RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Commissioner's National Priority Voucher (United States)

Structure/Sequence

Molecular FormulaC36H35BrN2O6

InChIKeyZLVSPMRFRHMMOY-WWCCMVHESA-N

CAS Registry845533-86-0

119

Clinical Trials associated with Bedaquiline Fumarate

NCT07485010

/ Not yet recruitingPhase 2IIT

A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:
* How well does Arm D treat mycobacterium abscessus pulmonary disease?
* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.
Participants will:
* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)
* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.
* Be reviewed by the study doctors weekly for checkups and tests.
* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

Start Date01 Apr 2027

Sponsor / Collaborator

The University of Queensland

[+1]

NCT07675954

/ Not yet recruitingPhase 3IIT

A Phase 3, Open-Label, Randomised Controlled Trial to Evaluate a 6-Month "MDR-END Plus" Regimen (Bedaquiline, Delamanid, Delpazolid, Levofloxacin and Pyrazinamide) Versus the South African Standard of Care Treatment for Rifampicin-Resistant Tuberculosis

This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.
The goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens.
The main questions this trial aims to answer are:
* Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens?
* Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens?
Researchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis.
Participants will:
* Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment.
* Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases.
* Attend study visits during treatment and after treatment is stopped.
* Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests.
* Be followed for 12 months after treatment is stopped.

Start Date01 Oct 2026

Sponsor / Collaborator

Seoul National University Hospital

[+5]

NCT06568484

/ RecruitingPhase 2/3IIT

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)

A seamless, staged Phase II/III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.

Start Date08 May 2026

Sponsor / Collaborator

The Johns Hopkins University

[+1]

100 Clinical Results associated with Bedaquiline Fumarate

100 Translational Medicine associated with Bedaquiline Fumarate

100 Patents (Medical) associated with Bedaquiline Fumarate

2,470

Literatures (Medical) associated with Bedaquiline Fumarate

01 Jul 2026·Life Science Alliance

Machine learning method for the prediction of Bedaquiline-resistant Mycobacterium tuberculosis.

Article

Author: Ghosh, Stuti ; Saha, Sudipto ; Bhattacharjee, Sudipto

The study addresses the increasing resistance to the FDA-approved drug Bedaquiline (BDQ) in Mycobacterium tuberculosis (MTB). The absence of any defined resistance locus and the wide variation in the drug targets across clinical isolates have raised a big question about our understanding of the molecular basis of BDQ resistance acquisition. Using machine learning (ML) methods, BDQ resistance was predicted from whole-genome sequencing data for MTB clinical isolates. Variant calling format data generation involved several steps, including adapter trimming and alignment to the H37Rv reference genome. The ML models, namely, Multilayer Perceptron and Random Forest (RF), achieved high accuracies of 83.60% and 79.64%, respectively. The top 50 features were mapped to the H37Rv reference genome, and several new drug targets were identified. In addition to the coding regions, some non-coding intergenic regions were also obtained. Mapping of these features to the H37Rv genome revealed 15 new antibiotic-resistant genes. In addition, the use of explainable AI (XAI) methods, such as SHapley Additive exPlanations, facilitated the identification of mutations associated with BDQ resistance. In conclusion, the ML models demonstrated effective predictive capabilities for BDQ resistance, whereas XAI contributed to understanding key resistance features.

01 Jul 2026·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

Sulfamethoxazole-trimethoprim-induced Stevens-Johnson syndrome in a NAT2 slow acetylator: A case for pre-emptive pharmacogenomic screening?

Article

Author: Kok Choon, Raymond Fong ; Lee, Siok Ying

OBJECTIVE:

Severe Cutaneous Adverse Reactions (SCAR), such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are serious complications associated with several high-risk medications and can result in significant morbidity and mortality. While HLA-mediated SCARs have been well-characterized-particularly involving drugs like carbamazepine, abacavir, and allopurinol-there is limited data on the role of N-acetyltransferase 2 (NAT2) polymorphisms in SCAR pathogenesis.

CASE SUMMARY:

We present a case of sulfamethoxazole-trimethoprim-(SMX-TMP)- induced SJS (Naranjo probability score: seven), hypothesized to be linked to NAT2 slow acetylator (SA) status.

PRACTICE IMPLICATIONS:

This case underscores the potential utility of pre-emptive pharmacogenomic screening to reduce the incidence of SCARs. NAT2 SA status has also been strongly associated with isoniazid-induced liver injury; Clinical Pharmacogenetics Implementation Consortium (CPIC) recently published a guideline that NAT2 SA predicted for hydralazine-induced systemic lupus erythematosus (SLE) and were at higher risk of side effects, suggesting broader clinical implications for routine NAT2 genotyping.¹ Aside from G6PD testing, there is an emergent role to test for NAT2 genotype in preparation for SMX-TMP therapy. Clinically relevant NAT2 alleles include *4, *5, *6, and *7. Given that multiple single nucleotide variant (SNV) must be tested, multiplex pharmacogenomic panels may offer a more cost-effective and comprehensive approach than reactive testing. Some multiplex panels that may be employed include: GeneXpert NAT2-PGx Assay--a rapid assay targeting 5 key polymorphisms to predict isoniazid-acetylation, nanopore sequencing-based panels --a scalable targeted sequencing panel useful for NAT2 and other antitubercular genes (rifampicin, linezolid and bedaquiline), Fulgent genetics pharmacogenomics comprehensive panel, CleanPlex® pharmacogenomics kit and GenoPharm®.

01 Jul 2026·ANNALS OF EPIDEMIOLOGY

Early adherence predicts treatment outcomes and mortality in people living with HIV and multidrug-resistant tuberculosis

Article

Author: Rivet Amico, K ; O'Donnell, Max R ; Cummings, Matthew J ; Friedland, Gerald ; Seepamore, Boitumelo ; Perumal, Rubeshan ; Zelnick, Jennifer ; Cheung, Ying Kuen ; Wolf, Allison ; Padayatchi, Nesri ; Daftary, Amrita ; Naidoo, Kogieleum ; Guzman, Kevin J ; Boodhram, Resha ; Reis, Karl ; Lu, Xuan

PURPOSE:

Treatment success for RR/MDR-TB remains suboptimal, particularly among people living with HIV. Electronic dose monitors support adherence, but strategies to act on these data are limited. We hypothesized that early adherence to bedaquiline predicts treatment outcomes and could guide individualized interventions.

METHODS:

We prospectively enrolled adults with RR/MDR-TB and HIV initiating bedaquiline-containing regimens in KwaZulu-Natal, South Africa. Adherence was measured using real-time electronic dose monitors. Weekly adherence data through week 24 trained time-aware XGBoost models to predict end-of-treatment outcomes, and latent class growth analysis (LCGA) at the earliest predictive time point identified distinct adherence trajectories.

RESULTS:

Among 282 participants, model performance improved over time, achieving good discrimination by week 4 (AUC > 0.80), predictive of subsequent adherence. LCGA using 4-week data identified three adherence trajectories: high, moderate-stable, and early-declining. Favorable outcomes were lowest in the early-declining group (55% vs. 77% and 76%), which also had the highest mortality (36% vs. 12% and 12%). Cox models confirmed a higher risk of unfavorable outcomes among early decliners.

CONCLUSION:

Adherence in the first four weeks of bedaquiline therapy provides a powerful, early signal of treatment outcomes. Real-time adherence monitoring could enable risk stratification and tailored interventions to improve RR/MDR-TB and HIV care.

News (Medical) associated with Bedaquiline Fumarate

20 Mar 2026

·www.einpresswire.com

ABL Diagnostics Expands HIV Sequencing Expertise into TB Drug Resistance Profiling with New NGS Solutions

WOIPPY, FRANCE, March 20, 2026 / EINPresswire.com / -- ABL Diagnostics (FR001400AHX6 – “ABLD”), an innovative company specialized in microbiology and pathogen sequencing, today announced major advancements in its Mycobacterium tuberculosis (MTB) portfolio, combining its current CE-IVD marked DeepChek ® Assay 13‑Plex KB and BacterioChek software with the development of new research next‑generation sequencing (NGS) solutions for comprehensive drug resistance detection and genomic surveillance. At the core of its current offering, ABL Diagnostics commercializes the CE-IVD marked DeepChek ® Assay 13-Plex KB Drug Susceptibility Testing assay, a multiplex PCR solution enabling the detection of key resistance-associated mutations across first- and second-line anti-TB drugs. Designed for use with NGS workflows, the assay supports amplification of MTB DNA directly from clinical specimens and provides actionable genotyping data to guide treatment decisions. This solution is complemented by BacterioChek, ABL Diagnostics’ CE-IVD software for automated analysis and interpretation of MTB Next-Generation Sequencing data, delivering standardized and clinically relevant reports to support laboratories and clinicians. Building on this integrated workflow, ABL Diagnostics has developed two new solutions intended for research use for now: - A 19-gene resistance panel, expanding coverage beyond the current DeepChek ® Assay 13-Plex but with the same input DNA extraction and using the same PCR cycling program, ensuring seamless adoption for existing users. This panel already covers the full set of genes known to be associated with resistance to currently prescribed anti-tuberculosis drugs. These include first and second line treatments such as rifampicin (rpoB), isoniazid (katG, inhA), ethambutol (embB), pyrazinamide (pncA), fluoroquinolones (gyrA, gyrB), aminoglycosides such as amikacin and kanamycin (rrs, eis), as well as newer and repurposed drugs like linezolid (rplC, rrl) and bedaquiline (atpE, Rv0678). By integrating an expanded set of resistance‑associated genes, the 19‑gene panel delivers broader and more informative insights into MTB drug resistance profiles, supporting ongoing research on emerging therapeutic targets and contributing to the development of next‑generation strategies for improved disease management. - A whole genome MTB solution (~4.4 Mb) based on capture technology, enabling broad exploration of resistance associated mutationsand supporting high-resolution epidemiological and transmission studies. Beyond addressing current research needs, this whole genome approach offers a forward looking platform capable of uncovering resistance mechanisms related to both established and emerging therapeutic options. This includes next-generation agents such as bedaquiline, delamanid, pretomanid, and linezolid, as well as future compounds under development. By capturing the full genomic landscape of MTB, this solution provides an adaptable foundation for ongoing research Both solutions will be commercialized for research use only from Q2 2026. ABL Diagnostics is actively seeking partner laboratories for verification and validation studies. The regulatory roadmap will then progressively evaluate potential future CE IVD marking under the new EU IVD regulation and WHO review process. Tuberculosis remains one of the leading infectious diseases worldwide, with significant unmet medical needs driven by the growing burden of drug-resistant forms. These trends are consistent with data from the U.S. CDC TB Surveillance Report , which highlights evolving resistance patterns in recent isolates. According to recent global estimates, hundreds of thousands of new multidrug-resistant (MDR) and rifampicin-resistant TB cases are reported annually, with treatment success rates remaining substantially lower than for drug-susceptible TB. In addition, surveillance data highlights the continued emergence of resistance to key drug classes, including fluoroquinolones and second-line injectable agents, further complicating treatment strategies. ( https://www.cdc.gov/tb-surveillance-report-2024/data/drug-resistance.html ) The global market for drug-resistant tuberculosis diagnosis and treatment is expanding rapidly, driven by increasing incidence, the complexity and cost of treatment regimens, and strong support from public health organizations and funding bodies. Market growth projections are supported by recent industry analyses (HTF Market Insights, “Drug Resistant Tuberculosis Treatment Market”). Market analysts project sustained growth over the coming years, fueled by the adoption of advanced molecular diagnostics and sequencing technologies that enable faster, more accurate, and scalable resistance profiling. The adoption of NGS in clinical microbiology is accelerating this shift toward comprehensive resistance profiling and genomic surveillance, enabling healthcare systems to improve patient outcomes while strengthening public health responses to TB transmission. ( https://www.htfmarketinsights.com/report/4354561-drugresistant-tuberculosis-treatment-market ) “Our CE-IVD DeepChek ® Assay 13-Plex and BacterioChek software already provide laboratories with a robust and integrated solution for MTB drug resistance testing,” said Dr. Sofiane Mohamed, Head of R&D at ABL Diagnostics. “With our expanded research pipeline, including a 19-gene panel and a whole genome approach, we are extending this foundation to deliver more research tools for ongoing research, helping accelerate the discovery of new resistance pathways and informing next generation strategies for improved disease management and therapeutic innovation.” About ABL Diagnostics (ABLD) ABL Diagnostics (ABLD) is an international company that specializes in innovative molecular biology tests and global solutions for its customers: - Molecular polymerase chain reaction (PCR) detection – UltraGene, and - Genotyping by DNA sequencing – DeepChek ® . ABL Diagnostics markets its entire product range globally through its own sales team and a network of exclusive distributors active on all continents. ABL Diagnostics' customers are academic clinical pathology laboratories, private reference laboratories and researchers willing to implement innovative and robust microbiological content in constant expansion. ABL Diagnostics has been marketing the products and services of its sister company CDL Pharma since the second half of 2025 through an intra-group strategy agreement. An expanding portfolio of microbiology products: - HIV – Drug resistance testing, including a whole genome kit. - SARS-CoV-2, Tuberculosis, Hepatitis B and C – Advanced Detection Solutions. - Microbiome and taxonomy – 16s/18s RNA-based analyses. - Other viral and bacterial targets – Comprehensive molecular assays. Integrated Solutions - Real-time syndromic PCR tests - Nadis ® – Patient Medical Record used in more than 200 hospitals in France for the management of HIV and hepatitis. - MediaChek ® – Clinical Sample Collection Kits. ABL Diagnostics, headquartered in Woippy, is a public limited company listed on compartment B of the regulated market of Euronext in Paris (Euronext: ABLD – ISIN: FR001400AHX6). These molecular biology products generate recurring revenues and cover one of the largest portfolios of applications in microbiology. Dr Sayada ABL Diagnostics SA +33 7 83 64 68 50 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical StudyDiagnostic Reagents

19 Feb 2026

·www.biospace.com

BioVersys and Partners’ Phase 2a Tuberculosis Trial Results Published in New England Journal of Medicine

Data from Phase 2a study demonstrated the first clinical proof of concept for alpibectir in combination with ethionamide (AlpE) in the treatment of patients with tuberculosis. The results, published in the prestigious New England Journal of Medicine, underscore the significant potential of AlpE to shape the future of TB treatment. BASEL, Switzerland, Feb. 19, 2026 (GLOBE NEWSWIRE) -- BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB. 1 Tuberculosis is one of the leading causes of death by infectious diseases globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis. The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project. Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are very pleased to see the favorable safety, tolerability and pharmacokinetics pro AlpE, and even more so for the promising signals of efficacy delivered from this Phase 2a clinical trial. These data give us real encouragement for the further Phase 2 studies in UNITE4TB, run by our partner GSK, where AlpE is being studied in combination with first line TB drugs. We are also excited as we plan to initiate a Phase 2 trial in meningeal TB later this year.” Michelle Nderu, Project Officer, EDCTP Association: “The bEto-TB trial demonstrates the power of sustained investment in global health research. The development of AlpE reflects not only scientific innovation but also the strength of collaborative partnerships. With support from EDCTP2, these results bring us a step closer to delivering shorter, safer and more effective treatment options for people living with TB.” Prof. Andreas Diacon, Founder and Chief Scientist at TASK: “At TASK we are grateful to our study participants whose collaboration allows yet another novel antibiotic to move a step forward. This study has shown that ethionamide, an established, low-cost and safe antibiotic, becomes more potent and better tolerated by the addition of alpibectir. The AlpE combination is now on its way to become part of drug combinations that treat tuberculosis patients with and without resistance to other drugs, and it appears particularly suitable for patients with tuberculosis meningitis where better treatments are direly needed.” Dr. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK: “TB remains one of the world’s deadliest infectious diseases, and tackling drug resistance is one of the biggest challenges we face. That’s why innovation is essential. The Phase 2a results for AlpE mark an exciting step forward, demonstrating the potential of novel approaches to strengthen existing therapies. We are proud to collaborate with BioVersys, TASK and partners, to advance research aimed at transforming TB care for patients globally, particularly in lower-income countries where the disease remains most prevalent.” About bEto-TB This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BVL-GSK098 greatly augments the activity of, and overcomes resistance to, the well-established second line drug Eto at a lower and well-tolerated dose. The objectives of this consortium are to determine the early bactericidal activity (EBA) of the combination of BVL-GSK098 and various doses of Eto. We will also evaluate the comparative anti-TB activity of bEto to that of standard dose INH and thus explore the potential for bEto as a replacement of INH in the current first-line regimen or to add a novel bactericidal drug to future regimens. The programme has previously received funding from the EU IMI 2 JU (TRIC-TB) and the Wellcome Trust. Project description website: X: Statements or views expressed in this release are those of the respective organizations or persons and the European & Developing Countries Clinical Trials Partnership is not responsible for any use of the information contained herein. About tuberculosis (TB) Tuberculosis (TB) remains one of the leading causes of death worldwide. It is caused by the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the WHO Global Tuberculosis Report 2025, an estimated 10.7 million people developed TB in 2024, and approximately 1.23 million died from TB. Drug resistance continues to pose a major challenge. There were about 390,000 people who developed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) in 2024. MDR-TB remains a public health crisis and a health security threat, with global treatment success rates at only 71%. The major burden of TB is concentrated within 30 high TB burden countries, accounting for 87% of the global total in 2024. Of those, the top eight countries for TB cases worldwide were, India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%). Globally, 8.3 million people were reported as newly diagnosed with TB in 2024, Significantly, it remains that 3.2% of new TB cases and 16% of previously treated cases are MDR/RR-TB. About EDCTP The vision of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to reduce the individual, social, and economic burden of poverty-related infectious diseases in sub-Saharan Africa. EDCTP funds collaborative clinical research that accelerates the development of accessible, suitable, and affordable medical interventions (drugs, vaccines, and diagnostics) to identify, prevent or treat infectious diseases, including emerging and re-emerging diseases. EDCTP’s approach integrates research with the development of African clinical research capacity and networking. EDCTP2 is supported by the European Union under Horizon 2020, its Framework Programme for Research and Innovation. For more information, visit . About TASK TASK is a social enterprise committed to developing, testing, and progressing novel medicines, vaccines, and diagnostics in various medical therapeutic areas, most notably in anti-tuberculosis drugs, aimed at improving global health care. Since its inception in 2005, TASK has grown exponentially and diversified into six distinct independent clinical research sites; a mycobacteriology bio-safety level 3 laboratory; a phase I to II clinical trial hospital with twenty-four beds; two registered dispensing pharmacies; a data management centre; regulatory, quality control and compliance office and a clinical research training academy. Over the last 15 years TASK has completed multiple research projects, many of global significance, and contributed to progressing the scientific field of TB medicine and vaccine development, most notably with early bactericidal activity (EBA) studies and clinical trials that in part led to the registration of bedaquiline. Find us at and follow us on Twitter @taskapplied. About BioVersys BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact Hernan Levett , CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com For media: media@bioversys.com Website: X: LinkedIn: The bEto-TB project (grant reference: RIA2019AMR-2657) is part of the EDCTP2 programme supported by the European Union. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. 1 The Revival of Ethionamide by Alpibectir (BVL-GSK098), Michel Pieren et a l , 2026;

Phase 2Clinical ResultPhase 3Microbial therapy

19 Nov 2025

·endpoints.news

US-backed group says new tuberculosis treatment worked in a Phase 2 study

A new antibiotic for tuberculosis outperformed other treatment options without compromising safety in drug-sensitive patients, according to trial results released Wednesday. TB Alliance reported that the experimental drug sorfequiline, when combined with two other antibiotics, displayed greater ability to kill tuberculosis bacteria than bedaquiline, another antibiotic used to treat the infectious disease. The sorfequiline combo also showed better potency than the standard of care, a four-drug antibiotic regimen. Sorfequiline is an oral pill developed by TB Alliance, a government- and nonprofit-backed organization that has been working on developing new antibiotics to fight tuberculosis since 2000. The objective of the trial was to see whether sorfequiline could be added to the arsenal of treatments against tuberculosis, to combat anti-microbial resistance and further shorten treatment time. The standard treatment involves a four-drug mix for eight weeks, followed by two of those drugs, isoniazid and rifampicin, for at least another four months. “Now, we have an opportunity to shorten treatment even further — representing an important milestone toward our goal of developing an ultra-short regimen capable of treating both drug-sensitive and drug-resistant TB,” TB Alliance chief Mel Spigelman said in a statement. Tuberculosis is an infectious disease spread through the air. Millions of people live with inactive infection, which is asymptomatic, but it can manifest into an active case at any time if untreated. The CDC says that about one in 10 cases of inactive tuberculosis becomes active, and the Phase 2 study was in patients who had an active case. Last year, more than 1.2 million people died of the disease, according to the World Health Organization. The Phase 2 trial included 22 sites across South Africa, Georgia, the Philippines, Uganda and the United Republic of Tanzania. The alliance reported that sorfequiline had a comparable safety profile to the standard of care. Phase 3 plans are underway, and that trial is set to begin next year. TB Alliance says it is also developing a long-acting injectable option that could possibly drop the treatment time to as little as one month. The alliance also developed pretomanid, which was first approved by the FDA in 2019 to treat highly drug-resistant strains of tuberculosis as part of a regimen with bedaquiline. Pretomanid is also part of the regimen studied with sorfequiline.

Phase 2Clinical ResultPhase 3Drug Approval

100 Deals associated with Bedaquiline Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D09873	Bedaquiline Fumarate	J04AK05	DB08903

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pulmonary Tuberculosis	Japan	Janssen Pharmaceutical KK	19 Jan 2018
Tuberculosis	South Korea	Janssen Korea Ltd.	21 Mar 2014
Multidrug resistant pulmonary tuberculosis	European Union	Janssen-Cilag International NV	05 Mar 2014
Multidrug resistant pulmonary tuberculosis	Iceland	Janssen-Cilag International NV	05 Mar 2014
Multidrug resistant pulmonary tuberculosis	Liechtenstein	Janssen-Cilag International NV	05 Mar 2014
Multidrug resistant pulmonary tuberculosis	Norway	Janssen-Cilag International NV	05 Mar 2014
Tuberculosis, Multidrug-Resistant	United States	Janssen Therapeutics, Inc.	28 Dec 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Leprosy, Multibacillary	Phase 3	-	Janssen Pharmaceutica NV	13 Aug 2024
Mycobacterium Avium-Intracellulare Infection	Phase 3	Japan	Janssen Pharmaceuticals, Inc.	08 Jan 2021
Mycobacterium Avium-Intracellulare Infection	Phase 3	South Korea	Janssen Pharmaceuticals, Inc.	08 Jan 2021
Mycobacterium Avium-Intracellulare Infection	Phase 3	Taiwan Province	Janssen Pharmaceuticals, Inc.	08 Jan 2021
Infectious Lung Disorder	Phase 3	United States	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014
Infectious Lung Disorder	Phase 3	China	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014
Infectious Lung Disorder	Phase 3	Brazil	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014
Infectious Lung Disorder	Phase 3	Cambodia	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014
Infectious Lung Disorder	Phase 3	Estonia	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014
Infectious Lung Disorder	Phase 3	Ethiopia	Janssen Infectious Diseases-Diagnostics BV	01 Mar 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05007821 (CTgov)	Phase 2	Multidrug resistant pulmonary tuberculosis \| Tuberculosis, Multidrug-Resistant	138	Linezolid 600 mg+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm A)	rgkdtvvoon(zgnnxkohhy) = gtnitrchhh vdujmxtfwo (ewiasgqhxy, dghdhkhllw - nkgitjtinp) View more	-	01 May 2026
				Linezolid+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm B)	rgkdtvvoon(zgnnxkohhy) = syfcorjsts vdujmxtfwo (ewiasgqhxy, bdczozxciq - xssunfkqjg) View more
NCT04630145 (CTgov)	Phase 2/3	Mycobacterium Avium-Intracellulare Infection	129	RBT+Rifamycin+Ethambutol (EB)+RFP+Clarithromycin (CAM) (Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB))	sywrhrbtmh = ehdkcojwxl xcquurrxnx (esvqrucvvp, qvdqzuhfgp - ntdjdlhxup) View more	-	15 Apr 2026
				Ethambutol (EB)+Bedaquiline (BDQ)+Clarithromycin (CAM) (Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB))	sywrhrbtmh = urcpwxfwly xcquurrxnx (esvqrucvvp, gnrerizcwr - hhqjqbxowp) View more
NCT05306223 (Pubmed \| Infection)	Phase 4	Tuberculosis, Multidrug-Resistant	217	Bedaquiline-containing SCR	xpsrkghcnl(uvameolclw) = djgfymgine nkaxeghxhq (pdwpryrebr ) View more	Positive	02 Apr 2026
				Non-Bedaquiline-containing SCR	xpsrkghcnl(uvameolclw) = eogdrjuvth nkaxeghxhq (pdwpryrebr ) View more
NTBERC (ATS2025)	Not Applicable	Rifampicin resistant tuberculosis	-	Bedaquiline	bsgrensqwm(reubjnsyvp) = nlquviayqn ssqvzvbkxf (jxzldkxuuf )	Positive	16 May 2025
				Delamanid	bsgrensqwm(reubjnsyvp) = yyeyvqapvr ssqvzvbkxf (jxzldkxuuf )
NCT03474198 (TRUNCATE-TB, Pubmed \| Lancet Infect Dis)	Phase 2/3	Pulmonary Tuberculosis	675	Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol)	zipvqorrdz(mnkahgsuuo) = ncidwliriw qafzgdwrli (vssrkptzqq ) View more	Negative	01 May 2025
				High-dose rifampicin and linezolid	zipvqorrdz(mnkahgsuuo) = lcnozhxteg qafzgdwrli (vssrkptzqq ) View more
CTRI/2021/03/032189 (Pubmed \| Clin Infect Dis)	Phase 3	Multidrug resistant pulmonary tuberculosis	403	Linezolid 600mg for 26 weeks	yxpuqcomww(ghkppsshiw) = shtozchzyx mgpwyrwnnm (cctmxdugit ) View more	Positive	17 Dec 2024
				Linezolid 600mg for 9 weeks followed by 300mg for 17 weeks	yxpuqcomww(ghkppsshiw) = vntalzldfa mgpwyrwnnm (cctmxdugit ) View more
ERS2024	Not Applicable	Drug-Resistant Tuberculosis	100	Long oral regimens (Bdq+Lfx or Mfx+Lzd+Cfz+Cs in n=73, Bdq+Lzd+Cfz+Cs+Dlm in n=7, Bdq+Lzd+Cfz+Cs+E in n=3)	fpphkezqjy(dlngrptmpf) = vqmcobimmu pwdovnbwff (fyelwsbhkf ) View more	Negative	07 Sep 2024
				Short oral regimen (4 months of Bdq+Hh+Eto+Cfz+Lfx+Z+E followed by 5 months of Cfz+Lfx+Z+E)	fpphkezqjy(dlngrptmpf) = bsoyatmkid pwdovnbwff (fyelwsbhkf ) View more
ERS2024	Not Applicable	-	58	bedaquiline+delamanid+clofazimine+pyrazinamide (24-36 weeks)	vcxuoiioqc(kjyqicuenv) = dzlcjqaidg mpplxscwmo (ggmrytkvwq ) View more	Positive	07 Sep 2024
				18-20 months WHO-recommended regimen	vcxuoiioqc(kjyqicuenv) = lzptlrornd mpplxscwmo (ggmrytkvwq ) View more
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	Phase 2	Pulmonary Tuberculosis	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	voiixepscw(ejgpdarqtk) = three participants [1%] unilpxdauj (cxldpyspzd ) View more	Positive	01 Sep 2024
NCT05406479 (BE-PEOPLE P2, CTgov)	Phase 2	Leprosy	313	Bedaquiline+BE-PEP (BE-PEP (Bedaquiline Post-Exposure Prophylaxis))	lgleuilxxp(zgumcrsaxn) = wpsmnrjoqp phddnofzqw (ilwifgvpqv, golfffheyx - nvoupbtcut) View more	-	28 Aug 2024
				SDR-PEP (SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis))	lgleuilxxp(zgumcrsaxn) = pbfrkwchql phddnofzqw (ilwifgvpqv, zsnptqbzzl - xoxfqtondf) View more

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