Sutezolid (PNU-100480) / Sequella - LARVOL DELTA

panTB-HM: a multi-arm clinical trial of a pan-TB regimen targeting both host and microbe. (PubMed, Trials) - P2/3 | "This trial is ground-breaking in its objectives and design for a 4-month pan-TB indication (in a non-inferiority comparison to standard treatment) and its evaluation of lung function recovery (in a superiority comparison)."

Journal • Pulmonary Disease • Respiratory Diseases

HIV-associated drug-resistant TB: expanded treatment options and emerging threats. (PubMed, Curr Opin HIV AIDS) - "Treatment options for DR-TB have improved dramatically with less toxic, more effective regimens, but managing HIV-associated DR-TB continues to require careful attention to drug-drug interactions and HIV related co-morbidities. Research into novel DR-TB regimens, especially for people with bedaquiline resistance, and host-directed therapies are critical to realize continued improvement in HIV-associated DR-TB outcomes."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Synergistic activity of fosfomycin combined with old and new oxazolidinones (linezolid, contezolid, delpazolid, and sutezolid) against bloodstream isolates of vancomycin-resistant Enterococcus faecium. (PubMed, Eur J Clin Microbiol Infect Dis) - "Our findings provide preclinical evidence supporting the use of fosfomycin in combination with novel oxazolidinones as a promising therapeutic strategy against VR E. faecium infections."

Journal • Infectious Disease

RAD-TB: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=315 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Mar 2027 ➔ Aug 2027 | Trial primary completion date: Mar 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Updates in the clinical management of Tuberculous meningitis. (PubMed, Expert Rev Anti Infect Ther) - "Emphasis is placed on high-dose rifampicin, linezolid, and novel oxazolidinones such as sutezolid and delpazolid...Steroids like dexamethasone are already used, while drugs like aspirin and thalidomide are being studied. Children, pregnant women, and people with HIV are at special risk and need extra care. With faster tests, stronger drugs, and safer treatment plans, there is new hope that more people will survive and recover well."

Journal • Review • CNS Disorders • Human Immunodeficiency Virus • Infectious Disease • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis • Vascular Neurology

RAD-TB: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=315 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Suspended ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Sutezolid in combination with bedaquiline, delamanid, and moxifloxacin for pulmonary tuberculosis (PanACEA-SUDOCU-01): a prospective, open-label, randomised, phase 2b dose-finding trial. (PubMed, Lancet Infect Dis) - P2b | "Sutezolid, combined with bedaquiline, delamanid, and moxifloxacin, was shown to be efficacious and added activity to the background drug combination, although we cannot make a final dose recommendation yet. This study provides valuable information for the selection of sutezolid doses for future studies, and described no oxazolidinone class toxicities at the doses used."

Journal • P2b data • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Neutropenia • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis

ACTG A5409 (RAD-TB): Study protocol for a phase 2 randomized, adaptive, dose-ranging, open-label trial of novel regimens for the treatment of pulmonary tuberculosis. (PubMed, Trials) - P2 | "Wave 1 of the RAD-TB platform aims to identify the optimal oxazolidinone(s), with regard to both efficacy and safety, to combine with the BPa backbone for the treatment of DS-TB. Subsequent waves of this platform trial may add a fourth drug to the regimen, study new diarylquinolines to substitute for bedaquiline, or study novel agents from other TB drug classes."

Journal • P2 data • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Cardiac safety of bedaquiline, delamanid and moxifloxacin co-administered with or without varying doses of sutezolid or delpazolid for the treatment of drug-susceptible TB. (PubMed, J Antimicrob Chemother) - "The drug regimens containing standard doses of bedaquiline, delamanid and moxifloxacin, and varying doses of sutezolid or delpazolid were not found to pose a high cardiac risk in a population without further QTc-relevant risk factors. However, close monitoring of the QTc interval remains essential in patients with TB treated with combination drug therapy with known QTc-prolonging drugs."

Journal • Cardiovascular

Improved Radiosynthesis of [18F]-Labeled Oxazolidinone Antibiotics for Future Clinical Translation. (PubMed, ACS Infect Dis) - "This study focuses on the radiosynthesis and optimization of fluorine-18 [18F]-labeled oxazolidinone antibiotics, specifically [18F]linezolid and [18F]sutezolid, followed by in vivo imaging of the latter...Dynamic PET imaging confirmed rapid clearance, predominant renal and hepatobiliary excretion, and consistent tissue uptake across infected and uninfected models. These findings support the feasibility of [18F]-labeled oxazolidinones as PET tracers for compartment-specific antibiotic exposures, paving the way for optimizing antibiotic dosing and future personalized treatments in patients."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

panTB-HM: A Pan-TB Regimen Targeting Host and Microbe (clinicaltrials.gov) - P2/3 | N=352 | Active, not recruiting | Sponsor: The Aurum Institute NPC | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2025 ➔ Jan 2026 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4

Genomic-based genotype and drug susceptibility profile of Mycobacterium kansasii in China. (PubMed, Front Microbiol) - "Rifabutin and clarithromycin were the most highly active against M. kansasii strains, with the susceptible rate of 100 and 99.35%, respectively. Followed by amikacin and linezolid, the resistance rate was 5.88 and 7.19%, respectively. The resistance rate to rifampin (RIF) was 22.22%. As for the antibiotics without the breakpoint values, all isolates had very low MIC50 (0.03 μg/mL) and MIC90 (≤0.06 μg/mL) values against bedaquiline, sutezolid, delamanid, and clofazimine. Except for ciprofloxacin and moxifloxacin, the resistance rate of other drugs in cluster 3 was higher than that in cluster 1 and cluster 2...The new drugs, used for the treatment of multidrug - resistant tuberculosis, have the potential to be potent agents in the treatment of M. kansasii infection. The clustering might contribute to the high resistance rate of M. kansasii."

Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Neuromyelitis optica causing vision loss during TB treatment with sutezolid: evidence of aberrant immunity following infection. (PubMed, IJTLD Open) - No abstract available

Journal • CNS Disorders • Immunology • Infectious Disease • Neuromyelitis Optica Spectrum Disorder • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Tuberculosis

CuF2/DTBP-Catalyzed Chan-Lam Coupling of Oxazolidinones with Arylboronic Acid Pinacol Ester: Scope and Application. (PubMed, J Org Chem) - "This methodology has also been applied to the synthesis of oxazolidinone-based marketed drugs, including Rivaroxaban, Linezolid, Sutezolid, and Toloxatone. Mechanistic investigations using various spectroscopic techniques and DFT studies revealed the role of DTBP/MeOH in the catalytic process."

Journal

RAD-TB: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=315 | Suspended | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Suspended

Trial suspension • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

ACTG A5409 (RAD-TB): Study Protocol for a Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis. (PubMed, Res Sq) - P2 | "The experimental treatment arms will consist of a bedaquiline and pretomanid backbone (BPa) in combination with one of three oxazolidinones. Arm 2 will study linezolid (BPaL) at a dose of 600 mg daily, Arms 3A and 3B will study TBI-223 at 1200 mg and 2400 mg daily, respectively, and Arms 4A and 4B will study sutezolid at 800 mg and 1600 mg daily, respectively...Trials registration : ClinicalTrials.gov NCT06192160. Registered on January 5, 2024, https://clinicaltrials.gov/study/NCT06192160."

Journal • P2 data • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Comparative In Vitro Drug Susceptibility Study of Five Oxazolidinones Against Mycobacterium tuberculosis in Hainan, China. (PubMed, Pathogens) - "In this study, we aimed to compare the in vitro activity of linezolid (LZD) and four oxazolidinones, including tedizolid (TZD), contezolid (CZD), sutezolid (SZD), and delpazolid (DZD), against multidrug-resistant tuberculosis (MDR-TB) and pre-extensively drug-resistant tuberculosis (pre-XDR-TB) isolates from Hainan. In vitro susceptibility testing indicated that SZD exhibited the strongest antibacterial activity, followed by TZD and LZD, while CZD and DZD demonstrated comparable but weaker effectiveness. Mutations in rplD and mce3R were discovered, but further research is needed to clarify their role in conferring oxazolidinone resistance in MTB."

Clinical • Journal • Preclinical • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

RAD-TB: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=315 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=93 | Terminated | Sponsor: Bill & Melinda Gates Medical Research Institute | N=514 ➔ 93 | Active, not recruiting ➔ Terminated; Data generated in the Gates MRI-TBD06-201 trial do not support the investigational regimens being able to achieve the trial objective of identifying a new regimen to treat tuberculosis in 3 months or less.

Enrollment change • Trial termination • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

RAD-TB: Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=315 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Apr 2026 ➔ Mar 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Assessment of tuberculosis drug efficacy using preclinical animal models and in vitro predictive techniques. (PubMed, NPJ Antimicrob Resist) - "Using a high-throughput in vitro checkerboard assay, we evaluated the interactions of Bedaquiline (BDQ) and other antibiotics including Capreomycin (CAP), Linezolid (LIN), and Sutezolid (SUT) against M.tb H37Rv. We determined that in vitro enhanced effect was not observed in some representative strains of M.tb lineage 4, indicating variability in drug effectiveness across M.tb lineages. This research underscores the complexity of TB treatment and the critical need for innovative approaches to combat this global health threat."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Targeting the Heart of Mycobacterium: Advances in Anti-Tubercular Agents Disrupting Cell Wall Biosynthesis. (PubMed, Pharmaceuticals (Basel)) - "Isoniazid, thioamides, and delamanid primarily disrupt mycolic acid synthesis, with recent evidence indicating that delamanid also inhibits decaprenylphosphoryl-β-D-ribose-2-epimerase, thereby impairing arabinogalactan biosynthesis. Furthermore, ethambutol interferes with arabinogalactan synthesis by targeting arabinosyl transferase enzymes, particularly embB- and embC-encoded variants. Beyond these, six promising molecules currently in Phase II clinical trials are designed to target arabinan synthesis pathways, sutezolid, TBA 7371, OPC-167832, SQ109, and both benzothiazinone derivatives BTZ043 and PBTZ169, highlighting advancements in the development of cell wall-targeting therapies."

Journal • Review • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy of Macozinone and Sutezolid against Mycobacterium leprae (ASTMH 2024) - "Results & Conclusion Results show that Macozinone and Sutezolid are effective against M. lepra e both in vitro (axenic and intracellular) and in vivo (MFP). Therefore, Macozinone and Sutezolid, having different modes of action, should be tested in combination with other first and second line drugs to explore new shorter treatment regimens for leprosy."

Clinical • Infectious Disease

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=514 | Active, not recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Trial completion date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Efficacy and Safety Evaluation of Two to Four Months of Treatment With the Combination Regimens of DBOS and PBOS in Adults With Pulmonary Tuberculosis (clinicaltrials.gov) - P2 | N=514 | Active, not recruiting | Sponsor: Bill & Melinda Gates Medical Research Institute | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2027 ➔ Oct 2024 | Trial primary completion date: Oct 2027 ➔ Oct 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis