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.

Start Date17 Jan 2025

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

CTIS2024-518592-60-00

/ Not yet recruitingPhase 1

- BPR-CP-101

Start Date17 Jan 2025

Sponsor / Collaborator-

ChiCTR2500096047

/ RecruitingEarly Phase 1IIT

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

Start Date28 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Ceftobiprole Medocaril Sodium

100 Translational Medicine associated with Ceftobiprole Medocaril Sodium

100 Patents (Medical) associated with Ceftobiprole Medocaril Sodium

454

Literatures (Medical) associated with Ceftobiprole Medocaril Sodium

01 Aug 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

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

Article

Author: 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.

01 Jun 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Phenyl urea based adjuvants for β-lactam antibiotics against methicillin resistant Staphylococcus aureus

Article

Author: Crow, Andrew H ; Young, Mikaeel ; Melander, Christian ; Butman, Hailey S ; Nemeth, Ansley M ; Walsh, Danica J ; Gondil, Vijay S ; Dunman, Paul M ; Stefaniak, Monica A ; Melander, Roberta J

Penicillin binding protein 4 (PBP4) is essential for Staphylococcus aureus cortical bone osteocyte lacuno-canalicular network (OLCN) invasion, which causes osteomyelitis and serves as a bacterial niche for recurring bone infection. Moreover, PBP4 is also a key determinant of S. aureus resistance to fifth-generation cephalosporins (ceftobiprole and ceftaroline). From these perspectives, the development of S. aureus PBP4 inhibitors may represent dual functional therapeutics that prevent osteomyelitis, and reverse PBP4-mediated β-lactam resistance. A high-throughput screen for small molecules that inhibit S. aureus PBP4 function identified compound 1. We recently described a preliminary structure activity relationship (SAR) study on 1, identifying several compounds with increased PBP4 inhibitory activity, some of which also inhibit PBP2a. Herein, we expand our exploration of phenyl ureas as antibiotic adjuvants, investigating their activity with penicillins and additional cephalosporins against PBP2a-mediated methicillin-resistant S. aureus (MRSA). We screened the previously reported pilot library, and prepared an additional series of phenyl ureas based on compound 1. Lead compounds potentiate multiple β-lactam antibiotics, lowering minimum inhibitory concentrations (MICs) below susceptibility breakpoints, with up to 64-fold reductions in MIC.

04 May 2025·Expert Opinion on Drug Metabolism & Toxicology

Ceftobiprole medocaril for skin and skin-structure infections

Review

Author: McCarthy, Matthew W.

INTRODUCTION:

On 3 April 2024, the United States Food and Drug Administration (FDA) approved ceftobiprole medocaril sodium (Zevtera) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) as well as patients with Staphylococcus aureus bloodstream infections and patients 3 months to less than 18 years old with community-acquired bacterial pneumonia.

AREAS COVERED:

Ceftobiprole is a fifth-generation cephalosporin that exerts antibacterial activity by binding to penicillin-binding proteins and inhibiting transpeptidases and has demonstrated broad antimicrobial activity against both Gram-positive and Gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). This manuscript involves a literature review of PubMed from 1 February 2024 through 8 January 2025.

EXPERT OPINION:

Ceftobiprole has demonstrated clinical efficacy in treating ABSSSI in a randomized, controlled, double-blind, multinational trial. The pharmacokinetics of this drug, coupled with its favorable safety profile, suggest ceftobiprole will be an important addition to the antimicrobial armamentarium. In the future, ceftobiprole may be used alone or in combination to treat antibiotic-resistant infections, which serve as an expanding threat to patients with and without immune impairment.

104

News (Medical) associated with Ceftobiprole Medocaril Sodium

07 May 2025

·www.businesswire.com

Innoviva Reports First Quarter 2025 Financial Results; Highlights Recent Company Progress

BURLINGAME, Calif.--(BUSINESS WIRE)--Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets, today reported financial results for the first quarter ended March 31, 2025, and highlighted select corporate progress and achievements. “We are pleased with our strong first quarter financial results, highlighted by robust cash flows from our GSK royalties portfolio and continued excellent growth from the IST-marketed products,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “Our therapeutics business remains a key driver, with an NDA filing for zoliflodacin on track and the U.S. commercial launch of ZEVTERA® (ceftobiprole) anticipated by mid-2025, underscoring our commitment to delivering innovative treatments to patients and our ability to leverage the operating platform.” “Additionally, we remain dedicated to creating value for our shareholders by strategically enhancing our healthcare assets. We are cognizant of the increased market volatility and believe that the strength of our balance sheet, combined with a disciplined approach to capital allocation, positions us well to advance our diversified portfolio and capitalize on new opportunities, thereby supporting sustained growth across market environments,” concluded Mr. Raifeld. Financial Highlights Royalty revenue: First quarter 2025 gross royalty revenue from Glaxo Group Limited (“GSK”) was $61.3 million, compared to $61.9 million for the first quarter of 2024. Net product sales: First quarter 2025 net product sales totaled $30.3 million, consisting of $26.4 million in U.S. net product sales and $3.9 million in ex-U.S. net product sales, compared to $19.1 million in net product sales for the first quarter of 2024. U.S. net product sales included $17.4 million from GIAPREZA ® , $5.8 million from XACDURO ® , and $3.2 million from XERAVA ® , representing a 52% increase compared to total U.S. net product sales of $17.4 million in the first quarter of 2024. Income from operations: First quarter 2025 income from operations was $41.4 million, an increase of 61% from $25.8 million in the first quarter of 2024. Equity and long-term investments: First quarter 2025 unfavorable changes in fair values of equity and long-term investments totaled $78.8 million, compared to favorable changes of $22.0 million in the first quarter of 2024, primarily due to the share price depreciation of Armata Pharmaceuticals and certain equity investments managed by ISP Fund LP. Net income: First quarter 2025 net loss was $46.6 million, or ($0.74) basic per share, compared to net income of $36.5 million, or $0.58 basic per share, for the first quarter of 2024. Cash and cash equivalents: Totaled $319.1 million. Royalty and net product sales receivables totaled $77.9 million as of March 31, 2025. Key Business and R&D Highlights Zoliflodacin: a potential first-in-class, single dose, oral antibiotic is currently being developed together with The Global Antibiotic Research & Development Partnership ("GARDP") for the treatment of patients with uncomplicated gonorrhea. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. Zoliflodacin NDA on track for filing with the U.S. FDA in the first half of 2025. ZEVTERA ® (ceftobiprole): an advanced-generation cephalosporin antibiotic that is approved in the U.S. for three specific treatment indications. ZEVTERA ® is the only FDA-approved methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB) and endocarditis. ZEVTERA ® is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. Following the exclusive distribution and license agreement with Basilea Pharmaceutica Ltd. in December 2024, Innoviva anticipates launching ZEVTERA ® in the U.S. in mid-2025. XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: a targeted antibacterial treatment for patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). In April, the Company presented in vivo and in vitro data on the activity of durlobactam against Enterobacterales at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global). Innoviva’s portfolio of strategic assets held through the Company’s various subsidiaries was valued at $457.6 million as of March 31, 2025. In the first quarter of 2025, we invested a total of $34.7 million in various strategic healthcare assets, including $15.0 million in a convertible note of Gate Neurosciences and $10.0 million in a term loan to Armata Pharmaceuticals. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other commercial and marketed products include infectious disease and critical care assets: GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock; XERAVA® (eravacycline), approved for the treatment of complicated intra-abdominal infections in adults; and XACDURO® (sulbactam for injection; durlobactam for injection), approved for the treatment of hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter in adults. In addition, ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, will be exclusively commercialized by us in the U.S. under a distribution and license agreement with Basilea Pharmaceutica Ltd., (“Basilea”), entered into in December 2024. We continue to advance our pipeline with zoliflodacin, a potentially first in class, single-dose oral treatment for uncomplicated gonorrhea. ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies. ZEVTERA® is a trademark of Basilea Pharmaceutica Ltd., Allschwil. Forward Looking Statements This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA®, XACDURO® and ZEVTERA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequently Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law. 2025 2024 $ 57,807 $ 58,415 30,279 19,084 546 — 88,632 77,499 8,842 10,971 6,475 6,440 73,315 60,088 27,491 30,405 4,396 3,878 31,887 34,283 41,428 25,805 (13,549 ) 35,342 (65,299 ) (13,335 ) 4,538 4,399 (4,711 ) (5,851 ) (996 ) (1,236 ) (38,589 ) 45,124 (7,995 ) (8,592 ) $ (46,584 ) $ 36,532 $ (0.74 ) $ 0.58 $ (0.74 ) $ 0.46 62,709 63,185 62,709 84,531 2025 2024 $ 61,263 $ 61,871 (3,456 ) (3,456 ) $ 57,807 $ 58,415 2025 2024 $ 319,090 $ 304,964 77,936 86,366 41,479 33,725 15,727 21,719 127,790 107,532 483 514 329,844 393,957 66,505 69,961 2,110 2,453 17,905 17,905 201,958 208,433 12,294 12,054 41,269 41,477 $ 1,254,390 $ 1,301,060 $ 40,695 $ 39,507 833 3,422 1,002 1,126 192,215 192,028 256,670 256,316 62,009 64,275 54,061 53,227 646,905 691,159 $ 1,254,390 $ 1,301,060 2025 2024 $ 48,617 $ 37,047 (34,674 ) (43,038 ) 183 (9,165 ) $ 14,126 $ (15,156 ) 304,964 193,513 $ 319,090 $ 178,357

License out/inDrug ApprovalFinancial Statement

24 Apr 2025

·www.globenewswire.com

Strong sales for Cresemba® (isavuconazole) in Japan trigger second milestone payment from Asahi Kasei Pharma to Basilea

Allschwil, Switzerland, April 24, 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, reported today that the sales of the antifungal Cresemba® (isavuconazole) in Japan exceeded the threshold triggering a sales milestone payment from its partner Asahi Kasei Pharma (AKP), amounting to approximately CHF 1.7 million. This is the second milestone payment from AKP to Basilea in consecutive quarters. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued strong Cresemba sales performance by our partner AKP. Japan is a key commercial market with significant growth potential in the long-term and the strong sales uptake in the country shows that Cresemba is meeting critical medical needs of patients with life-threatening fungal infections.” Cresemba is marketed in more than 70 countries. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between January and December 2024 amounted to USD 562 million, a 19 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 About Cresemba® (isavuconazole) Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. Basilea has entered into several license and distribution agreements for Cresemba covering approximately 115 countries. In Japan, the oral and intravenous formulations are approved for the treatment of adult patients with aspergillosis (invasive aspergillosis, chronic progressive pulmonary aspergillosis, and simple pulmonary aspergilloma), mucormycosis, and cryptococcosis.2 Isavuconazole is also approved in the European Union3, the United Kingdom4, the United States5, China and several additional countries including in the Asia Pacific region.6 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, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from www.basilea.com. References IQVIA Analytics Link, December 2024. In-market sales reported as moving annual total (MAT) in US dollar.PMDA List of Approved Drugs April 2022 to March 2023: https://www.pmda.go.jp/files/000267877.pdf [Accessed: April 23, 2025]European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 23, 2025]Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 23, 2025]Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 23, 2025]The registration status and approved indications may vary from country to country. Attachments Press release (PDF)

License out/inDrug Approval

21 Apr 2025

·www.globenewswire.com

Basilea reports presentation of new data for fosmanogepix, isavuconazole (Cresemba®) and ceftobiprole (Zevtera®) at ESCMID Global 2025

April 16, 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 scientific presentations on Basilea’s clinical-stage novel antifungal fosmanogepix given at ESCMID Global 2025, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 11 to 15, 2025 in Vienna, Austria. Further presentations covered the antifungal isavuconazole (Cresemba®) and the antibiotic ceftobiprole (Zevtera®). Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Invasive fungal infections are an increasing global health problem and novel antifungals are urgently needed. To date more than 250 patients suffering from difficult-to-treat invasive fungal infections have received fosmanogepix via expanded access. The data presented at ESCMID highlight the potential of fosmanogepix as a life-saving treatment option in severe fungal infections, based on the results from a large cohort of patients with invasive fusariosis, as well as from patients with mucormycosis, who received fosmanogepix via expanded access. We look forward to the start of our second phase 3 study with fosmanogepix covering a broad range of mold infections, including aspergillosis, fusariosis and mucormycosis.” More than 250 patients from 11 countries with serious or life-threatening invasive fungal infections, who progressed on antifungal standard-of-care treatment, experienced treatment-limiting toxicities, or had infections with resistant fungal pathogens, received fosmanogepix via expanded access to date (NCT06433128). As presented at ESCMID, treatment with fosmanogepix resulted in favorable response rates of 70% or higher in patients with invasive fusariosis or mucormycosis and it was tolerated for long treatment durations. Further presentations reported on the activity of fosmanogepix against diverse yeast and mold species collected as part of a worldwide surveillance program. — Presentation IPT13: Fosmanogepix – a novel clinical phase 3 stage antifungal agent – M. Engelhardt — Presentation O0419: Fosmanogepix expanded access in patients withFusariuminfections – S. Dadwal, A. Baluch, J. Dickter, J. R. Newman, M. H. Nguyen, R. Weihe, H. Schlamm, L. Ostrosky-Zeichner — Poster P4164: Fosmanogepix expanded access case series in patients with mucormycosis – A. Puing, A. Kaur, Y. J. Lee, P.Chang, A. Koff, D. Tyungu, M. Oldham, M. Shaughnessy, A. Tande, H. Schlamm, J. Maertens — Poster E0237:Activity of manogepix against a worldwide collection of mould isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2891:Activity of manogepix against a worldwide collection of yeast isolates from 2023–M. Winkler, S. Edeker, A. Klauer, P. R. Rhomberg, M. Castanheira — Poster P2944: Deciphering Connections between Isavuconazole (ISAV) Drug Exposures and Responses Among Different Infections: Mucorales – L. Kovanda, A. Desai — Poster P2945: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Dimorphic Fungi/Mould/Other Filamentous Fungi and Mixed Infections – A. Desai, L. Kovanda — Poster P2946: Deciphering Connections Between Isavuconazole Drug Exposures and Responses Among Different Infections: Invasive Candidiasis – L. Kovanda, A. Desai — Poster E0050: Enhancing Isavuconazole Pharmacokinetics: A Comprehensive Population (PPK) Model from Three Phase 3 Trials and Covariate Exploration – A. Desai, L. Kovanda — Poster E0055: High-dose isavuconazole therapy is well-tolerated and significantly improves survival in a fruit fly model of invasive mucormycosis – S. Wurster, N. D. Albert, N. P. Wiederhold, R. E. Lewis, D. P. Kontoyiannis Ceftobiprole (Zevtera) data presented at ESCMID Global 2025 — Poster E0792: Ceftobiprole alone versus in combination with ampicillin against borderline penicillin-resistant, vancomycin-resistant Enterococcus faecalis – O. Funk, I. Khan, J. Li, J. Cusumano Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 A phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis is ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. Cresemba, with the active ingredient isavuconazole, is an intravenous (i.v.) and oral azole antifungal. In the 27 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved for patients aged from 1 year of age and older for the treatment of invasive aspergillosis and for the treatment of mucormycosis in patients for whom amphotericin B is inappropriate.3 Isavuconazole is also approved in the United States (US)4 and several additional countries in Europe and beyond, including the United Kingdom5, the Middle East and North Africa region, the Asia Pacific region, China and Japan.6 It has orphan drug designation in the US, Europe and Australia for its approved indications. Ceftobiprole, the active moiety of the prodrug ceftobiprole medocaril, is an advanced generation cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive bacteria, such as Staphylococcus aureus, including methicillin-resistant strains (MRSA), and Gram-negative bacteria.7 In several countries in Europe and beyond, the brand is currently approved and marketed as Zevtera® and Mabelio® for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP).7 In the United States, ZEVTERA® is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP).8 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). References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239 Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC): ClinicalTrials.gov identifier: NCT05421858 European Public Assessment Report (EPAR) Cresemba: https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: April 15, 2025] Full US prescribing information: https://www.astellas.us/docs/cresemba.pdf [Accessed: April 15, 2025] Summary of Product Characteristics (SmPC) Cresemba: https://www.medicines.org.uk/emc/search?q=cresemba [Accessed: April 15, 2025] The registration status and approved indications may vary from country to country. Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: April 15, 2025] The content above comes from the network. if any infringement, please contact us to modify.

Orphan DrugClinical ResultDrug ApprovalFast Track

100 Deals associated with Ceftobiprole Medocaril Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ceftobiprole Medocaril Sodium	J01DI01	DB14733

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Community-acquired bacterial pneumonia	United States	ISTx LLC	03 Apr 2024
Right sided infective endocarditis	United States	ISTx LLC	03 Apr 2024
Skin and skin structure infections	United States	ISTx LLC	03 Apr 2024
Staphylococcus aureus bacteraemia	United States	ISTx LLC	03 Apr 2024
Community Acquired Pneumonia	Canada	Avir Pharma, Inc.	20 Mar 2018
Hospital-acquired pneumonia	Canada	Avir Pharma, Inc.	20 Mar 2018

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Indication	Highest Phase	Country/Location	Organization	Date
Skin Diseases, Infectious	NDA/BLA	European Union	Janssen Pharmaceutical Unlimited Co.	-
Soft Tissue Infections	NDA/BLA	European Union	Janssen Pharmaceutical Unlimited Co.	-
Neonatal Sepsis	Phase 3	United States	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Bulgaria	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Estonia	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Germany	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Latvia	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Lithuania	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Poland	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	Slovakia	Basilea Pharmaceutica AG	06 Aug 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03137173 (FDA_CDER) Manual	Phase 3	Skin and skin structure infections	679	ZEVTERA 667 mg	atxpsbqwgk(emeqsksigz) = jhtrsfrfmd htjqazbapu (pymfsbameu ) View more	Positive	03 Apr 2024
				Vancomycin plus aztreonam	atxpsbqwgk(emeqsksigz) = zwdmizjmkd htjqazbapu (pymfsbameu ) View more
NCT00326287 \| NCT03439124 (FDA_CDER) Manual	Phase 3	Community-acquired bacterial pneumonia	-	Ceftobiprole medocaril (Adult Patients)	yhrkdmgrpp(idptzftvnj) = epwxzxzoyv vtphrrranj (qheeokplxo ) View more	Positive	03 Apr 2024
				Ceftriaxone with or without Linezolid (Adult Patients)	yhrkdmgrpp(idptzftvnj) = tfiezxlzsw vtphrrranj (qheeokplxo ) View more
NCT03138733 (FDA_CDER) Manual	Phase 3	Staphylococcus aureus bacteraemia	387	ZEVTERA	mcfzuxdnoo(ofiqbudang) = luzhirthog rqytibalhx (nmloroyqgq ) View more	Positive	03 Apr 2024
				Daptomycin	mcfzuxdnoo(ofiqbudang) = ikftcnotkd rqytibalhx (nmloroyqgq ) View more
NCT03138733 (ERADICATE, Pubmed)	Phase 3	Staphylococcus aureus bacteraemia	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	xmitdjdltd(wuafuxncku) = ytvledfdub nqdcsfiljw (kigttfbotc ) View more	Positive	12 Oct 2023
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	xmitdjdltd(wuafuxncku) = jbhyibnnkf nqdcsfiljw (kigttfbotc ) View more
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	Phase 3	Staphylococcus aureus bacteraemia	390	Daptomycin	aqsawpxitt = xhtjxwiibc pzaolgnzax (tkwkhodhia, kgubvihdoy - jiwnafisdl) View more	-	06 May 2023
NCT03138733 (ERADICATE, Corporate Publications) Manual	Phase 3	Staphylococcus aureus bacteraemia	390	Ceftobiprole Medocaril Sodium	vqxkxjiypu(mmrxjbjvvi) = iocschhnhq mrqixctxjk (qcsqowmmnx ) View more	Non-inferior	24 Oct 2022
				Aztreonam+Daptomycin	vqxkxjiypu(mmrxjbjvvi) = ngfwvlrxag mrqixctxjk (qcsqowmmnx ) View more
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	Not Applicable	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	vxxqcauhdz(ihmuibapns) = fcrivkjuit unnoaqjjdr (ztubfcfvjj ) View more	-	01 Nov 2021
				Ceftobiprole (Patients 3 months to 17 years of age)	vxxqcauhdz(ihmuibapns) = fpwfujstmx unnoaqjjdr (ztubfcfvjj ) View more
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) Manual	Phase 3	Skin and skin structure infections	679	Ceftobiprole Medocaril Sodium	kwmnbeilms(qiriuqkavn) = plcqyzzyco exivkfbccx (xyhvboyrjy ) View more	Non-inferior	05 Oct 2021
				Vancomycin Hydrochloride+Aztreonam	kwmnbeilms(qiriuqkavn) = bpgaubbsle exivkfbccx (xyhvboyrjy ) View more
NCT03439124 (Pubmed \| Pediatr Infect Dis J)	Phase 3	Pneumonia in children	138	Ceftobiprole	xppomezamj(ikxzrasulh) = egojcqvvzy gzehwqsbtx (uwotxzooqz ) View more	Positive	21 Jan 2021
				Standard-of-care IV cephalosporin treatments (ceftazidime or ceftriaxone)	xppomezamj(ikxzrasulh) = njglqiqeoa gzehwqsbtx (uwotxzooqz ) View more
NCT02527681 (CTgov)	Phase 1	Bacterial Infections	15	Ceftobiprole (Ceftobiprole PK Population)	tztaaejtbf(wopfqvprvn) = hddwqdyvtc fuxmncfcju (fmjbllddmh, xtcmzuvvns - intijaquhg) View more	-	06 Jan 2021
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	gjuwezzmmo(zqntoibfzr) = dxdrevrzyp btcwigjblu (gwximckqio, uefregyoqx - pzpwqerdpt) View more

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