People living in high TB burden communities who undergo active case finding for TB may have chest X-ray changes suggestive of TB but their sputum test can be negative for the TB bacteria or they are unable to provide a sputum sample. This means they have bacteriologically unconfirmed TB. These individuals often have minimal or no symptoms and face uncertainty in clinical management-either receiving full 24-weeks TB treatment or often being discharged without treatment, risking loss to follow-up.
The RADIO-TB trial aims to address the following main questions in relation to people with bacteriologically unconfirmed TB.
1. What is the risk of progression if treatment is not immediately started but there is close and careful follow-up over 78 weeks?
2. If treatment is started immediately what is the shortest duration of TB treatment that is as effective as the standard 24-week TB treatment?
3. Are there better tests to confirm TB than the current routinely used, sputum-based tests?
4. What is the cost effectiveness of different treatment strategies and what might the impact on transmission be within communities?
Participants in the trial will be randomized into six groups: five receiving immediate standard TB treatment of varying durations (8 to 24 weeks), and one receiving deferred treatment with close monitoring. Deferred treatment will be initiated only if clinical deterioration occurs or TB is later confirmed. Participants will be closely followed for 78 weeks with at least 11 clinic visits.

Start Date01 Nov 2025

Sponsor / Collaborator

University College London

[+7]

NCT07073638

/ Not yet recruitingPhase 2

A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults With Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

A Phase 2 Trial to Evaluate the Safety and Tolerability and Early Bactericidal Activity of Nebulised RESP30TB in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

Start Date06 Oct 2025

Sponsor / Collaborator

Thirty Respiratory Limited

NCT07213765

/ RecruitingPhase 4IIT

Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease

The goal of this clinical trial is to learn if adding contezolid works to shorten the length of treatment in mycobacterium avium pulmonary disease in adults. It will also learn about the safety of extended usage of contezolid. The main questions it aims to answer are:
Does adding contezolid to standard regimen decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease? What medical problems do participants have when taking contezolid for an extended length? Researchers will compare standard regimen plus contezolid to standard regimen alone to see if contezolid helps further decrease the bacterial load, lesion severity and improve the life quality of patients with mycobacterium avium pulmonary disease?
Participants will:
Take contezolid and standard regimen (azithromycin, ethambutol, and rifampicin) for 6 months, contezolid is administered every day while other drugs are taken three times a week OR take standard regimen three times a week for 12 months.
Visit the clinic once every 1 month for checkups and tests.

Start Date24 Jul 2025

Sponsor / Collaborator

Capital Medical University

[+4]

100 Clinical Results associated with Ethambutol Hydrochloride

100 Translational Medicine associated with Ethambutol Hydrochloride

100 Patents (Medical) associated with Ethambutol Hydrochloride

8,573

Literatures (Medical) associated with Ethambutol Hydrochloride

31 Dec 2025·Emerging Microbes & Infections

Mixed infections and heteroresistance of Mycobacterium tuberculosis among multidrug-resistant tuberculosis in China: a genomic epidemiology study

Article

Author: Shen, Xin ; Lu, Xiaoyu ; Zhang, Qingping ; Lu, Yixiao ; Chen, Xin ; Takiff, Howard E. ; Zhang, Yangyi ; Jiang, Qi ; Liu, Yanping ; Jiang, Yuan ; Yuan, Jianhui ; Li, Jing ; Wang, Yunxia ; Ji, Yating ; Hou, Renjie ; Yang, Chongguang ; Wu, Zheyuan ; Zhang, Rui ; Li, Minjuan

Mixed infection refers to the presence of multiple Mycobacterium tuberculosis strains within one host, while heteroresistance denotes the coexistence of drug-susceptible and drug-resistant strains or genotypes. Mixed infections and heteroresistance with Mycobacterium tuberculosis can complicate drug resistance diagnosis, treatment options, and transmission inference. We conducted a population-based genomic epidemiological study of multidrug-resistant tuberculosis (MDR-TB) in Shanghai, China, between January 1, 2005, and December 31, 2018, to evaluate the prevalence and impact of mixed infection and heteroresistance on MDR-TB diagnosis and treatment outcomes. Demographic, clinical, and laboratory data were collected, and factors associated with mixed infections and heteroresistance were identified with multivariable logistic regression analysis. Among the 936 MDR-TB patients in our study, 10.8% (101/936) had mixed infections and 16.5% (154/936) exhibited heteroresistance, which was more frequent with second-line anti-TB drugs (P < 0.01). There was a higher risk of heteroresistance in older patients (≥60 years: aOR 1.91, 95% CI 1.02-3.57), patients with diabetes (2.59, 1.36-4.91), and mixed infections (2.85, 1.67-4.88). Mixed infections and heteroresistance accounted for 22.6% (58/257) of the strains with discrepancies between phenotypic and genotypic drug susceptibility testing (DST). Strains with heteroresistance to EMB had a higher discordance rate than those without (29.1% VS 17.2%, P < 0.05). Isolates that were phenotypically susceptible but genotypically resistant harboured minority or low-frequency resistance mutations and were more common in patients with mixed infections and heteroresistance. In summary, mixed infections are significantly associated with heteroresistance, and both mixed infections and heteroresistance can lead to discrepancies between phenotypic and genotypic DST.

31 Dec 2025·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

The new thiazolidine-2,4-dione-based hybrids with promising antimycobacterial activity: design, synthesis, biological evaluation, and drug interaction analysis

Article

Author: Trotsko, Nazar ; Głogowska, Agnieszka ; Kozieł, Katarzyna ; Kaproń, Barbara ; Augustynowicz-Kopeć, Ewa ; Paneth, Agata

The ever-increasing drug-resistant tuberculosis (TB) has invigorated the focus on the discovery and development of novel therapeutic agents and treatment options. Thiazolidinone-based compounds have shown good antitubercular properties in vitro. Here, we report the design and synthesis of a number of new derivatives inspired by the structure of thiazolidine-2,4-dione (TZD). The TZD-based hybrids with the thiosemicarbazone or the pyridinecarbohydrazone moiety were synthesised and their antimycobacterial activity was investigated against the reference H₃₇Rv and two wild Mycobacterium tuberculosis (Mtb) strains. In further studies, a two-drug interaction analysis was also performed for assessing their synergism with the current first-line drugs used for the treatment of TB. It was found that some of the compounds showed high antimycobacterial activity with MICs (0.078-0.283 µM) and a synergistic effect with isoniazid or rifampicin, thereby demonstrating their potential as a promising scaffold for the development of novel coadjuvants for the effective treatment of TB.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

A Novel Monoallelic Small Deletion Confers Gain-of-Function of STAT1 in a Child with Candidiasis and Mycobacterial Diseases

Letter

Author: Sanchez-Flores, Carlos ; Galicia, Lizbeth Blancas ; Téllez, Virginia Lora ; Blanco, Uriel Pérez ; Tello, Héctor Gómez ; Okada, Satoshi ; Padilla, Sara Espinosa ; Bustamante, Jacinta ; Tsumura, Miyuki

A novel GOF STAT1 deletion (N297del) in the coiled-coil domain (CCD) in a child presenting with an adverse BCG reaction and disseminated tuberculosis.A 4-yr-old boy from a rural area in central Mexico had three healthy older siblings and was born at 35 wk of gestation; he was hospitalized for one month due to respiratory distress syndrome (Fig. 1b). From the first.Few months of his life, he had chronic mucocutaneous candidiasis that was refractory to treatment.In a patient with several mycobacterial diseases, including those caused by M. tuberculosis, we identified a novel pathogenic variant, N297del, in STAT1 that exhibited GOF features.The mutant N297del exerted a dose-dependent dominant-neg. effect on WT-STAT1-mediated GAS induction after IFN-γ stimulation .For this variant, both parents and his siblings were WT/WT.The patient was discharged from the hospital with intensive antituberculosis treatment and prophylactic antifungal medication.During the most recent follow-up visit, the patient continued to have mucocutaneous candidiasis despite prophylactic treatment.This variant results in the loss of three nucleotides; thus, the open reading frame of the protein is retained (inframe deletion).The patient reported here was diagnosed with facial and ocular rosacea at 3 years of age, suggesting pediatric onset.The patient described in this study expands the genetic and clin. spectrum of patients with STAT1 GOF.

News (Medical) associated with Ethambutol Hydrochloride

27 Aug 2025

·www.globenewswire.com

BioVersys Receives EMA Orphan Designation for the Combination of Alpibectir and Ethionamide for the Treatment of Tuberculosis

Ad hoc announcement pursuant to Art. 53 LR BASEL, Switzerland, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Orphan designation is granted to drug candidates addressing life-threatening or chronically debilitating diseases affecting fewer than 5 in 10’000 EU residentsEMA orphan status provides key incentives, including reduced fees, research and clinical protocol support, and 10-year EU market exclusivity 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 that the European Medicines Agency Committee for Orphan Medicinal Products (EMA COMP) has granted orphan designation for the combination of alpibectir and ethionamide (AlpE) for the treatment of tuberculosis (TB). 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 significantly potentiating the activity of an existing antibiotic, ethionamide (Eto). It is being developed for pulmonary and meningeal TB. EMA’s orphan designation follows a successful clinical Phase 2a proof of concept trial and FDA’s Orphan Drug Designation (ODD) granted in 2023. The orphan designation reflects the potential for AlpE to improve treatment options for patients who have TB and to overcome resistance to TB medicines. Alpibectir was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. Currently, alpibectir is being studied in a Phase 2 trial in pulmonary TB in combination with first line TB drugs. This trial is being run within the European Union’s IMI2 UNITE4TB project with our partner GSK. In parallel, dosing in a Phase 2 trial for meningeal TB is anticipated to start in early 2026. Dr. Glenn Dale, Chief Development Officer of BioVersys: “The EMA orphan designation validates our mission to deliver urgently needed therapies for TB patients, who face prolonged treatment durations and unacceptably high mortality rates. We are pleased that this effort continues to be supported by a public-private partnership.” Dr. David Barros-Aguirre, VP and Head of Global Health Medicines R&D, GSK: “We are pleased with the progress being made with our partner BioVersys on the development of alpibectir for tuberculosis. The EMA orphan drug designation is an important step towards addressing drug resistance in TB treatment. This collaboration highlights GSK's commitment to working with partners to bring essential medicines and vaccines to those who need them.” Clinical development of AlpE has been supported by several European grants, including the EU IMI2 TRIC-TB Project, the EU IMI2 UNITE4TB project and the European & Developing Countries Clinical Trials Partnership (EDCTP2 program). About tuberculosis (TB) Tuberculosis (TB) is one of the leading causes of death worldwide. Its causative agent is the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the latest 2024 WHO TB report, worldwide an estimated 10.8 million people developed TB in 2023 and an estimated 1.25 million died from TB. WHO estimates that there were 400’000 new cases with resistance to rifampicin, most of them were multi-drug resistant (MDR). MDR-TB remains a public health crisis and a health security threat. Worldwide, only 68% of MDR-TB patients are currently successfully treated.1 In the modern world of global travel, and ease with which infections spread, it is very worrying to note that two-thirds of the global total of TB cases were recorded in eight countries: India (26%), Indonesia (10%), China (6.8%), the Philippines (6.8%), Pakistan (6.3%), Nigeria (4.6%), Bangladesh (3.5%) and the Democratic Republic of the Congo (3.1%). Furthermore, 3.2% of all new and 16% of reoccurring TB cases were MDR/RR-TB. About UNITE4TB UNITE4TB is one of nine projects within the AMR Accelerator. Working across a global clinical trials network, UNITE4TB conducts regulatory standard Phase 2 clinical trials to accelerate clinical evaluation of novel drugs and combinations of drugs for tuberculosis (TB). Innovative adaptive trial designs, treatment response biomarkers, pharmacokinetic-pharmacodynamic models and Artificial Intelligence / Deep Learning techniques are integrated across study protocols, deploying cutting-edge methodologies to find antibiotic regimens with the highest likelihood of improved clinical efficacy. This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research. About ENABLEThe ENABLE study will evaluate the 14 day EBA, safety, tolerability and dose-response of AlpE and AlpE with rifampicin (R), pyrazinamide (Z), and ethambutol (E) in adults with newly diagnosed, drug-susceptible pulmonary TB. The over-arching objective is to optimise the dose of AlpE and to evaluate the safety of the AlpE+RZE regimen for future evaluation as an alternative regimen for isoniazid mono-resistant TB. The data from the ENABLE study and the bEto study (NCT05473195) will support the evaluation of the optimal dose combination of AlpE to move forward into late phase studies. About the Innovative Medicines InitiativeThe Innovative Medicines Initiative (IMI) IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It was set up to improve health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in healthcare research, including universities, pharmaceutical companies, other companies active in healthcare research, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. This approach has proven highly successful, and IMI projects are delivering exciting results that are helping to advance the development of urgently-needed new treatments in diverse areas. IMI projects are now managed by the Innovative Health Initiative (IHI), which builds on the successes of IMI and is a cross-sectoral public-private partnership involving a wider range of health industries. More info on IHI: https://www.ihi.europa.eu/ Twitter: @IHIEuropeMore info on IMI AMR accelerator: https://amr-accelerator.eu/project/tric-tb/Working Group of new TB drugs: https://www.newtbdrugs.org/pipeline/compound/bvl-gsk098 About EMA orphan designation EMA orphan designation grants companies a number of benefits: reduced regulatory fees, research grants, clinical protocol support and 10-year market exclusivity in the EU. Orphan designation is granted to drugs/biologics intended to address life-threatening or chronically debilitating diseases that affect fewer than 5 in 10,000 EU residents. See: https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview About GSKGSK is a science-led global healthcare company. For further information please visit https://www.gsk.com/en-gb/about-us/ About BioVersysBioVersys 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.comFor media: media@bioversys.com Website: www.bioversys.comhttps://twitter.com/Bioversys https://www.linkedin.com/company/bioversys-ag 1 Global tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.

Phase 2Orphan Drug

28 Jan 2025

·www.drugs.com

Kansas Reports Largest Tuberculosis Outbreak in U.S. History

TUESDAY, Jan. 28, 2025 -- Kansas health officials are fighting the largest tuberculosis (TB) outbreak in U.S. history, with 67 confirmed cases since new year began. The outbreak includes 60 active cases in Wyandotte County and seven in Johnson County, according to the Kansas Department of Health and Environment (KDHE). That's the most since the 1950s, when the U.S. Centers for Disease Control and Prevention (CDC) began monitoring and reporting TB cases. Health officials are testing and treating affected individuals. "While there is a very low risk of infection to the general public in these communities, KDHE is working to ensure that patients are receiving appropriate treatment, which will limit the ability to spread this disease and prevent additional cases from occurring," KDHE spokeswoman Jill Bronaugh told the University of Minnesota's CIDRAP News in an email. "This outbreak is still ongoing, which means that there could be more cases." TB is caused by a bacterium called Mycobacterium tuberculosis, according to the CDC. It spreads through the air when someone with active TB disease coughs or speaks. People who spend time in close contact with someone who has active TB are at greatest risk of infection. TB typically affects the lungs but can also harm the brain, kidneys or spine. Here are the two forms : Kansas health officials are regularly screening anyone who tests positive to determine whether they have latent TB infection or active TB. Treatment for latent TB typically involves one or more medications, such as isoniazid or rifampin , for up to nine months. Active TB typically requires a longer treatment course with combinations of drugs, including ethambutol , rifampin and pyrazinamide . Although a TB vaccine exists (Bacille Calmette-Guérin), it is not commonly used in the U.S., the CDC said. Certain groups face a higher risk of TB , including people who: Local health departments in Kansas are conducting free testing for individuals, regardless of insurance coverage. SOURCES: Kansas Department of Health and Environment (KDHE), news release, Jan. 24, 2025; University of Minnesota CIDRAP News, news release, Jan. 27, 2025, USA Today , media report, Jan. 27, 2025 If you live in Kansas, especially in Wyandotte or Johnson County, consider getting tested for TB if you are at risk or have symptoms. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

VaccineClinical Study

16 Oct 2024

·www.globenewswire.com

Spero Therapeutics Announces Presentation of SPR719 (Active Moiety of SPR720) In Vitro Data Demonstrating Low Propensity for the Development of Resistance at IDWeek 2024

In vitro data on SPR719 show low propensity for resistance development in NTM-PD MAC strains when administered as a single agent and in combination with standard of care agents Study highlighting SPR720 potential benefits for prolonged combination regimens typical to NTM-PD treatment CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced a poster presentation at IDWeek 2024, entitled “Evaluation of the Spontaneous Mutation Frequencies of SPR719 Alone and in Combination with Other Agents Used to Treat Mycobacterium avium Complex Pulmonary Disease.” The poster will be presented on Friday, October 18, 2024, in Hall J & K, at 12:15 PM - 1:30 PM Pacific Time. A copy of the poster will be available on the Spero corporate website here. SPR720 is an oral, chemically stable phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety. SPR719 targets the ATPase site of DNA gyrase B in mycobacteria, a mechanism that is distinct from that of other antibiotics in use for nontuberculous mycobacterium pulmonary disease (NTM-PD). The study was conducted in collaboration with Microbiologics, a leading contract research and manufacturing organization (CRMO), partnering with pharmaceutical and diagnostic companies to bring new lifesaving technology, anti-infective drugs, vaccines and therapeutics to market. “These in vitro results present an important aspect of SPR719’s activity against MAC NTM-PD,” said Chris Pillar, Ph.D., Director of Science and Operations, Microbiologics. “Resistance to antibiotics is a major health problem, particularly in diseases such as NTM-PD with long courses of treatment where resistance mechanisms can spontaneously manifest. The data presented at ID Week 2024 confirm the high potency of SPR719 against both macrolide susceptible and resistant MAC strains, with a low propensity for the spontaneous development of resistance mechanisms. Importantly, these characteristics were maintained in the combination with current standard of care (SOC) antibiotics used in the treatment of NTM-PD, and presented lower resistance compared to SOC antibiotics alone.” Poster Presentation Highlights Activity of SPR719 and current standard of care antibiotics (clarithromycin, ethambutol and rifampin) were evaluated for potency (MIC concentration testing), propensity for the spontaneous development of drug-resistance (spontaneous mutation frequency [SMF] assay) and potential interactions for combination treatment (antibacterial synergy testing) against both macrolide susceptible and macrolide resistant mycobacterium avian complex (MAC) strains.SPR719 selection concentrations as low as 2-fold the MIC suppressed the emergence of resistance against both tested MAC isolates. Mutation frequencies for SPR719 against MAC observed in this study were about 3 orders of magnitude lower than those for SOC comparators tested in this study.In-line with previous reports, SPR719 demonstrated a high degree of potency with MIC values of 2 ug/mL for both macrolide susceptible and resistant strains. No resistant colonies were isolated when SPR719 was combined with clarithromycin or ethambutol in the SMF assay.In summary, SPR719 had a low propensity for resistance development in this study and showed no instances of antagonism when combined with clarithromycin or ethambutol, highlighting its potential for use in prolonged combination regimens typically required to treat NTM-PD. About Nontuberculous Mycobacterium Pulmonary Disease (NTM-PD) NTM-PD, also known as NTM lung disease, is caused by bacteria naturally found in soil, dust, and water. These bacteria are members of the Mycobacterium family and are distinct from tuberculosis and leprosy. The most common bacteria that cause of NTM infections is the Mycobacterium avium complex (MAC). NTM is a growing global health concern with significant unmet medical needs. Although rare, the incidence of NTM pulmonary disease is increasing worldwide. It is estimated that approximately 130,000 patients suffer from NTM in the U.S. and Europe, a figure that is growing at a rate of 8% annually. Patients with NTM lung disease experience progressive symptoms, lung damage, and reduced quality of life due to chronic symptoms and impaired lung function. NTM infections can occur after surgery, trauma, injections, or exposure to contaminated water. Prevention involves effective water management programs in healthcare facilities, and treatment typically requires consultation with infectious disease or pulmonary specialists. Patients currently have limited treatment options for NTM lung disease. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a multi-asset clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit www.sperotherapeutics.com Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing, progress and results of Spero's preclinical studies, clinical trials and research and development programs; the potential benefits of any of Spero’s current or future product candidates in treating patients; and Spero’s strategy, goals and anticipated financial performance, milestones, business plans and focus. . In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr, SPR720 and SPR206 will advance through the clinical trial process on a timely basis, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements. Investor Relations Contact:Shai Biran, PhDSpero Therapeutics IR@Sperotherapeutics.com Media Inquiries: media@sperotherapeutics.com

Clinical Result

100 Deals associated with Ethambutol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00878	Ethambutol Hydrochloride	J04AK02	DB00330

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Mycobacterium Infections, Nontuberculous	Japan	Sandoz Ltd.	20 May 2011
Tuberculosis	China	Wuhan Wuyao Pharmaceutical Co., Ltd.	01 Jan 1981
Pulmonary Tuberculosis	Japan	Kaken Pharmaceutical Co., Ltd.	31 Oct 1966
Tuberculosis, Renal	Japan	Kaken Pharmaceutical Co., Ltd.	31 Oct 1966

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04311502 (Clo-Fast, CTgov)	Phase 2	Tuberculosis \| Pulmonary Tuberculosis \| HIV Infections	104	Ethambutol+Rifapentine+Clofazimine loading dose+Isoniazid+Pyrazinamide (Arm 1: Experimental)	lldbkvpwai(kmdpkmcqtg) = lzxgrzjpde eefseacdvc (ogazjdzzuj, upekwykdts - qidvtxurlp) View more	-	27 Aug 2025
				Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Arm 2: Standard of Care)	lldbkvpwai(kmdpkmcqtg) = xpwtjccnlc eefseacdvc (ogazjdzzuj, lwjizinkky - dcprqvwlbp) View more
NCT06041919 (CTgov)	Phase 2	Pulmonary Tuberculosis	20	RESP301 (1 (Active))	vovvytckhl(dxrdyexnen) = sknufnqoil ypvruzdtcp (kvkszieagj, ktvatmnyag - nurfsahwld) View more	-	15 Jul 2025
				ethambutol+rifampicin+isoniazid+pyrazinamide (2 (Control))	vovvytckhl(dxrdyexnen) = ypogrhehkd ypvruzdtcp (kvkszieagj, gczpiksrfw - bcfoemzgjf) View more
NCT03474198 (TRUNCATE-TB, Pubmed \| Lancet Infect Dis)	Phase 2/3	Pulmonary Tuberculosis	675	Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol)	vyfnqffubf(hdevpacgje) = whmknfkxex nxivhnktnp (kinrcdqbiu ) View more	Negative	01 May 2025
				High-dose rifampicin and linezolid	vyfnqffubf(hdevpacgje) = okgqmiawsd nxivhnktnp (kinrcdqbiu ) View more
NCT04677543 (ARISE, CTgov)	Phase 3	Mycobacterium Infections, Nontuberculous \| Mycobacterium Avium-Intracellulare Infection	99	Ethambutol+Azithromycin+ALIS (ALIS + Background Regimen (Azithromycin + Ethambutol))	qbxrkrnxmf(nwifbrzgdh) = cnwiatwzwb onhdmbttmy (zykzrlxwkd, 0.82) View more	-	28 Jun 2024
				ELC+Ethambutol+Azithromycin (ELC + Background Regimen (Azithromycin + Ethambutol))	qbxrkrnxmf(nwifbrzgdh) = yrwkdwzzij onhdmbttmy (zykzrlxwkd, 0.90) View more
NCT02554318 (FSS, CTgov)	Not Applicable	Pulmonary Tuberculosis	147	Fermented soybean+Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Intervention)	uokdumdwdg(fcanzyqyqm) = aleoekhdys syvtyqcqrd (otobvnrmme, 2.33) View more	-	21 Jun 2022
				Ethambutol+Rifampicin+Isoniazid+Pyrazinamide (Control)	uokdumdwdg(fcanzyqyqm) = blzjrqxbre syvtyqcqrd (otobvnrmme, 2.42) View more
NCT02372383 (CTgov)	Not Applicable	Mycobacterium Infections, Nontuberculous \| Cystic Fibrosis	31	Ethambutol+Azithromycin+Rifampin	imuazkoerx(kaaqngivta) = jjfokvoqzz cqhzdjxhfs (ggjdhwyeur, axijtinroc - lifvnefuhr) View more	-	11 Feb 2021
NCT02024555 (CTgov)	Phase 2	Sarcoidosis, Pulmonary	97	levofloxacin+Ethambutol+Azithromycin+Rifampin (Concomitant Levaquin, Ethambutol, Azithromycin and Rifampin)	qqoyfzczxx(ggebddmydt) = qjtpwoicvs gscjbhsckv (yymssrtoju, 6.76) View more	-	09 Jul 2020
				Placebo (Placebo)	qqoyfzczxx(ggebddmydt) = zfvzcqibgz gscjbhsckv (yymssrtoju, 7.2) View more
NCT01601626 (CTgov)	Phase 2	Tuberculosis \| HIV Infections \| Tuberculosis, extrapulmonary	71	Ethambutol+Rifabutin+Pyridoxine+Standard-dose Lopinavir/Ritonavir+Isoniazid+Pyrazinamide (A: Standard-dose LPV/r w/RBT)	nasuzgqssp = unxlvjfgth jgutunfeme (zykbwfedlt, vjnyolmloa - ickbrqyqcr) View more	-	13 Feb 2018
				Ethambutol+Rifampin+Pyridoxine+Double-dose Lopinavir/Ritonavir+Isoniazid+Pyrazinamide (B: Double-dose LPV/r w/RIF)	nasuzgqssp = istrhxsqgu jgutunfeme (zykbwfedlt, gcnqguqpen - vprubuvfld) View more
NCT00864383 (REMoxTB, CTgov)	Phase 3	Pulmonary Tuberculosis	1,931	Ethambutol+Rifampicin+Moxifloxacin+Isoniazid+Pyrazinamide (Regimen 1 - 2EHRZ/4HR (Control Regimen))	dtwppbmqdp = ycjkeifqxt bgktmewjvp (zveljfygcu, qrrxtuznrf - tiivlyreho) View more	-	25 May 2015
				Ethambutol+Rifampicin+Moxifloxacin+Isoniazid+Pyrazinamide (Regimen 2 - 2MHRZ/2MHR)	dtwppbmqdp = fnlrtwpjfh bgktmewjvp (zveljfygcu, tkkaqlrmas - yzfdutgvez) View more
NCT01048697 (CTgov)	Phase 4	Tuberculosis \| Obesity	18	Ethambutol	zyqcvtzhut(qjqpbpjcsi) = ihhuqowbes lggpbwsdti (sohtwwcaxa, 18.6) View more	-	24 Jan 2013

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