Latest news with #cUTI
Yahoo
4 days ago
- Business
- Yahoo
Basilea announces in-licensing of a novel clinical phase 3-ready oral antibiotic
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 14, 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 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 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 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-mail media_relations@ This ad hoc announcement can be downloaded from References T. P. Lodise, T. Chopra, B. H. Nathanson et al. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infectious Diseases 2022, Jun 24;9(7):ofac315. M. D. Zilberberg, B. H. Nathanson, K. Sulham et al. Descriptive Epidemiology and Outcomes of Hospitalizations With Complicated Urinary Tract Infections in the United States, 2018. Open Forum Infectious Diseases 2022, Jan 10;9(1):ofab591 C. F. de Oliveira, M. B. Dorr, K. Lowe et al. Evaluation of Single and Multiple Dose Safety and Pharmacokinetics of Ledaborbactam Etzadroxil and Ceftibuten-Ledaborbactam Etzadroxil in Healthy Volunteers. Open Forum Infectious Diseases 2025, Jan 29;12(Suppl 1):ofae631.1425 J. A. Karlowsky, M. G. Wise, M. A. Hackel et al. Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018–2020 Global Surveillance Collection. Antimicrobial Agents and Chemotherapy 2022, Nov 15;66(11):e0093422 Attachment Press release (PDF)Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
Spero Therapeutics Announces Second Quarter 2025 Operating Results and Provides a Business Update
PIVOT-PO Phase 3 trial evaluating tebipenem Hbr in complicated urinary tract infection (cUTI) patients stopped early for efficacy following review by independent data monitoring committee (IDMC) Spero, along with its development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 2H 2025 Existing cash and earned and non-contingent development milestone payments from GSK provide anticipated runway to fund the Company's current operating expenses and capital expenditures into 2028 CAMBRIDGE, Mass., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. 'During the second quarter, we announced that the tebipenem Phase 3 PIVOT-PO trial met its primary endpoint, marking a significant milestone for this program. We look forward to working with GSK on next steps for this program which include completion of the Phase 3 data analysis and submission of the data package to the FDA,' said Esther Rajavelu, Chief Executive Officer and Chief Financial Officer of Spero. 'There remains a critical unmet need for an oral carbapenem to treat complicated urinary tract infections, including pyelonephritis. If approved, we believe tebipenem HBr could set a new standard of care for these infections, with the potential to shorten hospital stays, improve patient outcomes, and reduce pressure on healthcare resources.' Pipeline UpdateTebipenem HBr is an investigational oral carbapenem antibiotic being developed for the treatment of cUTI, including pyelonephritis, to help patients potentially reduce the duration of in-patient therapy. Spero granted GSK an exclusive license to commercialize tebipenem HBr in all territories, except certain Asian territories where Meiji holds development and commercialization rights. In May 2025, Spero and its development partner GSK announced that the Phase 3 PIVOT-PO trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit. The IDMC review did not identify any new safety concerns beyond what has been reported in other studies with tebipenem, with diarrhea and headache as the two most reported adverse events. GSK plans to work with U.S. regulatory authorities to include these data as part of a filing in 2H 2025. Full results will be submitted for presentation at an upcoming scientific meeting and for publication in a peer-reviewed journal. For more information on the PIVOT-PO trial, please refer to ID NCT06059846. SPR720 is an investigational, chemically stable phosphate ester prodrug that is converted rapidly in vivo to SPR719, the active moiety, after oral administration. SPR719 targets the ATPase site of DNA gyrase B in mycobacteria, a mechanism that is distinct from that of other antibiotics in use for nontuberculous mycobacterium pulmonary disease (NTM-PD). The oral development program in NTM-PD was suspended in 4Q 2024. This followed a planned interim analysis of 16 patients dosed in the Phase 2a trial, which demonstrated the trial did not meet its primary endpoint. The Company is determining next steps for the program. Corporate Update Esther Rajavelu was appointed as Spero's President and Chief Executive Officer, effective May 2, 2025. Ms. Rajavelu was also elected to the Board of Directors at Spero's 2025 annual meeting of stockholders. She continues to serve as the Company's Chief Financial Officer and Treasurer. As of June 30, 2025, Spero had cash and cash equivalents of $31.2 million. Spero estimates that its existing cash and cash equivalents, together with earned and noncontingent development milestone payments from GSK, including the final development milestone payment under the GSK License Agreement of $23.8 million received in August 2025, will be sufficient to fund its operating expenses and capital expenditures into 2028. Pursuant to the GSK License Agreement, Spero has adjusted the aggregate potential commercial milestone payments contingent upon first sales from up to $150.0 million to up to $101.0 million after PIVOT-PO was stopped early for efficacy. The trial was stopped early following completion of a pre-specified interim analysis with 1,690 patients enrolled in the trial, reducing the overall costs to Spero; the maximum potential milestone payment of $150.0 million was contingent upon the trial continuing to full enrollment with 2,637 patients enrolled in the trial. All other contingent milestone payments remain unchanged. For further details on upcoming milestones, please review the disclosure in our Form 10-Q, filed today. Second Quarter 2025 Financial Results Spero reported a net loss of $1.7 million for the second quarter of 2025 compared to a net loss of $17.9 million for the second quarter of 2024, or a diluted net loss per share of common stock of $0.03 and $0.33, respectively. Total revenue for the second quarter of 2025 was $14.2 million, compared with total revenue of $10.2 million for the second quarter of 2024. The revenue increase for the second quarter of 2025 was primarily due to collaboration revenue from GSK. Research and development expenses for the second quarter of 2025 were $10.7 million, compared to $23.7 million of research and development expenses for the same period in 2024. The decrease in research and development expenses compared with the prior year period was primarily due to reduced clinical expenses related to the PIVOT-PO trial. General and administrative expenses for the second quarter of 2025 were $5.9 million, compared to $5.5 million of general and administrative expenses for the same period in 2024. This increase compared with the prior year-period was primarily due to increased personnel and professional service expense. For further details on Spero's financials, refer to Spero's Quarterly Report on Form 10-Q, filed with the U.S. Securities and Exchange Commission (SEC) today. Conference Call and Live Webcast Spero management will host a conference call and live audio webcast at 4:30 p.m. ET today, August 12, 2025, to discuss the second quarter financial results and provide a business update. To access the call, please dial 1-844-825-9789 (domestic) or 1-412-317-5180 (international) and refer to conference ID 10200686, or click on this and request a return call with passcode 0605709. The audio webcast can be accessed live on this and also on the 'Investor Relations' page of the Spero Corporate Website at The archived webcast will also be available on Spero's website for 30 days following the call. Government Agency Research Support The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government. Tebipenem HBr Research SupportSelect tebipenem HBr studies have been funded in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; and Biomedical Advanced Research and Development Authority, under contract number HHSO100201800015C. About Spero TherapeuticsSpero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and MDR bacterial infections with high unmet need. For more information, visit Forward Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing, progress and results of Spero's Phase 3 PIVOT-PO trial; the timing of a planned FDA filing in 2H 2025 for tebipenem HBr; the potential of tebipenem HBr to be the first oral carbapenem antibiotic for US patients with cUTI, including pyelonephritis, and to set a new standard of care; the potential receipt of milestone payments under Spero's license and collaboration agreements; Spero's anticipated cash runway; and the potential benefits of any of Spero's current or future product candidates in treating patients. In some cases, forward-looking statements may be identified by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intent," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including whether tebipenem HBr will advance through the clinical development process, or at all, taking into account the effects of possible regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, clinical trial design and clinical outcomes; whether the results of such trials will warrant submission for approval from the FDA or equivalent foreign regulatory agencies; whether the FDA will ultimately approve tebipenem HBr and, if so, the timing of any such approval; whether the FDA will require any additional clinical data or place labeling restrictions on the use of tebipenem HBr that would delay approval and/or reduce the commercial prospects of tebipenem HBr; whether a successful commercial launch can be achieved and market acceptance of tebipenem HBr can be established; whether results obtained in preclinical studies and clinical trials will be indicative of results obtained in future clinical trials; Spero's reliance on third parties to manufacture, develop, and commercialize its product candidates, if approved, including, in the case of tebipenem HBr, Spero's reliance on GSK pursuant to the exclusive GSK License Agreement to develop tebipenem HBr and GSK's right thereunder to determine, in its sole discretion, whether to continue the PIVOT-PO trial or otherwise further develop tebipenem HBr; Spero's need for additional funding; the ability to commercialize Spero's product candidates, if approved; Spero's ability to retain key personnel; Spero's leadership transitions; whether Spero's cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; and other factors discussed in the "Risk Factors" set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements. Investor Relations Contact:Shai Biran, PhDSpero Therapeutics IR@ Media Inquiries: media@ Spero Therapeutics, Inc. Condensed Consolidated Balance Sheet Data (in thousands) (Unaudited) June 30,2025 December 31,2024 Cash and cash equivalents $ 31,194 $ 52,889 Other assets 30,925 57,654 Total assets $ 62,119 $ 110,543 Total liabilities 29,291 64,420 Total stockholder's equity 32,828 46,123 Total liabilities and stockholders' equity $ 62,119 $ 110,543 Spero Therapeutics, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Revenues: Grant revenue $ 2,387 $ 4,180 $ 3,150 $ 9,243 Collaboration revenue - related party 11,802 5,903 16,901 9,967 Collaboration revenue — 114 12 254 Total revenues 14,189 10,197 20,063 19,464 Operating expenses: Research and development 10,672 23,725 24,278 41,057 General and administrative 5,878 5,533 12,702 11,450 Restructuring 83 — 258 — Total operating expenses 16,633 29,258 37,238 52,507 Loss from operations (2,444 ) (19,061 ) (17,175 ) (33,043 ) Total other income, net 744 1,199 1,609 2,512 Net loss $ (1,700 ) $ (17,862 ) $ (15,566 ) $ (30,531 ) Net loss per share attributable to common shareholders per share, basic and diluted $ (0.03 ) $ (0.33 ) $ (0.28 ) $ (0.57 ) Weighted average shares outstanding, basic and diluted: 56,026,767 53,957,766 55,703,275 53,740,901 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
30-06-2025
- Business
- Globe and Mail
Complicated Urinary Tract Infection (cUTI) Market Analysis 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Prevalence, Statistics, Revenue, Therapies, Companies by DelveInsight
Complicated Urinary Tract Infection (cUTI) companies are Pfizer, Novartis, Spero Therapeutics, Tetraphase Pharmaceuticals, Wockhardt, Venatorx Pharmaceuticals, Cubist Pharmaceuticals, Janssen, Allecra Therapeutics, Nabriva Therapeutics AG, La Jolla Pharmaceutical Company, MerLion Pharmaceuticals, PRA Health Sciences, Qilu Pharmaceutical, Meiji Seika Pharma and others. (Albany, USA) DelveInsight's " Complicated Urinary Tract Infection (cUTI) Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Complicated Urinary Tract Infection (cUTI), historical and forecasted epidemiology as well as the Complicated Urinary Tract Infection (cUTI) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan. The Complicated Urinary Tract Infection (cUTI) market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Complicated Urinary Tract Infection (cUTI) market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Complicated Urinary Tract Infection (cUTI) treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Complicated Urinary Tract Infection (cUTI) market. Some facts of the Complicated Urinary Tract Infection (cUTI) Market Report are: According to DelveInsight, Complicated Urinary Tract Infection (cUTI) market size is expected to grow at a decent CAGR by 2034. In June 2025, Menarini Group announced a clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem ( fixed combination of meropenem and vaborbactam) in the paediatric population aged from 3 months to < 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration. In June 2025, Venatorx Pharmaceuticals Inc. conducted a Phase 3 study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults With Complicated Urinary Tract Infections (cUTI), Including Acute Pyelonephritis. In June 2025, Rempex organized a study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). In April 2025, Rempex announced a study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). In April 2025, Menarini Group announced clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem ( fixed combination of meropenem and vaborbactam) in the paediatric population aged from 3 months to < 18 years with complicated urinary tract infection (cUTI) including acute pyelonephritis (AP) in need of hospitalisation and intravenous (IV) antibiotic administration. In April 2025, Shionogi announced a study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections. In the 7MM, nearly 1,000,000 cUTI incident cases progressed from uUTI in the year 2023, which is expected to increase during the forecast period (2024-2034). In the US, maximum number of cUTI cases were observed for the age group of 65-84 years, followed by =85 years. Among the EU4 and the UK, Germany recorded the highest number of diagnosed-incident cases of cUTI with approximately 26% cases in 2023, which is estimated to rise by 2034, at a CAGR of 0.6%. Japan accounted for around 800,000 cases of cUTI in 2023 caused due to Uropathogenic Escherichia coli, followed by 100,000 cases caused by Klebsiella pneumonia. Leading Complicated Urinary Tract Infection (cUTI) companies working in the market are Pfizer, Novartis, Spero Therapeutics, Tetraphase Pharmaceuticals, Wockhardt, Venatorx Pharmaceuticals, Cubist Pharmaceuticals, Janssen, Allecra Therapeutics, Nabriva Therapeutics AG, La Jolla Pharmaceutical Company, MerLion Pharmaceuticals, PRA Health Sciences, Qilu Pharmaceutical, Meiji Seika Pharma and others. Key Complicated Urinary Tract Infection (cUTI) Therapies expected to launch in the market are Ceftazidime –avibactam, Cefepime, LYS228, Eravacycline, Ertapenem, Levofloxacin, CXA-101, TBPM-PI-HBr, Doripenem, Meropenem- FL058, Piperacillin –tazobactam, aztreonam and nacubactam, cefepime and nacubactam, Sulopenem Etzadroxil/Probenecid, Meropenem, Cefepime-zidebactam (FEP-ZID), and others. On June 2023, Meiji Seika Pharma Co announced a Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP). On May 2023, Wockhardt announced a Phase 3, randomized, double-blind, multicenter, non-inferiority study to evaluate the efficacy, safety, and tolerability of FEP-ZID vs. meropenem in the treatment of hospitalized adults with Complicated Urinary Tract Infection or AP. Complicated Urinary Tract Infection (cUTI) Overview A complicated urinary tract infection (UTI) refers to an infection that occurs in the urinary tract and is associated with additional factors or conditions that make it more challenging to diagnose, treat, or resolve. These factors can include urinary tract abnormalities, obstruction, kidney stones, immunocompromised state, diabetes, pregnancy, catheterization, or antibiotic resistance. Complicated UTIs may involve not only the lower urinary tract (bladder and urethra) but also the upper urinary tract (kidneys and ureters). The complexity of these infections often necessitates a multidimensional approach, including targeted antibiotic therapy, identification and management of underlying factors, and close monitoring for potential complications. Complicated Urinary Tract Infection (cUTI) Market The Complicated Urinary Tract Infection (cUTI) market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Complicated Urinary Tract Infection (cUTI) market trends by analyzing the impact of current Complicated Urinary Tract Infection (cUTI) therapies on the market and unmet needs, and drivers, barriers, and demand for better technology. This segment gives a thorough detail of the Complicated Urinary Tract Infection (cUTI) market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Complicated Urinary Tract Infection (cUTI) market data are presented with relevant tables and graphs to give a clear view of the market at first sight. According to DelveInsight, the Complicated Urinary Tract Infection (cUTI) market in 7MM is expected to witness a major change in the study period 2020-2034. Complicated Urinary Tract Infection (cUTI) Epidemiology The Complicated Urinary Tract Infection (cUTI) epidemiology section provides insights into the historical and current Complicated Urinary Tract Infection (cUTI) patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Complicated Urinary Tract Infection (cUTI) market report also provides the diagnosed patient pool, trends, and assumptions. Complicated Urinary Tract Infection (cUTI) Drugs Uptake This section focuses on the uptake rate of the potential Complicated Urinary Tract Infection (cUTI) drugs recently launched in the Complicated Urinary Tract Infection (cUTI) market or expected to be launched in 2020-2034. The analysis covers the Complicated Urinary Tract Infection (cUTI) market uptake by drugs, patient uptake by therapies, and sales of each drug. Complicated Urinary Tract Infection (cUTI) Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Complicated Urinary Tract Infection (cUTI) market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions. Complicated Urinary Tract Infection (cUTI) Pipeline Development Activities The Complicated Urinary Tract Infection (cUTI) report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Complicated Urinary Tract Infection (cUTI) key players involved in developing targeted therapeutics. Complicated Urinary Tract Infection (cUTI) Therapeutics Assessment Major key companies are working proactively in the Complicated Urinary Tract Infection (cUTI) Therapeutics market to develop novel therapies which will drive the Complicated Urinary Tract Infection (cUTI) treatment markets in the upcoming years are Pfizer, Novartis, Spero Therapeutics, Tetraphase Pharmaceuticals, Wockhardt, Venatorx Pharmaceuticals, Cubist Pharmaceuticals, Janssen, Allecra Therapeutics, Nabriva Therapeutics AG, La Jolla Pharmaceutical Company, MerLion Pharmaceuticals, PRA Health Sciences, Qilu Pharmaceutical, Meiji Seika Pharma and others. Complicated Urinary Tract Infection (cUTI) Report Key Insights 1. Complicated Urinary Tract Infection (cUTI) Patient Population 2. Complicated Urinary Tract Infection (cUTI) Market Size and Trends 3. Key Cross Competition in the Complicated Urinary Tract Infection (cUTI) Market 4. Complicated Urinary Tract Infection (cUTI) Market Dynamics (Key Drivers and Barriers) 5. Complicated Urinary Tract Infection (cUTI) Market Opportunities 6. Complicated Urinary Tract Infection (cUTI) Therapeutic Approaches 7. Complicated Urinary Tract Infection (cUTI) Pipeline Analysis 8. Complicated Urinary Tract Infection (cUTI) Current Treatment Practices/Algorithm 9. Impact of Emerging Therapies on the Complicated Urinary Tract Infection (cUTI) Market Table of Contents 1. Key Insights 2. Executive Summary 3. Complicated Urinary Tract Infection (cUTI) Competitive Intelligence Analysis 4. Complicated Urinary Tract Infection (cUTI) Market Overview at a Glance 5. Complicated Urinary Tract Infection (cUTI) Disease Background and Overview 6. Complicated Urinary Tract Infection (cUTI) Patient Journey 7. Complicated Urinary Tract Infection (cUTI) Epidemiology and Patient Population 8. Complicated Urinary Tract Infection (cUTI) Treatment Algorithm, Current Treatment, and Medical Practices 9. Complicated Urinary Tract Infection (cUTI) Unmet Needs 10. Key Endpoints of Complicated Urinary Tract Infection (cUTI) Treatment 11. Complicated Urinary Tract Infection (cUTI) Marketed Products 12. Complicated Urinary Tract Infection (cUTI) Emerging Therapies 13. Complicated Urinary Tract Infection (cUTI) Seven Major Market Analysis 14. Attribute Analysis 15. Complicated Urinary Tract Infection (cUTI) Market Outlook (7 major markets) 16. Complicated Urinary Tract Infection (cUTI) Access and Reimbursement Overview 17. KOL Views on the Complicated Urinary Tract Infection (cUTI) Market 18. Complicated Urinary Tract Infection (cUTI) Market Drivers 19. Complicated Urinary Tract Infection (cUTI) Market Barriers 20. Appendix 21. DelveInsight Capabilities 22. Disclaimer About DelveInsight DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
