Last update 21 Nov 2024

Ciprofloxacin

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCiprofloxacin is a fluoroquinolone antibiotic used to treat a number of bacterial infections. It can be taken by mouth, as eye drops, as ear drops, or intravenously. It is a second-generation fluoroquinolone with a broad spectrum of activity that usually results in the death of the bacteria. Ciprofloxacin was patented in 1980 and introduced in 1987. It is on the World Health Organization's List of Essential Medicines. The World Health Organization classifies ciprofloxacin as critically important for human medicine. It is available as a generic medication.Common side effects include nausea, vomiting, and diarrhea. Severe side effects include an increased risk of tendon rupture, hallucinations, and nerve damage.

Drug Type

Small molecule drug

Synonyms

Ciprfloxacin Lactate and Sodium Chloride, Ciprofioxacin Lactate, Ciprofloxacin (JP17/USP/INN)

+ [31]

Target

Bacterial DNA gyrase

Mechanism

Bacterial DNA gyrase inhibitors

Therapeutic Areas

Infectious DiseasesDigestive System DisordersOtorhinolaryngologic Diseases+ [4]

Active Indication

PlagueBronchiectasisPyelonephritis+ [17]

Inactive Indication

BurnsCholeraFebrile Neutropenia+ [8]

Originator Organization

Meiji Seika Pharma Co., Ltd.

Active Organization

Bayer HealthCare Pharmaceuticals, Inc.

Bayer Yakuhin Ltd.

Bayer Pharma AG

+ [1]

Inactive Organization

Bayer Healthcare Co., Ltd.

Bayer AG

Novartis AG

+ [3]

Drug Highest PhaseApproved

First Approval Date

JP (01 Jan 1987),

Bacterial Infections

RegulationOrphan Drug (US), Accelerated Approval (US)

Structure

Molecular FormulaC17H18FN3O3

InChIKeyMYSWGUAQZAJSOK-UHFFFAOYSA-N

CAS Registry85721-33-1

247

Clinical Trials associated with Ciprofloxacin

NCT04791579 / Not yet recruitingPhase 2IIT

Prophylactic Antibiotics Following Treatment of Neurogenic Overactive Bladder with Intradetrusor OnabotulinumtoxinA for the Reduction of Postoperative UTI: a Randomized Blinded Placebo-controlled Trial

Injection of Botox into the bladder is a procedure used to treat neurogenic overactive bladder at the Dianne and Irving Kipnes Urology Centre in the Kaye Edmonton Clinic. A common complication following bladder Botox is bladder infection. There are no well-studied preventative antibiotics given at the time of bladder Botox for the reduction of post-operative bladder infection. We are proposing a research study that will randomize participants into two groups - one receiving antibiotics and the other receiving placebo pills following bladder Botox. The main goal of our study is to determine if preventative antibiotics at the time of bladder Botox injection reduces post-operative bladder infection. It will provide a valuable learning opportunity for a trainee starting their academic career through working closely with established researchers across two disciplines. We hope the results of our study can ultimately be used to improve outcomes and safety for a common Urologic procedure. In addition, findings from our study could help reduce unnecessary use of antibiotics resulting in cost savings in the health care system and reduction in the risk of antibiotic resistance.

Start Date01 Nov 2024

Sponsor / Collaborator

University of Alberta

CTRI/2024/09/074256 / RecruitingPhase 1/2IIT

Evaluation of efficacy and safety of ciprofloxacin impregnated catheters in preventing catheter associated urinary tract infections in patients requiring short-term catheterization-An open labelled clinical trial. - NIL

Start Date04 Oct 2024

Sponsor / Collaborator-

NCT05959616 / Not yet recruitingPhase 1IIT

Safety and Feasibility of a Shigella Sonnei 53G Controlled Human Infection Model in Kenyan Adults: a Dose Finding and Dose Verification Study

Diarrhoea caused by Shigella (shigellosis) is of major public health importance. However, there are no licensed Shigella vaccines in routine use, with several candidates still in various stages of clinical development. Shigella human infection studies (HIS) have played a key role in vaccine development. These models also allow for the evaluation of immunity and other non-immunological parameters that are important to understand resistance and/or susceptibility to disease. This is particularly useful in individuals from endemic areas with varying levels of prior exposure and immunity to Shigella. Thus, establishing a Shigella HIS would enable the testing of interventions such as vaccines in a population that would most benefit from a subsequent vaccine and has potential to accelerate vaccine development. Here, the goal is to successfully establish a Shigella sonnei human infection model in Kenyan adults. This will be achieved by conducting dose-finding and dose verification Shigella studies that safely and reproducibly induce ≥60% attack rates. In this study, investigators aim to use Shigella HIS in healthy adults to develop a model as a platform to test vaccines, to study immune responses identifying potential correlates of infection, and non-immunological factors mediating and influencing susceptibility to disease. To achieve this, the study will be carried out in two phases over a period of 12-14 months. Phase A will enroll (N=up to 40 volunteers) and Phase B will enroll an additional (N=30 volunteers). To be eligible to receive a dose of 53G, volunteers must pass the screening visit. Investigators will vary the dose of bacteria in individuals enrolled for challenge to identify the dose needed to cause ≥60% shigellosis (attack rate) (Phase A) followed by testing and demonstrate the reproducibility of the model (Phase B). Thus, the main outcomes of the study will be: (1) optimisation of bacterial dose for infection success (≥60% attack rate); and (2) safety.

Start Date01 Oct 2024

Sponsor / Collaborator

University of Oxford

[+5]

100 Clinical Results associated with Ciprofloxacin

100 Translational Medicine associated with Ciprofloxacin

100 Patents (Medical) associated with Ciprofloxacin

31,309

Literatures (Medical) associated with Ciprofloxacin

01 Apr 2025·DEN Open

Duodenitis associated with ulcerative colitis and pouchitis after total colectomy successfully treated with upadacitinib: A case report

Article

Author: Shimizu, Masahito ; Kojima, Kentaro ; Onishi, Sachiyo ; Kubota, Masaya ; Takada, Jun ; Otani, Kiichi ; Ibuka, Takashi ; Tezuka, Yukari ; Masuda, Naoya

AbstractA 27‐year‐old man had ulcerative colitis (UC) 1 year prior and underwent a colectomy and two‐stage ileal pouch‐anal anastomosis for medically refractory UC 6 months ago. He visited our department with epigastric pain and discomfort, increased stool frequency, and bloody diarrhea. Esophagogastroduodenoscopy revealed continuous diffuse friable mucosa, erosions, and edema in the duodenum, and pouchoscopy revealed multiple ulcers and purulent mucus adhesions. Based on endoscopic and pathological findings, the patient was diagnosed with duodenitis associated with UC and pouchitis, for which he received oral prednisolone (40 mg/day) and ciprofloxacin. The frequency of stools and occurrence of bloody diarrhea reduced, and epigastric pain and discomfort improved after 2 weeks. However, when prednisolone was discontinued, the symptoms worsened, albumin level decreased, and C‐reactive protein level increased. Following this, we administered a 20 mg prednisolone sodium phosphate enema once daily, and the patient's symptoms improved. However, the symptoms relapsed when the enema was discontinued. Assuming that the patient had steroid‐dependent duodenitis associated with UC and pouchitis, we initiated upadacitinib. His symptoms improved within a few days, and biomarkers returned to normal after 1 month. Nine months after initiating the upadacitinib treatment, endoscopic remission was achieved in the mucosa of the duodenum and pouch. The patient has been in clinical remission for 1 year without any adverse events.

01 Apr 2025·Journal of Environmental Sciences

Photochemical properties and toxicity of fluoroquinolone antibiotics impacted by complexation with metal ions in different pH solutions

Article

Author: Cao, Shengkai ; Song, Heming ; Niu, Junfeng ; Zhang, Peng ; Ge, Linke

Acid-base dissociable antibiotic-metal complexes are known to be emerging contaminants in the aquatic environments. However, little information is available on the photochemical properties and toxicity of these complex forms. This study investigated the spectral properties of three fluoroquinolones (FQs) with and without metal ions Fe(III), Cu(II), and Al(III) in solutions under different pH conditions, as well as evaluated the changes in toxicity due to the complex with these metal ions using luminescent bacteria (vibrio fischeri). FQs showed a higher tendency to coordinate metal ions under alkaline conditions compared to neutral and acidic conditions, and the formation of complexes weakened the ultraviolet-absorbing ability of FQs. At pH = 7.0, Cu(II) quenched the fluorescence intensity of FQs. Moreover, their Fourier-transform infrared spectroscopy and X-ray photoelectron spectroscopy were explored, revealing that the coordination sites of Cu(II) in three FQs were situated in a bidentate manner through the oxygen atom of the deprotonated carboxyl group and cyclic carbonyl oxygen atom. This conclusion was further verified by the theory of molecular surface electrostatic potential. In addition, except for complexes of ciprofloxacin-metals, enhanced toxicity of FQs upon coordination with Fe(III) was observed, while reduced toxicity was found for coordination with Cu(II) and Al(III). These results are important for accurately evaluating the photochemical behavior and risk of these antibiotics in aquatic environments contaminated with metal ions.

01 Feb 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

SERS activity of silver nanoparticles and silver-modified 2D graphitic carbon nitride towards ciprofloxacin drug

Article

Author: Al-Saadi, Abdulaziz A ; Tahir, Muhammad N. ; Abdullahi, Mohammed T. ; Al-Saadi, Abdulaziz A. ; Tahir, Muhammad N ; Bello, Abdulraheem K. ; Bello, Abdulraheem K ; Abdullahi, Mohammed T

Herein, silver nanoparticles (AgNPs) and silver-loaded graphitic carbon nitride (Ag@g-C₃N₄) nanocomposites have been synthesized and used as an effective surface-enhanced Raman scattering (SERS) substrates for the detection of low concentrations (10^-14 M) of ciprofloxacin (CIP), a commonly bioactive medication used to treat bacterial illnesses. A combined approach of vibrational spectroscopy and density functional theory (DFT) has been developed to understand the possible modes of analyte (CIP) and SERS substrate (AgNPs and Ag@g-C₃N₄) interactions. Furthermore, it has been noticed that the behavior of drug molecules in terms of SERS response and energetics of interaction changed significantly when interacted with the noble metal AgNPs decorated onto the g-C₃N₄ framework in comparison to only AgNPs as substrate. The most prominent interaction scenario between AgNPs and CIP is likely to be through the -NH moiety of drug molecule with an interaction energy of -306 kcal/mol. Whereas, the CIP molecules adsorbed onto Ag@g-C₃N₄ nanocomposite were more flexible with interaction energy of -107 kcal/mol, suggesting a greater association of analyte with the skeletal modes of substrate leading to Raman enhancements in the low wavenumber region i.e. below 600 cm^-1. Hence, the Ag@g-C₃N₄ nanocomposite-based SERS substrates investigated served two distinct spectral ranges, making them complementary of each other in terms of SERS detection of CIP. The characteristics of the computed frontier molecular orbitals indicated a pronounced amount of charge transfer between the drug and the substrate, highlighting the significance of the chemical mechanism of the overall process. These results represent a successful approach to have an extended spectral range that covers lower wavenumber shifts by applying simple and meaningful modifications to the normally utilized noble metal-based nanoparticles, which can lead to more effective and reliable detection of bioactive drugs.

108

News (Medical) associated with Ciprofloxacin

28 Oct 2024

·www.prnewswire.com

NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission

Meeting discussion to focus on finalizing Phase 3 study design and NDA readiness, ensuring a clear regulatory path for submission based on trial success Parallel preparations in Canada: NeuroSense plans to submit its dossier in Q2 2025, with a regulatory decision on commercialization expected by Q1 2026 CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). The FDA Type C meeting, scheduled for November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements. NeuroSense plans to give an update on the results of the meeting following receipt of the meeting minutes which are expected approximately one month after the meeting. PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in disease progression clinical and biological markers. With an urgent unmet need in ALS, NeuroSense is positioning PrimeC as a potential breakthrough therapy. In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026. The Company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue. This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS. About ALS Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. About ALSFRS-R Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator. About PARADIGM PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time. As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. About PrimeC PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency. About NeuroSense NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings and regulatory decisions, the market opportunity in Canada and securing regulatory approval in global markets. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; that the market opportunity in Canada will not be as currently estimated; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law. Logo - SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultPhase 3Orphan DrugNDA

28 Oct 2024

·pipelinereview.com

Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections

ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades –Company to Host Conference Call on Monday, October 28 th at 8:30 a.m. EDT– DUBLIN, Ireland and CHICAGO, IL, USA I October 25, 2024 I Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. This is the first approved indication for ORLYNVAH™ and the first FDA-approved product for Iterum. “We are so pleased to have achieved this historic milestone and would like to thank all the patients, investigators, Iterum colleagues and Iterum consultants and vendors who participated in the development of ORLYNVAH™. ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians,” said Corey Fishman, Iterum’s Chief Executive Officer. “As the first oral penem approved in the U.S., ORLYNVAH™ offers an excellent alternative treatment option for appropriate patients in the underserved uUTI market. With FDA approval and a clear label, we will renew our efforts to achieve a strategic transaction involving ORLYNVAH™ with the goal of maximizing value for our stakeholders.” The FDA approval of ORLYNVAH™ was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy of ORLYNVAH™ compared to ciprofloxacin (SURE 1) and Augmentin™ (REASSURE) in the treatment of adult women with uUTI. SURE 1 showed superiority to ciprofloxacin in fluoroquinolone resistant infections, while REASSURE showed non-inferiority and statistical superiority to Augmentin™ in the Augmentin™ susceptible population. ORLYNVAH™ was generally well tolerated in both SURE 1 and REASSURE clinical trials. “The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, MD, FIDSA, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital. “Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community.” Conference Call Iterum will host a conference call on Monday, October 28, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows: United States: 1 833 470 1428 / International: 1 404 975 4839 Access code: 936149 The conference call replay will be available in the Events & Presentations section of Iterum’s website following the call. About uUTIs UTIs are among the most common bacterial infections encountered in the community. uUTIs are infections of the bladder occurring mainly in women. Up to 60% of women will have a uUTI in their lifetime. Up to 40% of women with a history of uUTI will have a recurrence of their infection. There are approximately 40 million uUTI prescriptions generated annually in the United States, and we estimate approximately 1% of those infections are caused by pathogens that are resistant to all commonly available classes of oral antibiotics. Rising antibiotic resistance, an aging population with comorbidities and sub-optimal safety profiles of existing oral treatment options are making antibiotic selection more challenging for treating physicians. About ORLYNVAH™ ORLYNVAH™ is a novel oral penem antibiotic for the treatment of uUTI. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode extended spectrum beta-lactamase (ESBL) or AmpC-type beta-lactamases that confer resistance to third generation cephalosporins. INDICATION AND IMPORTANT SAFETY INFORMATION INDICATIONS & USAGE ORLYNVAH™ a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uUTI caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Limitations of Use ORLYNVAH™ is not indicated for the treatment of: Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ORLYNVAH™ and other antibacterial drugs, ORLYNVAH™ should be used only to treat uUTI that are proven or strongly suspected to be caused by susceptible bacteria. Culture and susceptibility information should be utilized in selecting or modifying antibacterial therapy. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONS The most common adverse reactions (≥2%) in patients treated with ORLYNVAH™ were diarrhea, nausea, vulvovaginal mycotic infection, headache, and vomiting. DRUG INTERACTIONS USE IN SPECIFIC POPULATIONS To report SUSPECTED ADVERSE REACTIONS, contact Iterum Therapeutics plc at 1-866-414-SULO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Iterum Therapeutics plc Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received approval of its NDA for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options by the U.S. Food and Drug Administration and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com . SOURCE: Iterum Therapeutics

Phase 3Drug ApprovalFast TrackQualified Infectious Disease Product

28 Oct 2024

·www.biospace.com

Iterum Wins FDA Approval For Oral UTI Antibiotic, Seeks ‘Strategic Transaction’ for Asset

iStock, hapabapa Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders. The FDA on Friday signed off on Iterum Therapeutics’ oral antibiotic sulopenem etzadroxil and probenecid, which will now be marketed as Orlynvah, for the treatment of uncomplicated urinary tract infections in adult women. Orlynvah, Iterum’s first FDA-approved product, is cleared for three designated microorganisms— Escherichia coli , Klebsiella pneumoniae and Proteus mirabilis —and is indicated for women with limited or no available alternative oral antibiotic options. Iterum CEO Corey Fishman in a statement called Orlynvah’s approval a “historic milestone” that “offers new hope for patients suffering from difficult-to-treat uUTIs (uncomplicated urinary tract infections).” Orlynvah is “the first oral penem approved in the U.S.,” Fishman said, noting it is “an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians.” To bring Orlynvah to the market and boost its commercialization efforts, Iterum will “renew” its “efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders,” Fishman said. The FDA’s decision on Friday was backed by Iterum’s clinical data for Orlynvah, including two Phase III trials. In the pivotal late-stage REASSURE study, topline data which were released in January 2024 , the oral sulopenem showed statistical non-inferiority to Augmentin (amoxicillin/clavulanate) in terms of overall response. Orlynvah significantly outperformed Augmentin at overall treatment success. Safety outcomes were comparable between treatment groups. Iterum’s data package also included findings from the pivotal Phase III SURE 1 study, which in June 2020 showed that the oral sulopenem was better than ciprofloxacin in patients with quinolone-resistant infections. SURE 1 also found Orlynvah to be safe, with adverse events developing at a comparable frequency as in the ciprofloxacin-treated group. Iterum filed a New Drug Application to the FDA but failed to secure approval. In July 2021, the regulator handed the Dublin, Ireland-based biotech a Complete Response Letter, noting that while SURE 1 had established that oral sulopenem was superior than ciprofloxacin, Iterum would need to run an additional trial that uses a different comparator drug. Iterum filed its resubmission earlier this year, after which the FDA convened its Antimicrobial Drugs Advisory Committee. The panel was not asked to vote on the approvability of Orlynvah, but Fishman said in a statement after the meeting that the company was “encouraged” by the discussion, “which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI.”

Phase 3Drug ApprovalClinical ResultQualified Infectious Disease Product

100 Deals associated with Ciprofloxacin

External Link

KEGG	Wiki	ATC	Drug Bank
D00186	Ciprofloxacin	S01AE03 J01MA02 S03AA07 S02AA15	DB00537

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plague	US	Bayer HealthCare Pharmaceuticals, Inc.	02 Feb 2015
Bronchiectasis	CN	Bayer Pharma AG	22 Sep 2013
Pyelonephritis	US	Bayer HealthCare Pharmaceuticals, Inc.	25 Mar 2004
Anthrax	JP	Bayer Yakuhin Ltd.	21 Dec 2001
Cholangitis	JP	Bayer Yakuhin Ltd.	22 Sep 2000
Cholecystitis	JP	Bayer Yakuhin Ltd.	22 Sep 2000
Peritonitis	JP	Bayer Yakuhin Ltd.	22 Sep 2000
Pneumonia	JP	Bayer Yakuhin Ltd.	22 Sep 2000
Complicated urinary tract infection	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Sep 1997
Acute sinusitis	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Bone and joint infections	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Complicated intra-abdominal infection	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Cystitis	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Dysentery	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Gonorrhea	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Inhalation Anthrax	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Lower Respiratory Tract Infections	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Prostatitis	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Typhoid Fever	US	Bayer HealthCare Pharmaceuticals, Inc.	26 Dec 1990
Bacterial Infections	JP	Meiji Seika Pharma Co., Ltd.	01 Jan 1987

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Urinary Tract Infections	Phase 1	US	Bayer Pharmaceuticals Corp.	26 Dec 1990

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03354598 (FDA_CDER) Manual	Phase 3	Urinary Tract Infections	1,660	ORLYNVAH (micro-MITTR Population)	slequpesef(bewlbyoqau) = mgzmqrolui mepdqpxsae (hydckxwtvl ) View more	Positive	25 Oct 2024
				Ciprofloxacin (micro-MITTR Population)	slequpesef(bewlbyoqau) = aecpbrdheo mepdqpxsae (hydckxwtvl ) View more
NCT03850379 (Pubmed)	Phase 2	Hematopoietic stem cell transplantation	308	Ciprofloxacin	zcvnisirtx(fzeurecoca) = ewkdgnjhrm scbvcehnhj (yxlqetwmcl ) View more	Positive	15 Jul 2024
				Levofloxacin	zcvnisirtx(fzeurecoca) = bonrnlaqsb scbvcehnhj (yxlqetwmcl ) View more
NCT02773732 (phase 1b, Pubmed)	Phase 1	Refractory acute myeloid leukemia	11	Ciprofloxacin 750 mg	uxcbyrjsvz(uqzijpndsk) = cmzyspjdgc fbxhxqwzle (pjpcujacgn ) View more	Negative	06 Jun 2024
				Ciprofloxacin 1000 mg	uxcbyrjsvz(uqzijpndsk) = vekdinkzao fbxhxqwzle (pjpcujacgn ) View more
NCT03969758 (clinicaltrials.gov PRS ID: NCT03969758, 31/05/2019, Pubmed)	Phase 3	Liver Abscess	140	Ciprofloxacin	lwmacdwpqw(fysbzmrfcq) = kqhljkovgx mgmuftxyzm (ohgkfiedvt ) View more	Positive	20 May 2024
				Cefixime	lwmacdwpqw(fysbzmrfcq) = sipilrnhuv mgmuftxyzm (ohgkfiedvt ) View more
AAN2024	Not Applicable	Myasthenia Gravis	-	Ciprofloxacin	btwktqunzl(cjznheumhe) = ymyaxbkcul xwknteqaxm (qfcnfrcfna )	-	09 Apr 2024
				Levofloxacin	btwktqunzl(cjznheumhe) = jfwkvkzepc xwknteqaxm (qfcnfrcfna )
Pubmed Manual	Not Applicable	Dental Pulp Necrosis	38	modified 3Mix-Simvastatin combinationSimvastatin+cefixime+ciprofloxacin+metronidazole	zmmyubnxan(dhkrlmgmyl) = gjdtcqpylu nkdgdhhxnc (lqmoqloabx )	Positive	01 Apr 2024
				underwent conventional root canal treatment	zmmyubnxan(dhkrlmgmyl) = xuksqgtngw nkdgdhhxnc (lqmoqloabx )
Tandem Meetings ASTCT and CIBMTR2024	Not Applicable	Hematopoietic stem cell transplantation	400	Ciprofloxacin (Allogeneic haematopoietic cell transplantation (allo-HCT))	gbtddxizuf(lbvfnjkmpx) = feecdrapub pjbnbwqoxj (iztvsobdpy ) View more	Positive	01 Feb 2024
NCT04147260 (CTgov)	Phase 1	-	85	Placebo (Placebo QD)	lclyqoihoj(dbhfluahpv) = lephjijbtu fscatxlyqd (larxcszrsn, hfuvymyydg - ipctqaqxhl) View more	-	17 Jul 2023
				BI 730357 (400 mg QD BI 730357)	lclyqoihoj(dbhfluahpv) = rutnlrantx fscatxlyqd (larxcszrsn, jkbpijxbdd - bhmapvigvr) View more
NCT03850379 (not available, Tandem Meetings ASTCT and CIBMTR2023)	Phase 2	Hematopoietic stem cell transplantation	-	Ciprofloxacin	(opfycszvig) = zwkumhumeq gvglbenqle (knpxnxscni ) View more	Positive	01 Feb 2023
				Levofloxacin	(opfycszvig) = qgglvnfjiz gvglbenqle (knpxnxscni ) View more
Pubmed	Not Applicable	Spontaneous bacterial peritonitis First line	261	Cefotaxime	hhwwmxjfdq(yivliuaufg) = kdexolvhoh lgtchesomd (gebsfglkgx )	-	02 Jan 2023
				Ceftriaxone	hhwwmxjfdq(yivliuaufg) = bkbthceotp lgtchesomd (gebsfglkgx )

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