The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
* Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
* Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?
Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.
Participants will:
* Take NTZ or placebo for 3 days
* Receive regular visits from field research assistants
* Provide blood and urine samples

开始日期2025-09-01

申办/合作机构

Johns Hopkins Bloomberg School of Public Health

[+1]

NCT06993974

/ Recruiting临床2期IIT

Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.

Ulcerative colitis (UC) is a chronic inflammatory bowel Disease (IBD) that primarily affects the rectum and colon. The severity and persistence of mucosal inflammation are associated with morbidity and mortality.

开始日期2025-05-30

申办/合作机构

Alexandria University

NCT07086937

/ CompletedN/AIIT

To Compare the Efficacy of Nitrazoxinide Based Triple Therapy Versus Standard Triple Therapy for Eradication of Helicobacter Pylori Infection in Children at a Tertiary Care Hospital

This study aimed at comparing the efficacy of nitazoxanide-based triple therapy versus standard triple therapy for eradication of Helicobacter pylori infection in children at a tertiary care hospital.

开始日期2025-01-01

申办/合作机构

RESnTEC, Institute of Research

100 项与硝唑尼特相关的临床结果

登录后查看更多信息

100 项与硝唑尼特相关的转化医学

登录后查看更多信息

100 项与硝唑尼特相关的专利（医药）

登录后查看更多信息

1,586

项与硝唑尼特相关的文献（医药）

2025-10-01·BIOCHEMICAL PHARMACOLOGY

Novel aryl hydrocarbon receptor agonists as potential anti-inflammatory therapeutics: Identification and validation through drug repurposing

Article

作者: Künze, Georg ; Geisslinger, Gerd ; Buchholz, Mirko ; Köhl, Ulrike ; Metzger, Marco ; Schmidt, Johannes R ; Windshügel, Björn ; Haupt, Janine ; Neser, Christina ; Biermann, Melina K ; Neurath, Markus F ; Siegmund, Britta ; Lehmann, Jörg ; Kalkhof, Stefan ; Müller, Claudia ; Claussen, Carsten ; Scholz, Ulrike ; Schiefke, Ingolf ; Wiltzsch, Vivien ; Keminer, Oliver ; Oliveira da Rocha, Gustavo Henrique ; Zdzieblo, Daniela ; Pliushcheuskaya, Palina

The aryl hydrocarbon receptor (AhR) was shown to be an important regulator of inflammatory processes at epithelial barriers, and is thus considered a therapeutic target for several chronic inflammatory diseases, such as inflammatory bowel disease. We aimed to identify and validate new AhR agonists that sustainably attenuate intestinal inflammation. Using a high-throughput luciferase reporter gene assay, 90 AhR ligands were identified out of 7448 approved and investigational drugs. Out of these, 15 AhR ligands were selected based on substance class, half maximal effective concentration, known toxicity and pharmacokinetic/pharmacodynamic profiles, and preclinical/clinical evaluation status for other indications. While Febuxostat, Nitazoxanide, Rabeprazole, 2-(1'H-indole-3'-carbonyl)-thiazole-4-carboxylic acid methyl ester, 3-Indolepropionic acid, and Indirubin, were already known as AhR agonists, Nabumetone, Teriflunomide, Timapiprant/OC000459, and Caffeic acid phenylethyl ester have not yet been directly described in this context. Six compounds (Daidzein/Equol, as well as compounds no. 19, 22, 49, and 64, not yet disclosed due to pending patent applications) were newly described as AhR agonists. Hit compounds were studied in silico for their molecular interactions with AhR and in vitro for potential immunotoxicity and their ability to induce interleukin (IL)-10 and/or to suppress IL-1β in murine macrophages without significant cytochrome P450 1A1 induction in Caco-2 cells. Five compounds that met these criteria were functionally tested using organoid-based Transwell®-like models derived from gut biopsies. Five candidates restored the epithelial barrier, as evidenced by increased transepithelial electrical resistance and induction of the tight junction proteins claudin-1/-2 and occludin, while exhibiting anti-inflammatory effects, i.e., decreased expression of toll-like receptor 4. Out of these, one compound was selected for future in vivo preclinical studies.

2025-09-01·Molecular Metabolism

Diverse actions of 15 structurally unrelated mitochondrial uncouplers in cells and mice

Article

作者: Shah, Divya P ; Olzomer, Ellen M ; Vancuylenburg, Calum S ; Grams, Robert J ; Santos, Webster L ; Chen, Sing-Young ; Byrne, Frances L ; Hoehn, Kyle L ; Beretta, Martina

OBJECTIVE:

Mitochondrial uncouplers are used as chemical tools to study mitochondrial function in vitro and in vivo, and some molecules are in development for the treatment of metabolic diseases. One problem in the field is that any molecule that increases proton transport into the mitochondrial matrix independent of ATP production can be classified as an uncoupler regardless of off-target activities. Therefore, there are dozens of classes of molecules that exhibit a wide spectrum of phenotypes. Herein we directly compared 15 mitochondrial uncouplers side-by-side in a well-defined cell system to better understand their in vitro dose response profiles and the top molecules with suitable pharmacology and safety profiles were compared in db/db mice.

METHODS:

Fifteen mitochondrial uncouplers were characterised in vitro in CHO-K1 cells. The top five candidates were selected for further characterisation in male db/db mice based on their in vitro dose response and/or tolerability. We tested two doses of each mitochondrial uncoupler in mice and benchmarked their efficacy to a lifestyle intervention of 35% calorie restriction as well as to lean db/+ metabolically healthy mice. Eleven groups of mice were fed ad libitum either; 1) chow (control), 2) chow with 0.15% BAM15 (w/w), 3) chow with 0.2% BAM15 (w/w), 4) chow with 0.1% NEN (w/w), 5) chow with 0.25% NEN (w/w), 6) chow with 0.01% OPC-163493 (w/w), 7) chow with 0.02% OPC-63493 (w/w), 8) chow with 0.015% ES9 (w/w), 9) chow with 0.03% ES9 (w/w), 10) chow with 0.2% NTZ (w/w), and 11) chow with 0.4% NTZ (w/w). Another group of mice was fed chow to receive ∼65% of the average daily food intake of control mice as a model of calorie restriction (CR). Mice were metabolically phenotyped over 4 weeks of treatment with assessment of key readouts including body weight, HbA1c, blood glucose and glucose tolerance tests. At termination, key tissues were collected and plasma was analysed for markers of toxicity.

RESULTS:

Few mitochondrial uncouplers behaved similarly in vitro, with 11 molecules impairing maximal mitochondrial capacity. In vivo, BAM15 dose-dependently improved body weight and metabolic parameters in db/db mice, with 0.2% BAM15 treatment yielding statistically significant improvements in body weight, fat pad weight, glucose tolerance, blood glucose, HbA1c, liver weight and triglyceride content. The next-best treatment was 0.03% ES9 which significantly improved glucose tolerance, blood glucose levels, and HbA1c, but increased body weight, liver size and steatosis relative to db/db controls.

CONCLUSIONS:

Mitochondrial uncouplers BAM15 and ES9 had the greatest dose tolerance range in vitro, while BAM15 had the best overall effects on body weight, glucose control and liver steatosis in db/db mice. This study reveals diverse phenotypes across 15 classes of mitochondrial uncouplers and underscores the need for rigorous evaluation to identify molecules that drive stable mitochondrial respiration without unwanted mitochondrial inhibition or off-target effects. Ultimately, mitochondrial uncouplers should not be generalized and each uncoupler molecule needs to be considered by its own actions in well-defined experimental conditions.

2025-09-01·Multiple Sclerosis and Related Disorders

Effectiveness of anti-CD20 therapies following natalizumab discontinuation: insights from a cohort study

Article

作者: Matos, Sara ; Batista, Sónia ; Nunes, Carla ; Bernardes, Catarina ; Campelo, Isabel ; Cardoso, João ; Carvalho, Inês ; Sousa, Lívia ; Correia, Inês ; Macário, Carmo ; Cunha, Carolina

BACKGROUND:

Natalizumab (NTZ) is a highly effective multiple sclerosis (MS) treatment but carries a high risk of progressive multifocal leukoencephalopathy in JCV-positive patients. Switching to other therapies is sometimes necessary despite the risk of increasing disease activity, even with other highly effective treatments, such as anti-CD20 therapies.

OBJECTIVE:

To evaluate anti-CD20 therapies effectiveness after NTZ discontinuation.

METHODS:

A retrospective study including MS patients who switched NTZ to anti-CD20 therapies: rituximab (RTX), ocrelizumab (OCR), and ofatumumab (OFA). Demographic, clinical, and safety data were analyzed.

RESULTS:

We included 59 patients (41 female). Mean disease duration at data collection was 7,88 ± 6,62 years. The main reason for NTZ discontinuation was safety concerns related to JCV seroconversion and serum titer increase (n = 52). RTX patients had significantly longer and more active disease before transition. Comparing annualized relapse rate (ARR) and EDSS before and after switch, RTX significantly reduced ARR (0,65 vs 0,08; p = 0007) but led to a significant EDSS increase (3,65 vs 4,15; p = 0022). No significant changes were observed for OCR and OFA. ARR reduction was greater with RTX than OCR and OFA (p = 0018), though EDSS variation did not differ. Survival analysis showed no difference in time to disease activity between groups. In this cohort, 70 % of disability progression was due to progression independent of relapse activity (PIRA).

CONCLUSION:

Anti-CD20 therapies appear to be a safe option after NTZ discontinuation, with no rebound disease and stable EDSS. PIRA was the main driver for disability progression, emphasizing the need to control smoldering disease.

项与硝唑尼特相关的新闻（医药）

2025-05-30

·CPHI制药在线

人类诺如病毒及其小分子抑制剂研究进展

关注并星标CPHI制药在线人类诺如病毒（Human norovirus，HuNoV），也被称为诺瓦克病毒，是全球急性胃肠炎的主要原因之一。HuNoV影响所有年龄组，具有高度传染性，特别是免疫系统较弱的人群，并可能导致严重的临床后果。由于 HuNoV 具有遗传变异大、进化快的特点，这给抗病毒药物的研发造成了极大挑战。在全球范围内，大多数胃肠炎病例是由大流行性 GII.4 人类诺如病毒（HuNoV）毒株引起的。据估计，诺如病毒每年导致约 6.84 亿人患病，约 21.2 万人死亡。卫生系统和社会直接成本每年超过600 亿美元。作为一种传染性极强的肠道病原体，其对全球公共卫生造成重大威胁，引起了国际上的广泛关注。目前，还没有批准的疫苗和针对 HuNoV 的特异性治疗方法。诺如病毒（Norovirus，NoV）是无包膜的单股正链 RNA 病毒。HuNoV的RNA 基因组长约 7.7 kb，其基因组由三个开放阅读框（ORF）组成：ORF1 编码一个多聚蛋白，该蛋白被病毒蛋白酶裂解为六个非结构蛋白，其中包括 RNA 依赖的 RNA 聚合酶（RdRp），这是一种促进病毒 RNA 复制的关键酶；ORF2 编码主要衣壳蛋白 VP1，该蛋白结构上分为S和 P区两个相邻的区域，其中 S区形成内核，构成 VP1 的底座；P 区形成拱样结构突出于内核外，可进一步分为 P1和P2亚结构域；ORF3 编码次要衣壳蛋白VP2，VP2具有稳定病毒颗粒的作用。根据VP1 的氨基酸序列，NoV 被分类为至少10个基因组（GI-GX），这些基因组进一步细分为49个基因型。在可感染人类的五种基因组（GI、GII、GIV、GVIII和GIX）中，GI 和GII 突变体是导致肠胃炎病例的主要病原体。特别是 GII.4 基因型长期以来一直是全球胃肠炎暴发的主要原因，其变体每隔 2-4 年就会进化成新的变体，因其高传染性和引发大规模流行病的能力而闻名。NoV基因组测序有助于开发基于核酸的NoV 检测方法。20世纪90年代中期，第一个以 ORF1 中RNA 聚合酶基因相对保守区为靶点的 RT-PCR 被用于检测 NoV。此后，针对 NoV开发了更多实时、快速和灵敏的分子检测方法，包括 RT-qPCR、微滴数字 RT-PCR、多重 RT-PCR、巢式 PCR、高通量测序基因芯片、逆转录环介导等温扩增法等。通过靶向检测ORF1-ORF2 连接处的保守基因组区域，发现基于实时核酸的方法比抗原检测分析更灵敏、更具广泛的反应性。普通 RT-PCR 在电泳过程中易交叉污染。多重 RT-PCR 虽然具有同时检测多种目标分子的优点，但容易发生非特异性扩增。巢式 PCR 无法对病毒定量，耗时长且容易发生交叉污染。近年来，普通 RT-PCR、多重 RT-PCR 等逐步被新方法取代。诺如病毒小分子抑制剂人类诺如病毒抗病毒药物早期研究的进展缓慢，很大程度上是由于其细胞培养系统的建立困难。直到2016 年，人类诺如病毒在源自干细胞的人肠上皮细胞（human intestinal enteroids, HIEs）中的培养系统才初步建立，但 HIEs 系统中的病毒复制量仅为670倍，其有限的病毒复制量仍是研究疫苗和药物的障碍（诺如病毒在B细胞系中的复制量更低）。此外，人类诺如病毒具有物种特异性，无法感染其他物种。此前对人类诺如病毒的认知主要基于其他杯状病毒研究，例如通过鼠诺如病毒在细胞培养和小鼠模型中筛选潜在抗病毒药物。在肠道类器官培养模型中筛选诺如病毒抑制剂成为开发慢性感染治疗的新策略，许多广谱抗病毒药物已在实验中表现出对诺如病毒的抑制活性。1RNA 聚合酶抑制剂HuNoV的RNA 依赖的 RNA 聚合酶（RNA-dependent RNA polymerase，RdRp）在病毒基因组的转录和复制中发挥至关重要的作用，成为抗病毒治疗的重要靶点。RdRp是一种用于病毒复制的酶，在RNA 病毒中高度保守，且在哺乳动物细胞中无同源蛋白，是抗病毒药物研究的重要靶点。HuNoV 的RdRp 结构类似于其他正链 RNA 病毒，具有右手型结构，包括手指、手掌和拇指子结构域，以及连接手指和拇指的 N端结构域。手指和拇指子结构域协作包围手状结构，形成单链模板 RNA 的通道。①核苷类抑制剂RNA依赖性RNA 聚合酶（RdRp）是治疗诺如病毒感染的重要靶点。核苷类抑制剂（nucleoside inhibitors, NIs）作为底物类似物，通过竞争性抑制终止 RNA 合成，通常表现出广谱抗病毒活性。目前发现，针对其他 RNA 病毒开发的核苷抑制剂也可用于诺如病毒感染治疗。法匹拉韦（favipiravir, T-705）是一种前药，在体内快速转化为法匹拉韦三磷酸，通过竞争性抑制病毒复制转录并诱发致命突变。该药物已在部分国家广泛用于流感治疗，并在埃博拉病毒、COVID-19及拉沙热的治疗中发挥作用。法匹拉韦作为嘌呤类似物，可抑制人类诺如病毒复制子。实验表明其对鼠诺如病毒具有疗效，在小鼠模型中通过抗病毒诱变降低病毒载量，并观察到突变频率增加及病毒 RNA 传染性降低。然而，法匹拉韦可能在小鼠和患者体内诱导诱变，用于慢性诺如病毒感染存在潜在风险。利巴韦林（ribavirin）是广谱抗病毒药物，对DNA和RNA病毒均有效，临床用于呼吸道合胞病毒、流感、拉沙热、肝炎及麻疹治疗。利巴韦林通过抑制RdRp发挥作用，对鼠诺如病毒抑制效果显著，是当前治疗诺如病毒感染的主要药物，尤其在原发性免疫缺陷患者的慢性感染中疗效显著。但其与硝唑尼特联用效果存在争议，部分临床数据显示疗效欠佳。2′-FdC（2′-fluoro-2′-deoxycytidine）是核苷类似物，其通过转化为 2′-FdC-三磷酸（FdCTP）并入细胞 DNA/RNA，抑制病毒复制，对HCV、拉沙病毒及克里米亚-刚果出血热病毒等均有效。研究发现，在RAW264.7小鼠巨噬细胞模型中，2′-FdC 能有效抑制鼠诺如病毒传播。能够显著降低 RAW264.7 细胞中 MNV-1 的病毒RNA和NS1/2 蛋白表达。使用 100 μmol·L-1的 2′-FdC 处理后，诺如病毒滴度降低，其抑制 MNV-1 复制的 IC50 值为 20.92 μmol·L-1，RAW264.7 细胞中 2′-FdC 的CC50 值为 1.768 mmol·L-1。为进一步验证 2′-FdC 的功效，研究人员测试了急性清除菌株 MNVCW3 和持续性菌株 MNVCR6，结果显示 2′-FdC 同样能抑制两种病毒株的 RNA 复制及蛋白表达。2′-C-甲基胞苷（2′-C-methylcytidine, 2CMC）最初作为抗 HCV 药物开发，但其前药 Valopicitabine 因胃肠道副作用终止临床研究。然而，2CMC仍被报道为潜在抗诺如病毒药物。研究表明，2CMC 可抑制鼠诺如病毒形成及RNA合成，并在小鼠模型中减少病毒脱落及传播。在人类诺如病毒 BJAB 细胞培养系统中，2CMC的EC50值为0.3 μmol·L-1。研究人员评估了2CMC衍生物，如2FCMC、N-羟基胞苷NHC的活性。在 RAW264.7 细胞中，2CMC 和2FCMC 的EC50 分别为 6.9 μmol·L-1和 12.7 μmol·L-1，而 NHC 和拉米夫定无显著抑制。在 HG23 细胞中，2CMC、NHC和2FCMC的EC50分别为1.3 μmol·L-1、1.5 μmol·L-1和3.2 μmol·L-1。目前研究聚焦于开发更安全的 2CMC 衍生物。4-氨基吡咯[2,1-f][1,2,4]三嗪核苷衍生物具有显著抗诺如病毒活性。其通过修饰糖基和碱基获得系列衍生物，其EC50为0.007~11 μmol·L-1，CC50 为0.01~23.7 μmol·L-1。尽管存在细胞毒性，但其双重抗小鼠和人类诺如病毒活性为后续优化提供了基础。NCT（5-硝基胞苷三磷酸）最初作为抗脊髓灰质炎病毒药物被发现，其抑制 RdRp活性优于利巴韦林。过X射线晶体学测定了诺如病毒聚合酶与NCT结合的高分辨率结构。该结构显示，RdRp被包裹在一个包含互补引物模板RNA和两个金属离子的三元复合物中。NCT分子占据核苷酸结合位点，通过竞争性抑制导致RNA链终止，但其抑制诺瓦克病毒复制的潜力仍需更多实验验证。②非核苷类抑制剂非核苷类抑制剂（non-nucleoside inhibitors, NNIs）通过与RdRp变构位点结合，终止复制所需的构象变化。目前NNIs主要针对HCV或HIV开发，尚无专门针对人类诺如病毒的上市药物。苏拉明（suramin）通过脂质体递送可抑制鼠诺如病毒复制，但其临床应用受限于药代动力学和毒性问题。其衍生物PPNDS最初作为P2X1受体激动剂，后证实对人诺如病毒和MNV RdRp具有强效抑制。PPNDS通过结合RdRp的NAF2位点广泛抑制转录活性。在10 μmol·L-1浓度下，PPNDS对猫诺如病毒聚合酶的IC50达2.7 μmol·L-1。然而，苏拉明及PPNDS因细胞通透性差和非特异性脱靶活性，需进一步优化以克服研发障碍。近年研究发现，HCV NNIs如JTK-109可通过结合Thumb I位点（Q414和R419）抑制杯状病毒科，如诺如病毒属、沙波病毒属和拉戈病毒属等6个RdRp的转录活性，其抑制诺如病毒RdRp的IC50为4.3~16.6 μmol·L-1。NIC02、NIC04、NIC10和NIC12化合物也是潜在的药物支架。通过GTP掺入法动力学研究发现，NIC02和NIC04可同时结合游离酶及酶-底物复合物。而NIC10和NIC12只与酶-底物复合物结合，因此可能与底物结合位点不同的变构口袋结合，所以NIC02和NIC04、NIC10和NIC12在诺如病毒RdRp中可能占据不同的结合位点。23C样蛋白酶抑制剂诺如病毒3C样蛋白酶（3CLpro）是一种半胱氨酸蛋白酶，其核心结构与胰凝乳蛋白酶类似，由N端反平行β折叠和C端β桶结构域组成。活性位点位于两结构域间裂口处，催化三联体（Cys139、His30、Glu54）特异性识别P1 Gln残基，负责病毒多蛋白裂解，生成结构与非结构蛋白。因此，3CLpro是抗诺如病毒药物设计的重要靶点。芦平曲韦（rupintrivir）最初针对人类鼻病毒3CLpro开发，近期研究显示其可抑制人类诺如病毒3CLpro，EC50为（0.3 ± 0.1）μmol·L-1，EC90为（1.5 ± 0.2）μmol·L-1。但A105V和I109V突变可降低病毒对芦平曲韦的敏感性，耐药机制尚不明确。GC376 等一系列 3CLpro 过渡态抑制剂。过渡态类似物竞争性抑制剂在分子结构上与底物相似，在酶促反应中，抑制剂和底物竞争与酶的活性中心结合。过渡态抑制剂目前可分为两类，一类是肽基化合物（如 GC376），研究人员利用诺如病毒蛋白酶在谷氨酰胺-甘氨酸肽位点裂解的特点，通过谷氨酰胺替代物发挥抑制作用。基于此结构开发的一系列变体均显示出高水平抗病毒活性。另一类是大环化合物，作为肽基抑制剂的结构修饰版本，旨在提高膜透性和口服生物利用度以增强临床适用性。尽管其效果不及肽基抑制剂，但表现出对 RNA 病毒的广谱抗病毒活性。3未知作用靶点药物硝唑尼特（nitazoxanide, NTZ）最初作为抗寄生虫药物开发，后证实具有广谱抗病毒活性，临床用于流感及诺如病毒感染治疗。硝唑尼特作为新型药物的支架参与病毒复制的宿主调节过程。硝唑尼特生物利用度高且十分安全，具有丰富的上市后经验，超过7500万成人和儿童服用过此药物。而目前有多项临床实验表明，硝唑尼特对于治疗诺如病毒感染具有显著疗效。目前，其新型制剂正在进行全球III期临床试验，可抑制轮状病毒、冠状病毒、登革热病毒等多种RNA/DNA病毒。参考资料 [1]刘阳.靶向人类诺如病毒RdRp的小分子抑制剂的发现及生物活性评价[D].浙江中医药大学,2024. [2]普春敏,陈丽丽,索玉娟,等.食品中诺如病毒的分离、富集与分子检测技术研究进展[J].上海农业学报,2024,40(05):131-141. [3]孙睿阳,刘永祥,钟武.小分子诺如病毒抑制剂的研究进展[J].沈阳药科大学学报,2023,40(12):1656-1665.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【企业推荐】扫码领取CPHI China2025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~

疫苗

2025-03-19

·GlobeNewswire-Health Care

ANI Pharmaceuticals Announces the Launch of Nitazoxanide Tablets

PRINCETON, N.J., March 19, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Nitazoxanide Tablets, 500 mg. ANI’s Nitazoxanide Tablets are the generic version of the reference listed drug (RLD) Alinia®. "The market launch of Nitazoxanide Tablets, another niche limited competition product, underscores our purpose of ‘Serving Patients, Improving Lives’,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "We share ANI’s commitment to providing affordable, high-quality medicines for the patients who depend on them and are pleased to partner on the launch of this limited competition product,” stated Dr. Jagadeesh Rangisetty, Chief Executive Officer of Biophore. U.S. annual sales for Nitazoxanide Tablets total approximately $36.1 million, based on December 2024 moving annual total (MAT) IQVIA data. About ANI Pharmaceuticals, Inc.ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company committed to its mission of “Serving Patients, Improving Lives" by developing, manufacturing, and commercializing innovative and high-quality therapeutics. The Company is focused on delivering sustainable growth through its Rare Disease business, which markets novel products in the areas of ophthalmology, rheumatology, nephrology, neurology, and pulmonology; its Generics business, which leverages R&D expertise, operational excellence, and U.S.-based manufacturing; and its Brands business. For more information, visit www.anipharmaceuticals.com. About Biophore India Pharmaceuticals Pvt. Ltd.Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche, high quality pharmaceutical products for the generic industry. Since its inception in 2007, Biophore has emerged as a trusted partner for niche and complex products in the generic industry across US, Europe and other regulated markets. For more information, please visit our website, http://www.biophore.com/. Forward-Looking StatementsThis press release contains not only historical information, but also forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent the Company’s expectations or beliefs concerning future events, including statements regarding the benefits of the acquisition of Alimera Sciences. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “continue,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “shall,” “would” other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of our approved products, including Cortrophin Gel, ILUVIEN and YUTIQ, to achieve commercialization at levels of market acceptance that will continue to allow us to achieve profitability; our ability to complete or achieve any, or all of the intended benefits of acquisitions and investments, including the acquisition of Alimera, in a timely manner or at all; the limitation of our cash flow as a result of the indebtedness and liabilities incurred from the recent acquisition of Alimera; the risks that our acquisitions and investments, including the recent acquisition of Alimera, could disrupt our business and harm our financial position and operating results; delays and disruptions in production of our approved products, increased costs and potential loss of revenues if we need to change suppliers due to the limited number of suppliers for our raw materials, active pharmaceutical ingredients, expedients, and other materials; delays and disruptions in production of our approved products as a result of our reliance on single source third party contract manufacturing supply for certain of our key products, including Cortrophin Gel, ILUVIEN and YUTIQ; delays or failure in obtaining and maintaining approvals by the FDA of the products we sell; changes in policy or actions that may be taken by the FDA, United States Drug Enforcement Administration and other regulatory agencies, and the focus of the current U.S. presidential administration, including among other things, drug recalls, regulatory approvals, facility inspections and potential enforcement actions; risks that we may face with respect to importing raw materials and delays in delivery of raw materials and other ingredients and supplies necessary for the manufacture of our products from both domestic and overseas sources due to supply chain disruptions or for any other reason; the ability of our manufacturing partners to meet our product demands and timelines; the impact of changes or fluctuations in exchange rates; our ability to develop, license or acquire, and commercialize new products; our obligations in agreements under which we license, develop or commercialize rights to products or technology from third parties and our ability to maintain such licenses; the level of competition we face and the legal, regulatory and/or legislative strategies employed by our competitors to prevent or delay competition from generic alternatives to branded products; our ability to protect our intellectual property rights; the impact of legislative or regulatory reform on the pricing for pharmaceutical products; the impact of any litigation to which we are, or may become, a party; our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; our ability to maintain the services of our key executives and other personnel; and general business and economic conditions, such as inflationary pressures, geopolitical conditions including but not limited to the conflict between Russia and the Ukraine, the conflict in the Middle East, conflicts related to the attacks on cargo ships in the Red Sea, and the effects and duration of outbreaks of public health emergencies. More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as other filings with the SEC. All forward-looking statements in this news release speak only as of the date of this news release and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. Investor Relations:Lisa M. Wilson, In-Site Communications, Inc.T: 212-452-2793E: lwilson@insitecony.com Source: ANI Pharmaceuticals, Inc.

上市批准

2025-02-10

·GlobeNewswire-Health Care

GENFIT Announces Final Terms for Dual Proposal to the 2025 OCEANEs Holders

In conjunction with the royalty financing deal with HealthCare Royalty (HCRx) announced on January 30, 2025, GENFIT will request the consent of the holders of 2025 OCEANEs and proposes: to repurchase the 2025 OCEANEs at EUR 32.00 per bond from interested bondholders, or alternativelyto pay a consent fee of EUR 0.60 per bond still outstanding after the upcoming bondholder meeting and cancellation of the repurchased 2025 OCEANEs Both proposals are subject to approval of the royalty financing by the 2025 OCEANEs bondholders at the upcoming bondholders meeting and closing of the royalty financing Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), February 10, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the final terms of the 2025 OCEANEs repurchase proposal and the consent fee that would be paid to the holders of 2025 OCEANEs still outstanding after cancellation of repurchased 2025 OCEANEs. Context On January 30, 2025, GENFIT announced that it has entered into a non-dilutive capped royalty financing agreement (the “Royalty Financing”) with HealthCare Royalty (HCRx) for up to €185 million. This transaction significantly extends GENFIT’s cash runway, including after the repayment of its bonds convertible into new shares and/or exchangeable into existing shares due October 16, 2025 (the “2025 OCEANEs”). GENFIT also announced that it intended to offer to interested bondholders to repurchase their 2025 OCEANEs. In the Royalty Financing, HCRx will be compensated and repaid out of a portion of the royalties which GENFIT is eligible to receive on sales of Iqirvo® (elafibranor) pursuant to its long-term strategic partnership with Ipsen. To secure its obligations under the Royalty Financing, GENFIT will transfer the corresponding royalty receivables to a French law trust (fiducie-sûreté) for the benefit of the holders of the royalty financing bonds. The terms and conditions of the 2025 OCEANEs contain a negative pledge clause which limits GENFIT’s ability to grant security interests to its creditors on its present or future assets or revenues. Granting the fiducie-sûreté is not permitted under this clause. The closing of the Royalty Financing (i.e. the payment of the first €130 million under the Royalty Financing) is thus conditioned upon the holders of the 2025 OCEANEs approving an amendment to the negative pledge clause (the “Amendment of Terms”). If the Amendment of Terms is approved1, and the closing of the royalty financing is completed, GENFIT will pay a consent fee (the “Consent Fee”) to the holders of 2025 OCEANEs still outstanding after cancellation of the repurchased 2025 OCEANEs. Concurrently with the Amendment of Terms, GENFIT is proposing to repurchase the 2025 OCEANEs of any interested holder (the “Repurchase” and, together with the Amendment of Terms, the “Transaction”). Dual Proposal to the 2025 OCEANEs holders GENFIT and Natixis, its Solicitation Advisor, have collected feedback from the 2025 OCEANEs holders in order to set the definitive terms of the Transaction. GENFIT proposes: to repurchase 2025 OCEANEs at a price of EUR 32.00 per bond, or alternativelyto pay a Consent Fee of EUR 0.60 per 2025 OCEANE In the coming days, GENFIT will propose to all of the 2025 OCEANEs holders to enter into a Put Option Agreement, pursuant to which GENFIT will unconditionally and irrevocably undertake to repurchase the 2025 OCEANEs of such holder, subject to approval by the general meeting of the 2025 OCEANEs holders of the Amendment of Terms and the closing of the Royalty Financing. After execution of the Put Option Agreement, the holder will have until several days after the closing of the Royalty Financing to exercise its option under the Agreement. Holders of the 2025 OCEANEs who have not entered into the Put Option Agreement or who do not exercise their option will receive the Consent Fee. As stated above, both the Repurchase and the payment of the Consent Fee are subject to (i) the approval by the general meeting of the 2025 OCEANEs holders of the Amendment of Terms, and (ii) the closing of the Royalty Financing. 2025 OCEANEs holders interested in the Repurchase are invited to contact (i) with respect to qualified investors, GENFIT at investors@genfit.com or their usual sales contact at Natixis (the “Solicitation Advisor”), or at ld-m-equityflowsalescb@natixis.com or at ld-secm-syndicateteam@natixis.com, and (ii) with respect to retail holders, the 2025 OCEANEs Bondholders Representative (Représentant de la Masse) at genfit@aetherfs.com. The Consent Fee will only be paid after the Repurchase has taken place. 2025 OCEANEs that have been bought back by GENFIT as part of the Repurchase (or that have been converted prior to 5:00 p.m. (Paris time) on the date falling 2 business days prior to the date of payment of the Consent Fee) will thus not receive the Consent Fee. The terms and conditions of the 2025 OCEANEs contain a clean-up call option at par if the total number of 2025 OCEANEs still outstanding represents 15% or less of the number of 2025 OCEANEs originally issued (that is 912,162 2025 OCEANEs or less, compared to 1,902,698 2025 OCEANEs outstanding as of today). GENFIT undertakes that, following the Repurchase, it will not exercise this clean-up call option until the 2025 OCEANEs reach maturity. In the coming days, GENFIT will convene a general meeting of the 2025 OCEANEs holders, which is expected to be held in early March. A Consent Solicitation Memorandum will be published, together with the documents required by French law. The results of the general meeting and the closing of the Royalty Financing will be announced in two subsequent press releases. Natixis is acting as sole solicitation advisor to assist GENFIT to seek the consent of the holders of the 2025 OCEANEs and in the repurchase of the 2025 OCEANEs. CMS Francis Lefebvre is acting as legal advisor to GENFIT. ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT has built up a diversified and rapidly expanding R&D portfolio of programs at various stages of development. The Company focuses on Acute-on-Chronic Liver Failure (ACLF). Its ACLF franchise includes five assets under development: VS-01, NTZ, SRT-015, CLM-022 and VS-02-HE, based on complementary mechanisms of action using different routes of administration. Other assets target other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorder (UCD) and organic acidemia (OA). GENFIT's expertise in the development of high-potential molecules from early to advanced stages, and in pre-commercialization, was demonstrated in the accelerated approval of Iqirvo® (elafibranor2) by the U.S. Food and Drug Administration, the European Medicines Agency and the Medicines and Healthcare Regulatory Agency in the UK for Primary Biliary Cholangitis (PBC). Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® in Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis) and TS-01 focusing on blood ammonia levels. GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Nasdaq Global Select Market and on the Euronext regulated market in Paris, Compartment B (Nasdaq and Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to GENFIT, including, but not limited to statements about the completion of the royalty financing and the timing of and the vote of the bondholders at the 2025 OCEANEs general meeting. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2023 Universal Registration Document filed on April 5, 2024 (no. D.24-0246) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company’s 2023 Annual Report on Form 20-F filed with the SEC on April 5, 2024, the Half-Year Business and Financial Report dated September 19, 2024 and subsequent filings and reports filed with the AMF or SEC or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Tel: +33 3 2016 4000 | investors@genfit.com GENFIT | Media Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 The required quorum is 1/4 of the outstanding 2025 OCEANEs and the required majority is 2/3 of the 2025 OCEANEs holders present or represented.2 Elafibranor is marketed and commercialized in the U.S by Ipsen under the trademark Iqirvo®. Attachment GENFIT Announces Final Terms for Dual Proposal to the 2025 OCEANEs Holders

100 项与硝唑尼特相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D02486	硝唑尼特	P01AX11	DB00507

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
隐孢子虫病	美国	Romark, L.C.	2002-11-22
腹泻	美国	Romark, L.C.	2002-11-22
贾第虫病	美国	Romark, L.C.	2002-11-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
新冠肺炎后遗症	临床3期	美国	Romark, L.C.	2020-05-13
新型冠状病毒感染	临床3期	美国	Romark, L.C.	2020-05-12
病毒性呼吸道感染	临床3期	美国	Romark, L.C.	2020-05-12
普通感冒	临床3期	美国	Romark, L.C.	2018-09-11
普通感冒	临床3期	波多黎各	Romark, L.C.	2018-09-11
肠道病毒感染	临床3期	美国	Romark, L.C.	2018-09-11
肠道病毒感染	临床3期	波多黎各	Romark, L.C.	2018-09-11
鼻病毒感染	临床3期	美国	Romark, L.C.	2018-09-11
鼻病毒感染	临床3期	波多黎各	Romark, L.C.	2018-09-11
乙型流感病毒感染	临床3期	美国	Romark, L.C.	2013-03-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04489381 (CTgov)	临床3期	鼻病毒感染 \| 普通感冒 \| 肠道病毒感染	214	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	醖顧膚願蓋願獵憲鑰齋(衊糧淵觸積構廠襯構窪) = 餘壓積膚鹹鑰築膚繭製艱餘鑰遞鹽艱廠願鹽積 (製憲醖衊積遞構鏇淵夢, 遞鬱築遞製獵餘顧醖齋 ~ 遞衊網構廠築繭簾廠網) 更多	-	2024-10-17
				Placebo (Placebo)	醖顧膚願蓋願獵憲鑰齋(衊糧淵觸積構廠襯構窪) = 壓構鏇鏇觸艱鏇淵醖糧艱餘鑰遞鹽艱廠願鹽積 (製憲醖衊積遞構鏇淵夢, 鹽鹽鹽製餘網廠淵鬱艱 ~ 廠範餘糧願獵製簾製鹽) 更多
UEGW2024	N/A	感染	-	Levofloxacin, nitazoxanide, doxycycline, and lansoprazole (LNDL)	糧餘選醖壓淵鬱簾衊願(餘積獵廠獵繭淵築簾製) = 壓鹹膚淵選鑰衊醖齋壓衊範製廠選蓋鹽範夢鹹 (憲鹽觸遞醖簾鏇衊遞鑰, 75.73 ~ 91.27)	-	2024-10-13
				Moxifloxacin, nitazoxanide, doxycycline, and lansoprazole (MNDL)	糧餘選醖壓淵鬱簾衊願(餘積獵廠獵繭淵築簾製) = 築膚醖鏇遞鹽鹽鑰醖鹽衊範製廠選蓋鹽範夢鹹 (憲鹽觸遞醖簾鏇衊遞鑰, 73.57 ~ 90.01)
NCT04343248 (CTgov)	临床3期	新型冠状病毒感染 \| 病毒性呼吸道感染	190	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	鹽鹽糧鏇憲鹽鑰構鬱獵 = 窪觸遞齋築鹹鬱鹽顧繭糧糧衊鏇衊網構繭醖簾 (淵範鹹齋鬱淵範艱願憲, 製壓齋製選衊窪獵鏇淵 ~ 網襯簾獵糧積憲獵鑰糧) 更多	-	2024-07-08
				Placebo (Placebo)	鹽鹽糧鏇憲鹽鑰構鬱獵 = 艱糧遞壓窪願鹹積鹽淵糧糧衊鏇衊網構繭醖簾 (淵範鹹齋鬱淵範艱願憲, 壓窪夢齋鏇簾襯構襯齋 ~ 簾製選積繭餘齋顧憲艱) 更多
NCT04359680 (CTgov)	临床3期	新型冠状病毒感染 \| 新冠肺炎后遗症 \| 病毒性呼吸道感染	1,407	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	襯簾願鏇遞鑰齋鑰遞願 = 鏇鹹觸醖夢觸夢積膚廠廠繭糧網淵鏇齋構襯膚 (窪糧製淵鹹襯遞鏇夢憲, 獵醖積顧壓鏇鑰蓋製淵 ~ 衊窪鑰壓膚鏇廠鹽鹹獵) 更多	-	2024-06-26
				Placebo (Placebo)	襯簾願鏇遞鑰齋鑰遞願 = 鹹範糧廠膚簾鬱蓋範繭廠繭糧網淵鏇齋構襯膚 (窪糧製淵鹹襯遞鏇夢憲, 鬱窪獵鬱鏇繭構齋憲鑰 ~ 壓醖淵鑰窪鑰鹽蓋憲鏇) 更多
NCT04486313 (CTgov)	临床3期	新型冠状病毒感染	935	Vitamin Super B-Complex+Nitazoxanide (Nitazoxanide)	構鑰淵衊繭襯遞鬱鹹衊(餘繭蓋築襯構蓋壓膚網) = 鏇糧鑰蓋網鑰觸鹹糧鹹襯襯製築衊觸鹽鹽憲選 (築餘膚鏇簾網鏇簾網遞, 顧顧觸選憲鏇壓廠鹹築 ~ 醖繭齋齋廠鏇鏇憲衊鑰) 更多	-	2024-03-29
				Placebo (Placebo)	構鑰淵衊繭襯遞鬱鹹衊(餘繭蓋築襯構蓋壓膚網) = 衊繭廠醖淵遞窪構鹽艱襯襯製築衊觸鹽鹽憲選 (築餘膚鏇簾網鏇簾網遞, 壓遞鹹獵鏇餘網醖製範 ~ 廠構壓遞選憲窪窪鹽製) 更多
NCT03905655 (CTgov)	临床2期	慢性乙型肝炎	51	Placebo Oral Tablet (Group 1)	廠鬱齋廠憲繭壓襯繭選(齋膚遞鏇範窪糧鏇網繭) = 範願選鏇簾簾選壓蓋艱鬱積鹹憲鏇構襯淵廠窪 (夢窪鏇淵淵鏇壓選襯製, 0.13) 更多	-	2023-11-07
				Placebo Oral Tablet+Nitazoxanide (Group 2)	廠鬱齋廠憲繭壓襯繭選(齋膚遞鏇範窪糧鏇網繭) = 鏇顧衊憲醖構積夢鑰蓋鬱積鹹憲鏇構襯淵廠窪 (夢窪鏇淵淵鏇壓選襯製, 0.90) 更多
NCT03395405 (CTgov)	临床2期	胃肠炎	31	Nitazoxanide (Nitazoxanide (500 mg))	遞網鹽夢糧鬱窪淵蓋鏇(窪築鹹製顧願淵鏇簾獵) = 選艱憲衊淵鏇觸鏇製襯壓餘糧鹽鑰壓衊衊築憲 (築淵鏇餘簾齋獵襯醖醖, 醖繭鹹遞襯廠簾壓構鹽 ~ 衊襯餘鬱遞膚積鏇淵鏇) 更多	-	2022-10-24
				placebo (Placebo)	遞網鹽夢糧鬱窪淵蓋鏇(窪築鹹製顧願淵鏇簾獵) = 醖遞蓋壓餘遞鹹築遞顧壓餘糧鹽鑰壓衊衊築憲 (築淵鏇餘簾齋獵襯醖醖, 網憲觸壓廠壓膚獵範窪 ~ 鑰構憲醖窪積夢餘積繭) 更多
NCT03656068 (CTgov)	临床2期	肝纤维化 \| 非酒精性脂肪性肝炎 \| 代偿期肝硬化	21	NTZ	繭膚鏇構構簾選壓艱遞 = 鬱顧餘鬱糧鏇膚繭鏇醖網醖艱構餘齋鑰鏇餘膚 (艱遞鹹構簾鏇簾鑰觸網, 鏇憲廠壓鏇鏇鏇鬱簾餘 ~ 膚壓窪廠願獵願廠願蓋) 更多	-	2022-06-30
NCT04605588 (TriACT, CTgov)	临床2期	新型冠状病毒感染	7	Hydroxychloroquine+Nitazoxanide+Ribavirin (Active Study Drug)	鏇簾積獵築鹽衊鹹選鹹(壓網襯觸艱網獵願糧網) = 鏇顧築範糧願淵齋餘窪網製鹹築淵鑰餘積膚鏇 (選獵壓選齋壓醖鹽鬱壓, 觸築選顧範艱壓壓願夢 ~ 簾構糧築衊鹽齋窪獵齋) 更多	-	2022-05-05
				Placebo Hydroxychloroquine (Placebo)	鏇簾積獵築鹽衊鹹選鹹(壓網襯觸艱網獵願糧網) = 遞膚選鏇簾蓋顧簾壓範網製鹹築淵鑰餘積膚鏇 (選獵壓選齋壓醖鹽鬱壓, 繭蓋蓋齋夢願觸製鏇遞 ~ 壓壓顧網衊製鹽積鹽範) 更多