PRophylaxis Against Early VENTilator-associated Infections to Reduce Mortality in Mechanically Ventilated Intensive Care Unit (ICU) Patients With Acute Brain Injuries: a Phase 3 Randomised, Double Blind, Parallel Group, Placebo-controlled Two-side Superiority Trial

This research is about whether treatment with a commonly used antibiotic can prevent infections in airway and lungs and improves the chance of surviving, if it is given soon after patients commence mechanical ventilation when they have been admitted to hospital with an acute severe brain injury.
An acute severe brain injury can occur as a result of a stroke, a traumatic injury or due to lack of oxygen to the brain that happens as a result of a cardiac arrest.
Patients who are unconscious after an acute severe brain injury often need assistance to breath adequately, and this assistance is given by a breathing tube, connected to a mechanical ventilator. This treatment is an emergency medical treatment. The breathing tube is inserted into the patients' airway by either their mouth or neck. For patients who need assistance with their breathing from a mechanical ventilator, infections in the airways and lungs, known as pneumonia, are a common complication. Everyone naturally has bacteria in their mouth, esophagus and stomach. Clinicians think that during the process of inserting the breathing tube, small amounts of these bacteria can be introduced into the airways and lung when people are unconscious following an acute severe brain injury, or during the process of placing the breathing tube into the airways. These bacteria are now in a place they aren't meant to be and can cause an infections in the airways and lungs known as pneumonia.
The purpose of this research is to see if giving one dose of a common antibiotic can prevent patients developing pneumonia, which is associated with having a breathing tube inserted and being on a ventilator, improving the chance of recovery following the acute severe brain injury and ultimately improving the chance of surviving.
When patients have a known infection, current guidelines are to treat them with antibiotics. Antibiotics work to kill the bacteria causing the infection. When a patient has an infection in their lungs, they often need to stay on the mechanical ventilator for longer. While current practice is to give patients with a proven infection in their airways and lungs (pneumonia) antibiotics, it is unknown if giving an antibiotic to patients to prevent these infections before they show signs of pneumonia may lead to better outcomes.

Start Date01 Oct 2025

Sponsor / Collaborator

The George Institute for Global Health

NCT03895567

/ Not yet recruitingPhase 1IIT

A Randomised Crossover Study of the Pharmacokinetics, Safety and Tolerability of Two Rectal Formulations of Ceftriaxone Compared to Parenteral Ceftriaxone, in Healthy Thai Adults.

Phase 1, three-way cross-over, randomised, open label comparison of intravenous versus two rectal dosage forms of ceftriaxone in 37 healthy Thai adults.
The following regimens will be evaluated in random order in all participants:
A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection) B. Ceftriaxone rectal dosage form test formulation 1-hard-shell gelatin capsule (1 x 500mg) C. Ceftriaxone rectal dosage form test formulation 2-rectodispersible mannitol-based tablet (1 x 500mg)
Possible schedules: ABC, ACB, BAC, BCA, CAB, CBA. Each recipient will receive a single treatment dose of each of the three formulations in an order predetermined by a computer generated randomisation list. This will be a constrained randomization which ensures approximately balanced proportions for all six schedules (either 6 or 7 participants per schedule). There will be 7-28 days washout period between doses. The last follow up visit is 28 (+ 2) days after final dose. Participants lost to follow-up or unevaluable for any reason before completion of pharmacokinetic sampling after the final dose will be replaced at the discretion of the investigators with another participant of the same population, if either sample size or completeness of dataset is compromised.
This study is funded by the Medical Research Council. The grant reference number is MR/W021560/1

Start Date01 Sep 2025

Sponsor / Collaborator

University of Oxford

NCT06785402

/ Not yet recruitingPhase 1/2IIT

Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Trial of Pulse Dosed Ceftriaxone for Post-Treatment Lyme Disease

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 Date15 Aug 2025

Sponsor / Collaborator

Hackensack Meridian Health, Inc.

100 Clinical Results associated with Ceftriaxone Sodium

100 Translational Medicine associated with Ceftriaxone Sodium

100 Patents (Medical) associated with Ceftriaxone Sodium

29,129

Literatures (Medical) associated with Ceftriaxone Sodium

01 Jan 2026·CLINICA CHIMICA ACTA

Multicenter evaluation of the ProNephro AKI™ assay performance and stability in pediatric patients

Article

Author: Malaeb, Hind ; El-Khoury, Joe M ; Tsaniklides, Nicholaos ; Klause, Ursula ; Jarden, Angela ; Zilka, Sarah ; Colón-Franco, Jessica M

INTRODUCTION:

Acute Kidney Injury (AKI), defined by increased serum creatinine or decreased urine volume, is highly prevalent in critically ill pediatric patients. Reliance on these for AKI diagnosis is unreliable due to inaccuracy and delayed response. Neutrophil Gelatinase-Associated Lipocalin (NGAL) is a promising biomarker for early AKI detection. This study investigated the analytical performance of a new automated urine NGAL test in pediatric patients.

MATERIALS AND METHODS:

The ProNephroAKI™ particle-enhanced turbidimetric immunoassay was run on the Roche cobas® c501 analyzer to measure urine NGAL in pediatric patients. The test sensitivity, specificity, and linearity were evaluated. The test reproducibility was studied in three laboratories using seven pediatric urine samples. The stability of urine NGAL was assessed in sixteen native urine pediatric samples after storage at room temperature, refrigerated, and frozen.

RESULTS:

The limits of blank (LoB), detection (LoD), and quantitation (LoQ) were determined as 9, 14, and 18 ng/mL, respectively. Linearity was confirmed across the range of 50-3000 ng/mL. Precision studies following CLSI EP5-03 guidelines showed coefficients of variation (CVs) for repeatability, between-run, between-day, and total precision at ≤5.0 %, ≤3.1 %, ≤1.7 %, and ≤4.9 %, respectively. Reproducibility across three laboratories was ≤6.6 %. Specificity tests showed no significant interference from high specific gravity, 15 endogenous substances, 3 contrast agents, pH variations (3.3-10.3), or 33 pharmaceutical compounds, except very high concentrations of cefepime and ceftriaxone. Cross-reactivity was not observed from 10 potential cross-reactive biomarkers. NGAL stability in urine was tested with samples from 16 patients, demonstrating stability for 2 days at ambient temperature, 4 days refrigerated, 13 months frozen (-70 °C or below), and 3 freeze/thaw cycles.

CONCLUSIONS:

The ProNephroAKI™ assay shows excellent precision, reproducibility, sensitivity, specificity, and stability, meeting the required analytical performance for clinical use in diagnosing and managing AKI in critically ill pediatric patients.

01 Jan 2026·FOOD MICROBIOLOGY

Population structure of Bacillus cereus sensu lato associated with foodborne outbreaks in France between 2004 and 2023

Article

Author: Firmesse, Olivier ; Bonis, Mathilde ; Pairaud, Sylvie ; Mozhaitseva, Ksenia

Bacillus cereus sensu lato (Bcsl) is a group of closely related bacterial species known for their resistant spores, enabling them to persist in a dormant state and thereby colonize and adapt across diverse environments. Bcsl is known for its harmful impact on human health, producing toxins that cause emetic and diarrheal syndromes or provoking extradigestive infections. Importantly, Bcsl is the most frequent confirmed or presumptive causative agent associated with foodborne outbreaks (FBOs) in France. In our study, we assessed the population structure of a large collection of Bcsl isolated during FBOs investigation in France between 2004 and 2023, focusing on the association between distinct populations and food categories. Using 294 genomes from 183 FBOs, we applied genomic clustering and phylogenomic analysis and then identified three predominant Bcsl populations. B. cereus sensu stricto (17.0 %) prevailed in composite dishes, B. paranthracis (16.1 %) was positively associated with cereals, and B. thuringiensis subsp. kurstaki (7.6 %) was predominantly found in vegetable-based salads. Some strains were phylogenetically closely related to clinical isolates, highlighting the need to assess the antibiotic susceptibility of Bcsl. Notably, one Bcsl clade, B. cytotoxicus, lacking beta-lactamase-encoding genes showed a greatly increased sensitivity to ampicillin than other Bcsl considered to be naturally resistant to beta-lactams. Additionally, various strains from distinct populations showed reduced susceptibility to macrolides and cyclins. Finally, accurately differentiated populations will be used in further epidemiological studies and in dose-response modeling.

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.

News (Medical) associated with Ceftriaxone Sodium

11 Aug 2025

·www.pharmaceutical-technology.com

GSK’s oral antibiotic for gonorrhoea set for FDA review

Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI). Credit: 1take1shot via Shutterstock.com. A new pill that combats antibiotic-resistant strains of gonorrhoea has inched closer to approval in the US, after the US Food and Drug Administration (FDA) accepted GSK’s gepotidacin for priority review. A priority review expedites the FDA’s decision on a drug application, cutting review time down from 10 to six months. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 11 December 2025. If approved, it would be indicated for the treatment of uncomplicated urogenital gonorrhoea in patients aged 12 years and older who weigh at least 45kg. Gepotidacin is already available in the US under the brand name Blujepa for the treatment of urinary tract infections (UTI) in women and girls aged 12 years and above, courtesy of an FDA approval in March 2025. Currently, gonorrhoea treatment options in the US mostly rely on injectable drugs, such as Roche’s Rocephin (ceftriaxone). While there are oral antibiotics approved by the FDA, these are often broad-use drugs such as Pfizer’s Zithromax (azithromycin). In a Phase III trial (NCT04010539) that enrolled than 600 adults and teenagers, gepotidacin was shown to successfully treat about 92% of patients when taken twice daily. This was non-inferior when compared with a standard combination therapy of Rocephin and Zithromax, which had success rates of 91.2%. There were also no failures at the urogenital site due to bacterial persistence arising from gonorrhoea, signifying gepotidacin’s important role against resistant strains. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Data from the World Health Organization (WHO) shows a rise in the prevalence of multi-resistant gonorrhoea. As of 2023, out of 87 countries where enhanced gonorrhoea antimicrobial resistance surveillance was conducted, nine countries reported elevated levels of resistance to Rocephin. Antibiotic-resistant strains of gonorrhoea mean tackling its spread is harder at public health levels. Developed by GSK but with funding from US infectious disease grants, Gepotidacin is a triazaacenaphthylene antibiotic that inhibits bacterial DNA replication. The drug inhibits two different Type II topoisomerase enzymes, which gives it activity against a range of pathogens that target the urinary system. Another oral antibiotic could also be set to join gepotidacin in the US drug armoury against gonorrhoea. In June, the FDA accepted a new drug application for zoliflodacin, co-developed by Innoviva Specialty Therapeutics and Global Antibiotic Research & Development Partnership (GARDP). Zoliflodacin’s PDUFA date is assigned for 15 December 2025, four days later than that for gepotidacin. A major milestone in the gonorrhoea treatment space occurred in the UK last week when the NHS rolled out free vaccines for those at high risk of infection. The GSK-developed 4CMenB vaccine is approved to prevent meningococcal B, but a UK vaccine committee recommended its off-label use to curb rising cases. It marks the first time in the world that a vaccine is being used to combat gonorrhoea. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Phase 3Drug ApprovalPriority ReviewClinical ResultVaccine

12 Jun 2025

·pipelinereview.com

FDA Grants Priority Review for Zoliflodacin New Drug Application for the Treatment of Uncomplicated Gonorrhea and Assigns Target PDUFA Date of December 15, 2025

FDA is expected to notify Innoviva Specialty Therapeutics regarding its decision to conduct an Advisory Committee Meeting in the Day 74 letter If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades WALTHAM, MA, USA & GENEVA, Switzerland I June 12, 2025 I Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for zoliflodacin, an investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. The FDA assigned a target action date of December 15, 2025 under the Prescription Drug User-Fee Act (PDUFA). It is expected the FDA will notify Innoviva Specialty Therapeutics regarding the FDA’s decision to conduct an Advisory Committee Meeting in the Day 74 letter. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About Uncomplicated Gonorrhea With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections, the World Health Organization (WHO) has identified antimicrobial resistance (AMR) as one of the ten most critical global threats to public health. The bacterium Neisseria gonorrhoeae, which causes gonorrhea, has progressively developed resistance to most classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. About Zoliflodacin Zoliflodacin is an investigational first-in-class antibacterial that is administered in a single oral dose for the treatment of uncomplicated gonorrhea. The oral route of administration simplifies treatment by providing a convenient option for patients unable to receive an intramuscular injection. Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In in vitro studies, zoliflodacin demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae , including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. In a pivotal Phase 3 clinical trial, zoliflodacin demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection with a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of 500mg ceftriaxone followed by 1g of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. Innoviva also markets ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. through an exclusive license from Basilea Pharmaceutica International Ltd, Allschwil. For more information about Innoviva, go to www.innoviva.com . For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com . SOURCE: Innoviva

Phase 3Priority ReviewDrug ApprovalLicense out/inClinical Result

10 Jun 2025

·pipelinereview.com

Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults

WALTHAM, MA, USA & GENEVA, Switzerland I June 10, 2025 I Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections and the World Health Organization (WHO) identifying antimicrobial resistance (AMR) as one of the ten most critical global threats to public health, the bacterium Neisseria gonorrhoeae has progressively developed resistance to many classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. “Today’s acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains,” said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. “We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S.” Recent reports ( The Lancet Infectious Diseases ) of emergent ceftriaxone-resistant infections have heightened the urgency for new antibiotics. Effective treatment options are essential to reducing the burden of disease for individuals and preventing the spread of highly drug-resistant gonorrhea globally. If left untreated, gonorrhea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease. 2 The FDA’s acceptance of the zoliflodacin NDA is based on the totality of data collected from several clinical trials as part of an innovative public-private partnership with GARDP. These trials include a pivotal Phase 3 clinical trial which demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of ceftriaxone followed by 1 week of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. “This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis,” said Dr. Manica Balasegaram, Executive Director, Global Antibiotic Research Development Partnership (GARDP). “If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea.” Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae , including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. This investigational antibacterial is administered in a single, oral dose, simplifying treatment by providing a convenient option for patients unable to receive an intramuscular injection. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world’s countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR ® /BREO ® ELLIPTA ® and ANORO ® ELLIPTA ® . Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO ® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA ® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA ® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA ® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. For more information about Innoviva, go to www.innoviva.com . For information about Innoviva Specialty Therapeutics, go to www.innovivaSpecialtytherapeutics.com . SOURCE: Innoviva

Phase 3Drug ApprovalPriority ReviewLicense out/inNDA

100 Deals associated with Ceftriaxone Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00924	Ceftriaxone Sodium	J01DD04	DB01212

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Arthropathy associated with infection	Australia	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Infection of bone	Australia	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Postoperative infection	Australia	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Skin and skin structure infections	Australia	Juno Pharmaceuticals Pty Ltd.	28 Jan 2003
Genitourinary tract infection	China	Shanghai Roche Pharmaceuticals Ltd.	01 Jan 1998
Lyme Disease	China	Shanghai Roche Pharmaceuticals Ltd.	01 Jan 1998
Reproductive Tract Infections	China	Shanghai Roche Pharmaceuticals Ltd.	01 Jan 1998
Respiratory Tract Infections	China	Shanghai Roche Pharmaceuticals Ltd.	01 Jan 1998
Wound Infection	China	Shanghai Roche Pharmaceuticals Ltd.	01 Jan 1998
Biliary tract infection	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Bone and joint infections	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Gonorrhea	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Infectious Diseases	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Intraabdominal Infections	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Lower Respiratory Tract Infections	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Meningitis	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Pelvic Infection	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Sepsis	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Skin structures and soft tissue infections	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991
Urinary Tract Infections	China	Dongbei Pharmaceutical Group Co. Shenyang No 1 Pharm Co. Ltd.	01 Jan 1991

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ileitis	Phase 2	Canada	Theriva Biologics, Inc.	01 Jun 2015
Infection of ear	Clinical	China	Shanghai Bao Pharmaceutical Co. Ltd.	04 Aug 2025
Nasal infection	Clinical	China	Shanghai Bao Pharmaceutical Co. Ltd.	04 Aug 2025
Peritonitis	Clinical	China	Shanghai Bao Pharmaceutical Co. Ltd.	04 Aug 2025
Pharyngitis	Clinical	China	Shanghai Bao Pharmaceutical Co. Ltd.	04 Aug 2025
Pneumonia	Clinical	China	Shanghai Bao Pharmaceutical Co. Ltd.	04 Aug 2025
HIV Infections	Clinical	United States	Hoffmann-La Roche, Inc.	31 Aug 2001
Neurosyphilis	Clinical	United States	Hoffmann-La Roche, Inc.	31 Aug 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Literature Manual	Phase 2/3	Whipple Disease	64	oral doxycycline +hydroxychloroquine	hmckssfvws(oyahqtmgbx) = trgptrslyz jljbtnkvwi (llswoqeeal ) View more	Non-inferior	17 Feb 2025
				intravenous ceftriaxone+oral trimethoprim-sulfamethoxazole	hmckssfvws(oyahqtmgbx) = qaliohpmpw jljbtnkvwi (llswoqeeal ) View more
NCT05027516 (ResistAZM, CTgov)	Phase 4	Gonorrhea	42	Rocephin (Rocephine®)	bbauzxrlqm(pwjxevtssv) = lqxydvmocr dxqxebeklg (khvweruzhz, tzccqrggja - vavfgmgnrz) View more	-	02 Aug 2024
				Azithromycin+Rocephin (Rocephine® + Azithromycin)	rxloufdoub = hfwgrwoife nmuaajwpzg (yelyletpoz, imgkjoheek - ocdeavttmk) View more
NCT02265406 (PROPHY-VAP, Pubmed \| Lancet Respir Med) Manual	Phase 3	Pneumonia, Ventilator-Associated	319	Ceftriaxone 2 g	tjsilereuw(uwarcruzey) = ontzorroaf tqqfsffteh (uporamhpnb )	Positive	19 Jan 2024
				Placebo	tjsilereuw(uwarcruzey) = hykygcankz tqqfsffteh (uporamhpnb )
NCT04218695 (Pubmed) Manual	Phase 4	Infectious Diseases	30	ceftriaxone	pijeniirpr(hvtvgeirfb) = There were no observed statistically significant differences between groups in incidence of infection, mortality, length of stay, or key laboratory parameters, including C-reactive protein and procalcitonin. ccbvmvvukb (kfzmxugegg )	Negative	01 Jan 2024
				Placebo
NCT05149287 (PROPER, CTgov)	Phase 2	Meniscus disorder \| Inflammation \| Cartilage Injury ... View more	5	Ceftriaxone (Experimental)	xndqzxjsss(wmtgyiynmw) = zoiqihsbyu aqxegapqhz (ltwokljqky, 1.11) View more	-	05 Sep 2023
				Placebo (Placebo)	xndqzxjsss(wmtgyiynmw) = koqstcuamb aqxegapqhz (ltwokljqky, 2.97) View more
NCT01265173 (Pubmed \| Am J Gastroenterol)	Not Applicable	Spontaneous bacterial peritonitis First line	261	Cefotaxime	hrpbybvjuh(xlsnlqjfad) = zdtvdrdbzy dsebasgwlm (yksmrwvxqh )	-	02 Jan 2023
				Ceftriaxone	hrpbybvjuh(xlsnlqjfad) = uvkbmiyzts dsebasgwlm (yksmrwvxqh )
NCT04218695 (CTgov)	Phase 4	Fibrosis \| Liver Cirrhosis	32	Ceftriaxone (Treatment)	krsplbfryd = ojmitvhvzp ovhhpexwdv (qntwvbaksv, dbyaygwodz - ltmusczopk) View more	-	31 Aug 2022
				Normal saline (Placebo)	krsplbfryd = flbqcqdcfp ovhhpexwdv (qntwvbaksv, hpdschvudk - kbiznqqzmb) View more
NCT05216744 (Pubmed \| BMC Infect Dis) Manual	Phase 2	Gonorrhea \| Chlamydia trachomatis infection	125	Ceftriaxone + Doxycycline	leqjncurfd(caqboteeid) = leijhnixmw xcligetnfr (zatmbjjxsl, 88.8 - 99.1)	Positive	09 Jul 2022
				Cefixime + Doxycycline	leqjncurfd(caqboteeid) = iycpurjkzq xcligetnfr (zatmbjjxsl, 87.1 - 98.4)
NCT02334124 (CHOICE, Pubmed \| Lancet Infect Dis)	Not Applicable	Cellulitis	180	Intravenous ceftriaxone at home	zkbfmuwqoq(xqxnhbwqkk) = rirqxrwbie agxdpbkvxb (iylraszsfm ) View more	Positive	01 Oct 2019
				Intravenous flucloxacillin in hospital	zkbfmuwqoq(xqxnhbwqkk) = fkshraoalt agxdpbkvxb (iylraszsfm ) View more
NCT02384200 (CTgov)	Phase 4	Kidney Calculi \| Urinary Tract Infections	86	nitrofurantoin monohydrate+gentamicin+ceftriaxone+ampicillin+Vancomycin (Antibiotic)	bvpmcocxwr = wtasdbfjtb qbsczipert (oweynkxyeo, wkiitpvjow - jxbxjrhcyd) View more	-	22 Aug 2019
				gentamicin+ceftriaxone+ampicillin+Vancomycin (No Preoperative Oral Antibiotics)	bvpmcocxwr = tjlzqddjbd qbsczipert (oweynkxyeo, hmjeujgzsk - plxftlhvus) View more

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