Pa-L regimen * If initiation of ARV therapy is indicate, participants who are known to be intolerant, non-responsive to DTG/TFV/3TC or have DTG/TFV/3TC as a contraindication.

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug sensitive tuberculosis Pulmonary TB Pulmonary tuberculosis

Contacts and locations

Locations

  • Care Clinical Trial Group Inc.

    Dasmariñas, 4114, Philippines

  • Case Western Reserve University- Research collaboration Uganda

    Kampala, Uganda

  • Desmond Tutu Health Foundation

    Cape Town, 7750, South Africa

  • Enhancing Care Foundation

    Durban, 4052, South Africa

  • Isango Lethemba TB Research Unit

    Port Elizabeth, 6200, South Africa

  • Joint Clinical Research Centre (JCRC)

    Kampala, Uganda

  • Kilimanjaro Christian Medical Centre

    Moshi, Tanzania

  • Lung Center of the Philippines

    Quezon City, 1104, Philippines

  • Madibeng Centre for Research

    Brits, 0250, South Africa

  • NIMR-MBEYA Medical Research Center

    Mbeya, Tanzania

  • National Center for Tuberculosis and Lung Diseases

    Tbilisi, 0101, Georgia

  • National Institute for Medical Research (NIMR)

    Mwanza, Tanzania

  • Perinatal HIV Research Unit (PHRU)

    Klerksdorp, 2571, South Africa

  • Setshaba Research Centre

    Soshanguve, Gauteng, 0152, South Africa

  • Synergy Biomed Research Institute (SBRI)

    East London, 5201, South Africa

  • TASK Brooklyn

    Cape Town, 7405, South Africa

  • TASK Eden

    George, 6529, South Africa

  • TB and HIV Investigative Network (THINK)

    Hillcrest, 3610, South Africa

  • The Aurum Institute

    Rustenburg, 2999, South Africa

  • Tropical Disease Foundation

    Makati City, 1230, Philippines

  • University of Cape Town Lung Institute (UCTLI)

    Cape Town, 7700, South Africa

  • WITS, Clinical HIV Research Unit (CHRU) Themba Lethu Clinic, Helen Joseph Hospital

    Johannesburg, 2092, South Africa

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