Fosfomycin and nitrofurantoin are increasingly being prescribed in outpatients for the oral treatment of urinary tract infection (UTI). The newest guidelines for empirical treatment of women with uncomplicated urinary tract infections (UTIs) advise clinicians to choose among three venerable antibiotics: trimethoprim-sulfamethoxazole, nitrofurantoin, and fosfomycin. Although both nitrofurantoin and fosfomycin have shown efficacy against most urinary pathogens, no recent head-to-head comparisons have been reported. So, this study will be conducted to compare effectiveness of both drugs.

Start Date01 Jan 2025

Sponsor / Collaborator-

KCT0009011

/ RecruitingNot ApplicableIIT

(Study comparing the rate of hypophosphatemia and side effect when using Preoperative Ferric Carboxymaltose (FCM) vs Iron isomaltoside in unilateral Total Knee Arthroplasty: Randomized controlled trial)

Start Date04 Dec 2023

Sponsor / Collaborator

Bundang CHA Hospital

CTRI/2023/11/059661

/ Not yet recruitingNot ApplicableIIT

Effectiveness, acceptability, feasibility, and mapping of the operational pathway for administration of single dose intravenous ferrous carboxymaltose in moderate-to-severely anemic pregnant and immediate postpartum women in selected districts of Bihar

Start Date17 Nov 2023

Sponsor / Collaborator

Gates Foundation (United States)

100 Clinical Results associated with Fosfomycin Sodium

100 Translational Medicine associated with Fosfomycin Sodium

100 Patents (Medical) associated with Fosfomycin Sodium

842

Literatures (Medical) associated with Fosfomycin Sodium

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Evaluating the cost-utility of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Norway

Article

Author: Detlie, T. E. ; Karlsen, L. N. ; Pollock, R. F. ; Nanu, N. ; Jørgensen, E.

AIMS:

Iron deficiency anemia (IDA) is among the most common extraintestinal sequelae of inflammatory bowel disease (IBD). Intravenous iron is often the preferred treatment in patients with active inflammation with or without active bleeding, iron malabsorption, or intolerance to oral iron. The aim of the present study was to evaluate the cost-utility of ferric derisomaltose (FDI) versus ferric carboyxymaltose (FCM) in patients with IBD and IDA in Norway.

MATERIALS AND METHODS:

A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA from a Norwegian national payer perspective. Iron need was modelled based on bivariate distributions of hemoglobin and bodyweight combined with simplified tables of iron need from the FDI and FCM summaries of product characteristics. Patient characteristics and disease-related quality of life data were obtained from the PHOSPHARE-IBD trial. Cost-utility was evaluated in Norwegian Kroner (NOK) over a five-year time horizon.

RESULTS:

Patients required 1.64 fewer infusions of FDI than FCM over five years (5.62 versus 7.26), corresponding to 0.41 fewer infusions per treatment course. The reduction in the number of infusions resulted in cost savings of NOK 5,236 (NOK 35,830 with FDI versus NOK 41,066 with FCM). The need for phosphate testing in patients treated with FCM resulted in further cost savings with FDI (no costs with FDI versus NOK 4,470 with FCM). Total cost savings with FDI were therefore NOK 9,707. FDI also increased quality-adjusted life expectancy by 0.071 quality-adjusted life years (QALYs) driven by reduced incidence of hypophosphatemia and fewer interactions with the healthcare system.

CONCLUSIONS:

FDI resulted in cost savings and improved quality-adjusted life expectancy versus FCM in patients with IDA and IBD in Norway. FDI therefore represents the economically preferable iron formulation in Norwegian patients with IBD and IDA in whom it is indicated.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

A Swedish cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in the treatment of iron deficiency anemia in patients with inflammatory bowel disease

Article

Author: Manxhuka, Bardh ; Lindgren, Stefan C. ; Strid, Hans ; Nanu, Neesha ; Hjortswang, Henrik ; Pollock, Richard F.

OBJECTIVES:

Iron deficiency anemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD), driven by impaired iron absorption, inflammation of intestinal mucosa and blood loss due to intestinal bleeding. Exogenous iron is indicated to correct iron deficiency, with intravenous iron preferred in patients with malabsorption or intolerance of oral iron, active bleeding, systemic inflammation, or a need for rapid iron replenishment. The objective was to assess the cost-utility of two high-dose, rapid-infusion iron formulations-ferric derisomaltose (FDI) and ferric carboxymaltose (FCM)-in the treatment of patients with IBD and IDA in Sweden.

METHODS:

The analysis used a previously-published micro-simulation model. Phosphate monitoring was modeled based on the product labelling, while iron need and disease-related quality of life (QoL) were modeled based on data from the PHOSPHARE-IBD randomized controlled trial. Cost-utility was evaluated from the national healthcare payer perspective over a five-year time horizon. Sensitivity and scenario analyses were performed.

RESULTS:

For each iron treatment course, patients treated with FDI required 0.41 fewer infusions than those treated with FCM. The reduced number of infusions resulted in savings of SEK 9,876 over five years from iron administration costs alone (SEK 44,216 with FCM versus SEK 34,340 with FDI). Phosphate monitoring in patients treated with FCM cost SEK 2,776 over five years versus no monitoring costs with FDI. Total cost savings with FDI were SEK 14,962. FDI also resulted in a 0.076 quality-adjusted life year (QALY) improvement versus FCM driven primarily by the QoL improvements reported in PHOSPHARE-IBD, and FDI was therefore the dominant intervention.

LIMITATIONS:

The analysis did not capture costs or outcomes associated with hypophosphatemic osteomalacia or fractures.

CONCLUSION:

Relative to FCM, fewer infusions of FDI were required, there was no need for phosphate monitoring, and disease-related QoL was improved, while overall costs were reduced.

01 May 2025·AMERICAN JOURNAL OF HEMATOLOGY

Ferric Carboxymaltose (FCM)–Associated Hypophosphatemia (HPP): A Systematic Review

Review

Author: Carson, Kenneth R. ; Bennett, Charles L. ; Knopf, Kevin ; Hrushesky, William J. ; Magagnoli, Joseph

ABSTRACT:

Background:

Since 2015, ferric carboxymaltose (FCM), an intravenous (IV) iron formulation used for treating iron deficiency anemia (IDA), has been associated with an increasing number of reported hypophosphatemia (HPP) cases. Information on HPP clinical manifestations and incidence has not been reviewed.

Methods:

We reviewed HPP‐associated adverse events reported to the FDA, case reports, case series, observational databases, clinical trials, meta‐analyses, and FDA‐approved labels. Our analysis found that FCM‐associated HPP is a clinically important adverse drug reaction (ADR). The most common clinical manifestations are general weakness, fatigue, bone pain, muscle pain, osteomalacia, and fractures. Information on rates of FCM‐associated HPP was from a review of clinical trials, observational databases, systematic reviews, and meta‐analyses.

Results:

Clinical trials comparing FCM with other IV iron preparations identified FCM‐associated HPP rates between 50% and 92% versus 2% and 8% with other IV iron formulations. Meta‐analyses and systematic reviews confirmed these numbers. FDA‐approved FCM labels do not include details of available ADR information in case reports, case series, observational databases, randomized trials, and meta‐analyses.

Conclusion:

We conclude that although the FDA‐approved FCM Prescribing Label was updated in 2023, more robust recommendations on FCM‐associated HPP are needed to prevent negative outcomes including osteomalacia and fractures. For patient safety, FCM label should advise monitoring serum phosphate levels prior to initiating first doses and before subsequent doses for all patients. Given differences between the FDA‐approved FCM label and data reviewed herein, clinicians must be educated about FCM‐associated HPP, difficulties treating HPP cases, and should consider administering other IV iron formulations that have lower rates of HPP.

News (Medical) associated with Fosfomycin Sodium

11 Dec 2024

·www.businesswire.com

Meitheal Pharmaceuticals Grows Specialty Biopharmaceuticals Portfolio with Exclusive Commercial Licensing Agreement for XENLETA® (lefamulin acetate)

CHICAGO--( BUSINESS WIRE )--Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago focused on the development and commercialization of generic, fertility, biologic, and branded injectable products, announced it has secured exclusive commercial rights in the U.S. to XENLETA ® (lefamulin acetate) through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industrial Co., Ltd. (HKF). XENLETA ® belongs to a new class of novel antibiotics and is approved in intravenous and oral formulations in the U.S. and multiple other countries for the treatment of community-acquired bacterial pneumonia (CABP) in adults. HKF has acquired global rights to XENLETA ® (with the exception of Greater China) from Nabriva Therapeutics. Through the acquisition, HKF has obtained substantially all global assets related to XENLETA ® , including results of development and regulatory activities. “The licensing of XENLETA ® bolsters our portfolio of novel antibiotics and reflects our focus on addressing the growing issue of antimicrobial resistance,” said Tom Shea, Chief Executive Officer of Meitheal. “As the first approved medicine of an entirely new class of antibiotics, XENLETA ® is an innovative therapeutic option that will be available to the patients affected by CABP and has been shown to be active against various bacterial strains. We look forward to leveraging our end-to-end expertise in biopharmaceutical development and commercialization to bring this important therapeutic to patients in need.” XENLETA ® is a first-in-class semi-synthetic pleuromutilin antibiotic. As a monotherapy offering a complete spectrum of coverage for the main CABP pathogens and with a low propensity for the development of bacterial resistance, XENLETA ® represents a critical step in addressing the growing global public health crisis of antimicrobial resistance (AMR) and supports the principles of antimicrobial stewardship. “Antimicrobial resistance, unfortunately, undermines the treatment paradigms of many infectious diseases globally, leading to poor patient outcomes and increased costs to healthcare systems,” said Brett Novak, Meitheal’s Senior Vice President of Commercial Operations. “XENLETA ® provides a unique and well-tolerated product profile for the more than five million annual cases of CABP in the U.S., where it has the potential to serve as a first-line monotherapy option in both the inpatient and outpatient settings. We are pleased that this agreement will allow us to unlock synergies with our existing franchises and deliver critical medicines that address large gaps in the antibiotic treatment landscape.” Global approvals of XENLETA ® in CABP are based on the results of two global, pivotal Phase 3 trials, LEAP 1 and LEAP 2, in which XENLETA ® met all primary endpoints. Meitheal recently added the first anti-infective to its portfolio through an exclusive commercialization agreement with HKF—CONTEPO™. Meitheal will leverage its new aligned-to-CONTEPO ™ marketing, sales, and medical science liaison teams to support the launch of XENLETA ® , which shares similar hospital call points. Meitheal will further establish practice-based support for key prescribers and patients that could benefit from XENLETA ® . “We are pleased to have acquired the rights to XENLETA ® and look forward to supporting Meitheal as it delivers this important medication to patients in the U.S.,” said Eric Tang, President of HKF. “We are committed to supporting Meitheal’s work to deliver accessible, sustainable, and innovative healthcare solutions and we remain focused on continuing to invest in the research, development, and commercialization of branded pharmaceuticals to achieve this goal.” HKF and its related entities have invested over $300 million in capital and research and development in recent years to support sustainable product supply across key focus areas, including branded biopharmaceuticals. The licensing agreement for XENLETA ® adds a third branded biopharmaceutical and first on-market branded product to Meitheal’s portfolio. ABOUT COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA (CABP) Pneumonia is an infection of the lung that can be serious and fatal, especially among older adult patients with comorbidities. CABP is among the most common types of pneumonia, with five million cases in the U.S. each year. 1 In the U.S., CABP is the leading cause of infection-related death 2 and the fourth leading cause of hospitalization, 3 a setting where mortality rates are approximately 15% 4 . Certain bacteria that cause CABP have become resistant to one common antibiotic, macrolides, at a rate on average of 50%. 5 The U.S. FDA has also issued multiple warnings about the resistance of one current class of CABP treatments called fluoroquinolones. 6 Antimicrobial resistance (AMR) is a top global public health threat that creates challenges treating infections and performing medical procedures and increases the risk of death and disability. 7 Novel antibiotics that kill bacteria, including those that cause CABP, in a different way are essential to addressing AMR. 8 ABOUT XENLETA ® XENLETA ® (lefamulin acetate) is a first-in-class, semi-synthetic pleuromutilin antibiotic for systemic administration in humans. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA ® ’s binding occurs with high affinity, high specificity, and at molecular sites that are different than other antibiotic classes. Two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP demonstrated XENLETA ® ’s efficacy. In these trials, XENLETA ® was compared with moxifloxacin, and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA ® had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. CONTRAINDICATIONS XENLETA ® is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA ® . Concomitant use of XENLETA ® tablets with CYP3A substrates that prolong the QT interval is contraindicated. WARNINGS AND PRECAUTIONS QT Prolongation: Avoid use in patients with known QT prolongation, ventricular arrhythmias including torsades de pointes, and patients receiving drugs that prolong the QT interval such as antiarrhythmic agents. Embryo-Fetal Toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. Clostridioides difficile-associated Diarrhea: Evaluate patients who develop diarrhea. ADVERSE REACTIONS The most common adverse reactions associated with XENLETA ® Injection include administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia and headache. The most common adverse reactions associated with XENLETA ® Tablets include diarrhea, nausea, vomiting, hepatic enzyme elevation. Please see Full Prescribing Information for more information. ABOUT MEITHEAL PHARMACEUTICALS, INC. Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly-priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of Nanjing King-Friend Biochemical Pharmaceutical Company, founded in 2010. ABOUT NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of the world’s leading manufacturers of heparin-related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA-approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. NKF is publicly listed on the Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. ABOUT NABRIVA THERAPEUTICS PLC Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. FDA approval for XENLETA ® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics also previously developed CONTEPO™ (fosfomycin for injection), a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI). ___________________________ 1 National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 -2010. https://archive.cdc.gov/#/details?url=https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed December 4, 2024). 2 el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA.2018;319(12):1248–1260. doi:10.1001/jama.2018.2089. 3 McDermott KW, Roemer M. Most frequent principal diagnoses for inpatient stays in U.S. Hospitals, 2018: Statistical Brief, no 277. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality. 2021. https://hcup-us.ahrq.gov/reports/statbriefs/sb277-Top-Reasons-Hospital-Stays-2018.pdf . 4 2017 CHARTBOOK STATIC ANALYSES -Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation -Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017. 5 Classi P, Landsman-Blumberg P, Carroll C, et al. The relationship between macrolide-resistant streptococcus pneumoniae and treatment failure in adults with community-acquired pneumonia by CDC region in the United States. Abstract J03. In: Meeting abstracts, Academy of Managed Care Pharmacy Nexus 2016; October 3-6, 2016; National Harbor, MD. 6 Food and Drug Administration. FDA updates warnings for fluoroquinolone antibiotics on risks of mental health and low blood sugar adverse reactions. https://www.fda.gov/news-events/press-announcements/fda-updates-warnings-fluoroquinolone-antibiotics-risks-mental-health-and-low-blood-sugar-adverse . Accessed December 4, 2024. 7 World Health Organization. Antimicrobial resistance. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance . Accessed December 4, 2024. 8 Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2013, US Department of Health and Human Services.

Phase 3License out/inDrug ApprovalClinical Result

19 Jul 2024

·firstwordpharma.com

Meitheal taps Nabriva’s antibiotic Contepo, hoping third time lucky with the FDA

Meitheal Pharmaceuticals has secured North America rights to Nabriva Therapeutics’ intravenous broad-spectrum antibiotic Contepo (fosfomycin for injection), which has been stuck in regulatory limbo in the US since 2020. However, an FDA decision on the injectable for treating complicated urinary tract infections (cUTIs) is expected later this year. Dubbing it a “novel therapeutic with the potential to address a significant unmet need around increasing antibiotic resistance,” Tom Shea, chief executive of Meitheal, said the company is “uniquely positioned to advance Contepo through the final stages of the regulatory process and…deliver a…high-quality antibiotic to patients and providers.”As part of the deal, Meitheal gains licensing rights and all associated intellectual property, technology and know-how for Contepo, while Nabriva stands to receive an undisclosed payment at closing and royalties on US sales.While the oral form of fosfomycin – marketed as Monurol in the US by AbbVie – was cleared by the FDA in 1997 to treat uncomplicated UTIs in women, Nabriva’s injectable version has been rejected twice by the US regulator in 2019 and 2020. Both complete response letters cited deficiencies related to facility inspections and manufacturing processes at contract manufacturing sites in Europe.With this acquisition, Meitheal has added a second asset to its specialty portfolio, after bagging North America rights to Xentria’s anti-TNFα antibody XTMAB-16 last year. Meitheal’s buyouts align with the broader vision of its parent company Nanjing King-Friend Biochemical Pharmaceutical to focus on branded biopharmaceuticals.

Drug ApprovalAcquisitionLicense out/in

06 Jan 2023

·www.globenewswire.com

Nabriva Therapeutics Provides Corporate Update

-Company To Focus on Preserving Cash to Fund Orderly Wind Down of Operations- -Company To Continue Work With Torreya Capital On Asset Monetization- DUBLIN, Ireland, Jan. 06, 2023 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV) today announced that, after an assessment of strategic options, its Board of Directors approved a plan to preserve cash in order to adequately fund an orderly wind down of the Company’s operations. As previously disclosed, the Company engaged Torreya Capital to facilitate the exploration of a range of strategic options, including potential in-licensing or out-licensing of commercial stage assets. While the Company continues to work with Torreya Capital on identifying and evaluating potential strategic options with the goal of maximizing shareholder value, the Company is currently focused on the sale of its existing assets, including Lefamulin and IV Fosfomycin. To preserve cash in order to adequately fund an orderly wind down and enable a sale of its assets, Nabriva plans to terminate all employees, including officers of the Company, not deemed necessary to execute an orderly wind-down of the Company. Nabriva estimates that it will incur approximately $6.0 million for severance and other employee termination-related costs in the first quarter of 2023. The Company also has terminated its agreement with Amplity Health, the contract sales organization responsible for promoting SIVEXTRO and XENLETA, to preserve cash, but will continue to make both products commercially available. The Company expects to transition responsibility for the promotion and distribution of SIVEXTRO back to Merck & Co. Inc. and terminate that agreement over the coming months. In addition, on January 5, 2023, the Company repaid $4.5 million to Hercules Capital, including principal, accrued and unpaid interest, fees and other expenses, under its loan agreement. Effective at the time of repayment, the Hercules loan agreement was terminated, and Hercules released all security interests held on the assets of the Company and its subsidiaries. Nabriva’s Board of Directors continues to evaluate alternatives to maximize shareholder value. In the event that the Board of Directors determines that a liquidation and dissolution of the Company pursuant to a Plan of Dissolution to be approved by shareholders is the best method to maximize shareholder value, the Company would file proxy materials with the Securities and Exchange Commission and schedule an extraordinary meeting of its shareholders to seek approval of such a Plan of Dissolution as required. About Nabriva Therapeutics plc Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. About SIVEXTRO SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and Drug Administration in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. About XENLETA XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to identify, assess and execute a strategic transaction, its ability to preserve cash in order to adequately fund an orderly wind down of the Company’s operations, the ability of shareholders and other stakeholders to realize any value or recovery as part of a wind down process, the Company’s workforce reduction and future charges expected to be incurred in connection therewith, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to continue to pay its obligations in the ordinary course of business as they come due; successfully execute its commercialization plans for XENLETA and SIVEXTRO and whether market demand for XENLETA and SIVEXTRO is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA and SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release. CONTACT: For Investors and MediaKim AndersonNabriva Therapeutics plcir@nabriva.com

Drug ApprovalLicense out/inClinical Result

100 Deals associated with Fosfomycin Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D02188	Fosfomycin Sodium	J01XX01	DB00828

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Parametritis	South Korea	Shinpoong Pharmaceutical Co., Ltd.	09 Sep 2024
Pelvic Inflammatory Disease	South Korea	Shinpoong Pharmaceutical Co., Ltd.	09 Sep 2024
Sepsis	South Korea	Shinpoong Pharmaceutical Co., Ltd.	09 Sep 2024
Bacteremia	Canada	Verity Pharmaceuticals, Inc.	01 May 2019
Complicated lower urinary tract infection	Canada	Verity Pharmaceuticals, Inc.	01 May 2019
Lower Respiratory Tract Infections	Canada	Verity Pharmaceuticals, Inc.	01 May 2019
Meningitis, Bacterial	Canada	Verity Pharmaceuticals, Inc.	01 May 2019
Osteomyelitis	Canada	Verity Pharmaceuticals, Inc.	01 May 2019
Otitis Externa	Japan	Meiji Seika Pharma Co., Ltd.	30 Jun 1989
Otitis Media	Japan	Meiji Seika Pharma Co., Ltd.	30 Jun 1989
Adnexitis	Japan	Meiji Seika Pharma Co., Ltd.	28 Jan 1985
Intrauterine infection	Japan	Meiji Seika Pharma Co., Ltd.	28 Jan 1985
Acute Bronchitis	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Cystitis	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Empyema	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Hemorrhagic Septicemia	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Lung Abscess	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Peritonitis	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Pneumonia	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980
Pyelonephritis	Japan	Meiji Seika Pharma Co., Ltd.	25 Oct 1980

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated urinary tract infection	NDA/BLA	Ireland	Nabriva Therapeutics Plc	30 Jan 2022
Complicated intra-abdominal infection	Phase 1	Ireland	Nabriva Therapeutics Plc	30 Jan 2022
Hospital-acquired pneumonia	Phase 1	Ireland	Nabriva Therapeutics Plc	30 Jan 2022
Pneumonia, Bacterial	Phase 1	Ireland	Nabriva Therapeutics Plc	30 Jan 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03453177 (Pubmed \| Arch Dis Child)	Phase 2	Neonatal Sepsis	120	SOC-F (ampicillin, gentamicin, and fosfomycin)	rstzpxkxtt(wbqvstebyn): events/100 infant-days = -0.95 (95% CI, -2.1 to 0.2) View more	-	25 Jan 2022
				SOC (ampicillin and gentamicin)
EHA2021	Not Applicable	Hematopoietic stem cell transplantation	190	Aerobic antibiotics	htfyonwgmd(bqbupuqzch) = uxusbakmdn wzzypltiwa (hnriqudskq )	-	09 Jun 2021
NCT03235947 (Pubmed \| Nephrol Dial Transplant)	Phase 4	Urinary Tract Infections \| Renal transplant rejection	82	FOS disodium	ixefrrqqfr(fdmropxsas) = xenqezdjcz hquivvjyck (femmyttfra )	Positive	28 Dec 2019
				Placebo	ixefrrqqfr(fdmropxsas) = sfzlddpgyo hquivvjyck (femmyttfra )
NCT02753946 (Pubmed \| Clin Infect Dis)	Phase 2/3	Complicated urinary tract infection	465	ZTI-01	auvtfbhpxm(fbvgxdcxjt) = xcxbmllxwx mxwsmylsrf (jwborvdepk ) View more	Positive	27 Nov 2019
				Piperacillin-tazobactam	auvtfbhpxm(fbvgxdcxjt) = frkgjojsfh mxwsmylsrf (jwborvdepk ) View more
NCT02753946 (ZEUS, CTgov)	Phase 2/3	Acute pyelonephritis \| Complicated urinary tract infection	465	ZTI-01 (ZTI-01)	yvxwwdxbqc = uedicmtfvn dzelgwffvh (mmrzgiexyc, cypwpjgxcs - koncimdhkx) View more	-	11 Dec 2018
				Piperacillin-tazobactam (Piperacillin Tazobactam)	yvxwwdxbqc = ptejinjelk dzelgwffvh (mmrzgiexyc, cpmlquvzsg - xvsrclngtt) View more
ERS2018	Not Applicable	Cystic Fibrosis	15	Fosfomycin IV	iftackwfkt(nuetvkyqmf) = Only 1 had nausea xifbmwxrtg (kzmyzfgikh ) View more	-	15 Sep 2018
ASN2015	Not Applicable	Kidney Failure, Chronic	-	Fosfomycin	uzhoznuhgf(kcucfwnnln) = dtvinqqlgs iztdakowth (eflnpwuimc ) View more	-	03 Nov 2015
NCT00871104 (Pubmed \| Clin Infect Dis)	Phase 4	Bacteremia due to Methicillin resistant Staphylococcus aureus	50	Fosfomycin plus imipenem	oubdcmztrp(loofihgjzz) = ippdiitylb geyvixznhv (sfrfcqomyj )	Positive	15 Oct 2014

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