Lyme disease is a public health crisis in the US. It is estimated that over 400,000 cases occur every year with 10-20% of those infected going on to develop Post-Treatment Lyme disease Syndrome (PTLDS). The goal of this study is to investigate if giving Ceftriaxone every 5 days for about 6 weeks kills the organism that produces persistent Lyme infection.
Enrolled participants will be randomized 1:1 receiving either pulse-dosed ceftriaxone or placebo [dextrose (5% in water), (D5W)], intravenously. Participants will be evaluated at each of the study visits, and then in a follow-up phase out to 12 months. They will be unblinded at 6 months and those randomized to the placebo group will be offered pulse-dosed ceftriaxone on the same schedule as those randomized to the drug group. All patients will be followed up for a total of 12 months post treatment initiation.

Start Date01 Feb 2025

Sponsor / Collaborator

Ocean Medical Center Association, Inc.

NCT06406114

/ Not yet recruitingPhase 2IIT

Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing

Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Start Date01 Feb 2025

Sponsor / Collaborator

The General Hospital Corp.

[+1]

NCT06611111

/ RecruitingEarly Phase 1IIT

Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

The goal of this clinical trial is to learn if an FDA approved drug, Ceftriaxone, given intermittently, can treat people between 18 and 75 years old with a history of Lyme disease, who are still experiencing persistent or returning symptoms after they have completed treatment. The main questions it aims to answer are:
* Will giving Ceftriaxone approximately every 5 days for 6 weeks be safe and well tolerated when compared to a group that receives placebo (a look-alike substance that contains no drug)?
* Will giving Ceftriaxone improve symptoms?
Participants will be asked to do the following:
* Come to the clinic approximately every 5-6 days to receive an IV infusion of either the Ceftriaxone or placebo.
* Answer questions about their level of tiredness, body pain, general health and physical ability, sleep, anxiety, depression and any suicidal thoughts.
* Give blood so we can make sure your body is handling the drug okay or to help us learn more about how the drug is affecting the persistent Lyme disease symptoms.

Start Date01 Jan 2025

Sponsor / Collaborator

SUNY Upstate Medical University

100 Clinical Results associated with Ceftriaxone Sodium

100 Translational Medicine associated with Ceftriaxone Sodium

100 Patents (Medical) associated with Ceftriaxone Sodium

22,987

Literatures (Medical) associated with Ceftriaxone Sodium

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Pharmacist-led antibiotic interventions in infectious disease patients: a Pakistani tertiary care antimicrobial stewardship study

Article

Author: Ur Rehman, Naeem ; Maqbool, Sumeira ; Arif, Mehreen ; Hassan, Ali

Background:

Antibiotics are widely used medications among infectious disease patients; therefore, proper monitoring and assessment are critical for ensuring rational use. Antimicrobial stewardship addresses the rational and appropriate use of antibiotics, which reinforces overall health outcomes. Ongoing antimicrobial resistance scenarios are an alarming condition for healthcare, necessitating continued practice of such assessments.

Objectives:

To evaluate the use of antibiotics in patients with infectious diseases, implement and evaluate clinical pharmacy interventions that adhere to antimicrobial stewardship protocols.

Methods:

A before and after study was designed to evaluate clinical pharmacy and antimicrobial stewardship interventions for infectious disease patients at a tertiary care hospital in Lahore. A Performa was designed for manual data collection. Study first identified the signal of error, implemented intervention and noted post-interventional followups.

Results:

102 infectious disease cases were analyzed in total and proposed 136 interventions. Physicians accepted 66% of the interventions (90) and rejected the remaining ones as unjustified. The most accepted intervention was the spectrum-based choice (n = 30), followed by de-escalation of dose (n = 17). Use of ceftriaxone was very high (54 Pt.), followed by vancomycin (30 Pt.).

Conclusion:

Antimicrobial stewardship programmes are critical for any institution's proper health care system. It ensures proper antibiotic outflow to patients, thereby improving their health status. The role of pharmacists in establishing an AMS in a hospital setting is a highly commendable activity that enhances healthcare collaboration and outcomes. Clinical pharmacists should implement such activities to improve patient care.

31 Dec 2025·Gut Microbes

A modelling framework to characterize the impact of antibiotics on the gut microbiota diversity

Article

Author: de Gunzburg, Jean ; Corbel, Tanguy ; Burdet, Charles ; Ferreira, Stéphanie ; Guedj, Jeremie ; Olivares, Carlos ; Ruppé, Etienne ; Andremont, Antoine

Metagenomic sequencing deepened our knowledge about the role of the intestinal microbiota in human health, and several studies with various methodologies explored its dynamics during antibiotic treatments. We compared the impact of four widely used antibiotics on the gut bacterial diversity. We used plasma and fecal samples collected during and after treatment from healthy volunteers assigned to a 5-day treatment either by ceftriaxone (1 g every 24 h through IV route), ceftazidime/avibactam (2 g/500 mg every 8 h through IV route), piperacillin/tazobactam (1 g/500 mg every 8 h through IV route) or moxifloxacin (400 mg every 24 h through oral route). Antibiotic concentrations were measured in plasma and feces, and bacterial diversity was assessed by the Shannon index from 16S rRNA gene profiling. The relationship between the evolutions of antibiotic fecal exposure and bacterial diversity was modeled using non-linear mixed effects models. We compared the impact of antibiotics on gut microbiota diversity by simulation, using various reconstructed pharmacodynamic indices. Piperacillin/tazobactam was characterized by the highest impact in terms of intensity of perturbation (maximal [IQR] loss of diversity of 27.3% [1.9; 40.0]), while moxifloxacin had the longest duration of perturbation, with a time to return to 95% of baseline value after the last administration of 13.2 d [8.3; 19.1]. Overall, moxifloxacin exhibited the highest global impact, followed by piperacillin/tazobactam, ceftazidime/avibactam and ceftriaxone. Their AUC between day 0 and day 42 of the change of diversity indices from day 0 were, respectively, -13.2 Shannon unit.day [-20.4; -7.9], -10.9 Shannon unit.day [-20.4; -0.6] and -10.1 Shannon unit.day [-18.3; -4.6]. We conclude that antibiotics alter the intestinal diversity to varying degrees, both within and between antibiotics families. Such studies are needed to help antibiotic stewardship in using the antibiotics with the lowest impact on the intestinal microbiota.

31 Dec 2025·Emerging Microbes & Infections

Emerging epidemic of the Africa-type plasmid in penicillinase-producing Neisseria gonorrhoeae in Guangdong, China, 2013–2022

Article

Author: Chen, Wen-Tao ; Qin, Xiao-Lin ; Zhou, Han ; Xue, Yao-Hua ; Tang, San-Mei ; Cheng, Kui ; Huang, Jin-Mei ; Zhan, Qing-Xian ; Wu, Xing-Zhong ; Zhang, Zi-Yan ; Feng, Zhan-Qin ; Lan, Yin-Yuan ; Chen, Yang ; Zheng, He-Ping

The prevalence of penicillinase-producing Neisseria gonorrhoeae (PPNG) is a crucial public health concern because of its resistance to penicillin and cephalosporins. From 2013 to 2022, a total of 1748 N. gonorrhoeae isolates from Guangdong, China, were examined for their antibiotic susceptibility and molecular epidemiological characteristics. PPNG prevalence increased markedly from 37.25% to 63.87%. This increase was accompanied by a shift in predominant plasmid types carried by PPNG isolates: the rate of PPNG isolates carrying the Africa-type plasmid increased from 18.42% to 91.55%, whereas the rate of isolates carrying the Asia-type plasmid decreased from 81.58% to 7.58%. The prevalence of bla_TEM-135, which is linked to cephalosporin resistance, declined from 52.63% to 4.37%, whereas that of bla_TEM-1 increased from 47.37% to 86.88%, and new bla_TEM variants emerged (10.99% by 2022). Most bla_TEM-1 (88.26%) and new bla_TEM alleles (83.70%) were associated with the Africa-type plasmid, whereas 86.79% of bla_TEM-135 alleles were linked to the Asia-type plasmid. Resistance to ceftriaxone was higher in the Asia-type group (11.67%) than in the Africa-type, Toronto/Rio-type and non-PPNG groups. Genotyping identified diverse sequence types (STs) among PPNGs, in which MLST ST7363, NG-STAR ST2477, NG-MAST ST17748, and NG STAR CC1124 were predominant. This study underscores the rising prevalence of PPNG in Guangdong driven by clonal expansion and changing plasmid dynamics, affecting cephalosporin resistance and highlighting the need for continued surveillance and research into effective treatment strategies.

News (Medical) associated with Ceftriaxone Sodium

23 Jan 2025

·www.businesswire.com

binx health and Mass General Hospital Study Shows Significant Positive Impact on Antibiotic Stewardship in Sexual Health

BOSTON--( BUSINESS WIRE )--binx health, a healthcare technology and diagnostics company focused on making routine testing convenient, today announced key findings from a new Massachusetts General Hospital (MGH) study designed to assess the real-world impact of Point of Care (“POC”) testing for Chlamydia trachomatis (“CT”) and Neisseria gonorrhoeae (“NG”) testing in symptomatic patients presenting at a sexual health clinic. The study comes on the heels of The Food and Agriculture Organization of the United Nations (“FAO”), the United Nations Environment Program (“UNEP”), the World Health Organization (“WHO”) and the World Organization for Animal Health (WOAH) welcoming a declaration made at the UN General Assembly meeting, which included the target to reduce human deaths from AMR by 10% by 2030 i . In the USA, antibiotic stewardship has become even more critical since the emergence of new multidrug-resistant gonorrhea strains in Massachusetts in 2023. In response, CDC now recommends the use of high doses of the antibiotic ceftriaxone for treatment ii , making rapid and accurate identification of gonorrhea (NG) even more important to appropriately identify and treat those who are indeed infected and avoiding over treatment in those who are negative. Trials conducted as part of the study focused on comparing the outcomes of POC testing vs Standard of Care (“SOC”) testing as well as key outcomes associated with empiric antibiotic use per patient, time to results, time to etiologic treatment, duration of clinic visit, and implementation potential. The accuracy of binx CT/NG test demonstrated sufficient accuracy to be considered for replacing gram stain SOC testing for both males and females delivering rapid nucleic acid amplification test (NAAT) results 3.75 days faster than the state lab and reduced inappropriate antibiotic treatment by 63%. “Accurate, rapid test results are incredibly helpful for patients and providers,” said Dr. Jana Jarolimova, MD MPH, Infectious Disease Physician, Massachusetts General Hospital. “When clinicians are able to quickly and accurately prescribe treatments in clinic, we can better manage their STIs and ultimately, help patients experience better outcomes.” Today, thirty-five million CT/NG tests are processed annually at central laboratories iii , with most patients leaving the clinic before results are ready. Under this traditional care model, patients who are subsequently determined to be positive for chlamydia or gonorrhea may not return for treatment once they leave the clinic, leading to further infection spread and comorbidities. Findings from the study confirmed that patients want to have their test results before they leave the clinic. 80% of patients acknowledged that they would be willing to wait in clinic for their rapid PCR POC results. Importantly, POC testing can have a dramatic impact on treatment accuracy and improved Healthcare Effectiveness Data and Information Set (“HEDIS”) scores as a standardized measure used to assess the quality of health plans and clinician performance. The 10% improvement observed by MGH for appropriate treatment observed when using the binx CT/NG test over SOC demonstrates positive potential to improve HEDIS scores long term. "Our mission at binx health is to be a key proponent that improves STI care,” said Michael Karsonovich, President of binx health. “The ability to collaborate with Mass General specialist sexual health clinic with this study is a fantastic opportunity to demonstrate how POC testing can truly move the needle in STI diagnosis and treatment. This study allows us to leverage our proprietary technology to identify and assess the benefits of testing and treating in the same visit and the need for transformative technology to help tackle the rise of these infections." About binx health binx health is a healthcare technology and clinical diagnostics company focused on innovating solutions to improve routine testing and convenience, providing timely results to improve patient care. The binx io point-of-care molecular platform is the first ever FDA-cleared, CLIA-waived point-of-care system for the detection of chlamydia and gonorrhea in both males (urine) and females (vaginal swab) that provides central lab performance results in about 30 minutes. The binx io platform is highly flexible, easy to use, and enables rapid testing and treatment in a single patient visit. For more information, visit https://mybinxhealth.com/ i https://www.who.int/news/item/26-09-2024-world-leaders-commit-to-decisive-action-on-antimicrobial-resistance ii https://www.cdc.gov/mmwr/volumes/69/wr/mm6950a6.htm iii Huang W, Gaydos CA et al (2012). Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. Sex Transm Infect. 2013 Mar;89(2):108-14. doi: 10.1136/sextrans-2011-050355. Epub 2012 Sep 14. PMID: 22984085; PMCID: PMC3671871. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671871/

Clinical Study

21 Jan 2025

·www.prnewswire.com

RedHill's Talicia® Adds 8 Million Lives With Coverage by Humana®'s Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published

Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists Additionally, new data describing the foundations for Talicia's recent FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, has been published in the Journal of Clinical Pharmacology The published data describe the use of physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence of the TID regimen to the previous every 8-hour (Q8H) dosing regimen H. pylori infection affects approximately 35% of the U.S. adult population and is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease RALEIGH, N.C. and TEL-AVIV, Israel, Jan. 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the coverage of Talicia by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without the requirement for prior therapeutic steps or authorizations, for both treatment-naïve and treatment-experienced patients, effective as of January 1, 2025. "There is broad recognition of the clinical efficacy of Talicia and the recently updated American College of Gastroenterology (ACG) Clinical Guideline, listing Talicia as a first-line treatment option. Talicia is the only FDA-approved low-dose rifabutin-based therapy for the eradication of H. pylori, and continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists1," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "We are pleased that coverage in the Medicare arena is growing as the Part D payers recognize the importance of treating H. pylori with the right therapy the first time and look forward to expanding coverage in Medicare." The Company also announced the publication of new data in The Journal of Clinical Pharmacology2. The published data describe the foundations for Talicia's recently FDA-approved label change to a more convenient three-times daily (TID) with food (at least 4 hours apart, e.g., breakfast, lunch, and dinner) dosing routine, further simplifying the patient experience and supporting increased patient adherence. The result of a successful collaboration with Certara, the published study utilized Certara's Simcyp™ Simulator for physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence in plasma and within the stomach for all three of Talicia's components, regardless of dosing TID or Q8H. These data support the provision of a more patient-friendly Talicia regimen and further demonstrate RedHill's ongoing commitment to enhanced patient experience and outcomes. "Treating H. pylori infection is challenging and often requires patients to take multiple different pills multiple times a day. Simplified dosing regimens improve patient adherence. In the treatment of H. pylori infection, adherence to dosing is critical for optimizing patient outcomes, while also mitigating against the development of bacterial resistance. Therefore, it is important to use an effective therapy that is most likely to eradicate H. pylori infection at the first attempt," said Colin W. Howden, MD, Professor Emeritus, University of Tennessee College of Medicine, and co-author of the paper. "These important data, and the retention of Talicia's pharmacokinetic profile across dosing regimens, support the change to a more simplified TID dosing schedule. Talicia's efficacy, tolerability, and resistance profile, along with its convenient all-in-one formulation and TID dosing, further support its inclusion as an empirically prescribed first-line option in the 2024 ACG Clinical Guideline on the treatment of H. pylori infection3." About H. pylori H. pylori is a bacterial infection that affects approximately 35%4 of the U.S. population, with an estimated two million patients treated annually3. Worldwide, around 66% of the population has H. pylori infection5, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer6 and a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma8. More than 27,000 Americans are diagnosed with gastric cancer annually9. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies10. About Talicia® Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. More specifically, the high rates of H. pylori resistance to clarithromycin have led to significant increases in treatment failures with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent11 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm12. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Patients should check coverage details with their health plan. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at . About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S commercialization and development of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults13. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. All information contained herein is the sole responsibility of RedHill Biopharma Ltd. Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Commercial 1 IQVIA XPO Data on file 2 Vakil N, Howden CW, Shah SC, Chen KF, Offman E, Almenoff JS, Sheldon KL. Physiologically Based Pharmacokinetic Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025 Jan 2. doi: 10.1002/jcph.6178. Epub ahead of print. PMID: 39745109. 3 Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH, FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI: 10.14309/ajg.0000000000002968 4 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 5 6 Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 7 NIH – Helicobacter pylori and Cancer, September 2013. 8 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 9 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 10 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. 11 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. 12 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). 13 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Clinical ResultDrug Approval

15 Jan 2025

·www.prnewswire.com

Visby Medical Secures Additional $3.9M from CARB-X to Fight Antibiotic Resistance with PCR-Based Mutation Detection at the POC

SAN JOSE, Calif., Jan. 15, 2025 /PRNewswire/ -- Visby Medical™, a leading innovator in rapid PCR diagnostics, has secured an additional $3.9 million from the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator ( CARB-X) to accelerate its fight against antibiotic resistance. This funding builds on a $1.2 million grant awarded in December 2023 and propels Visby's development of groundbreaking diagnostic tools that pinpoint resistance-conferring mutations in infections, starting with ciprofloxacin susceptibility. Continue Reading The additional funding will advance Visby's pioneering work funded by CARB-X, which has demonstrated its preliminary ability to detect Neisseria gonorrhoeae (NG) from urine and vaginal swabs and distinguish ciprofloxacin-susceptible strains. Next, Visby will continue development toward integrating these capabilities into its Visby Medical Sexual Health Test, which detects chlamydia, gonorrhea, and trichomoniasis. The company is also developing a digital companion app and AI-driven tools to make result interpretation seamless, while working on cost-cutting innovations for its platform. Latest CARB-X grant propels Visby development of diagnostics to pinpoint resistant mutations in STIs. Post this Ciprofloxacin is a former frontline antibiotic that has been sidelined due to widespread resistance. With Visby's rapid test, doctors could determine if this convenient, inexpensive oral antibiotic is effective and reserve ceftriaxone—currently the only antibiotic that remains effective against resistant gonorrhea—for truly resistant cases. "Antibiotic resistance is a critical concern across all of healthcare, and especially in sexually transmitted infections for which numbers continue to rise," explained Gary Schoolnik, MD, Chief Medical Officer of Visby Medical. "Particularly for N. gonorrhoeae, which is a poster child for acquiring resistance, unlocking the treatment potential of ciprofloxacin could mean the difference between extending the lifetime of ceftriaxone either for decades, or only a handful of years." About Visby Medical Founded in 2012, Visby Medical is transforming the order of diagnosis and treatment for infectious diseases so clinicians can test, talk with, and treat the patient in a single visit. The Company developed a proprietary technology platform that is the world's first instrument-free, single-use PCR platform that fits in the palm of your hand and rapidly tests for serious infections. Their commercialized point-of-care tests for sexually transmitted infections (STIs) and respiratory infections (COVID-19 and the flu) deliver true PCR results in under 30 minutes. For more information, visit . Follow Visby Medical on LinkedIn. CARB-X funding for this research is supported by federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; under agreement number 75A50122C00028, and by awards from Wellcome (WT224842), Germany's Federal Ministry of Education and Research (BMBF), and the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund (GAMRIF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views CARB-X or its funders. Media Contact: [email protected] SOURCE Visby Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Ceftriaxone Sodium

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KEGG	Wiki	ATC	Drug Bank
D00924	Ceftriaxone Sodium	J01DD04	DB01212

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Arthropathy associated with infection	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Infection of bone	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Lower Respiratory Tract Infections	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Meningitis	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Postoperative infection	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Sepsis	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Skin and skin structure infections	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Urinary Tract Infections	AU	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Gonorrhea	CN	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Infectious Diseases	CN	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Bacterial Infections	US	Hoffmann-La Roche, Inc.	21 Dec 1984

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ileitis	Phase 2	CA	Theriva Biologics, Inc.	01 Jun 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05027516 (ResistAZM, CTgov)	Phase 4	Gonorrhea	42	Rocephin (Rocephine®)	qjpgzlezch(mearihgemo) = axewtzoeym icbkgtdliq (keupjukvms, bknsuckniv - unisectwnv) View more	-	02 Aug 2024
				Azithromycin+Rocephin (Rocephine® + Azithromycin)	xowqecrvnc(jrkgflscbn) = mucnmuqlwm wnleibdodg (icpvhyovof, fmsudjjqea - diqgyqlxxo) View more
NCT02265406 (PROPHY-VAP, Pubmed \| Lancet Respir Med) Manual	Phase 3	Pneumonia, Ventilator-Associated	319	Ceftriaxone 2 g	ujnkipsqbv(alazotpvpk) = dchcmwheip pccgugiqam (budkujvpcv )	Positive	19 Jan 2024
				Placebo	ujnkipsqbv(alazotpvpk) = ifusgedgxa pccgugiqam (budkujvpcv )
NCT05149287 (PROPER, CTgov)	Phase 2	Meniscus disorder \| Inflammation \| Cartilage Injury ... View more	5	Ceftriaxone (Experimental)	mtcfgnuycv(sdqeokpauk) = gtshsesolm hypkbrmexw (nxtlqfkhoh, yohhewkbts - pzvyoazqei) View more	-	05 Sep 2023
				Placebo (Placebo)	mtcfgnuycv(sdqeokpauk) = nmaxkpktlt hypkbrmexw (nxtlqfkhoh, fcmpwpzmuv - dlacjdoupn) View more
NCT01265173 (Pubmed \| Am J Gastroenterol)	Not Applicable	Spontaneous bacterial peritonitis First line	261	Cefotaxime	viavykdhfz(qidxbinzoi) = poafensejc jbizhkwbuf (zhtycetsbo )	-	02 Jan 2023
				Ceftriaxone	viavykdhfz(qidxbinzoi) = lvywcbyakp jbizhkwbuf (zhtycetsbo )
NCT04218695 (CTgov)	Phase 4	Fibrosis \| Liver Cirrhosis	32	Ceftriaxone (Treatment)	dpxxcdmwgd(wcapucycis) = fgxthguqqh mqcrgerzki (xbvacznviv, aosurwzitd - ubvawivxpl) View more	-	31 Aug 2022
				normal saline (Placebo)	dpxxcdmwgd(wcapucycis) = uznunxitra mqcrgerzki (xbvacznviv, tavfuynyhy - aclalqvmqd) View more
NCT05216744 (Pubmed \| BMC Infect Dis)	Phase 2	Chlamydia trachomatis infection	125	Ceftriaxone + Doxycycline	oasxglqtxm(jygiappuzi) = eisykugoxf qxwjxlwoeo (cjmutfsbne, 88.8 - 99.1)	Positive	09 Jul 2022
				Cefixime + Doxycycline	oasxglqtxm(jygiappuzi) = geqftybnhh qxwjxlwoeo (cjmutfsbne, 87.1 - 98.4)
ATS2021	Not Applicable	Community-acquired bacterial pneumonia	-	Ceftriaxone-sensitive (CTX-S) organisms	xdcrqnaerm(dqwkgrzdrn) = jnatdxgsxd bxczlknzlr (acbxqsgvke )	-	03 May 2021
ERS2020	Not Applicable	Community Acquired Pneumonia	457	Ceftriaxone 1g x2	nuhorlgaup(aanoarudxn) = cbgmlppoll uzqkdhxzha (frbyrqvivh ) View more	-	07 Sep 2020
				Ceftriaxone 2g x1	nuhorlgaup(aanoarudxn) = vsrvlgzyxy uzqkdhxzha (frbyrqvivh ) View more
IAS2020	Not Applicable	HIV Infections	149	Ceftriaxone	lxsletvrpg(wvbebmisbj) = alzoayrybk indgxbmgbk (gnwkuvtfli )	-	01 Jan 2020
NCT02334124 (CHOICE, Pubmed \| Lancet Infect Dis)	Not Applicable	Cellulitis	180	Intravenous ceftriaxone at home	igspvesuze(jhausakwgx) = ywbngzbdij uzhnwjgcqr (jpnascysrr ) View more	Positive	01 Oct 2019
				Intravenous flucloxacillin in hospital	igspvesuze(jhausakwgx) = jnkzwipahb uzhnwjgcqr (jpnascysrr ) View more

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