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New TB cocktail aims to shorten treatment

NCT ID NCT07672405

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 8 times

Summary

This study tests a new combination of three drugs—sorfequiline, pretomanid, and linezolid—in 100 adults with newly diagnosed, drug-sensitive tuberculosis. Participants take the pills daily for 17 weeks. The goal is to see if the combo is safe and can clear the infection faster than standard care.

What this could mean

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

Active substance
sorfequiline, pretomanid, and linezolid
What this could lead to
If successful, this could lead to a shorter, simpler treatment regimen for drug-sensitive tuberculosis, potentially reducing side effects and improving cure rates.
What could go wrong
This is an early phase 2b trial with only 100 participants, so results may not apply to everyone. The drugs can cause side effects like nerve damage or vision problems, and the regimen may not work better than current 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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2028

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: * 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 k Exclusion Criteria: * Karnofsky score \< 60 at screening * Any evidence of extrapulmonary TB * Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding * Laboratory abnormalities as defined in the protocol. • 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 study treatment if ARV therapy is indicated * If initiation of ARV therapy is indicated, 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.

Tuberculosis, pulmonary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Durban International Clinical Research Site

    RECRUITING

    Wentworth, Durban, 4052, South Africa

  • INUKA Africa

    NOT_YET_RECRUITING

    Dar es Salaam, Tanzania

  • Isango Lethemba TB Research Unit

    RECRUITING

    Port Elizabeth, Eastern Cape, 6200, South Africa

  • Kilimanjaro Clinical Research Institute(KCRI)

    NOT_YET_RECRUITING

    Moshi, Tanzania

  • Madiberg Centre for Research

    RECRUITING

    Brits, North West Provinvce, 0250, South Africa

  • NIMR-Mbeya

    NOT_YET_RECRUITING

    Mbeya, Tanzania

  • NIMRI-Mwanza

    NOT_YET_RECRUITING

    Mwanza, Tanzania

  • Perinatal HIV Research Unit, Tshepong Hospital

    NOT_YET_RECRUITING

    Klerksdorp, Northwest Province, 2571, South Africa

  • Setshaba Research Centre

    RECRUITING

    Soshanguve, Gauteng, 0152, South Africa

  • Synergy Biomed Research Institute

    NOT_YET_RECRUITING

    East London, 5201, South Africa

  • The Aurum Institute, Rustenburg

    RECRUITING

    Rustenburg, North West, 2999, South Africa

  • University of Capetown Lung Institute

    RECRUITING

    Cape Town, Mowbray, 7700, South Africa

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