A Phase 1, Single-center, Open-label, Non-randomized, Fixed-sequence, Drug-drug Interaction Study to Assess the Effect of Repeated Doses of Intravenous Ceftobiprole on the Pharmacokinetics of Oral Pitavastatin (OATP1B Substrate) and on Plasma Levels of Coproporphyrin I (OATP1B Biomarker) in Healthy Subjects

The goal of this clinical study is to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction will be investigated by pharmacokinetic (PK) assessments.
The PK of pitavastatin will be assessed when administered alone and when administered together with ceftobiprole in a study design including two treatment periods.
The clinical study will also investigate the safety of ceftobiprole and how well ceftobiprole is tolerated by healthy subjects when it is administered in combination with pitavastatin. In addition, the effect of ceftobiprole on a specific marker, called coproporphyrin I, will be assessed in the blood.
The duration of the study will be a maximum of 38 days.

开始日期2025-01-17

申办/合作机构

Basilea Pharmaceutica AG

[+1]

CTIS2024-518592-60-00

/ Not yet recruiting临床1期

- BPR-CP-101

开始日期2025-01-17

申办/合作机构-

ChiCTR2500096047

/ Recruiting早期临床1期IIT

Pharmacokinetic Characteristics and Blood-Brain Barrier Penetration of Ceftobiprole in Patients with Proposed or Confirmed Central Nervous System Infection

开始日期2024-10-28

申办/合作机构-

100 项与头孢比罗酯钠相关的临床结果

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100 项与头孢比罗酯钠相关的转化医学

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100 项与头孢比罗酯钠相关的专利（医药）

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465

项与头孢比罗酯钠相关的文献（医药）

2025-09-01·Journal of Global Antimicrobial Resistance

Activity of ceftobiprole against methicillin-resistant Staphylococcus aureus of diverse genetic types

Article

作者: Sader, Helio S ; Winkler, Marisa L ; Mendes, Rodrigo E ; Kimbrough, John H ; Castanheira, Mariana

BACKGROUND:

Ceftobiprole was approved by the United States (US) Food and Drug Administration (FDA) in 2024 and by the European Medicines Agency in 2013 for the treatment of pneumonia, bacterial skin and skin structure infections, and Staphylococcus aureus bloodstream infections. Numerous methicillin-resistant S. aureus (MRSA) lineages have been identified with unique assemblages of resistance determinants and virulence factors.

METHODS:

MRSA isolates (n = 150) were collected from bloodstream infections in 2018-2019. Broth microdilution antimicrobial susceptibility testing was performed, and results were interpreted by US FDA, Clinical and Laboratory Standards Institute, and European Committee on Antimicrobial Susceptibility Testing guidelines. Genome sequencing was performed to determine multi-locus sequence, clonal complex (CC), spa, and SCCmec types; typing results were used to determine clonal group.

RESULTS:

Overall, 97.3% of isolates were ceftobiprole susceptible by FDA and European Committee on Antimicrobial Susceptibility Testing criteria compared to 85.3% for ceftaroline, 73.3%-74.0% for clindamycin, 94.7% for trimethoprim-sulfamethoxazole, and 100.0% for linezolid, vancomycin, and daptomycin. More than 90% of isolates were CC5, CC8, or CC22, and ceftobiprole inhibited 97.7%, 98.3%, and 94.1% of these isolates, respectively, compared to 84.1%, 91.5%, and 70.6% activity of ceftaroline. Only 4 (2.7%) ceftobiprole non-susceptible isolates were identified compared to 22 (14.7%) non-susceptible to ceftaroline; all non-susceptible isolates were from clonal groups within CC8 (USA500 (Lyon) and Hungarian/Brazilian), CC5 (USA100 (Swiss) and USA100), or CC22 (UK-EMRSA-15).

CONCLUSIONS:

Ceftobiprole demonstrated higher activity than ceftaroline against a phylogenetically diverse set of MRSA isolates and may represent a preferred broad-spectrum antimicrobial choice for the treatment of MRSA infections.

2025-08-01·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

In Vitro activity of ceftobiprole against 20,255 recent clinical bacterial isolates in Canada (CANWARD 2015-2023)

Article

作者: Adam, Heather J ; Walkty, Andrew ; Baxter, Melanie ; Gemme, Élodie ; Karlowsky, James A ; Zhanel, George G ; Weiss, Karl ; Lagacé-Wiens, Philippe

BACKGROUND:

Ceftobiprole is a fifth-generation cephalosporin active against methicillin-resistant Staphylococcus aureus (MRSA). In this study, we determined the in vitro activities of ceftobiprole and comparator agents against 20,225 common Gram-positive and Gram-negative bacteria isolated from patients who presented for care at 16 tertiary-care hospitals across Canada between 2015 and 2023.

METHODS:

Minimum inhibitory concentrations (MICs) were determined using the Clinical and Laboratory Standards Institute (CLSI) reference M07 broth microdilution method. MICs were interpreted using CLSI M100 breakpoints where available. As CLSI does not publish MIC breakpoints for ceftobiprole, ceftobiprole MICs were interpreted using United States Food and Drug Administration (FDA), European Committee on Antimicrobial Susceptibility Testing (EUCAST), and Health Canada breakpoints.

RESULTS:

Ceftobiprole inhibited 100 % of MRSA at ≤ 4 μg/ml; 100 % of methicillin-susceptible S. aureus (MSSA) and 99.8% of MRSA at ≤ 2 μg/ml; 100 % of Streptococcus pneumoniae and Streptococcus pyogenes at ≤ 0.5 μg/ml; and 97.9 % of ESBL-negative Escherichia coli, 97.4 % of ESBL-negative Klebsiella pneumoniae, 97.8 % of Proteus mirabilis, 89.3 % of Serratia marcescens, 78.2 % of Enterobacter cloacae, 55.7 % of Klebsiella oxytoca at ≤ 0.25 μg/ml. Ceftobiprole was inactive against ESBL-positive E. coli and ESBL-positive K. pneumoniae.

CONCLUSIONS:

Ceftobiprole demonstrated potent in vitro activity against MRSA, MSSA, S. pneumoniae, S. pyogenes, ESBL-negative E. coli and K. pneumoniae, and P. mirabilis isolated from clinical specimens of patients seeking care at Canadian tertiary-care hospitals.

2025-07-01·Microbial Drug Resistance

In Vitro Activity of Novel Antibiotics Against Corynebacterium spp. Clinical Isolates Responsible for Difficult-to-Treat Infections.

Article

作者: Cattoir, Vincent ; Collet, Anaïs ; Penven, Malo ; Piau, Caroline ; Guérin, François ; Bichali, Ahmad Rami ; Reissier, Sophie ; Lecourt, Maxime

Corynebacterium species can be responsible for difficult-to-treat (DTT) infections, for which novel therapeutic options may be used. This study assessed the in vitro activity of newer antibiotics against Corynebacterium clinical isolates responsible for DTT infections between 2021 and 2023 in our center. Minimum inhibitory concentrations (MICs) were determined by the broth microdilution method or the gradient diffusion method. Interpretation was done according to the 2024 Comité de l'Antibiogramme de la Société Française de Microbiologie breakpoints. In total, 116 isolates were collected, including 73 (66%) responsible for bone and joint infections, among which half were device related. C. striatum was the most frequently isolated species. The activity of ceftaroline (MIC₉₀ >2 mg/L), ceftobiprole (MIC₉₀ >8 mg/L), and delafloxacin (MIC₉₀ >1 mg/L) was limited. By contrast, other molecules tested showed higher activity with low MIC₉₀ values: linezolid (MIC₉₀ ≤0.5 mg/L), tedizolid (MIC₉₀ = 0.12 mg/L), dalbavancin (MIC₉₀ = 0.12 mg/L), tigecycline (MIC₉₀ = 0.12 mg/L), eravacycline (MIC₉₀ = 0.06 mg/L), and omadacycline (MIC₉₀ = 0.5 mg/L). One C. striatum strain exhibited a high level of daptomycin resistance after antibiotic exposure (MIC >16 mg/L). The in vitro activity of most of these novel antibiotics is excellent against Corynebacterium clinical isolates. They could represent a real alternative for treating DTT infections due to Corynebacterium spp.

157

项与头孢比罗酯钠相关的新闻（医药）

2025-08-19

·GlobeNewswire-Health Care

Basilea on track with strong 2025 half-year results

Cresemba® and Zevtera®-related revenues rise by 24% to CHF 90.5 millionTotal revenue grows significantly by 36% to CHF 104.0 millionOperating profit surges by 160% to CHF 24.0 millionOperating cash flow increases by 29% to CHF 23.1 millionFull-year 2025 guidance: on track and updated to reflect recent in-licensing of a novel oral phase 3-ready antibiotic Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 19, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today its results for the first half-year ended June 30, 2025. David Veitch, Chief Executive Officer, stated: “The first half of 2025 has marked a period of strong execution and meaningful progress across both the antibacterial and antifungal parts of our portfolio. The launch of Zevtera in the US, its most important commercial market, is a major milestone and represents a pivotal moment in the brand’s history. On the antifungal side, we have seen encouraging momentum from our global commercial partnerships, including the first milestone payments for Cresemba sales in Japan. A further highlight was the release of another USD 39 million from BARDA to support the ongoing development of fosmanogepix and BAL2062. The recent start of a phase 3 clinical study for fosmanogepix in invasive mold infections, conducted in parallel with the ongoing phase 3 study in invasive yeast infections provides strong evidence of the clinical progress we are making. Our stated goal to deliver new treatment options for patients with life-threatening fungal infections is becoming reality. Furthermore, the agreement we just announced to acquire the global rights to a novel oral phase 3-ready antibiotic for the treatment of complicated urinary tract infections, marks yet another strategic milestone to strengthen our late-stage clinical pipeline with innovative assets.” Adesh Kaul, Chief Financial Officer, said: “We are reporting another period of strong financial performance, with increasing revenues, operating profits and operating cash flows. We expect continued strong in-market sales growth, which will result in increasing royalty revenue and milestone payments in the second half of this year. We strengthened our balance sheet by reducing the outstanding value of our convertible bonds by 14% to CHF 83 million in nominal value, while at the same time increasing our cash position. Our strong financial position demonstrates the robustness of our unique business model and enables us to continue investing in the expansion of our pipeline.” Financial summary For the first half year (H1) 2025, Basilea recognized total revenue of CHF 104.0 million (H1 2024: CHF 76.3 million), an increase of 36.3% year-on-year. This included royalty income of CHF 52.1 million (H1 2024: CHF 42.8 million), which increased by 21.7% year-on-year, and product revenue of CHF 31.5 million (H1 2024: CHF 27.6 million). Milestone and upfront payments have also increased to CHF 6.9 million (H1 2024: CHF 2.9 million). Other revenue amounted to CHF 13.5 million (H1 2024: CHF 3.0 million). This included CHF 11.1 million BARDA[1] reimbursements (H1 2024: CHF 2.0 million) and CHF 1.9 million CARB-X[2] funding (H1 2024: CHF 0.6 million). BARDA reimbursements were for activities related to the fosmanogepix phase 3 program, the antifungal BAL2062, and ceftobiprole, while CARB-X funding supports preclinical activities related to the antibiotic BAL2420. In H1 2025, Basilea invested CHF 38.3 million (H1 2024: CHF 33.6 million) in research and development (R&D), mainly related to the ongoing phase 3 clinical study of fosmanogepix in invasive yeast infections, the preparations for starting a second phase 3 clinical study with fosmanogepix in invasive mold infections, the preclinical profiling of BAL2062 and BAL2420 (the LptA inhibitor program), and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, amounted to CHF 17.4 million (H1 2024: CHF 15.3 million) and cost of products sold increased to CHF 24.2 million (H1 2024: CHF 18.1 million), reflecting the increase in product revenue. Basilea recorded an operating result of CHF 24.0 million (H1 2024: CHF 9.3 million). In H1 2025, Basilea reported income tax expense of CHF 3.5 million (H1 2024: CHF 13.4 million income tax benefit due to the one-time effect from releasing the deferred tax asset valuation allowance) and a net profit of CHF 15.8 million (H1 2024: CHF 20.7 million), resulting in a basic and diluted earnings per share of CHF 1.29 and CHF 1.26, respectively (H1 2024: basic and diluted earnings per share CHF 1.72 and CHF 1.61, respectively). In H1 2025, a positive net cash flow of CHF 23.1 million was provided by operating activities (H1 2024: CHF 17.9 million). The Company also repurchased senior unsecured convertible bonds due July 2027 in the amount of CHF 14.3 million nominal value out of a total CHF 97.1 million nominal value. Cash and cash equivalents and restricted cash amounted to CHF 132.7 million as of June 30, 2025 (June 30, 2024: CHF 69.5 million). Basilea has reduced its total financial debt by approximately CHF 138 million since the beginning of 2022 and increased its net cash position to CHF 50.7 million as of June 30, 2025 (June 30, 2024: net debt of CHF 26.2 million). Key financial figures (In CHF million, except per share data)H1 2025H1 2024 Product revenue31.527.6 Contract revenue59.045.7 Other revenue13.53.0Total revenue 104.076.3 Cost of products sold(24.2)(18.1) Research & development expenses, net(38.3)(33.6) Selling, general & administrative expenses(17.4)(15.3)Total cost and operating expenses (79.9)(67.0)Operating result24.09.3Profit before taxes19.37.3 Income taxes(3.5)13.4Net profit15.820.7Net cash provided by operating activities23.117.9Basic earnings per share, in CHF1.291.72Diluted earnings per share, in CHF1.261.61 (in CHF million)June 30, 2025June 30, 2024Cash and cash equivalents and restricted cash132.769.5 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2025 can be found on the company’s website at https://www.basilea.com/financial-reports. Updating 2025 financial guidance – expecting higher total revenue and reflecting recent in-licensing of a novel oral phase 3-ready antibiotic Basilea provides the following guidance for the full year (FY) 2025: Total revenue is expected to increase by 8% to CHF 225 million Basilea can offset the impact of the strengthening of the Swiss Franc and the previously announced decrease in product supply to Pfizer on Cresemba & Zevtera-related revenue.The expected 14% increase in royalty income to CHF 110 million reflects primarily the continued strong double-digit sales growth of Cresemba in its key markets.Following a year of exceptionally high milestone payments in 2024, milestone and upfront payments in 2025 are expected to remain at the level of prior years of around CHF 32 million, despite being impacted by the strengthening of the Swiss Franc, primarily versus the US Dollar.The increase in BARDA and CARB-X reimbursements is reflecting the significant operational progress with fosmanogepix, BAL2062 and BAL2420. The increase in cost and operating expenses reflects the expected impact of the recent strategic addition of ceftibuten-ledaborbactam to our late-stage clinical pipeline and our continued investment in progressing our exciting R&D portfolio of first-in-class antifungals and antibacterials. Nevertheless, we expect to maintain a high operating profit level of CHF 50 million in 2025.We expect no material cash outflow related to income taxes as a result of the use of tax loss carry forwards, but a 10.7% income tax expense will be reflected in the 2025 net profit, in contrast to a CHF 17.3 million one-time income tax benefit from releasing the deferred tax valuation allowance in 2024. (in CHF million)FY 2025enewFY 2025epreviousFY 2024 Cresemba and Zevtera-related revenue~190~190194.9 of which royalty income~110~11096.7Total revenue ~225~220208.5Research & development expenses, net~105~8877.1Operating result~50~6261.2 Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 19, 2025, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=AAxPAsgp. Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 5000(Switzerland, Europe and RoW)+1 (1) 866 291 4166 (USA)+44 (0) 207 107 0613(UK) Replay The webcast, along with the presentation will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. 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 Basilea Pharmaceutica Ltd, Allschwil 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 Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil 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. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS), provided partial funding for Basilea’s ceftobiprole Phase 3 program under contract number HHSO100201600002C. This funding covered approximately USD 111 million, or about 75% of the costs for the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) Phase 3 studies, regulatory activities, and non-clinical work. BARDA is also supporting Basilea’s fosmanogepix and BAL2062 programs under OTA number 75A50124C00033. CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) funding for this project is provided in part by federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). Attachment Press release (PDF).pdf

临床3期财报引进/卖出

2025-08-14

·PipelineReview

Basilea announces in-licensing of a novel clinical phase 3-ready oral antibiotic

ALLSCHWIL, Switzerland I August 14, 2025 I Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive license agreement with Venatorx Pharmaceuticals, Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil, a clinical phase 3-ready oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for the potential treatment of complicated urinary tract infections (cUTI), including pyelonephritis. Ceftibuten-ledaborbactam etzadroxil is the combination of ceftibuten, an orally bioavailable cephalosporin antibiotic, and ledaborbactam etzadroxil, the orally bioavailable prodrug of the novel beta-lactamase inhibitor ledaborbactam. The combination demonstrates bactericidal activity against Enterobacterales, including multidrug-resistant pathogens, the major cause of cUTI. [1] In the USA, cUTI account for more than 600,000 hospital admissions each year. [2] This underscores the significant clinical burden and need for effective oral treatment options, which may shorten or entirely avoid hospitalization. In preclinical and clinical phase 1 studies, ceftibuten and ledaborbactam etzadroxil were shown to be safe and well tolerated. [3] David Veitch, Chief Executive Officer of Basilea, said: “This agreement allows us to strengthen our late-stage clinical pipeline and supports our strategy of ensuring that we have a continuous stream of potential new product launches in the near-term future, positioning us for sustainable substantial revenue growth. Ceftibuten-ledaborbactam etzadroxil holds strong promise in addressing the critical unmet need for the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria and represents a compelling global commercial opportunity. We expect starting a registrational phase 3 program in cUTI in about 18 months.” Under the terms of the agreement, Basilea will make an upfront payment and potential milestone payments in 2025. Following the successful completion of the phase 3 clinical development program and after the grant of regulatory approval and start of commercialization, Venatorx is eligible to receive tiered mid-single-digit royalties and additional potential milestone payments of up to USD 325 million in total, if all agreed commercial milestone events are triggered over the term of the contract. The transaction is expected to result in approximately CHF 15 million of additional research and development expenses in 2025, including the full upfront payment, all potential pre-commercial milestone payments and expected R&D expenses in 2025. Basilea will provide updated financial guidance for the full-year 2025, reflecting this transaction, with the half-year earnings report on August 19, 2025. About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections by multidrug-resistant bacterial pathogens. About ceftibuten-ledaborbactam etzadroxil Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. [4] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. About complicated urinary tract infections (cUTI) Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. [1] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx also developed cefepime-taniborbactam, an intravenous-only antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. The ceftibuten-ledaborbactam etzadroxil project has been funded in whole or in part with Federal funds from National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201600029C and the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00050. For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com . About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com . References SOURCE: Basilea

临床3期引进/卖出上市批准临床1期快速通道

2025-08-14

·Firstwordpharma

Basilea nets rights to Venatorx’s Phase III-ready oral antibiotic combo

Looking to expand its antibiotic arsenal beyond Zevtera (ceftobiprole medocaril), Basilea signed a licensing pact with Venatorx Pharmaceuticals, securing global rights to the latter’s Phase III-ready oral antibiotic combination to treat complicated urinary tract infections (cUTI), including pyelonephritis. The licensed asset – which pairs ceftibuten, an orally bioavailable beta-lactam, with ledaborbactam etzadroxil, a prodrug of the beta-lactam inhibitor ledaborbactam — has shown in vitro and in vivo bactericidal activity against Enterobacterales, including hard-to-treat pathogens responsible for cUTI. Moreover, preclinical and Phase I studies have established the combination's safety and tolerability profile."Ceftibuten/ledaborbactam etzadroxil holds strong promise in addressing the critical unmet need for the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria," said David Veitch, chief executive officer of Basilea.Under the agreed terms, Basilea will pay Venatorx an undisclosed upfront sum and potential milestone payments this year. Additionally, post successful Phase III completion, regulatory approval, and commercialisation, Venatorx stands to receive tiered mid-single-digit sales royalties and additional milestone payments totalling up to $325 million.With the transaction adding around CHF 15 million ($18.6 million) to the current year’s R&D expenses, Basilea expects to initiate the registrational Phase III programme within approximately 18 months. Basilea has inked key deals with iNtRON and Spexis for antibiotic assets in the past. Last year, the Swiss pharma also bagged funding worth up to $268 million from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to develop next-generation antimicrobials.

临床1期引进/卖出临床3期

100 项与头孢比罗酯钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢比罗酯钠	J01DI01	DB14733

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
社区获得性细菌性肺炎	美国	ISTx LLC	2024-04-03
右侧感染性心内膜炎	美国	ISTx LLC	2024-04-03
皮肤和皮肤结构感染	美国	ISTx LLC	2024-04-03
金黄色葡萄球菌菌血症	美国	ISTx LLC	2024-04-03
社区获得性肺炎	加拿大	Avir Pharma, Inc.	2018-03-20
医院获得性肺炎	加拿大	Avir Pharma, Inc.	2018-03-20

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10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
传染性皮肤病	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
软组织感染	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
新生儿败血症	临床3期	美国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	保加利亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	爱沙尼亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	德国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	拉脱维亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	立陶宛	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	波兰	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	斯洛伐克	Basilea Pharmaceutica AG	2023-08-06

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适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03137173 (FDA_CDER) 人工标引	临床3期	皮肤和皮肤结构感染	679	ZEVTERA 667 mg	鬱淵獵壓獵膚窪壓衊顧(蓋鹹鏇範窪餘鑰憲範鹽) = 窪鹹淵窪繭獵廠憲範築遞醖糧淵顧簾糧築遞艱 (廠齋膚衊築願網鏇遞膚 ) 更多	积极	2024-04-03
				Vancomycin plus aztreonam	鬱淵獵壓獵膚窪壓衊顧(蓋鹹鏇範窪餘鑰憲範鹽) = 遞製鏇憲壓膚鬱簾選衊遞醖糧淵顧簾糧築遞艱 (廠齋膚衊築願網鏇遞膚 ) 更多
NCT00326287 \| NCT03439124 (FDA_CDER) 人工标引	临床3期	社区获得性细菌性肺炎	-	Ceftobiprole medocaril (Adult Patients)	餘遞膚構築鑰鬱餘觸遞(鏇糧範製製選網鑰艱齋) = 願顧艱衊築繭醖鹹觸製糧鬱鬱齋糧壓鏇糧糧範 (構蓋淵鹹廠顧選夢憲夢 ) 更多	积极	2024-04-03
				Ceftriaxone with or without Linezolid (Adult Patients)	餘遞膚構築鑰鬱餘觸遞(鏇糧範製製選網鑰艱齋) = 鹽鹹窪餘築觸顧衊鑰網糧鬱鬱齋糧壓鏇糧糧範 (構蓋淵鹹廠顧選夢憲夢 ) 更多
NCT03138733 (FDA_CDER) 人工标引	临床3期	金黄色葡萄球菌菌血症	387	ZEVTERA	觸鬱鏇鑰膚廠選願鬱夢(憲鑰網選餘鹹艱齋繭壓) = 築鬱網積製製衊築廠鹽襯壓獵構蓋艱獵構襯襯 (網築鬱餘選鏇鑰蓋製觸 ) 更多	积极	2024-04-03
				Daptomycin	觸鬱鏇鑰膚廠選願鬱夢(憲鑰網選餘鹹艱齋繭壓) = 襯網壓遞範繭積醖構膚襯壓獵構蓋艱獵構襯襯 (網築鬱餘選鏇鑰蓋製觸 ) 更多
NCT03138733 (ERADICATE, Pubmed)	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	範顧簾顧淵夢願艱範觸(鹹構築鹹鬱構觸範築衊) = 積簾願窪選壓衊淵觸範淵餘蓋製鏇遞鹽願觸廠 (顧繭餘遞餘築鏇醖憲築 ) 更多	积极	2023-10-12
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	範顧簾顧淵夢願艱範觸(鹹構築鹹鬱構觸範築衊) = 淵膚餘鬱簾選鬱繭觸壓淵餘蓋製鏇遞鹽願觸廠 (顧繭餘遞餘築鏇醖憲築 ) 更多
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	临床3期	金黄色葡萄球菌菌血症	390	Daptomycin	構窪網壓淵構繭餘鏇窪 = 艱網餘範鹽衊齋鏇鹹網膚衊構願糧獵遞製範願 (構願餘憲淵繭繭艱獵齋, 簾齋衊繭選積膚艱遞醖 ~ 蓋獵範糧繭夢網選壓窪) 更多	-	2023-05-06
NCT03138733 (ERADICATE, Corporate Publications) 人工标引	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole Medocaril Sodium	夢淵憲顧顧鏇齋艱鏇壓(窪鬱鹽艱夢餘衊蓋簾積) = 鏇淵構鏇製顧顧壓膚選構鬱鏇壓淵築襯製鏇窪 (選膚齋顧鏇網遞壓膚鹹 ) 更多	非劣	2022-10-24
				Aztreonam+Daptomycin	夢淵憲顧顧鏇齋艱鏇壓(窪鬱鹽艱夢餘衊蓋簾積) = 淵築範顧顧鹹衊選選廠構鬱鏇壓淵築襯製鏇窪 (選膚齋顧鏇網遞壓膚鹹 ) 更多
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	N/A	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	簾糧鏇齋窪鬱範鑰遞廠(築齋醖網範齋淵鑰衊襯) = 獵構簾夢遞製淵網廠顧醖餘糧獵築夢廠顧選憲 (衊廠鹹齋製艱願襯簾遞 ) 更多	-	2021-11-01
				Ceftobiprole (Patients 3 months to 17 years of age)	簾糧鏇齋窪鬱範鑰遞廠(築齋醖網範齋淵鑰衊襯) = 觸鹽積網鏇淵憲顧繭壓醖餘糧獵築夢廠顧選憲 (衊廠鹹齋製艱願襯簾遞 ) 更多
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) 人工标引	临床3期	皮肤和皮肤结构感染	679	Ceftobiprole Medocaril Sodium	積製憲簾鹽鹹選築簾遞(糧糧膚艱廠遞夢鑰憲襯) = 淵獵簾遞遞製簾獵蓋製齋鏇鏇顧壓構廠鏇廠夢 (窪衊築憲願願衊鑰窪網 ) 更多	非劣	2021-10-05
				Vancomycin Hydrochloride+Aztreonam	積製憲簾鹽鹹選築簾遞(糧糧膚艱廠遞夢鑰憲襯) = 鬱獵衊願鹹膚衊艱壓夢齋鏇鏇顧壓構廠鏇廠夢 (窪衊築憲願願衊鑰窪網 ) 更多
NCT03439124 (Pubmed \| Pediatr Infect Dis J)	临床3期	儿童肺炎	138	Ceftobiprole	膚選衊獵範夢鏇餘夢壓(簾膚鹹醖選蓋衊網觸糧) = 顧廠製積顧製窪網艱衊構蓋衊願鬱夢衊鏇網廠 (糧鬱齋構遞窪範蓋衊淵 ) 更多	积极	2021-01-21
				Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone)	膚選衊獵範夢鏇餘夢壓(簾膚鹹醖選蓋衊網觸糧) = 獵顧衊衊鬱壓餘壓襯鏇構蓋衊願鬱夢衊鏇網廠 (糧鬱齋構遞窪範蓋衊淵 ) 更多
NCT02527681 (CTgov)	临床1期	细菌感染	15	Ceftobiprole (Ceftobiprole PK Population)	鬱齋鹽餘鑰蓋鹹夢膚艱(醖築醖積顧憲鬱觸製願) = 顧願願壓艱蓋積獵餘製壓艱壓鹽壓獵繭廠餘構 (鹽衊蓋鬱壓築獵壓窪膚, 廠顧網餘夢選遞糧獵遞 ~ 蓋廠鹹繭淵鹽壓艱淵網) 更多	-	2021-01-06
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	壓齋壓願餘願餘醖簾觸(糧範製憲製繭構遞夢製) = 構顧鬱衊襯膚鑰壓鏇窪簾衊壓淵鹹醖襯獵憲襯 (選窪顧築構艱範夢襯壓, 製淵範鏇憲獵鏇鏇繭範 ~ 齋簾艱範範網積鹹鏇淵) 更多