A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.

Start Date03 Jun 2024

Sponsor / Collaborator

Melinta Therapeutics, Inc.

[+1]

NCT05977868

/ TerminatedPhase 4IIT

Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial

This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous (IV) antimicrobial therapy to complex outpatient oral antimicrobial therapy (COpAT) across various infectious diseases (endovascular, bone and joint, skin and soft tissue, pulmonary, gastrointestinal, and genitourinary infections).
All patients referred for outpatient parenteral antimicrobial therapy (OPAT) will be evaluated by the research team with respect to inclusion/exclusion criteria. If determined eligible for enrollment, patients will be approached by a study investigator who will present the COPAT Trial. Once informed consent is obtained, patients will be randomized 2:1 using computer software into experimental or control (standard of care) group, respectively: Experimental: COpAT only on hospital discharge; Control: Conventional OPAT, OPAT transitioned to COpAT later in outpatient setting, or long-acting parenteral lipoglycopeptides. Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2, 6, and 12 weeks after hospital discharge. At the 6-week ID Clinic follow-up, patients will be asked to complete a patient satisfaction survey. The following 2 primary outcomes will be assessed: cure at 3 months using clinical (resolution of infection) and laboratory parameters (improvement in inflammatory markers) and adverse events related to antimicrobial therapy/vascular access complication. The following 3 secondary outcomes will be assessed: overall readmission at 3 months, readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months, and patient satisfaction at 6 weeks. The experimental group is being compared to standard of care in current clinical practice.
As this is a pragmatic clinical trial, patients will not undergo additional invasive testing or procedures.

Start Date04 Aug 2023

Sponsor / Collaborator

West Virginia University

CTR20213149

/ CompletedPhase 1

国产注射用德拉沙星在健康受试者中的安全性、耐受性、药代动力学特征评价以及与原研药的药代动力学比较的I期临床研究

[Translation] Phase I clinical study on the safety, tolerability and pharmacokinetic characteristics of domestic delafloxacin for injection in healthy subjects and the pharmacokinetic comparison with the original drug

1、评价国产注射用德拉沙星在中国健康受试者中单剂和多剂静脉滴注给药后的安全性、耐受性及药代动力学特征； 2、评价国产注射用德拉沙星试验药与对照药（商品名：Baxdela®）单剂静脉滴注给药后的药代动力学相似性，并评价两制剂单剂给药在中国健康受试者中的安全性。

[Translation]

1. To evaluate the safety, tolerability and pharmacokinetic characteristics of domestic delafloxacin injection after single and multiple intravenous infusion in healthy Chinese subjects; 2. To evaluate the pharmacokinetic similarity of the domestic delafloxacin injection test drug and the control drug (trade name: Baxdela®) after single intravenous infusion, and to evaluate the safety of single-dose administration of the two preparations in healthy Chinese subjects.

Start Date20 Feb 2022

Sponsor / Collaborator

Jiangsu Yangtze River Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Delafloxacin meglumine

100 Translational Medicine associated with Delafloxacin meglumine

100 Patents (Medical) associated with Delafloxacin meglumine

302

Literatures (Medical) associated with Delafloxacin meglumine

01 Dec 2025·JOURNAL OF BIOLOGICAL PHYSICS

Structural insight in understanding the impact of mutation at position 88 and 94 of DNA gyrase A of Mycobacterium tuberculosis in developing resistance against delafloxacin

Article

Author: Singh, Satendra ; Rai, Sumit Kumar ; Singh, Dev Bukhsh

DNA gyrase is a target for treating tuberculosis caused by Mycobacterium tuberculosis. Many cases of antibiotic resistance have been reported due to different point mutations in the Chain A of DNA gyrase. Based on literature information on drug-resistance related study for DNA gyrase, we generated 4 different mutant models 3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H by inserting two mutations at each position 88 and 94 in DNA gyrase chain A. Antibiotics Clinafloxacin, Gatifloxacin, Moxifloxacin, Sitafloxacin, Prulifloxacin, Besifloxacin, Delafloxacin, Ozenoxacin were docked with 3ILW_wild to understand their stability, binding affinity, and interaction pattern with the wild-type DNA gyrase (3ILW_wild). Delafloxacin has shown more stable and favorable binding interaction with the 3ILW_wild (BFE, -8.6 kcal/mol). Docking of Delafloxacin with four mutant models (3ILW_G88A, 3ILW_G88C, 3ILW_D94G, and 3ILW_D94H) was performed to understand the impact of these mutations on binding stability and interaction. A complete loss of binding interaction with Ser118 and Pro119 was observed in mutant complexes as compared to 3ILW_wild, suggesting the role of these residues in developing resistance. Molecular dynamics simulations over 100 ns were carried out for the complex of Delafloxacin with 3ILW_wild and four mutant models. Parameters like RMSD, RMSF, radius of gyration, H-bond, and solvent-accessible surface area revealed that the mutant models are more rigid and less flexible as compared to wild-type DNA gyrase, which in turn results in loss of some interactions. It is worth noting that mutation at position 94 of DNA gyrase A has a very profound effect as it shows a positive contribution towards increased resistance due to reduced binding affinity with delafloxacin. This study explains the structural changes and mechanism behind the resistance against Delafloxacin, and may also guide the structural changes required in existing Delafloxacin or other antibiotics to develop new therapeutics to overcome the issue of resistance.

01 Nov 2025·DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE

Delafloxacin and levofloxacin activities on Helicobacter pylori in Bulgaria over four years

Article

Author: Boyanova, Lyudmila ; Katsarov, Nikolay ; Markovska, Rumyana ; Gergova, Galina ; Gergova, Raina ; Kandilarov, Nayden ; Boyanova, Liliya Yordanova ; Kamburov, Victor ; Hadzhiyski, Petyo ; Medeiros, José

Delafloxacin is a potent 4th-generation fluoroquinolone with enhanced activity in acidic environments. However, recently, delafloxacin resistance in facultative anaerobic species has been reported. Thus, we examined levofloxacin and delafloxacin susceptibility of 98 Helicobacter pylori strains in 2020-2023. Minimum inhibitory concentrations (MICs) were detected with E tests. Levofloxacin resistance was 33.7%, while delafloxacin resistance was 2.0% at 1 mg/l (the levofloxacin resistance breakpoint for H. pylori), and 9.2% at 0.125 mg/l (the recently suggested delafloxacin ECOFF for the species). Overall proportion of the strains exhibiting >0.125 mg/l delafloxacin MICs was similar to that in the previous study in 2018-2019 (8.5%). None of the 65 levofloxacin susceptible strains had delafloxacin MICs of >0.125 mg/l. Among levofloxacin resistant strains, delafloxacin MICs >1 mg/l (6.1%, 2/33 strains) were detected only in 2022 and 2023. Briefly, the results showed the much higher activity of delafloxacin over levofloxacin. The high delafloxacin activity in acidic environments is an additional advantage of the newer fluoroquinolone for treating H. pylori infection. Given that fluoroquinolone-based eradication regimens can be used as a second- or third-line therapy for H. pylori, testing the susceptibility of levofloxacin-resistant strains to delafloxacin could provide a useful option for eradication of the frequent and potentially carcinogenic bacteria. New regimens, such as the combination of vonoprazan with delafloxacin and another antibiotic deserve investigation.

03 Jul 2025·Expert Review of Anti-Infective Therapy

An overview of potential combination therapies with ceftriaxone as a treatment for gonorrhoea

Review

Author: Kenyon, Chris ; Vanbaelen, Thibaut ; Santhini Manoharan-Basil, Sheeba ; Kanesaka, Izumo ; Kong, Fabian Yuh Shiong

INTRODUCTION:

Ceftriaxone is the last available single dose therapy for gonorrhea that effectively treats infections at all sites. Over a quarter of isolates are now resistant to ceftriaxone in some countries. The introduction of carefully chosen combination therapy with ceftriaxone could retard the emergence of ceftriaxone resistance.

AREAS COVERED:

This review summarizes the findings of a PubMed search on the use of partner antimicrobial that could be used with ceftriaxone to prevent the emergence and spread of ceftriaxone resistance. We review 16 antimicrobials that could be partnered with ceftriaxone in terms of pharmacokinetic and pharmacodynamic compatibilities, activity against ceftriaxone resistant isolates and probability of antimicrobial resistance emerging.

EXPERT OPINION:

Of these 16 antimicrobials, we reject antimicrobials such as fosfomycin due to poor clinical efficacy and tigecycline due to its considerably longer half-life which would likely select for tetracycline resistance. The most promising agents for combination with ceftriaxone are zoliflodacin, delafloxacin, sitafloxacin, eravacycline and possibly gepotidacin and gentamicin. Clinical studies should be conducted to evaluate the efficacy of these combinations on the eradication of N. gonorrhoeae and their impact on AMR in N. gonorrhoeae and other bacterial species.

News (Medical) associated with Delafloxacin meglumine

07 Aug 2025

·pipelinereview.com

CorMedix to acquire Melinta Therapeutics, Creating Diversified Specialty Company With Strong Presence in Acute Care Settings

BERKELEY HEIGHTS, NJ, USA I August 07, 2025 I CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, and Melinta Therapeutics LLC (“Melinta”), a private commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced a definitive agreement for CorMedix to acquire Melinta. The selling shareholders will receive $300 million in total consideration at closing, including $40 million of CorMedix equity, and will be eligible to receive a regulatory milestone of up to $25 million and royalties on net sales of MINOCIN ® and REZZAYO™. The proposed acquisition will expand CorMedix’s team and commercial platform, and increase the commercial portfolio with six marketed, highly differentiated, hospital- and clinic-focused infectious disease products, including REZZAYO™ (rezafungin for injection), MINOCIN ® (minocycline) for Injection, VABOMERE ® (meropenem and vaborbactam), KIMYRSA ® (oritavancin), ORBACTIV™ (oritavancin), BAXDELA ® (delafloxacin), and an additional well-established cardiovascular product, TOPROL-XL ® (metoprolol succinate). REZZAYO™ is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplantation. The completion of the Phase III study for REZZAYO™ is expected in 1H 2026. “This acquisition is a transformational step in the evolution of CorMedix, providing an attractive revenue base of highly synergistic assets, as well as multiple opportunities to drive future growth. We are excited to acquire Melinta, which enables us to expand our product portfolio in the hospital space while delivering therapies to patients with high unmet need,” said Joseph Todisco, CEO of CorMedix Inc. “I would like to congratulate Christine Ann Miller, Melinta Therapeutics President & CEO, on building a high-performing organization. The combination with Melinta creates a formidable and diversified specialty platform with a deep and experienced team in the hospital acute care and infectious disease arena. This transaction reflects the type of high-impact, cash-flow generating opportunities we are targeting and strengthens our position to further expand, as we strive to create shareholder value through both organic growth and additional acquisitions in the future.” “The synergistic combination of Melinta and CorMedix represents an exciting new chapter in our company’s evolution,” said Christine Ann Miller, President and CEO of Melinta Therapeutics. “Over the past five years, we have built a robust commercial infrastructure with a high-performing team, deep expertise, and relationships within the hospital and acute care ecosystem, while achieving significant revenue growth and sustained profitability. CorMedix recognizes not just our innovative therapies, but the exceptional capabilities of our organization. I’m confident that Melinta’s commercial excellence and proven track record will augment CorMedix’s team and track record of operational execution and success, to create an even stronger platform for future growth.” Strategic and Financial Benefits Terms and Financing Under the terms of the agreement, which has been approved by the CorMedix and Melinta Board of Directors respectively, CorMedix will pay $300 million in upfront consideration, comprised of $260 million in cash and $40 million in CorMedix equity issued to Melinta shareholders of Deerfield Management Company, L.P. (“Deerfield”). The cash consideration will be funded by a combination of CorMedix’s existing cash on hand and the proceeds of a $150 million convertible debt financing with high quality healthcare focused institutional investors, including Deerfield, the terms of which will be described in a Current Report on Form 8-K to be filed by the Company today. The agreement contains an additional regulatory milestone of up to $25 million (payable in cash or shares at CorMedix’s election) for the FDA approval of the expanded indication of REZZAYO™ for prophylaxis of invasive fungal infections in adults undergoing allogeneic blood and marrow transplantation, if this milestone event is achieved by June 30, 2029. Furthermore, the agreement includes tiered royalties on REZZAYO™ U.S. net sales and low-single-digit royalties on MINOCIN ® U.S. net sales. The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the ‘HSR Act’). The Company expects the transaction to close as early as September 1, 2025. Full Year Financial Guidance Advisors Moelis & Company LLC is acting as exclusive financial advisor for CorMedix in connection with the acquisition of Melinta and sole placement agent for convertible debt financing. Willkie Farr & Gallagher LLP is acting as legal advisor to CorMedix in connection with the acquisition of Melinta and the convertible debt financing. RBC Capital Markets is acting as a financial advisor to CorMedix in connection with the convertible debt financing. Goodwin Procter LLP is acting as a legal advisor to Moelis & Company LLC for the convertible debt financing. Conference Call and Webcast Information Management will host a conference call and a live webcast today, August 7, 2025, at 8:30 a.m. ET, to discuss the transaction and CorMedix’s second quarter 2025 financial results. The conference call can be accessed by dialing 1-844-676-2922 from the United States or 1-412-634-6840 internationally. The live webcast will be accessible in the “ Presentations & Events ” section of the CorMedix Investor Relations website or using the following Webcast Link . About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath ® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath ® in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in Total Parenteral Nutrition and Pediatric patient populations in 2025 and also intends to develop DefenCath ® as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com . About Melinta Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: MINOCIN ® (minocycline), REZZAYO™ (rezafungin), VABOMERE ® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA ® (delafloxacin), KIMYRSA ® (oritavancin), and TOPROL-XL ® (metoprolol succinate). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit www.melinta.com . SOURCE: CorMedix

Drug ApprovalPhase 3AcquisitionLicense out/in

02 Dec 2024

·www.businesswire.com

Melinta Joins NHIA Future of Infusion Advisory Council

ALEXANDRIA, Va. & PARSIPPANY, N.J.--( BUSINESS WIRE )--The National Home Infusion Association (NHIA) and Melinta Therapeutics, LLC (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, are pleased to announce the addition of Melinta to NHIA’s Future of Infusion Advisory Council (FIAC). FIAC is a strategic advisory group comprised of manufacturing and service companies that are intensely invested in the home and alternate site infusion industry. The group consistently works with the association staff and Board of Directors to address critical issues, challenges, and opportunities facing this growing segment of healthcare. For Melinta, membership in the FIAC provides the opportunity for critical collaboration with the association and other organizations serving patients requiring infusion therapies. This work helps to enhance continuity of care as patients transition out of the hospital. “We’re excited to join FIAC and collaborate with health care professionals on the patient experience both immediately and long-term,” said John Harlow, Chief Commercial Officer at Melinta. “Through our partnership with NHIA, we have built a stronger understanding of the home infusion marketplace and customer needs, helping us address the changing landscape in outpatient infusion. Together, we can make a real difference in patient care – today and tomorrow.” Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on therapeutic areas with unmet needs to make the greatest possible impact on patients. Through collaboration with health care providers, we ensure the patients who need our therapies receive them. “We look forward to building on our long-standing partnership with Melinta through their engagement in FIAC,” said Connie Sullivan, NHIA President and CEO. “By collaborating with industry leaders in this way, we can improve upon the ways we mutually serve the infusion community, which helps more patients lead healthy, independent lives.” About NHIA National Home Infusion Association (NHIA) is a trade association that represents companies accredited to provide medically necessary infusion therapies to patients with acute and chronic health conditions, as well as companies that manufacture and supply infusion related products and services. Infusion therapy involves patient-specific compounded medications, supplies, and a range of pharmacy, nursing, and other clinical services for delivering care to patients in the home or suite setting. About Melinta Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA ® (delafloxacin), KIMYRSA ® (oritavancin), MINOCIN ® (minocycline) for Injection, ORBACTIV ® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL ® (metoprolol succinate) and VABOMERE ® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, including their important safety information, visit Melinta.com .

Executive ChangeDrug Approval

23 May 2024

·www.biospace.com

Melinta Therapeutics Announces Publication of the Outcomes by Candida Species from the ReSTORE Phase 3 trial and Recently Approved Rezafungin CLSI Breakpoints for Candida glabrata and Candida auris

Publication reaffirms the efficacy of rezafungin for treatment of candidemia and invasive candidiasis (IC) in adult patients across Candida species PARSIPPANY, N.J.--(BUSINESS WIRE)-- Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed ReSTORE phase 3 global clinical trial evaluating REZZAYO® (rezafungin for injection) for the treatment of candidemia and invasive candidiasis (IC) in adults. The data analyses in the article, “Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis,” published in the American Society for Microbiology Antimicrobial Agents and Chemotherapy, demonstrates the efficacy of rezafungin in adult patients across a variety of Candida species. Rates of global cure and mycological eradication at day 14 and all-cause mortality at day 30 were generally comparable between the two treatment groups. The article additionally highlights the approval of the Clinical and Laboratory Standards Institute (CLSI) susceptibility breakpoints for rezafungin against several Candida species including Candida glabrata, a species increasingly associated with reduced susceptibility to treatment with echinocandins, and Candida auris, a highly resistant pathogen that is associated with life-threating infections. Rezafungin is the only antifungal, based on in vitro data, that has a defined susceptibility breakpoint for C. auris approved by CLSI; the efficacy of rezafungin in treating candidemia or invasive candidiasis caused by this pathogen has not been established in adequate and well-controlled clinical trials. Christine Ann Miller, president and chief executive officer of Melinta Therapeutics, said, "We are delighted with the release of this analysis of data from the ReSTORE Phase 3 trial, which supports the effectiveness and safety of REZZAYO in comparison to caspofungin and are also pleased to see that CLSI approved the REZZAYO susceptibility breakpoints for Candida pathogens, including C. auris, which has been identified as a potential global threat by the CDC and WHO.” She added, "Melinta has been leveraging our expertise in hospital and acute care environments to commercialize REZZAYO, making it available to healthcare providers and their patients affected by candidemia and invasive candidiasis. This effort supports our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses." Melinta holds the exclusive rights to commercialize rezafungin in the U.S. from Mundipharma. About REZZAYO® (rezafungin for injection) REZZAYO (rezafungin for injection) is a novel once weekly echinocandin approved in the United States for the treatment of candidemia and invasive candidiasis in adults. REZZAYO is currently being studied for the prevention of invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. INDICATIONS AND USE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. IMPORTANT SAFETY INFORMATION Contraindications REZZAYO is contraindicated in patients with known hypersensitivity to rezafungin or other echinocandins. Warnings and Precautions Infusion-related Reactions: REZZAYO may cause infusion-related reactions, including flushing, sensation of warmth, urticaria, nausea, or chest tightness. If these reactions occur, slow or pause the infusion. Photosensitivity: REZZAYO may cause photosensitivity. Advise patients to use protection from sun exposure and other sources of UV radiation. Hepatic Adverse Reactions: Abnormalities in liver tests have been seen in clinical trial patients treated with REZZAYO. Monitor patients who develop abnormal liver tests and evaluate patients for their risk/benefit of continuing REZZAYO therapy. Adverse Reactions Most common adverse reactions (incidence ≥ 5%) are hypokalemia, pyrexia, diarrhea, anemia, vomiting, nausea, hypomagnesemia, abdominal pain, constipation, and hypophosphatemia. Please see the full Prescribing Information for REZZAYO (rezafungin for injection), available at . About Melinta Therapeutics, LLC Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Our portfolio currently includes seven commercial-stage products: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO® (rezafungin for injection), TOPROL-XL® (metoprolol succinate) and VABOMERE® (meropenem and vaborbactam). For more information about Melinta Therapeutics, our commitment to patients, and to learn about our portfolio of therapies, visit .

Phase 3Drug ApprovalLicense out/inClinical Result

100 Deals associated with Delafloxacin meglumine

External Link

KEGG	Wiki	ATC	Drug Bank
D09331	Delafloxacin meglumine	J01MA23	DB11943

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bacterial Infections	Canada	Xediton Pharmaceuticals, Inc.	01 Jan 2025
Community Acquired Pneumonia	European Union	A. Menarini Industrie Farmaceutiche Riunite Srl	16 Dec 2019
Community Acquired Pneumonia	Iceland	A. Menarini Industrie Farmaceutiche Riunite Srl	16 Dec 2019
Community Acquired Pneumonia	Liechtenstein	A. Menarini Industrie Farmaceutiche Riunite Srl	16 Dec 2019
Community Acquired Pneumonia	Norway	A. Menarini Industrie Farmaceutiche Riunite Srl	16 Dec 2019
Community-acquired bacterial pneumonia	United States	Melinta Subsidiary Corp.	19 Jun 2017
Skin and skin structure infections	United States	Melinta Subsidiary Corp.	19 Jun 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Surgical Wound Infection	Phase 3	Italy	A. Menarini Industrie Farmaceutiche Riunite Srl	25 Sep 2019
Gonococcal urethritis	Phase 3	United States	Melinta Therapeutics, Inc.	23 Jan 2014
Erysipelas	Phase 3	United States	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Croatia	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Israel	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Latvia	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Russia	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Spain	Melinta Therapeutics, Inc.	01 Apr 2013
Erysipelas	Phase 3	Ukraine	Melinta Therapeutics, Inc.	01 Apr 2013
Skin Diseases, Bacterial	Phase 3	United States	Melinta Therapeutics, Inc.	01 Apr 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04042077 (DRESS, CTgov)	Phase 3	Surgical Wound Infection	268	Delafloxacin (Delafloxacin)	aocjwnxgkg = hdrevsmlbt ewcrrqnkvi (mafcbqkuwz, dscmzkvzrn - utuafilbkh) View more	-	29 Oct 2021
				Tigecycline+Piperacillin/Tazobactam+Linezolid+Vancomycin (Best Available Therapy)	aocjwnxgkg = ptyqkqkauu ewcrrqnkvi (mafcbqkuwz, jhfbyahhpo - djnctdwaaw) View more
NCT02679573 (DEFINE-CABP, CTgov)	Phase 3	Community-acquired bacterial pneumonia	860	Delafloxacin (Delafloxacin)	dkarfjnhej = mugkvedobu coqcuteiaw (kcotjuphjs, vtpmnxrrsg - cozjgldbwf) View more	-	27 Feb 2020
				Moxifloxacin+Linezolid (Moxifloxacin/Linezolid)	dkarfjnhej = bfyipghqmm coqcuteiaw (kcotjuphjs, tubbagxpyj - negwfvtltk) View more
NCT03534622 (DEFINE-CABP, Pubmed) Manual	Phase 3	Community-acquired bacterial pneumonia	-	Delafloxacin	lorlxmqxdw(flxlfcjuzb) = zskwpfboag avleyzdlup (engfghlczw ) View more	Non-inferior	05 Dec 2019
				Moxifloxacin	lorlxmqxdw(flxlfcjuzb) = ibqmbqmviq avleyzdlup (engfghlczw ) View more
NCT02015637 (Pubmed \| Sex Transm Dis) Manual	Phase 3	Gonorrhea	328	Delafloxacin	mhumhgqoyp(qarargbval) = loylwwogab cqmhhcplxt (wbcqtcbhyn )	Non-superior	01 May 2019
				ceftriaxone	mhumhgqoyp(qarargbval) = dlwkperefg cqmhhcplxt (wbcqtcbhyn )
NCT01811732 \| NCT01984684 (Pubmed \| Open Forum Infect Dis)	Phase 3	Skin and skin structure infections	-	Delafloxacin	xhwwlaynop(itbuxvdxis) = bufyayzrym rqtvfvohea (ohtoluvkep )	-	01 Oct 2018
				Comparators	xhwwlaynop(itbuxvdxis) = plrovpjkvs rqtvfvohea (ohtoluvkep )
NCT01984684 (Pubmed) Manual	Phase 3	Skin and skin structure infections First line	850	Delafloxacin	pphooukmsr(rqgoiiyzol) = vjgysjmikt ctfgtjbatf (vyicracxlx ) View more	Non-inferior	16 Aug 2018
				vancomycin+aztreonam	pphooukmsr(rqgoiiyzol) = fzniagogch ctfgtjbatf (vyicracxlx ) View more
NCT02015637 (CTgov)	Phase 3	Gonococcal urethritis	460	Delafloxacin (Delafloxacin)	cotqnnyqtv: Difference in cure rate = -5.9 (95% CI, -13.18 to 1.36) View more	-	26 Apr 2018
				Ceftriaxone (Ceftriaxone)
NCT01811732 (Pubmed \| J Antimicrob Chemother) Manual	Phase 3	Skin and skin structure infections	660	delafloxacin	vzrwhluxgs(zbtebwdovf) = ripcysuiaq tossioqcvt (fzxhqtnltb ) View more	Non-inferior	01 Dec 2017
				vancomycin+aztreonam	vzrwhluxgs(zbtebwdovf) = yfaubduhqd tossioqcvt (fzxhqtnltb ) View more
NCT01984684 (CTgov)	Phase 3	Skin Diseases, Bacterial \| Erysipelas	850	delafloxacin (Delafloxacin)	dhfrnyvczj: Difference in Responder Rates = 3.1 (95% CI, -2.0 to 8.3) View more	-	28 Aug 2017
				aztreonam+vancomycin (Vancomycin Plus Aztreonam)
NCT01811732 (CTgov)	Phase 3	Skin Diseases, Bacterial \| Erysipelas	660	Placebo+Delafloxacin (Delafloxacin Plus Placebo)	sqpjmcrmkr = xdjdisnncv swiirmjalg (mlvsbdusms, dutdnmvfwe - ckamberdeg) View more	-	24 Aug 2017
				Placebo+Aztreonam+Vancomycin (Vancomycin Plus Aztreonam + Placebo)	sqpjmcrmkr = twcpjiqfik swiirmjalg (mlvsbdusms, cpmvtzbxqw - qsknfhhfky) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis