A Phase 2 Multicentre, Open-label Study to Evaluate the Efficacy, Safety and Tolerability, and Pharmacokinetics of 28 Days Telacebec Treatment in Adult Participants With Buruli Ulcer.

The goal of this interventional clinical trial is to determine if treatment with 4 weeks of telacebac (T) will completely heal lesions in participants with Buruli ulcer (BU) by 52 weeks after treatment initiation, without relapse and/or surgery. Males and females age 18 and older will be included.
• Participants will attend visits every 2 weeks during treatment and thereafter every 2 weeks until week 24 Thereafter they will be followed by visits at weeks 30, 40, and 52. From week 10 to week 52, if the lesion has healed, follow-up visits may be remote.

Start Date09 Jul 2024

Sponsor / Collaborator

Barwon Health

[+1]

NCT04847583

/ TerminatedPhase 2

A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease

This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease

Start Date29 Jul 2021

Sponsor / Collaborator

Qurient Co., Ltd.

NCT03563599

/ CompletedPhase 2

An Open-label Randomized Study to Evaluate the Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203) in Treatment-naïve Patients With Newly Diagnosed Drug-sensitive Sputum Smear-positive Pulmonary Tuberculosis

This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).

Start Date23 Jul 2018

Sponsor / Collaborator

Qurient Co., Ltd.

100 Clinical Results associated with Telacebec

100 Translational Medicine associated with Telacebec

100 Patents (Medical) associated with Telacebec

Literatures (Medical) associated with Telacebec

01 Nov 2025·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Discovery of novel Cytochrome bd oxidase inhibitors against Mycobacterium tuberculosis

Article

Author: Zhang, John Z H ; Zhou, Bing ; Zhao, Fanyu ; Xia, Wei ; Huang, Kaifang ; Zhang, Yu ; Ji, Changge ; Zhang, Xu ; Wu, Xue ; Wang, Jian

Drug-resistant Mycobacterium tuberculosis remains a major challenge to effective tuberculosis (TB) control. Cytochrome bd oxidase (Cyt-bd), a critical terminal oxidase within the electron transport chain of M. tuberculosis, maintains bacterial survival under respiratory stress but remains an underexplored therapeutic target. Here, we developed an integrated computational and experimental workflow to identify novel Cyt-bd inhibitors. Among the candidates, TB25, TB25-2, and TB25-14 exhibited substantial antimycobacterial efficacy, each reducing intracellular M. tuberculosis survival in macrophages by over 94 %. Importantly, co-treatment with Q203, a cytochrome bcc oxidase (Cyt-bcc) inhibitor, resulted in pronounced synergistic bactericidal effects. These findings highlight the potential of dual Cyt-bd/Cyt-bcc inhibition as a new strategy for treating drug-resistant and latent TB, and validate the effectiveness of our virtual screening pipeline for discovering new anti-TB agents.

17 Jun 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Mycobacteriophage-mediated gene transfer enables in vitro drug screening and in vivo tracking of Mycobacterium leprae

Article

Author: Chen, Bing ; Mullholland, Claire V. ; Vilcheze, Catherine ; Andrews, Patrick K. ; Das, Lahari ; Jacobs, William R. ; Rajagopalan, Saranathan ; Edwards, Ashley ; Lahiri, Ramanuj ; Berney, Michael

Mycobacterium leprae , the causative agent of leprosy, has never been cultured in vitro, posing significant challenges for genetic manipulation and drug discovery. Current antileprosy drug screening methods relying on microscopic count, radiorespirometry, and qPCR are time consuming and require the use of radioactive elements. We demonstrate mycobacteriophage-mediated introduction of foreign DNA using the broad-host range mycobacteriophage TM4 and the application of the luciferase reporter mycobacteriophage (LRM) for drug screening. Mycobacteriophage infection of M. leprae was shown using TM4 expressing the highly sensitive BRET-nanoluciferase-based reporter, GeNL (TM4 ::GeNL ), which enables luminescence measurement for over 72 h. When M. leprae was exposed to rifampicin, dapsone, and Q203 for 24 and 48 h, followed by TM4 ::GeNL infection, the luminescence output decreased in a dose-dependent manner, establishing an in vitro two-day screening assay for drugs. We have also electroporated M. leprae with a ColE1 -integration proficient plasmid expressing GeNL and shown that the transformed leprosy bacilli could be propagated in mice footpads and detected using an in vivo imaging system (IVIS). These findings introduce powerful genetic tools for M. leprae research enabling in vivo tracking and in vitro viability testing.

04 Jun 2025·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Efficacy of novel regimens targeting oxidative phosphorylation in Mycobacterium tuberculosis

Article

Author: Nuermberger, Eric ; Cheng, Kai ; Xu, Rui ; Xu, Jian ; Li, Dongshuo ; Yan, Chenxia ; Fu, Lei ; Lu, Yu ; Wang, Bin ; Liang, Wenwen ; Li, Liang ; Zhang, Ye ; Qi, Xianglong

ABSTRACT:

Mycobacterium tuberculosis in both replicating and non-replicating states relies on oxidative phosphorylation (OxPhos) to generate ATP for its growth and survival. Our research delved into the efficacy of novel regimens targeting the OxPhos pathway in murine models. The combination of bedaquiline, clofazimine, pyrazinamide, alongside telacebec, and SQ109 was investigated against both wild-type M. tuberculosis H37Rv and an Rv0678 mutant with cross-resistance between bedaquiline and clofazimine. The results demonstrated that the combination regimens, particularly bedaquiline + clofazimine + pyrazinamide (BCZ) along with telacebec (BCZT) and SQ109 (BCZS), exhibit significantly enhanced bactericidal activity compared to bedaquiline alone and sterilizing potential against M. tuberculosis in vivo . Notably, the BCZT regimen showed superior activity compared to other treatment regimens in Rv0678 mutant-infected BALB/c mice. The addition of T to BCZ prevented the amplification of bedaquiline-resistant mutants and reduced the number of mice relapsing. Our finding underscores the potential of targeting the OxPhos pathway to combat M. tuberculosis , paving the way for innovative approaches in tuberculosis therapy.

News (Medical) associated with Telacebec

25 Sep 2025

·www.prnewswire.com

Lonza's Synaffix Collaborates with Qurient Therapeutics to Enable Development of Dual-Payload ADC

License agreement centered around technology enabling dual-payload ADC Unique combination of Synaffix's exatecan-based technology with Qurient's CDK7 inhibitor AMSTERDAM and SEONGNAM-SI, South Korea , Sept. 25, 2025 /PRNewswire/ -- Synaffix B.V. ("Synaffix"), a Lonza company (SWX:LONN) focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates (ADCs) with potential best-in-class therapeutic index, today jointly announced that it has entered into a licensing agreement with Qurient Co., Ltd., a clinical-stage biopharmaceutical company based in South Korea, for the development of a dual-payload ADC. Dual-payload ADCs are designed to deliver two separate cytotoxic agents with distinct mechanisms of action to target cancer cells, aiming to enhance therapeutic efficacy and mitigate payload resistance. Their therapeutic promise can potentially expand the current range of effective treatments while minimizing toxicity to healthy tissues, especially in refractory cancer cases. The collaboration aims to develop a dual-payload ADC consisting of Synaffix's exatecan-based technology and Qurient's CDK7 inhibitor, aiming to target unmet medical needs in solid tumors. Under the terms of the agreement, Qurient will gain access to Lonza's clinical-stage, site-specific ADC technology platform powered by Synaffix services including GlycoConnect® antibody conjugation, HydraSpace® polar spacer, and exatecan-based linker-payload technologies, as well as Lonza's market-leading expertise and experience in developing and manufacturing bioconjugates. Lonza will manufacture components related to its proprietary Synaffix technologies, and Qurient will perform the research, development, manufacturing and commercialization of the ADC, and manufacturing of Qurient's CDK7 inhibitor. Peter van de Sande, Head of Synaffix, said: "This licensing collaboration with Qurient signifies the versatility of our industry-leading ADC platform technology. Enabling the development of a dual-payload ADC built with Synaffix technology reflects our drive to continue pioneering innovation in the field." Kiyean Nam, CEO at Qurient, said: "Dual-payload ADCs represent the next frontier in targeted antibody therapeutics, and we look forward to advancing this novel combination of our CDK7 inhibitor and Synaffix's SYNtecan™ linker-payload. The combination of our proprietary technology with Synaffix's industry-leading platform has the potential to be applicable to a wider range of targets and antibodies, and we look forward to exploring those possibilities in the future." Notes to Editors About Synaffix Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform based on GlycoConnect®, HydraSpace® and toxSYN® technologies, that together enable any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Synaffix holds granted patents to its technology. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its partner pipeline. Synaffix was fully acquired by Lonza in June 2023. For more information about Synaffix's ADC platform technology, please visit: About Lonza Lonza is one of the world's largest development and manufacturing organizations (CDMOs). Working across five continents, our global team of more than 19,000 colleagues works alongside pharma and biotech companies to turn their breakthrough innovations into viable therapies. We support our customers in bringing life-saving and life-enhancing treatments to patients worldwide with a combination of cutting-edge science, smart technology and lean manufacturing. Our company generated sales of CHF 3.6 billion with a CORE EBITDA of CHF 1.1 billion in Half-Year 2025. Find out more at About Qurient Co., Ltd. Qurient Co., Ltd. is a public clinical-stage biotechnology company headquartered in South Korea and listed on KOSDAQ, with a mission to develop innovative medicines and targeted therapies across oncology and infectious diseases. The company's pipeline includes mocaciclib (Q901), a CDK7 inhibitor targeting transcriptionally addicted cancers; adrixetinib (Q702), an AXL/MER/CSF1R inhibitor being explored for chronic graft-versus-host disease (cGvHD) and oncology indications; and telacebec (Q203), a first-in-class antibiotic in late-stage development for Tuberculosis, Buruli ulcer and other mycobacterial diseases. Qurient combines strong translational research expertise with global partnerships to advance programs from discovery through clinical development. By strategically focusing on high-unmet-need indications such as hard-to-treat cancers, drug-resistant mycobacteria, and immune-driven diseases, Qurient positions itself at the intersection of precision oncology and infectious disease innovation. For more information, please visit . SOURCE Synaffix WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inAcquisitionADC

06 Feb 2023

·www.pharmaceutical-technology.com

Qurient partners with TB Alliance to develop telacebec

Telacebec will be developed to treat tuberculosis and few non-tuberculosis mycobacteria infections. Credit: Department of Pathology, Calicut Medical college / Wikimedia. South Korean biotechnology company Qurient has entered a licence agreement with TB Alliance for the development and commercialisation of telacebec (Q203). Under the deal, TB Alliance will have the exclusive global license to develop and market telacebec except in Russia, South Korea, and the Commonwealth of Independent States (CIS) countries. The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. It will be developed to treat tuberculosis (TB) and other non-tuberculosis mycobacteria (NTM) infections. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB. It was successfully evaluated in Phase IIa early bactericidal activity (EBA) study for the treatment of TB. In March 2020, the findings from the trial were published in The New England Journal of Medicine . Qurient CEO Kiyean Nam said: “As telacebec’s unique mechanism of action of blocking energy metabolism of the Mycobacterium can address all types of TB, including drug-resistant TB, we expect telacebec to potentially become an essential component of drug combination regimens for the treatment of TB. “We believe telacebec will greatly contribute to the global efforts to combating the TB pandemic, which remains a serious public health challenge worldwide. “Our partnership with the TB Alliance will accelerate the widespread availability of telacebec and bring it to those in need.” The US Food and Drug Administration (FDA) has granted Fast Track Designation and Orphan Drug Designation to telacebec. The drug was also found to be effective against buruli ulcer (Mycobacterium ulcerans), a chronic, necrotising disease that affects the skin and sometimes bone. TB Alliance president and CEO Mel Spigelman said: “New drugs like telacebec are urgently needed in the fight against TB as well as certain NTM infections – compounds with potentially impactful novel mechanisms of action can have a significant benefit in combating the TB pandemic. “We look forward to advancing this new compound as part of combination regimens that could yield a short, simple, safe, and highly effective cure for all forms of TB.”

Clinical ResultPhase 2Orphan DrugLicense out/inFast Track

03 Feb 2023

·www.prnewswire.com

Qurient Co. Ltd. and TB Alliance Announce Exclusive License Agreement for Telacebec (Q203), a New Anti-Tuberculosis Agent

Landmark Agreement for New Tuberculosis Treatment SEONGNAM-SI, South Korea and NEW YORK, Feb. 3, 2023 /PRNewswire/ -- Qurient Co. Ltd. ("Qurient", KRX: 115180), a clinical-stage biotechnology company based in South Korea, and TB Alliance, a not-for-profit organization dedicated to the discovery, development and delivery of better, faster-acting and affordable tuberculosis drugs, announced today that they have entered into a license agreement to develop and commercialize telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for the treatment of tuberculosis (TB) and other non-tuberculosis mycobacterium infections. Under the terms of the license agreement TB Alliance obtains the exclusive worldwide license (except for South Korea, Russia and the Commonwealth of Independent States (CIS) countries) to develop and commercialize telacebec for the treatment of tuberculosis and some non-tuberculosis mycobacteria (NTM) infections. Kiyean Nam, Ph.D., CEO of Qurient, commented "As telacebec's unique mechanism of action of blocking energy metabolism of the Mycobacterium can address all types of TB, including drug-resistant TB, we expect telacebec to potentially become an essential component of drug combination regimens for the treatment of TB. We believe telacebec will greatly contribute to the global efforts to combating the TB pandemic, which remains a serious public health challenge worldwide. Our partnership with the TB Alliance will accelerate the widespread availability of telacebec and bring it to those in need." Mel Spigelman, MD, President and CEO of TB Alliance, said "TB Alliance is excited to partner with Qurient to bring about the next generation of TB cures. New drugs like telacebec are urgently needed in the fight against TB as well as certain NTM infections – compounds with potentially impactful novel mechanisms of action can have a significant benefit in combating the TB pandemic. If we expect to regain ground lost to COVID-19, we need to use every tool we have to give patients the best possible treatment and save lives. We look forward to advancing this new compound as part of combination regimens that could yield a short, simple, safe, and highly effective cure for all forms of TB." About Telacebec (Q203) Telacebec is a first in class investigational drug that selectively inhibits the cytochrome bc1 complex of Mycobacterium tuberculosis. This complex is a critical component of the electron transport chain, and its inhibition disrupts the bacterium's ability to generate energy. The potent efficacy of telacebec against both drug sensitive and drug resistant TB has been demonstrated in preclinical and clinical studies. Telacebec was successfully tested in Phase 2a early bactericidal activity (EBA) study for tuberculosis and the results were published in the New England Journal of Medicine (March, 2020). Telacebec has received Orphan Drug Designation and Fast Track Designation from the U.S. FDA. Tuberculosis is a tropical disease eligible for the FDA Priority Review Voucher (PRV) program. About Qurient Qurient is a clinical-stage biopharmaceutical company based in South Korea and is listed on the Korea Exchange (KRX 115180). Qurient focuses on the development of novel therapeutics from discovery to human proof-of-concept stages through virtual R&D project management platform. Qurient currently has four programs in clinical development: Q301, a topical leukotriene inhibitor for atopic dermatitis that has completed a Phase 2b study; telacebec (Q203), a first-in-class orally available cytochrome bc1 inhibitor for tuberculosis that has completed a Phase 2a study; Q702, a first-in-class Axl/Mer/CSF1R receptor tyrosine kinase inhibitor in Phase 1/2; and Q901, a selective CDK7 inhibitor in Phase 1. A subsidiary of Qurient, QLi5 is developing immunoproteasome inhibitors targeting multiple Myeloma and other indications. For more information, please visit . About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Korea International Cooperation Agency, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Diseases, Netherlands Ministry of Foreign Affairs, South Korea's Ministry of Foreign Affairs, United Kingdom Department for International Development, and the United States Agency for International Development. For more information, please visit: SOURCE TB Alliance

Phase 2Orphan DrugLicense out/inFast TrackClinical Result

100 Deals associated with Telacebec

External Link

KEGG	Wiki	ATC	Drug Bank
D11263	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Buruli Ulcer	Phase 2	Australia	Global Alliance for TB Drug Development	09 Jul 2024
COVID-19	Phase 2	South Africa	Qurient Co., Ltd.	29 Jul 2021
Pulmonary Tuberculosis	Phase 2	South Africa	Qurient Co., Ltd.	23 Jul 2018
Tuberculosis, Multidrug-Resistant	Phase 2	South Africa	Qurient Co., Ltd.	23 Jul 2018
Latent Tuberculosis	Preclinical	United States	Global Alliance for TB Drug Development	01 Oct 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03563599 (Pubmed \| Am J Respir Crit Care Med)	Phase 2	Pulmonary Tuberculosis	64	Telacebec 300 mg	gexmftyosl(pmargdlvil) = Telacebec was well tolerated and safe, with low adverse event rates across all doses oenntdeqda (ekyrdmiysd )	Positive	01 Aug 2025
NCT03563599 (Pubmed \| Am J Respir Crit Care Med)	Phase 2	Pulmonary Tuberculosis	64	Standard four-drug treatment		Positive	01 Aug 2025
NCT03563599 (BusinessWire) Manual	Phase 2	Tuberculosis	-	Rifampin+Isoniazid+Pyrazinamide+Ethambutol Hydrochloride+Telacebec	rgxuyheyuq(fqcjoyfbln) = a daily increase in the time samples required to become culture positive after sputum inoculation pfcanfjxsi (kxzxbwwekm )	-	25 Mar 2020

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