The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.

开始日期2025-06-01

申办/合作机构

Medical University of Silesia

[+1]

NCT05521880

/ Terminated临床4期IIT

Anchoring Intermittent Long Acting Antimicrobials to Medication for Opioid Use Disorder Treatment to Facilitate Structured Transitions of Care for People Who Use Drugs Admitted to the Hospital With Invasive Infections

Standard of care for patients with opioid use disorder and complicated infections is discharge to subacute nursing facilities on IV antibiotics until completion of treatment course. We aim to determine the efficacy of an alternative strategy using intermittent outpatient oritavancin therapy dosed weekly combined with initiation and continuation of medication assisted treatment for opioid use disorder for completion of antimicrobial therapy in a 12 week prospective, open-label study. Patients hospitalized for a drug use related infection and thought to need prolonged parenteral antimicrobial therapy will be assessed by a substance use consultant and Infectious Diseases service. If they are not on Medication for Opioid Use Disorder (MOUD), they will be assessed for initiation of MOUD. A collaborative multidisciplinary discharge planning process will be initiated and will involve linkage to care. If they have an infection with a gram positive organism, and are thought to be clinically stable for hospital discharge, they will be assessed for appropriateness for oritavancin and first dose will be administered prior to discharge. They will have an intake into an opioid treatment program where they can access collocated services and will be discharged with linkage to care through a peer recovery coach. They will be assessed in this collocated clinic post discharge for optimization of MOUD and progress of infection and subsequent dose/s of oritavancin will be administered. Patients will be followed for 12 weeks for cure/completion of therapy and MOUD outcomes.

开始日期2024-07-15

申办/合作机构

University of Maryland Baltimore

NCT05599295

/ Recruiting临床2期

A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin vs SoC for the Treatment of Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs).
This study involves two oritavancin products, ORBACTIV? and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both).
The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

开始日期2023-06-15

申办/合作机构

Melinta Therapeutics, Inc.

100 项与奥利万星磷酸盐相关的临床结果

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100 项与奥利万星磷酸盐相关的转化医学

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100 项与奥利万星磷酸盐相关的专利（医药）

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470

项与奥利万星磷酸盐相关的文献（医药）

2025-08-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Unveiling the effect of chemical degradation on cyclic lipoglycopeptide Oritavancin using Orbitrap mass spectrometry

Article

作者: Gandhi, Gunjan ; Sharma, Nitish ; Paritala, Sree Teja ; Dongare, Jayesh

Oritavancin is the second-generation approved semisynthetic cyclic lipoglycopeptide by the United States Food and Drug Administration (USFDA) for acute bacterial skin and skin-structure infections which serves as a last resort of treatment. Unlike other lipoglycopeptides, the stability behavior of Oritavancin was least explored, which is a prerequisite. The current study endeavors to elucidate the oxidative, hydrolytic, thermal and photolytic stability behavior of Oritavancin by exposing the drug to respective stress conditions. A simple liquid chromatography (LC) method was developed, where significant resolution between Oritavancin and the generated degradation products was achieved. In total 13 degradation products were identified under various stress conditions. Using LC-HRMS, MS/MS studies, the generated degradation products were identified and characterized. The intact mass for DP-2,7,12 was m/z 724.7219(2), DP-6,11, 13 was m/z 796.2672(2), DP-3,10 was m/z 643.6953(2). However isomeric mass as of ORT intact form was seen for DP-4 and unique masses were identified for DP-1,4,8,10 with m/z 725.4293(2), m/z 905.2965(2), m/z 863.2896(2), m/z 904.2890(2) respectively. The mechanistic fragmentation pathway for all the generated DP's were established and the plausible structure for the identified DP's were postulated based on the MS/MS data. According to the findings, Oritavancin is highly susceptible to photolytic, thermal and hydrolytic condition and least susceptible under oxidative condition. The developed reversed-phase high-performance liquid chromatographic (RP-HPLC) method was validated in accordance with ICH guidelines for Oritavancin using C₁₈ analytical reverse-phase column which could be utilised for routine quality control and therapeutic drug monitoring of Oritavancin.

2025-07-08·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

Oritavancin in a patient with recurrent endocarditis by Enterococcus faecalis: a new therapeutic option?

Article

作者: Bongiovanni, Marco ; Turicchi, Giulia

2025-07-01·CLINICAL ORTHOPAEDICS AND RELATED RESEARCH

CORR Insights®: Can Oritavancin Be Used for Treatment and/or Suppressive Antimicrobial Therapy of Bone and Joint Infections Caused by Vancomycin-resistant Enterococcus faecium?

Article

作者: Webb, Matthew L.

项与奥利万星磷酸盐相关的新闻（医药）

2025-08-07

·PipelineReview

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

上市批准临床3期并购引进/卖出

2025-06-19

·CPHI制药在线

环肽的药理作用研究进展(一）

关注并星标CPHI制药在线环肽是在蛋白质或非蛋白质氨基酸之间以环状序列通过酰胺键形成的多肽链，多来源于自然状态，是克服肽类缺点的有效途径之一。与传统的直线肽相比具有更高的细胞渗透性和更好的生物学活性，其具有的有限构象柔韧性极大地增加了它们的代谢稳定性，并提高了它们对靶标的结合亲和力和特异性。另外，环肽的表面积较大，在降低吉布斯自由能的熵项中起着重要作用，使这些分子以非常高的亲和力与多种不相关的受体结合，并且环肽比直线肽缺少了氨基和羧基末端官能团，使整体结构更耐降解，延长作用时间，这些特点使其在药学领域具有广泛应用。1、抗癌环肽环肽的独特构象约束提供了更大的表面积来同时与靶点相互作用，与线性肽相比，提高了膜的通透性和体内的稳定性。从机制上讲，环肽可以通过多种机制发挥抗癌活性，包括膜破坏和随后的坏死、细胞凋亡、肿瘤血管生成抑制、免疫调节、破坏细胞信号通路、细胞周期调节、DNA 修复通路和细胞死亡通路。此外，环肽与现有的抗癌药物显示出协同作用。因此，天然环肽是开发新型抗癌药物的有效先导化合物。嗜冷菌素A-H是从不同的青霉菌株中发现的环三肽。研究显示，嗜冷菌素D对P388鼠白血病细胞具有可接受的抗癌活性范围；嗜冷菌素G显示出对HepG2肝癌细胞具有明显的降脂能力；而嗜冷菌素E对 HCT116 (结肠) 细胞系表现出选择性抗增殖活性，比顺铂更有效。裸藻肽A和B是从蘑菇裸藻(Gymnopus fusipes)中分离出的两个高度N甲基化的环肽。研究发现，裸藻肽A 和B在许多人类癌细胞系(例如皮肤表皮细胞系(A431)，宫颈细胞系 (Hela)和乳腺癌细胞系(MCF7，T47D 和MDAMB-231)中显示出潜在的抗增殖活性。Reniochalistatin A-E是一种从中国南海永兴岛采集的海生海绵 Reniochalina stalagmitis 中分离的四种环七肽和一种环八肽，研究表明，环状八肽Reniochalistatin E对骨髓瘤 RPMI-8226和胃MGC-803细胞具有生物活性，IC50 值分别为4.9 μmol / L和9.7 μmol / L。巴利沙福肽（balixafortide）是一种含有14个氨基酸的环肽，是一种趋化因子受体 4型（CXCR4）拮抗剂，能抑制肿瘤生长和转移，并激活肿瘤微环境中的免疫反应。莫替沙福肽（motixafortide）是一种合成环肽，是CXCR4（一种趋化因子受体，在包括胰脏癌在内的许多人类癌症中过表达，在肿瘤生长、侵袭、血管生成、转移和治疗抵抗中起关键作用，其过度表达与预后不良有关）的拮抗剂。目前，莫替沙福肽已被授予在欧盟和美国用于治疗胰腺癌以及在美国用于治疗急性髓性白血病的孤儿药资格。2、抗细菌环肽滥用抗生素导致耐药菌株的不断涌现，正日益威胁着人类和动物的健康安全。抗菌肽已成为解决这一问题最有效的武器之一。新型环肽类抗生素由于具有更强的抗菌活性和出色的药动学性质，已受到全世界药物科学家的关注，并展现出了广阔的市场前景和结构研究价值。1944年，英国科学家首次在土壤细菌 Bacillus brevis 中发现短杆菌肽S(gramicidin S，GS)的存在，并在之后的几年里确定其晶体结构和作用机制。继GS之后，科研人员又发现了一系列天然环肽、环肽类似物作为抗生素应用，如杆菌肽、多粘菌素 B、紫霉素、黏菌素、达托霉素、恩维霉素、卷曲霉素、万古霉素、替考拉宁、特拉万星、达巴万星、奥古霉素等。万古霉素是一种经典而功能强大的环状糖肽抗生素，于1958年被 FDA 批准上市，作为治疗耐甲氧西林金黄色葡萄球菌(MRSA)菌血症的一线抗生素用药。万古霉素的结合靶标不是某些特定的酶，而是含有 N-Acglucosamine (NAG) 和 N-Ac-muramic acid (NAM) 的肽。这种结合作用可能抑制 NAG 和NAM 聚合物的生物合成，并进一步阻止形成细菌细胞壁的骨干结构。此外，万古霉素还可能影响交联酶的功能，并进一步影响细菌细胞壁的交联。目前万古霉素已经在临床中广泛使用了近60年。达托霉素是一种从土壤细菌玫瑰链霉菌中分离出来的环状脂肽抗生素。自2003年获得 FDA 批准以来，达托霉素一直被用于治疗革兰阳性细菌引起的严重感染。在临床上，它被认为是抵抗耐药病原体的最后手段。达托霉素包含13个氨基酸残基，其中10个组成环状骨架，其他3个残基( LTrp，D-Asn和L-Asp)与癸酰基脂质体一起形成环状长链。除天然存在的环肽外，人们还通过化学修饰的方法合成一系列半合成的环状脂糖肽，包括2009年FDA 接收的特拉万星（telavancin）和 2014 年相继批准的达巴万星（dalbavancin）以及奥利万星（oritavancin）。这三种新抗生素与万古霉素属于同一种类，均包含 5 个固定残基的共同七肽核心，这些核心充当 D-Ala-D-Ala靶标的主要结合位点，且均含有亲脂性侧链，这些药物与其靶标的结合会阻止肽聚糖前体在细菌细胞壁中的转肽作用。通过微调它们对不同细菌菌株或不同药代动力学特性的活性，其结构上的细微变化可引起药理作用的细微差异。结核病（tuberculosis，TB）仍然是世界上最致命的传染病之一。尽管已经发现了几种抗结核药物，但由于耐药性结核菌株的存在、需要长期治疗以及药物相互作用的不良反应，各种因素阻碍了对抗这种疾病的努力。TB的治疗目前至少需要6个月。潜伏性结核分枝杆菌（Mycobacterium tuberculosis，Mtb）对大多数抗结核药物具有表型耐受性。与人类宿主协同进化的结核分枝杆菌已进化出抵抗宿主引发的亚硝化及氧化应激的机制。研究表明，基因敲除或药物抑制 Mtb 蛋白酶体（Mtb20S）可使非复制状态的 Mtb 在体外对活性氮物质敏感，且无法在小鼠肺部存活，这证实了 Mtb 蛋白酶体是抗结核药物的一个有前景的靶点。研究表明，在印度尼西亚海绵Callyspongia aerizusa中发现的环肽callyaerin A～G中，callyaerins A和B显示出强大的抗结核活性，MIC90值分别为2和5 μmol·L-1，且 callyaerin A 对THP-1 或MRC-5 均未表现出细胞毒性（IC50 >10 μmol·L-1），表明这些化合物具有作为抗结核药物的潜力。3、抗真菌环肽真菌感染的日益流行以及抗真菌药物耐药性的不断增强对公共卫生安全构成了重大挑战。近年来，科学界越来越关注探索环肽作为对抗病原真菌引起的抗真菌感染的有前途的策略。目前已上市的抗真菌类的环肽药物有很多，如棘白菌素类抗真菌药物卡泊芬净（caspofungin）、米卡芬净（micafungin）、阿尼芬净（anidulafungin）和雷扎芬净（rezafungin）等。这类药物主要通过非竞争性抑制真菌细胞壁β-(1，3)-D-葡聚糖合成酶，干扰葡聚糖聚合物合成，破坏细胞壁的完整性和稳定性，加速细胞溶解和死亡。因为人类细胞没有细胞壁，棘白菌素类相对没有毒性。卡泊芬净是首个批准临床使用的棘白菌素类抗真菌药物，于 2001 年获得美国 FDA 许可用于成人和 3个月及以上的儿童患者。卡泊芬净对耐氟康唑、伊曲康唑的念珠菌有较好活性。米卡芬净对念珠菌属、耐唑类和耐两性霉素 B菌株有较好的抑制活性，且在治疗严重念珠菌感染时毒性较小。阿尼芬净具有更大的分布容积和更广的抗菌谱，对白念珠菌的抗菌活性大大高于两性霉素 B、伊曲康唑和氟康唑，在侵袭性真菌病治疗中发挥重要作用。雷扎芬净是一种口服棘珠菌素类抗真菌环肽药物，其主要疗效已被证明用于治疗侵袭性念珠菌感染，同时也适用于肺孢子虫和曲霉菌感染的预防。雷扎芬净具有增强的稳定性、溶解性和改善的药代动力学（即长半衰期）特点，可实现每周一次的剂量给药和前期暴露。这种给药方式可能更适合儿童或老年人以及长期治疗。研究发现，从真菌菌株 MF-347833.83的培养液中分离出一种抗真菌环状六肽ASP2397，该化合物的结构类似于异羟肟酸酯铁氧体，具有螯合铝离子的能力，并对曲霉菌种表现出有效的抗真菌活性，在高浓度(50 μg/ ml)下对哺乳动物细胞无细胞毒性作用，且ASP2397比其他衍生物更易溶，并显示出更大的药物开发潜力。Colisporifungin 是一种在尚未报道过的Colispora cavincola 液体培养液中发现的新型环状去脂肽，结果发现，剂量为2μg/ml 的Colisporifungin可诱导卡泊芬净对病原性真菌产生很强的抗真菌活性，从而使卡泊芬净的IC50从约33 nmol/ L降至6.2nmol / L，效能提高5.3倍。此外，当针对白色念珠菌进行测试时，剂量为1 μg/ml的Colisporifungin 会降低卡泊芬净的 IC50。Theonellamide G是从埃及洪加达红海沿岸的海绵 Theonella swinhoei 中分离出来的一种双环糖肽，它对白色念珠菌和两性霉素B的耐药菌株表现出有效的抗真菌活性。此外，它还对人结肠癌细胞系( HCT-116)具有优异的细胞毒活性。有学者成功从维氏气单胞菌 V03 中分离出四种结构不同的环二肽，它们分别为环（L-Pro-L-Leu）、环（L-Pro-L-Val）、环（D-Pro-L-Ile）和环（L-Pro-D-Tyr），并深入评估了它们的抗菌特性。研究结果显示，这些环二肽对金葡菌、奇异变形杆菌、铜绿假单胞菌以及嗜水气单胞菌等多种细菌病原体均表现出抗菌活性。此外，这些分子展现出作为新型抗真菌药物的潜力，尤其是针对白色念珠菌感染的治疗方面。参考资料[1]陈恩奇,马惠钟,王昱壁,等.环肽在药学领域的应用进展[J].药学学报,2025,60(05):1390-1406.[2]董家潇,宋亚红,李修政,等.环肽的结构多样性及药理作用[J].河北医药,2022,44(19):3009-3013+3019.作者简介：小泥沙，食品科技工作者，食品科学硕士，现就职于国内某大型药物研发公司，从事营养食品的开发与研究。END领取CPHI & PMEC China 2025展会门票来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

2024-12-02

·Business Wire

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 .

高管变更上市批准

100 项与奥利万星磷酸盐相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05271	奥利万星磷酸盐	J01XA05	DB04911

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
皮肤和皮肤结构感染	美国	Melinta Therapeutics, Inc.	2014-08-06

未上市

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
细菌感染	申请上市	加拿大	Xediton Pharmaceuticals, Inc.	2024-08-01
脓肿	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
蜂窝织炎	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
伤口感染	临床3期	美国	Melinta Therapeutics, Inc.	2010-12-01
丹毒	临床2期	美国	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	保加利亚	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	希腊	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	拉脱维亚	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	立陶宛	Melinta Therapeutics, Inc.	2023-06-15
丹毒	临床2期	波兰	Melinta Therapeutics, Inc.	2023-06-15

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临床结果

适应症

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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


NCT02925416 (CTgov)	临床4期	细菌性皮肤疾病 \| 丹毒	22	Oritavancin (Oritavancin/Oritavancin)	繭顧範憲鏇鹹選餘餘構 = 壓簾壓築壓積鏇構遞獵餘衊廠顧艱憲獵窪繭鹽 (齋鬱觸膚壓齋築蓋憲餘, 網選願膚積醖衊廠衊觸 ~ 餘淵糧憲齋繭積鑰鹽築) 更多	-	2024-02-01
				Placebo (D5W)+Oritavancin (Oritavancin/Placebo)	繭顧範憲鏇鹹選餘餘構 = 顧願築選構願廠積構觸餘衊廠顧艱憲獵窪繭鹽 (齋鬱觸膚壓齋築蓋憲餘, 齋構範鹽夢壓餘壓膚蓋 ~ 衊網廠襯艱選範獵夢鏇) 更多
NCT02452918 (CTgov)	临床4期	皮肤和皮肤结构感染 \| 丹毒 \| 蜂窝织炎	17	Oritavancin (Oritavancin 1200 mg Without Concomitant Warfarin Therapy)	壓積選醖繭窪醖製選醖 = 鹽淵鹹衊鏇簾築餘鑰製餘網選選簾鑰遞網鬱鑰 (選衊製襯衊糧網繭鑰憲, 觸窪鹹簾鏇鹹觸窪衊淵 ~ 範顧壓鏇鏇壓構選鑰襯) 更多	-	2023-12-20
				Warfarin+Oritavancin (Oritavancin 1200 mg With Concomitant Warfarin Therapy)	壓積選醖繭窪醖製選醖 = 襯顧膚襯襯糧衊築壓選餘網選選簾鑰遞網鬱鑰 (選衊製襯衊糧網繭鑰憲, 夢願淵襯範艱夢積齋製 ~ 願觸獵鏇觸膚鬱築遞艱) 更多
NCT01252719 (SOLO I, CTgov)	临床3期	脓肿 \| 蜂窝织炎 \| 伤口感染	968	Oritavancin (Single-Dose 1200 mg Oritavancin)	獵積構衊鑰鹽願餘淵鹹 = 鬱鹹壓壓窪壓衊鬱簾窪鏇製衊簾膚遞憲簾壓糧 (衊繭糧積鑰廠艱夢築鹽, 遞鬱鹽鬱襯繭餘壓觸製 ~ 憲窪鏇觸蓋願齋襯顧鑰) 更多	-	2022-08-01
				Vancomycin (Vancomycin)	獵積構衊鑰鹽願餘淵鹹 = 網艱壓鏇廠積顧構製衊鏇製衊簾膚遞憲簾壓糧 (衊繭糧積鑰廠艱夢築鹽, 膚窪遞餘壓夢獵鏇膚膚 ~ 願願選範衊網觸製夢積) 更多
NCT01252732 (SOLO II, CTgov)	临床3期	脓肿 \| 蜂窝织炎 \| 伤口感染	1,019	Oritavancin (Single-Dose 1200 mg Oritavancin)	夢艱衊積壓蓋淵簾鹽鏇 = 襯窪獵壓願膚膚網廠獵衊醖壓艱製齋繭製願窪 (糧壓齋窪願膚廠齋獵壓, 繭觸膚鑰蓋願糧鹽醖鬱 ~ 壓窪鬱艱鬱簾窪範衊鑰) 更多	-	2021-04-13
				Vancomycin (Vancomycin)	夢艱衊積壓蓋淵簾鹽鏇 = 顧築窪廠壓窪膚糧範鹽衊醖壓艱製齋繭製願窪 (糧壓齋窪願膚廠齋獵壓, 顧選糧製壓範鬱觸觸製 ~ 廠窪簾窪鑰糧鹽衊選積) 更多
NCT03873987 (CTgov)	临床1期	皮肤和皮肤结构感染 \| 丹毒 \| 蜂窝织炎	102	Kimyrsa	鹽築鹹觸製鏇築網衊淵 = 鑰顧鏇選壓醖襯廠糧繭積鹹壓簾網鑰蓋鬱繭簾 (願齋糧襯網積糧窪壓鬱, 繭鬱齋觸膚廠壓淵餘廠 ~ 餘願餘餘築鹽餘顧鬱製)	-	2021-04-13
NCT01252719 \| NCT01252732 (SOLO II \| SOLO I, Pubmed) 人工标引	临床3期	皮肤和皮肤结构感染	792	Oritavancin	膚鏇選鬱網網憲窪糧繭(艱膚淵壓齋襯製構糧鬱) = 網願積壓築鏇範觸鏇鹽願鬱糧鹽壓積網夢齋鹽 (壓廠窪獵鏇積醖繭憲廠 ) 更多	积极	2017-01-19
				Vancomycin	膚鏇選鬱網網憲窪糧繭(艱膚淵壓齋襯製構糧鬱) = 網簾齋艱遞壓構淵膚膚願鬱糧鹽壓積網夢齋鹽 (壓廠窪獵鏇積醖繭憲廠 ) 更多
NCT01252732 (SOLO II, Pubmed \| Clin Infect Dis) 人工标引	临床3期	革兰氏阳性细菌感染	1,005	oritavancin	繭鹽鏇顧遞觸鹽鑰遞餘(積鑰窪醖繭遞齋鏇襯選) = 遞憲糧鏇膚獵鬱願膚製醖淵構衊艱範餘餘範糧 (廠衊觸廠淵遞繭糧廠淵 ) 更多	非劣	2015-01-15
				vancomycin	繭鹽鏇顧遞觸鹽鑰遞餘(積鑰窪醖繭遞齋鏇襯選) = 構膚齋窪鹽鏇鬱築製獵醖淵構衊艱範餘餘範糧 (廠衊觸廠淵遞繭糧廠淵 ) 更多
NCT01252719 (SOLO I, Pubmed \| N Engl J Med)	临床3期	细菌性皮肤疾病	475	Oritavancin 1200 mg	鬱觸襯衊糧鏇簾壓窪遞(襯製夢淵願衊獵醖簾糧) = nausea was more common among those treated with oritavancin 構選選鬱遞鑰淵夢齋網 (鬱積艱艱襯積製鏇鏇積 )	积极	2014-06-05
				Vancomycin
NCT00514527 (SIMPLIFI, Pubmed \| Antimicrob Agents Chemother)	临床2期	脓肿 \| 链球菌感染 \| 皮肤和皮肤结构感染 ... 更多	302	Daily-dose group	築糧餘襯憲鬱簾窪獵範(選獵鹽夢簾鬱築願廠艱) = 壓蓋淵衊觸鏇鹹蓋簾鏇製選顧範衊廠壓夢膚積 (憲積齋網窪遞窪壓廠齋 ) 更多	积极	2011-07-01
				1,200-mg-single-dose group	築糧餘襯憲鬱簾窪獵範(選獵鹽夢簾鬱築願廠艱) = 襯憲築積築衊衊鑰夢鹹製選顧範衊廠壓夢膚積 (憲積齋網窪遞窪壓廠齋 ) 更多