A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

Start Date06 Aug 2023

Sponsor / Collaborator

Basilea Pharmaceutica AG

EUCTR2022-001837-35-BG / Unknown statusPhase 3

A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety,pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-termneonates and infants up to 3 months of age with late-onset sepsis

Start Date06 Mar 2023

Sponsor / Collaborator

Basilea Pharmaceutica International Ltd.

NCT04171674 / Unknown statusNot ApplicableIIT

A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia

The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.

Start Date01 Sep 2021

Sponsor / Collaborator

Centre Hospitalier Universitaire de Bordeaux

100 Clinical Results associated with Ceftobiprole Medocaril Sodium

100 Translational Medicine associated with Ceftobiprole Medocaril Sodium

100 Patents (Medical) associated with Ceftobiprole Medocaril Sodium

398

Literatures (Medical) associated with Ceftobiprole Medocaril Sodium

01 Dec 2024·THERAPEUTIC DRUG MONITORING

From Bed to Bench: Pre-analytical Stability of 29 Anti-infective Agents in Plasma and Whole Blood to Improve Accuracy of Therapeutic Drug Monitoring

Article

Author: Lamy, Brigitte ; Akinotcho-Relouzat, Judith ; Pierredon, Dorine ; Magreault, Sophie ; Méchaï, Frédéric ; Jullien, Vincent ; Jaureguy, Françoise

Background::

Therapeutic drug monitoring requires a validated assay and appropriate conditions for sample shipment and storage based on the stability of the compound to be analyzed. This study evaluated the stability of 29 antimicrobial compounds in whole blood (WB) and plasma samples under various storage conditions.

Methods::

The pre-analytical stability of 22 antibiotics (amoxicillin, aztreonam, cefazolin, cefepime, cefotaxime, cefoxitin, ceftazidime, ceftobiprole, ceftolozane, ceftriaxone, ciprofloxacin, clindamycin, cloxacillin, daptomycin, levofloxacin, linezolid, meropenem, metronidazole, moxifloxacin, piperacillin, sulfamethoxazole, and trimethoprim), 2 beta-lactamase inhibitors (avibactam, tazobactam), and 5 antituberculosis drugs (ethambutol, isoniazid, pyrazinamide, rifabutin, and rifampicin) was assessed by WB for up to 24 hours at room temperature (RT) and 72 hours at +4°C. The stability in plasma was evaluated for up to 6 hours at RT, 24 hours at +4°C, 1 month at −20°C, and 6 months at −80°C.

Results::

Concerning WB stability, all investigated compounds were stable for 24 hours at RT, except meropenem and isoniazid, which were stable for 6 hours; however, for 24 hours at +4°C, all the compounds were stable. For storage durations of 48 and 72 hours at +4°C, all compounds were stable, except for ciprofloxacin, cotrimoxazole, and isoniazid. Concerning stability in plasma, all compounds were stable for 6 hours at RT, and all except isoniazid were stable for 24 hours at +4°C. All the tested compounds were stable for 7 days at −20°C, except isoniazid, for which a degradation of approximately 20% was observed. An important degradation was observed for beta-lactam antibiotics after 1 month at −20°C. All compounds were stable at −80°C for 6 months.

Conclusions::

The pre-analytical stabilities of several anti-infective compounds was described. The present results can be used to determine the appropriate conditions for shipping and storing samples dedicated to therapeutic drug monitoring of the investigated compounds.

01 Nov 2024·New Microbiologica

One stage extraction and reimplantation of ICD/PM in patients with CIED related endocarditis and spondiloscitis due to E. faecalis treated with double beta-lactam combination: ampicillin plus ceftobiprole.

Article

Author: Giuliano, Simone ; Martini, Luca ; Pecori, Davide ; Bontempo, Giulia ; Rebellato, Luca ; Narducci, Maria Lucia ; Geminiani, Monica ; Tascini, Carlo ; Imazio, Massimo

The time of re-implantation of removed CIED for local infection or endocarditis has been debated because no randomized studies are available. Many authors prefer to delay reimplantation to the time of blood culture negative or clinical stability. In this case report we describe the case of E. faecalis CIED endocarditis treated with the combination ampicillin plus ceftobiprole and one-stage removal and re-implantation with early follow-up without relapse of infection. In case of E. faecalis infection, we hypothesize that ampicillin plus ceftobiprole combination might have bactericidal and anti-biofilm activity, therefore allowing one state re-implantation without relapse.

01 Oct 2024·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Comparative in vitro efficacy of antibiotics against the intracellular reservoir of Staphylococcus aureus

Article

Author: Yamauchi, Joe ; Wong-Beringer, Annie ; Beadell, Brent

Abstract:

Staphylococcus aureus (SA) is a leading cause of bloodstream infection. The liver represents the sentinel immune organ for clearance of bloodstream pathogens and eradication of intracellular SA from liver-resident macrophages (Kupffer cells, KCs) eliminates the likely pathogenic reservoir that contributes to persistent bacteraemia.

Objectives:

We assessed antimicrobial activity at phagolysosome-mimicking pH, intracellular penetration, and SA eradication within KCs in vitro for clinically prescribed antistaphylococcal agents alone or in combination: vancomycin, daptomycin, ceftaroline, ceftobiprole, oritavancin, oxacillin, cefazolin; rifampin and fosfomycin.

Methods:

pH-adjusted broth microdilution assays, intracellular bioaccumulation assays, and intracellular killing assays against clinical bloodstream isolates were performed using a murine KC line with study agents.

Results:

Rifampin and β-lactams exhibited enhanced activity [2- to 16-fold minimum inhibitory concentrations (MIC) decrease] at phagolysosomal pH while vancomycin, oritavancin, daptomycin and fosfomycin demonstrated reduced activity (2- to 32-fold MIC increase in order of least to greatest potency reduction). All agents evaluated had poor to modest intracellular to extracellular concentration ratios (0.024–7.8), with exceptions of rifampin and oritavancin (intracellular to extracellular ratios of 17.4 and 78.2, respectively). Finally, we showed that the first-line treatment for SA bacteraemia (SAB), vancomycin, performed worse than all other tested antibiotics in eradicating intracellular SA at human Cmax concentration (0.20 log cfu decrease), while oritavancin performed better than all other agents alone (2.05 versus 1.06–1.36 log cfu decrease).

Conclusions:

Our findings raise concerns about the efficacy of commonly prescribed antibiotics against intracellular SA reservoirs and emphasize the need to consider targeting pathogen eradication from the liver to achieve early control of SAB.

News (Medical) associated with Ceftobiprole Medocaril Sodium

16 Dec 2024

·www.businesswire.com

Innoviva Specialty Therapeutics Signs Exclusive Distribution and Licensing Agreement to Acquire U.S. Marketing Rights for Zevtera® (ceftobiprole)

BURLINGAME, Calif.--( BUSINESS WIRE )--Innoviva Specialty Therapeutics, Inc., (“IST”) a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), for the commercialization of Zevtera ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the United States. "The licensing of Zevtera expands IST’s diverse yet complementary portfolio of differentiated treatments that address substantial unmet medical needs,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “We are excited to leverage our operating platform to deliver this important drug to patients. The transaction reinforces the significant opportunity for growth we see in our therapeutics business, building on the momentum and success we have had with our existing marketed products.” In April 2024, the U.S. Food and Drug Administration (FDA) approved Zevtera for three specific treatment indications, and it 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, 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). 1 "Zevtera strengthens our role as a provider of essential therapeutics for infectious diseases and critical care within our primary customer base," stated David Altarac, Chief Medical Officer of Innoviva Specialty Therapeutics, Inc. “Drug-resistant pathogens, like MRSA, pose significant challenges for patients in hospitals and other healthcare facilities with a high mortality rate and huge cost burden. Zevtera will enable physicians to treat this important pathogen more effectively, as it is the only approved cephalosporin specifically for MRSA bloodstream infections.” Under the terms of the agreement, Innoviva, Inc., will be granted exclusive marketing rights to Zevtera in the U.S. Basilea will receive a $4 million upfront payment in addition to tiered royalties and milestones on net sales in the U.S. Innoviva Specialty Therapeutics anticipates commercializing Zevtera in mid-year 2025. Reference Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk About Zevtera ® (ceftobiprole medocaril sodium for injection) 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. 1 Outside the U.S., the brand is currently approved and marketed in several countries in Europe and beyond 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). Basilea has entered into license and distribution agreements covering more than 80 countries. Important US safety information for ZEVTERA (ceftobiprole medocaril sodium for injection) Contraindications ZEVTERA is contraindicated in patients with a known history of severe hypersensitivity to ZEVTERA, or to other members of the cephalosporin class. Warnings and precautions Increased Mortality with Unapproved use in Ventilator-Associated Bacterial Pneumonia (VABP) Patients: The safety and effectiveness of ZEVTERA for the treatment of VABP has not been established and the use of ZEVTERA for VABP is not approved. Hypersensitivity Reactions: Discontinue ZEVTERA if a hypersensitivity reaction occurs, and institute appropriate treatment. Seizures and other adverse central nervous system (CNS) reactions have been associated with the use of ZEVTERA. If seizures or other CNS adverse reactions occur, evaluate patients to determine whether ZEVTERA should be discontinued. Clostridioides difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including ZEVTERA. Evaluate if diarrhea occurs. Adverse reactions SAB (adult patients): The most common adverse reactions occurring in ≥ 4% of adult patients were anemia, nausea, hypokalemia, vomiting, hepatic enzyme and bilirubin increased, diarrhea, blood creatinine increased, hypertension, leukopenia and pyrexia. ABSSSI (adult patients): The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, diarrhea, headache, injection site reaction, hepatic enzyme increased, rash, vomiting, and dysgeusia. CABP (adult and pediatric patients 3 months to less than 18 years of age): Adult Patients: The most common adverse reactions occurring in ≥ 2% of adult patients were nausea, hepatic enzyme increased, vomiting, diarrhea, headache, rash, insomnia, abdominal pain, phlebitis, hypertension and dizziness. Pediatric Patients: The most common adverse reactions occurring in ≥ 2% of pediatric patients were vomiting, headache, hepatic enzyme increased, diarrhea, infusion site reaction, phlebitis and pyrexia. For full US prescribing information, please visit here: www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk About Staphylococcus aureus bacteremia (SAB) Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection associated with significant morbidity and mortality. Complications include concomitant infections such as bone, joint or heart valve infections, persistent bacteremia or bacteremia in patients on dialysis. With a 30-day all-cause mortality of around 20% there is a high medical need for improved therapies for SAB. About acute bacterial skin and skin structure infections (ABSSSI) Acute bacterial skin and skin structure infections (ABSSSI) are common infections in the healthcare setting. Staphylococcus aureus is the most common pathogen associated with these infections, which can be difficult to treat if methicillin-resistant Staphylococcus aureus (MRSA) is involved. About community-acquired bacterial pneumonia (CABP) Community-acquired bacterial pneumonia (CABP) is a leading cause of morbidity and mortality worldwide. It is the leading cause of infectious disease-related death in the US. For full prescribing information go to https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk 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 innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. ANORO ® , RELVAR ® and BREO ® are trademarks of the GSK group of companies.

License out/inDrug Approval

16 Dec 2024

·endpts.com

Candid inks three T cell engager deals; PepGen trial put on hold

Plus, news about Foghorn Therapeutics, Incyte, BioNTech, Galderma, Basilea, Innovia, Pharming, bit.bio, Promise Bio, Outlook Therapeutics and Trevi Therapeutics: Candid Therapeutics’ trio of T cell engager deals: The company is paying up to $320 million in upfront and milestones to Nona Biosciences to develop next-generation T cell engagers. It’s also partnering with Ab Studio to discover T cell engagers that treat autoimmune diseases. No terms were disclosed. And, in its third announcement, Candid also said Monday that it will spend up to $1 billion in a deal with EpimAb Biotherapeutics that also aims to develop T cell engagers in the autoimmune category. — Jaimy Lee PepGen’s Duchenne trial put on hold: The biotech said the FDA put its CONNECT2-EDO51 study on hold. It’s a Phase 2 trial assessing multiple ascending doses in patients with Duchenne muscular dystrophy. Its stock $PEPG sank 28% on Monday morning. — Jaimy Lee Foghorn to drop AML candidate: The company is stopping work on an experimental drug for acute myeloid leukemia called FHD-286, and it’s seeking a potential partner for the drug. Foghorn said that it saw responses to the drug in a Phase 1 study, but “the observed response rate did not meet the company’s threshold to continue development by Foghorn alone.” — Lei Lei Wu Incyte stops developing anemia drug for patients with myelofibrosis: During an investor day last week, the company said zilurgisertib “does not significantly improve anemia in patients with myelofibrosis,” and it had halted work on the drug. — Katherine Lewin BioNTech, OncoC4’s partial clinical hold is lifted: The FDA gave the go-ahead to the partners to continue a Phase 3 lung cancer trial of an anti-CTLA-4 antibody called gotistobart, but only in a subset of patients, BioNTech disclosed Friday. In October, the study was put on partial clinical hold due to a “a possible variance in results between the squamous and non-squamous NSCLC patient populations.” The study will now only enroll squamous NSCLC patients. — Lei Lei Wu FDA approves Galderma’s Nemluvio in moderate-to-severe atopic dermatitis: The drug is now approved to treat patients 12 years and older. Nemluvio is also approved for prurigo nodularis, another chronic skin condition. According to Galderma, Nemluvio is the first approved monoclonal antibody that specifically targets the cytokine IL-31, which causes the itching and inflammation associated with the disease. Its Swiss-listed shares $GALD were up about 7% on Monday. — Katherine Lewin Basilea inks deal with Innoviva to market antibiotic: Innoviva is paying Basilea $4 million upfront and up to $223 million in sales milestones, plus royalties, to commercialize Zevtera in the US. The anti-MRSA antibiotic received FDA approval in April. — Jaimy Lee Pharming’s $66M offer to buy Abliva: Pharming wants to buy the Swedish company, which is developing a treatment for mitochondrial disease. The lead asset is currently in a pivotal trial. — Jaimy Lee Bit.bio raises $30M for cell therapy pipeline: The biotech plans to use the proceeds to invest in new tools for drug discovery and research. The fundraise was led by M&G Investments, with support from backers including ARCH Venture Partners and Milky Way. The company unveiled its lead program , which is designed to regenerate the liver, a year ago. — Ayisha Sharma Israeli biotech secures $8.3M in seed funding: Promise Bio expects to use the cash to develop a computational platform powered by AI and epiproteomics that could help predict patient responses to treatment. The round was led by Awz Ventures. AION Labs also invested. — Ayisha Sharma Outlook to cut 23% of its workforce: The company underwent a strategic review as it aims to shore up funds to support the launch of its new wet AMD treatment, which was approved in Europe and the UK this year. The company plans to submit its formulation of bevacizumab to the FDA in the first three months of next year after receiving a complete response letter last year. Outlook had 24 full-time employees, as of September 2023.— Jaimy Lee Trevi is selling 12.5 million shares at $4.00 apiece to raise $50 million. — Jaimy Lee

Phase 2Drug ApprovalCell TherapyPhase 1Phase 3

17 Dec 2024

·www.globenewswire.com

Basilea announces agreement with Innoviva Specialty Therapeutics for the commercialization of antibiotic Zevtera® (ceftobiprole) in the United States

December 16, 2024 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 distribution and license agreement with Innoviva Specialty Therapeutics, Inc., a wholly owned subsidiary of Innoviva Inc. (NASDAQ: INVA), for the commercialization of Basilea’s hospital anti-MRSA antibiotic Zevtera® (ceftobiprole) in the United States (US). Innoviva Specialty Therapeutics is a US-based biopharmaceutical company with an established hospital sales force and a core competence in commercializing anti-infective medicines. David Veitch, Chief Executive Officer of Basilea, stated: “We are very pleased with our collaboration with Innoviva Specialty Therapeutics for the commercialization of Zevtera in the US. The company is a highly committed, focused and capable partner that shares our vision and ambitions for Zevtera in the US. They also have recent experience of launching a hospital antibiotic in the US. We are looking forward to working with Innoviva Specialty Therapeutics towards a successful launch and bringing Zevtera to patients in need in the US.” “With this agreement, Zevtera will become an important asset in our company’s portfolio, allowing us to advance our strategy of providing differentiated therapies in infectious disease and critical care,” said Pavel Raifeld, Chief Executive Officer, Innoviva, Inc. “There is a significant medical need for treatments targeting complicated Staphylococcus aureus infections, particularly Staphylococcus aureus bacteremia. We are therefore excited to bring this important new medicine to patients who are suffering from these severe infections.” Under the terms of the agreement, Basilea will receive a USD 4 million upfront payment and tiered royalties on net sales in the high-teens to mid-twenties percentage range. Basilea will be eligible to receive sales milestones of up to USD 223 million. In addition, Innoviva Specialty Therapeutics will purchase its demand of Zevtera drug product from Basilea. 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.1 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). Basilea has entered into license and distribution agreements covering more than 80 countries. 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).2 Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities and non-clinical work. 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 other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. 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 Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: December 15, 2024] Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk The content above comes from the network. if any infringement, please contact us to modify.

License out/inDrug Approval

100 Deals associated with Ceftobiprole Medocaril Sodium

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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	US	Basilea Pharmaceutica International Ltd.	03 Apr 2024
Right sided infective endocarditis	US	Basilea Pharmaceutica International Ltd.	03 Apr 2024
Skin and skin structure infections	US	Basilea Pharmaceutica International Ltd.	03 Apr 2024
Staphylococcus aureus bacteraemia	US	Basilea Pharmaceutica International Ltd.	03 Apr 2024
Community Acquired Pneumonia	CA	Avir Pharma, Inc.Startup	20 Mar 2018
Hospital-acquired pneumonia	CA	Avir Pharma, Inc.Startup	20 Mar 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Skin Diseases, Infectious	NDA/BLA	EU	Janssen Pharmaceutical Unlimited Co.	-
Soft Tissue Infections	NDA/BLA	EU	Janssen Pharmaceutical Unlimited Co.	-
Neonatal Sepsis	Phase 3	US	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	BG	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	EE	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	DE	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	LV	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	LT	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	PL	Basilea Pharmaceutica AG	06 Aug 2023
Neonatal Sepsis	Phase 3	SK	Basilea Pharmaceutica AG	06 Aug 2023

Clinical Result

Indication

Phase

Evaluation

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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	vntfysyeiq(xnkyyfcjbi) = ovfmvzgktp tkamcbuiws (lkwimshmen ) View more	Positive	03 Apr 2024
				Vancomycin plus aztreonam	vntfysyeiq(xnkyyfcjbi) = osajdnegvv tkamcbuiws (lkwimshmen ) View more
NCT00326287 \| NCT03439124 (FDA_CDER) Manual	Phase 3	Community-acquired bacterial pneumonia	-	Ceftobiprole medocaril (Adult Patients)	psaebketlu(ggvguqagbw) = qyereusbbb vzzogqjdra (lpjxraaepb ) View more	Positive	03 Apr 2024
				Ceftriaxone with or without Linezolid (Adult Patients)	psaebketlu(ggvguqagbw) = akxpqwqplw vzzogqjdra (lpjxraaepb ) View more
NCT03138733 (FDA_CDER) Manual	Phase 3	Staphylococcus aureus bacteraemia	387	ZEVTERA	cekczobsoc(romfmhntzs) = jtwteqrcfs mqarglupvn (qzdsfvtvlh ) View more	Positive	03 Apr 2024
				Daptomycin	cekczobsoc(romfmhntzs) = unxrjrquqx mqarglupvn (qzdsfvtvlh ) View more
NCT03138733 (Trial 1 \| ERADICATE, CTgov)	Phase 3	Staphylococcus aureus bacteraemia	390	Daptomycin	wzkvdfzskf(lsoztzaoxy) = ctdlgptyrg czbdfcjeqg (hgvrjyqwjo, fxxmlgxerb - cbluznkdnx) View more	-	06 May 2023
NCT03138733 (ERADICATE, Corporate Publications) Manual	Phase 3	Staphylococcus aureus bacteraemia	390	Ceftobiprole Medocaril Sodium	wwoztewikn(hlraahlhle) = mfmrdwezoz ohfeuxaftt (npesgfcpjn ) View more	Non-inferior	24 Oct 2022
				Aztreonam+Daptomycin	wwoztewikn(hlraahlhle) = rvaozasuee ohfeuxaftt (npesgfcpjn ) View more
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) Manual	Phase 3	Skin and skin structure infections	679	Ceftobiprole Medocaril Sodium	rsglcdimae(wtiiwgybat) = sklnjlqcia zhegeujein (iyvfnoejjo ) View more	Non-inferior	05 Oct 2021
				Vancomycin Hydrochloride+Aztreonam	rsglcdimae(wtiiwgybat) = zdrxfpjybh zhegeujein (iyvfnoejjo ) View more
NCT02527681 (CTgov)	Phase 1	Bacterial Infections	15	Ceftobiprole (Ceftobiprole PK Population)	ymhybbmsve(sgeweypmvr) = oakhoboifd gnplmlvhhm (mxhdliumxq, lkbywuzylk - rhyqthfltl) View more	-	06 Jan 2021
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	vxgnioegiv(jahsnifwnj) = xiayynkyai hhqhhpkcuv (wsvfjcvftb, jxgdzaptxo - evnfdyvyrq) View more
NCT03439124 (Trial 5, CTgov)	Phase 3	Community Acquired Pneumonia \| Hospital-acquired pneumonia	138	ceftobiprole medocaril (Ceftobiprole Medocaril)	jecfunvzds(dmhuctodta) = dakxudchuc yewmfkjejy (jsdsrzxvcx, cvnddgqvxx - agwlwcnwnt) View more	-	11 Sep 2020
				IV standard-of-care cephalosporin (IV Standard-of-care Cephalosporin)	jecfunvzds(dmhuctodta) = fujrgrejzf yewmfkjejy (jsdsrzxvcx, emwthzdnjk - mibehlklbg) View more
NCT03137173 (TARGET \| Trial 2, CTgov)	Phase 3	Skin and skin structure infections	679	ceftobiprole medocaril (Ceftobiprole Medocaril)	xkoujelogk(dddhfafxux) = cfjzpevicg ixocxxehui (ezzzspaadc, zyesylablh - mhtvxcbmdu) View more	-	18 May 2020
				aztreonam+vancomycin (Vancomycin+Aztreonam)	xkoujelogk(dddhfafxux) = suohopuhpw ixocxxehui (ezzzspaadc, dqnnhhdjjd - dyfrlqbshs) View more
NCT00229008 \| NCT00210964 (Pubmed \| Clin Infect Dis)	Phase 3	Hospital-acquired pneumonia	781	Ceftobiprole	uxqgqgrhet(mtgnwduqop) = bujauyigvn wpmstaynsg (qezsqhcczk ) View more	-	01 Jul 2014
				Ceftazidime plus Linezolid	uxqgqgrhet(mtgnwduqop) = xoekzrbrmv wpmstaynsg (qezsqhcczk ) View more

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