A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea

This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.

开始日期2019-11-06

申办/合作机构

Global Antibiotic Research & Development Partnership

NCT03718806

/ Completed临床1期IIT

A Phase 1, Open-Label, Study to Investigate Pharmacokinetics, Effect of Food and Safety of a New Immediate-Release Formulation of Zoliflodacin in Healthy Subjects

This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food.
It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses of zoliflodacin will be assessed within each cohort in a two period cross-over design.
Each subject will receive one of the following regimens per period, depending on cohort, in a sequence according to the randomization schedule (per cohort, subjects will be randomized immediately before dosing in Period 1), separated by a minimum 4 day washout between each period. The actual length of washout period may change pending emerging PK data.
Cohort 1:
* Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast
* Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast
Cohort 2
* Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast
* Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast

开始日期2018-10-03

申办/合作机构

Drugs for Neglected Diseases initiative

[+1]

NCT03404167

/ Completed临床1期IIT

A Phase 1 Clinical Trial to Evaluate the Plasma Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Subjects

The trial is to evaluate the pharmacokinetics and safety profiles of the single-dose of zoliflodacin in eight healthy male or female subjects ages 18 to 45 years inclusive. All subjects will be dosed in the morning of Day 1 in a staggered fashion with a minimum of several minutes apart. Each subject will receive a single 4g dose of zoliflodacin (2 x 2 g sachets of zoliflodacin) after at least an 8-h fast, which will continue for at least 4 h after dosing. Consumption of water will be permitted during the fasting period. Subjects will be monitored as inpatients in the Clinical Trial Unit (CTU) up to Day 4 and at the Final Visit (Day 8 ± 2). Study duration is approximately 4 weeks with subject participation duration up to 10 days (from dosing to final visit). The primary objective of this study is to evaluate the plasma PK of zoliflodacin after administration of a single 4-g oral dose under fasting conditions.

开始日期2018-02-02

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 Zoliflodacin 相关的临床结果

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100 项与 Zoliflodacin 相关的转化医学

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100 项与 Zoliflodacin 相关的专利（医药）

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项与 Zoliflodacin 相关的文献（医药）

2025-01-10·FEMS MICROBIOLOGY LETTERS

In vitro evolution of ciprofloxacin resistance in Neisseria commensals and derived mutation population dynamics in natural Neisseria populations

Article

作者: Robinson, Leah R ; McDevitt, Caroline J ; Quail, Sophie L ; Wadsworth, Crista B ; Regan, Molly R

Abstract:

Commensal Neisseria are members of a healthy human oropharyngeal microbiome; however, they also serve as a reservoir of antimicrobial resistance for their pathogenic relatives. Despite their known importance as sources of novel genetic variation for pathogens, we still do not understand the full suite of resistance mutations commensal species can harbor. Here, we use in vitro selection to assess the mutations that emerge in response to ciprofloxacin selection in commensal Neisseria by passaging four replicates of four different species in the presence of a selective antibiotic gradient for 20 days; then categorized derived mutations with whole genome sequencing. Ten out of sixteen selected cells lines across the four species evolved ciprofloxacin resistance (≥1 ug/ml); with resistance-contributing mutations primarily emerging in DNA gyrase subunit A and B (gyrA and gyrB), topoisomerase IV subunits C and E (parC and parE), and the multiple transferable efflux pump repressor (mtrR). Of note, these derived mutations appeared in the same loci responsible for ciprofloxacin-reduced susceptibility in the pathogenic Neisseria, suggesting conserved mechanisms of resistance across the genus. Additionally, we tested for zoliflodacin cross-resistance in evolved strain lines and found 6 lineages with elevated zoliflodacin minimum inhibitory concentrations. Finally, to interrogate the likelihood of experimentally derived mutations emerging and contributing to resistance in natural Neisseria, we used a population-based approach and identified GyrA 91I as a substitution circulating within commensal Neisseria populations and ParC 85C in a single gonococcal isolate. A small cluster of gonococcal isolates shared commensal alleles at parE, suggesting recent cross-species recombination events.

2024-11-01·INTERNATIONAL JOURNAL OF STD & AIDS

Assessing novel partner antimicrobials to protect ceftriaxone against gonococcal resistance: An in vitro evaluation

Article

作者: de Block, Tessa ; Manoharan-Basil, Sheeba Santhini ; Van Den Bossche, Dorien ; Baranchyk, Yuliia ; Gestels, Zina ; De Baetselier, Irith ; Kenyon, Chris ; Abdellati, Saïd

Background:

The emergence of ceftriaxone-resistant Neisseria gonorrhoeae poses a significant threat to existing treatment regimens. Our study aimed to assess the efficacy of antimicrobials that could be combined with ceftriaxone to reduce the probability of ceftriaxone resistance emerging and spreading in N. gonorrhoeae.

Methods and Results:

Broth microdilution was used to determine the minimal inhibitory concentrations (MICs) for a panel of ceftriaxone-resistant (WHO X, Y, Z) and ceftriaxone-susceptible (WHO L, N, P) N. gonorrhoeae WHO reference strains for the following antimicrobials: ceftriaxone, doxycycline, azithromycin, zoliflodacin, fosfomycin, pristinamycin, ramoplanin, gentamicin and NAI-107. The MICs for zoliflodacin and pristinamycin for all strains were lower than or equal to the available breakpoints. A checkerboard assay was used to determine the drug-drug combination effect, which showed either an indifferent or an additive effect for all the combinations tested with ceftriaxone.

Conclusions:

The low MICs of zoliflodacin and pristinamycin for the three ceftriaxone-resistant strains suggest that these antimicrobials could be used as partner drugs with ceftriaxone to reduce the probability of ceftriaxone resistance spreading in areas with a high prevalence of ceftriaxone resistance.

2024-10-11·ACS Infectious Diseases

Role of DNA Double-Strand Break Formation in Gyrase Inhibitor-Mediated Killing of Nonreplicating Persistent Mycobacterium tuberculosis in Caseum

Article

作者: Ashwath, Priyanka ; Sarathy, Jansy P. ; Via, Laura E. ; Weiner, Danielle ; Osiecki, Paulina

Tuberculosis is the leading cause of mortality by infectious agents worldwide. The necrotic debris, known as caseum, which accumulates in the center of pulmonary lesions and cavities is home to nonreplicating drug-tolerant Mycobacterium tuberculosis that presents a significant hurdle to achieving a fast and durable cure. Fluoroquinolones such as moxifloxacin are highly effective at killing this nonreplicating persistent bacterial population and boosting TB lesion sterilization. Fluoroquinolones target bacterial DNA gyrase, which catalyzes the negative supercoiling of DNA and relaxes supercoils ahead of replication forks. In this study, we investigated the potency of several other classes of gyrase inhibitors against M. tuberculosis in different states of replication. In contrast to fluoroquinolones, many other gyrase inhibitors kill only replicating bacterial cultures but produce negligible cidal activity against M. tuberculosis in ex vivo rabbit caseum. We demonstrate that while these inhibitors are capable of inhibiting M. tuberculosis gyrase DNA supercoiling activity, fluoroquinolones are unique in their ability to cleave double-stranded DNA at low micromolar concentrations. We hypothesize that double-strand break formation is an important driver of gyrase inhibitor-mediated bactericidal potency against nonreplicating persistent M. tuberculosis populations in the host. This study provides general insight into the lesion sterilization potential of different gyrase inhibitor classes and informs the development of more effective chemotherapeutic options against persistent mycobacterial infections.

项与 Zoliflodacin 相关的新闻（医药）

2025-06-12

·PipelineReview

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

临床3期优先审批上市批准引进/卖出临床结果

2025-06-10

·药明康德

潜在数十年来首款！美国FDA受理小分子疗法上市申请；蛋白尿下降近70%，疗效持续一年！潜在重磅疗法3期结果公布……

潜在数十年来首款！美国FDA受理小分子疗法上市申请Innoviva Specialty Therapeutics今日宣布，美国FDA已受理旗下药品zoliflodacin的新药申请（NDA）。Zoliflodacin是一款潜在“first-in-class”的spiropyrimidinetrione类口服抗生素，设计用于治疗12岁及以上成人和青少年的单纯性淋病。根据新闻稿，如获批准，该药将成为数十年来首个用于治疗淋病的新型抗生素，为当前耐药性日益严峻的感染治疗提供全新选择。FDA此次受理该NDA是基于多项临床试验的完整数据支持，这些试验是在与全球抗菌药物研发伙伴关系（GARDP）合作框架下完成的。其中，关键的3期临床试验结果显示，单次口服zoliflodacin在治疗泌尿生殖道淋病感染方面，在微生物治愈率上不劣于当前标准治疗方案（单次肌肉注射500毫克头孢曲松加口服1克阿奇霉素）。此外，试验中zoliflodacin整体耐受性良好，未观察到严重不良事件或死亡报告。蛋白尿下降近70%，疗效持续一年！潜在重磅疗法3期结果公布Apellis Pharmaceuticals与Sobi近日公布其3期VALIANT研究开放标签期的新数据，该试验评估Empaveli（pegcetacoplan）在治疗C3肾小球病（C3G）及原发性免疫复合物性膜增生性肾小球肾炎（IC-MPGN）中的疗效与安全性。结果显示，与安慰剂相比，Empaveli在第26周实现了蛋白尿下降达68%，差异具有统计学意义。这一疗效在治疗持续一年后仍得以维持。同时，接受Empaveli治疗的患者在估算肾小球滤过率（eGFR）指标上显示出肾功能的持续稳定。此外，在开放标签期开始时从安慰剂转为Empaveli治疗的患者，也观察到与试验早期用药组相近程度的蛋白尿下降与肾功能稳定改善，进一步验证了该药在不同起始时间下的一致的疗效表现。Empaveli整体安全性良好，耐受性与既往研究结果一致，未发现新的安全性信号，支持其在该类补体介导性肾病中的持续开发潜力。美国FDA与欧洲药品管理局（EMA）正在对该药物用于肾病的监管申请进行审评。Empaveli是一款靶向C3补体蛋白的聚乙二醇化（PEGylated）双环肽疗法。双环肽分子集抗体、小分子药物及肽类的特性于一身，具有与抗体类似的亲和性和精确的靶向特异性；同时，由于它们分子量较小，使得其能够快速深入地渗透组织。2021年5月，Empaveli获FDA批准用于治疗阵发性睡眠性血红蛋白尿症（PNH）。2023年2月，它获得FDA批准用以治疗由年龄相关性黄斑变性（AMD）引起的地图样萎缩（GA）。值得一提的是，这款药物被行业媒体Evaluate评为2023年有望获批的十大潜在重磅疗法之一。首款！RNAi疗法在欧盟再获批准Alnylam Pharmaceuticals日前宣布，欧盟委员会（EC）已批准其RNAi疗法Amvuttra（vutrisiran）用于治疗伴有心肌病的转甲状腺素蛋白淀粉样变性（ATTR-CM）患者。根据新闻稿，这一批准使Amvuttra成为获得EC批准可用于治疗ATTR-CM及遗传性转甲状腺素蛋白介导（hATTR）淀粉样变性的多发性神经病（polyneuropathy）的首个RNAi疗法。此次批准主要基于关键3期HELIOS-B研究的积极结果。该研究为一项随机、双盲、安慰剂对照的多中心全球试验。分析显示，Amvuttra在总体和单药治疗人群中均达成所有10项预设的主要与次要终点，显著降低全因死亡与复发性心血管事件，同时改善6分钟步行距离、健康状态、生活质量（KCCQ评分）以及心力衰竭症状与严重程度（NYHA分级）。在总体人群中，与安慰剂相比，Amvuttra在主要复合终点（全因死亡和复发性心血管事件）方面实现了28%的风险降低。在一项预设的次要终点分析中，包括最长36个月的双盲期及6个月的开放标签延长期，该患者群体的死亡率显著下降了36%，进一步印证其临床益处。参考资料：[1] Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults. Retrieved June 10, 2025 from https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-receives-fda-new-drug-application-acceptance-for-zoliflodacin-a-first-in-class-oral-antibiotic-for-uncomplicated-gonorrhea-in-adults/[2] Apellis and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN. Retrieved June 10, 2025 from https://www.globenewswire.com/news-release/2025/06/06/3095128/0/en/apellis-and-sobi-announce-empaveli-pegcetacoplan-showed-sustained-efficacy-at-one-year-in-phase-3-study-for-c3g-and-primary-ic-mpgn.html[3] Alnylam Receives European Commission Approval for AMVUTTRA® (vutrisiran) for the Treatment of ATTR Amyloidosis with Cardiomyopathy. Retrieved June 10, 2025 from https://www.businesswire.com/news/home/20250609199979/en/Alnylam-Receives-European-Commission-Approval-for-AMVUTTRA-vutrisiran-for-the-Treatment-of-ATTR-Amyloidosis-with-Cardiomyopathy免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果突破性疗法加速审批申请上市

2025-06-10

·PipelineReview

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

临床3期上市批准优先审批引进/卖出申请上市

100 项与 Zoliflodacin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11726	Zoliflodacin	-	DB12817

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
淋病	申请上市	美国	Innoviva Specialty Therapeutics, Inc.	2025-06-10

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03959527 (CTgov)	临床3期	淋病	1,011	zoliflodacin (Zoliflodacin)	膚夢鑰夢餘製願選選獵 = 壓鑰醖鹽顧鹹壓淵鹽夢艱膚構鬱淵廠鬱獵範蓋 (蓋壓顧衊觸夢觸襯構構, 醖遞餘顧鏇醖艱糧網鏇 ~ 窪鹹製鬱夢醖範醖鬱膚) 更多	-	2024-07-26
				azithromycin+ceftriaxone (Ceftriaxone and Azithromycin Combination)	膚夢鑰夢餘製願選選獵 = 鑰鹽遞襯膚鑰網鏇繭願艱膚構鬱淵廠鬱獵範蓋 (蓋壓顧衊觸夢觸襯構構, 願製遞壓窪積築獵廠遞 ~ 簾積築壓遞網醖淵構窪) 更多
NCT03959527 (Corporate Publications) 人工标引	临床3期	淋病	930	zoliflodacin	艱蓋齋蓋壓築積壓繭衊(顧鏇廠繭醖繭簾壓鏇鏇) = met 鑰網遞膚餘鑰醖鏇襯觸 (膚蓋夢蓋衊繭顧膚鹽鏇 ) 达到更多	非劣	2023-11-01
				ceftriaxone+azithromycin
NCT03404167 (CTgov)	临床1期	淋病	8	AZD0914	獵製選窪構蓋壓鹽鑰廠(夢願夢鏇遞鹽築願夢齋) = 齋衊醖選簾醖憲積遞醖襯艱鏇鏇積選簾醖構膚 (鏇觸醖廠窪醖窪觸網顧, 7129) 更多	-	2019-03-18
NCT01929629 \| NCT02298920 (Pubmed \| Antimicrob Agents Chemother)	临床2期	-	100	Zoliflodacin	廠鏇壓觸窪窪夢夢淵餘(衊積鹽齋簾積壓網觸膚) = delayed (Tmax, 4h) 鬱夢餘壓齋網簾齋鬱製 (襯鬱艱範遞鏇築艱淵衊 ) 更多	-	2019-01-01
NCT02257918 (Pubmed \| N Engl J Med)	临床2期	淋菌性尿道炎	179	Zoliflodacin 2g	襯窪簾膚膚鬱艱蓋選鏇(製選鏇鬱齋網壓遞遞簾) = 鏇鏇顧觸鹹鏇構築膚襯憲觸齋齋獵構網窪鑰廠 (襯顧製鹹廠齋網糧獵蓋 )	-	2018-11-08
				Zoliflodacin 3g	襯窪簾膚膚鬱艱蓋選鏇(製選鏇鬱齋網壓遞遞簾) = 窪顧齋觸夢範壓窪遞憲憲觸齋齋獵構網窪鑰廠 (襯顧製鹹廠齋網糧獵蓋 )
NCT02257918 (CTgov)	临床2期	淋病	180	AZD0914 (AZD0914/ETX0914 2000mg)	壓觸願艱醖糧醖餘膚構 = 淵衊繭鏇繭醖遞膚壓鹽簾鑰遞鏇鏇鹽積鏇顧網 (窪觸膚築鏇膚糧鏇積顧, 築襯積願構餘鬱齋築構 ~ 選簾簾築衊糧築獵廠衊) 更多	-	2017-02-08
				ETX0914 (AZD0914/ETX0914 3000mg)	壓觸願艱醖糧醖餘膚構 = 襯廠糧鹽夢積壓鏇淵繭簾鑰遞鏇鏇鹽積鏇顧網 (窪觸膚築鏇膚糧鏇積顧, 繭壓蓋觸齋淵簾鏇艱範 ~ 獵鹹憲鹹築醖衊鬱鹹積) 更多