Effect of Ferrous Ascorbate Versus Liposomal Iron on Hemoglobin Concentration and Iron Indices in 6 to 59 Months Age Children With Nutritional Iron-Deficiency Anemia: A Double-blinded Single Centre Randomized Clinical Trial

This trial is designed to compare the efficacy of ferrous ascorbate versus liposomal iron for the treatment of nutritional iron deficiency anemia (IDA) amongst 6 to 59 months age children as determined by the increase in hemoglobin concentration and change in iron indices after 12 weeks of treatment. This study will be a randomized double-blinded single-center study done at the outpatient department of the Department of Pediatrics. All the children between 6 months to 59 months with nutritional IDA will be enrolled in the study. Written informed consent will be taken from the caregiver. At baseline detailed history will be taken and a complete physical examination will be done. Complete blood count (CBC), Peripheral smear, corrected reticulocyte count, Serum iron, Serum ferritin, and serum Total iron binding capacity(TIBC) will be done at baseline. Transferrin saturation will be calculated with the formula Serum Iron/ TIBC ×100. C Reactive Protein (CRP) and alpha1- acid glycoprotein (AGP) will be done to look for inflammation. Eligible subjects would be randomized in a 1:1 ratio by computerized software to receive either ferrous ascorbate or liposomal iron. Subjects in the ferrous ascorbate group would be given the drug at a dose of 3mg/kg/day OD of elemental iron. Subjects in the liposomal group would be given 1mg/kg/day OD of liposomal iron. Follow-up visits would be done at 4 and 12 weeks. Follow-up at 4 weeks is required to check the initial response to treatment and identify nonresponders and at 12 weeks is required to see the final response and thus decide upon continuation or discontinuation of treatment. In the follow-up visit at 4 and 12 weeks, CBC, Iron profile (Iron, Ferritin, and TIBC), CRP, and AGP will be done. Corrected Reticulocyte will be done at 4 weeks only. Any adverse effects of therapy will be noted. Adherence to therapy will be checked by measuring the volume of unused medicine in the bottle at each visit. All the statistically analyzed continuous data will be presented as mean ± standard deviation (SD). The categorical data will be reported as a percentage. Student's t-tests will be used to compare means. The χ2 test will be used to compare categorical outcomes, including the proportion of patients with dropouts, adverse effects, and adherence measures. The percentage volume of unused study medication returned at each visit will be compared using the Wilcoxon rank sign test. p<0.05 will be considered statistically significant.

开始日期2023-08-01

申办/合作机构

All India Institute of Medical Sciences

NCT05714176 / Not yet recruiting临床4期IIT

Comparative Clinical Study to Evaluate the Efficacy and Safety of Oral Liposomal Iron, Oral Iron Supported Lactoferrin and IV Iron Dextran in Children With Chronic Kidney Disease

This is a randomized, parallel study that will be conducted on pediatric patients with CKD.

开始日期2023-02-01

申办/合作机构

Menoufia University

[+1]

CTRI/2022/06/042974 / Not yet recruiting临床3期

A Phase 3, Multicenter, Randomized, Single-blind, Placebo-controlled, Parallel-arm Study to Evaluate the Efficacy and Safety of Ferric Pyrophosphate Citrate Administered via Dialysate to Maintain Hemoglobin Concentration in Chronic Kidney Disease Patients Receiving Hemodialysis

开始日期2022-06-07

申办/合作机构-

100 项与焦磷酸铁柠檬酸相关的临床结果

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100 项与焦磷酸铁柠檬酸相关的转化医学

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100 项与焦磷酸铁柠檬酸相关的专利（医药）

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323

项与焦磷酸铁柠檬酸相关的文献（医药）

2024-01-01·The Journal of Pain

Autonomic Small-Fiber Pathology in Patients With Fibromyalgia

Article

作者: De Stefano, Gianfranco ; Falco, Pietro ; Litewczuk, Daniel ; Leone, Caterina ; Truini, Andrea ; Di Pietro, Giuseppe ; Tramontana, Lorenzo ; Di Stefano, Giulia ; Esposito, Nicoletta ; Galosi, Eleonora

In this clinical and skin biopsy study, we aimed to investigate whether fibromyalgia-associated small-fiber pathology (SFP), consisting of an intraepidermal nerve fiber loss, implies damage of dermal autonomic nerve fibers and how this damage is associated with autonomic symptoms that patients with fibromyalgia syndrome experience. Using skin biopsy, we investigated intraepidermal nerve fiber density, piloerector muscle, and sweat gland nerve fiber density (SGNFD) in 138 participants, that is, 58 patients with fibromyalgia syndrome, 48 healthy subjects, and 32 patients with small-fiber neuropathy. In patients with fibromyalgia-associated SFP, we also investigated how the different skin biopsy variables correlated with autonomic symptoms, as assessed with the Composite Autonomic Symptom Score 31 questionnaire. We found that in patients with fibromyalgia-associated SFP, the piloerector muscle and SGNFD were lower than that in healthy subjects. However, the autonomic small-fiber damage had no correlation with autonomic symptoms severity. In patients with SFP, the intraepidermal, piloerector muscle, and SGNFD were higher than that in patients with small-fiber neuropathy. Our clinical and skin biopsy study shows that patients with fibromyalgia have a reduction of dermal autonomic small fibers paralleling the intraepidermal nerve fiber loss, thus indicating that SFP also implies autonomic small nerve fiber damage. However, the autonomic small-fiber damage we found had no correlation with the severity of autonomic symptoms, and thus its clinical impact is still undetermined. PERSPECTIVE: In patients with fibromyalgia, SFP also affects autonomic fibers. These novel data provide additional insights into the pathophysiology of fibromyalgia syndrome, highlighting the complex role of small-fiber damage in the clinical picture of fibromyalgia.

2024-01-01·Molecular Reproduction and Development

Dynamics of seminal fluid production after mating

Article

作者: Mariën, Janine ; Nakadera, Yumi ; Koene, Joris M ; Kortsmit, Yvonne

AbstractSeminal fluid proteins (SFPs) play vital roles for optimizing reproductive success in diverse animals. Underlining their significance, SFP production and transfer are highly plastic, e.g., depending on the presence of rivals or mating status of partners. However, surprisingly little is known about replenishing SFPs after mating. This is especially relevant in species that mate multiple times, as they continuously produce and use SFPs throughout their reproductive life. Here we examined the expression pattern of SFP genes after mating in the great pond snail, Lymnaea stagnalis. Our results show that two out of the six SFP genes investigated here were upregulated 1 week after mating. Surprisingly, most SFP genes did not change their expression immediately after mating. Even after 1 week, when supposedly seminal fluid is fully replenished, the expression of SFP genes is rather high. In addition, the difference with previous studies hints at the possibility that SFP production after mating is plastic and depends on the mating history of female‐acting snails. Our results shed light on unexplored aspects of SFP production, thereby expanding the understanding of reproductive strategies in animals.

2023-12-01·International Journal of Biological Macromolecules

Chiral resolution of (±)-flurbiprofen using molecularly imprinted hydrazidine-modified cellulose microparticles

Article

作者: Abomuti, May Abdullah ; Zghab, Imen ; Alnoman, Rua B ; Al-Goul, Soha T ; Aljohani, Majed S ; AlSalem, Huda S ; Alharbi, Hussam Y ; Shafik, Amira L ; Elkaeed, Eslam B ; Monier, M

Flurbiprofen (FP) is one of the non-steroidal anti-inflammatory drugs (NSAIDs) commonly used to treat arthritic conditions. FP has two enantiomers: S-FP and R-FP. S-FP has potent anti-inflammatory effects, while R-FP has nearly no such effects. Herein, molecularly imprinted microparticles produced from hydrazidine-cellulose (CHD) biopolymer for the preferential uptake of S-FP and chiral resolution of (±)-FP were developed. First, cyanoethylcellulose (CECN) was synthesized, and the -CN units were transformed into hydrazidine groups. The developed CHD was subsequently shaped into microparticles and ionically interacted with the S-FP enantiomer. The particles were then imprinted after being cross-linked with glutaraldehyde, and then the S-FP was removed to provide the S-FP enantio-selective sorbent (S-FPCHD). After characterization, the optimal removal settings for the S- and R-FP enantiomers were determined. The results indicated a capacity of 125 mg/g under the optimum pH range of 5-7. Also, S-FPCHD displayed a noticeable affinity toward S-FP with a 12-fold increase compared to the R-FP enantiomer. The chiral resolution of the (±)-FP was successfully attempted using separation columns, and the outlet sample of the loading solution displayed an enantiomeric excess (ee) of 93 % related to the R-FP, while the eluent solution displayed an ee value of 95 % related to the S-FP.

项与焦磷酸铁柠檬酸相关的新闻（医药）

2023-10-31

·IQVIA艾昆纬

IQVIA《中国终末期肾病白皮书》正式发布

导读终末期肾病（end stage renal disease, ESRD）是慢性肾病（chronic kidney disease, CKD）的终末阶段，患者肾功能几乎完全丧失，需长期依靠肾脏替代治疗维持生命，具有疾病严重程度高、多并发症高发、治疗花费负担重等特点。ESRD患者常见并发症包括肾性贫血、高磷血症、甲状旁腺功能亢进、高钾血症等。IQVIA深入分析ESRD及相关并发症，全面梳理疾病现状、治疗方案与市场机会，并于近期正式发布终末期肾病白皮书，本文节选部分内容与读者分享。1. ESRD介绍与患者数量终末期肾病（end stage renal disease, ESRD）指各类慢性肾病进展至终末阶段，肾功能不可逆转性衰竭的病理状态，患者人数约占全部CKD患者的2-3%。除ESRD，“肾衰竭”等词汇亦常见用于描述“慢性肾病进展至终末期阶段”。2020年全球ESRD患者人数已突破1200万人，预计至2030年将达1450万。中国ESRD患者数量位居全球首位，占比接近30%，折合现有患者人数达350万。中国每年新增ESRD患者10-20万人，预计至2032年患者规模将增至480万人。ESRD患者增长主要来自于早中期CKD患者进展至疾病终末期，并且现有患者受益于医疗水平提高，平均生存时间增加。图1：中国ESRD患者规模及增速2. 肾脏替代治疗与应用现状肾脏替代治疗包括肾移植和透析，其中透析为ESRD的主要治疗方式，全球接受肾脏替代治疗患者中约80%进行透析治疗。但由于费用较高，长期透析给患者家庭和社会均带来沉重的经济负担。2022年中国接受透析治疗的患者总人数接近100万人，每位患者年透析费用平均6-10万，据此计算仅透析一项年社会医疗支出近千亿元。中国ESRD患者透析治疗率不足30%，相较于欧美等发达国家75%的透析渗透率仍有一定差距。近年来，国家大力投入透析中心建设，并不断提高透析医保与报销，中国透析医疗水平已显著改善，据中华医学会肾脏病学分会统计，中国接受透析治疗的患者人数由2017年61万人增长至2022年98万人，增速远高于全球水平（中国10%vs全球4%）。考虑到中国目前透析渗透率仍有较大的提升空间，预计未来透析患者仍保持较高增长，随着患者经济水平提升与慢性肾病早期患者疾病进展，2032年预计中国将有240万ESRD患者接受透析治疗。图2：中国透析患者规模及透析治疗率3. ESRD并发症患病率及治疗效果ESRD患者肾病症状随肾功能丧失而逐渐加重，并引发全身多个重要脏器和系统的功能衰退，导致多类并发症的发生，其中血液及骨骼系统相关并发症最为常见，其他包括心血管系统、消化系统、呼吸系统等。ESRD常见并发症包括肾性贫血、高磷血症、继发性甲状旁腺功能亢进、高钾血症等。药物治疗是ESRD各类并发症的重要治疗手段之一。根据中国临床指南标准，整理透析患者并发症治疗相关指标达标率，结合各并发症患病率，汇总如下：表1：ESRD常见并发症发病率和指标达标率4. 高磷血症治疗现状与市场规模高磷血症为ESRD患者最常见并发症，且存在较高的临床未满足需求。此外，磷结合剂支出在透析患者药物治疗支出中比重最高，且呈上升趋势。高磷血症治疗遵从“3D原则”，即限磷饮食（diet）、充分透析（dialysis）和降磷药物治疗（drug）。由于饮食治疗难度较大、透析治疗效率有限，使用降磷药物已成为临床实践中高磷血症患者减少磷肠道吸收的一项重要治疗手段。表2：高磷血症治疗3D原则据艾昆纬数据，2022年高磷血症药物市场已近16亿元规模，2018-2020年、2020-2022年复合增长率分别为65%、35%，预计未来十年仍保持约20%的速度增长，创新药物因其降磷效果更好、药物负担更小等优势将成为未来主要增长引擎。5. 高磷血症创新管线目前获批降磷药物均为磷结合剂，磷结合效率相对有限，为达到降磷效果需服用较高剂量，易引起恶心呕吐等胃肠道不良反应，从而影响患者依从性与生活质量。在研创新药物有望提高现有方案降磷效力以及改善副作用，按照作用机制可分为新型含铁磷结合剂、钠/质子交换蛋白抑制剂和磷转运蛋白抑制剂：新型含铁磷结合剂：新型含铁磷结合剂在肠道内高效结合食物中摄入的磷酸盐，从而减少胃肠道的磷酸盐吸收，控制血磷。相较现有磷结合剂，新型含铁磷结合剂磷结合效率更高、副作用更小。日本DOPPS研究显示，新型含铁磷结合剂可有效降低心血管事件以及整体死亡风险，相比非含铁磷结合剂降低约20%。此外，新型含铁磷结合剂药物剂量负担低，可潜在提升高磷血症患者治疗依从性。新型含铁磷结合剂（蔗糖氢氧化氧铁PA21、柠檬酸铁）于国外上市近10年，已占据美国高磷血症药物市场超50%市场份额。中国高磷血症药物市场尚缺乏成熟商业化的新型含铁磷结合剂，预计未来其将成为降磷领域的重要方案。钠/质子交换蛋白3（NHE3）抑制剂：细胞旁途径下，磷通过细胞之间的紧密连接进入细胞间隙，然后进入血液。NHE3是一种表达在肠道上皮细胞顶端表面的逆向转运蛋白，通过交换质子（H+）调节钠的吸收。NHE3抑制剂减少钠转运到肠上皮细胞中，并增加质子浓度，导致细胞间连接收紧，从而减少磷的肠道吸收。全球首个NHE3抑制剂Tenapanor已被美国FDA批准作为附加治疗降低血磷水平，用于接受肾透析治疗的CKD成人患者。磷转运蛋白抑制剂：跨细胞途径下，2b型钠依赖性磷酸盐转运体（NaPi-2b）主动将磷从肠腔转运到肠细胞，而磷酸盐转运蛋白（PiT1&2）也参与了肠上皮细胞对磷的细胞内转运。肠道内90%以上的磷主动转运依靠钠磷转运蛋白，对其抑制具有显著降磷的潜力。AP306通过抑制多个钠磷协同转运蛋白，以达到抑制肠道磷吸收的作用，为目前唯一进入临床试验的磷转运蛋白抑制剂，中国临床试验已进展至II期。6. 疾病经济负担ESRD治疗费用需综合考虑透析治疗、并发症药物等一系列费用，平均年花费近10万元：透析治疗年花费约6-10万不等，包括透析前准备、使用耗材、医疗服务等多项费用。单项ESRD并发症药物年治疗支出1000-5000元不等，ESRD患者常罹患多种并发症，整体并发症药物年花费逾1万元。作为特殊的肾病阶段，中国接受治疗的CKD患者中ESRD患者比例不足25%，但ESRD肾脏替代治疗及并发症药物的医疗花费超过所有慢性肾病治疗总花费的80%。疾病的有效控制以及患者生存质量的提高将成为破局的关键。未来具有更优临床表现的创新药物被寄予厚望，从而提高患者临床获益，惠及更多ESRD患者。如需购买完整白皮书，请联系您的客户经理或以下顾问：Chang ZhangIQVIA艾昆纬管理咨询高级执行总监chang.zhang@iqvia.comXiaofeng ZhangIQVIA艾昆纬管理咨询总监xiaofeng.zhang@iqvia.comYuwei GanIQVIA艾昆纬管理咨询顾问yuwei.gan@iqvia.com

临床研究

2023-07-17

·CPHI制药在线

新药 | 从NHE3抑制剂替纳帕诺在国内报产，浅谈高磷血症治疗进展

关注并星标CPHI制药在线 7月12日，Ardelyx/复星医药递交的「盐酸替纳帕诺片」进口申请获CDE受理，据悉申报的适应症为：正在接受血液透析治疗的慢性肾脏病（CKD）成人患者的高磷血症。替纳帕诺（Tenapanor）是一款口服肠道钠/氢交换体3（NHE3）抑制剂，通过抑制肠道上皮细胞顶端表面的NHE3，减少小肠和结肠对钠的吸收，导致进入肠腔的水分分泌增加，从而加快肠道蠕动并使粪便更加柔软疏松，使便秘型肠易激综合征(IBS-C)患者排便增加、腹痛减轻。2019年9月，该药被FDA批准用于治疗便秘型肠易激综合征(IBS-C)，商品名为Ibsrela。 NHE3是一种表达在小肠和结肠肠道上皮细胞顶端表面的逆向转运蛋白，通过交换质子（H+）吸收钠（Na+），主要负责膳食钠的吸收。Tenapanor通过抑制NHE3可以减少胃肠道从食物中摄取的钠离子量，从而增加胃肠道细胞中质子的浓度。而增加的质子（H+）选择性地收紧细胞之间的连接，导致上皮细胞连接的构象变化，降低了特定于磷酸盐的透过性，导致通过细胞旁途径（paracellular pathway，膳食磷酸盐吸收的主要途径）的磷酸盐吸收减少，从而降低血清磷水平。多项在美国和日本开展的2、3期临床研究表明：Tenapanor可显著降低血液透析患者升高的血磷水平。遗憾的是，目前Tenapanor还未被FDA批准用于治疗接受透析的对磷酸盐结合剂治疗反应不足或不耐受的成年慢性肾病（CKD）患者的高磷血症。 2021年6月，FDA发出完整回复函（CRL），表示Tenapanor可有效降低患者的血清磷水平，但降幅小且临床意义不明确，要求Ardelyx进行额外的临床试验以证明Tenapanor对降低血清磷水平或CKD导致的高磷血症有效。不过，Ardelyx没有接受FDA关于开展额外临床试验的要求，并提出了上诉。2022年11月，FDA心血管和肾脏药物咨询委员会（CRDAC）以9比4的投票结果，支持批准Tenapanor作为单药协助进行透析治疗的成人慢性肾病（CKD）患者控制血磷含量。虽然投票结果是好的，但FDA依然认为Tenapanor疗效较弱，其平均降幅为0.7mg/dL，而已上市药物的降幅为1.5-2.2mg/dL。而且，Tenapanor会导致长时间严重腹泻（中重度腹泻平均持续43天）。尽管如此，FDA还是在一个月后通过了Ardelyx的上诉，随后FDA与Ardelyx召开会议讨论了重新提交Tenapanor的NDA的途径。2023年4月，Ardelyx宣布已重新向FDA提交Tenapanor治疗高磷血症的NDA。 Tenapanor由Ardelyx研发。2012年10月,Ardelyx与阿斯利康签署协议,授予阿斯利康在全球开发Tenapanor，但2015年6月该协议终止，Ardelyx收回Tenapanor的所有权。2017年12月,复星医药与Ardelyx签订协议,获得Tenapanor在中国大陆、中国香港及中国澳门特别行政区域内的独家临床开发和商业化等许可。 2023年6月，复星医药在第68届日本透析医学会年上口头汇报了Tenapanor中国3期临床研究TEN C-03-002的结果。而且，TEN C-03-002研究结果还入选2023年血液净化论坛壁报交流。 TEN C-03-002是一项在中国开展的评估Tenapanor治疗ESRD血液透析患者高磷血症有效性和安全性的随机、双盲、安慰剂对照、多中心3期临床研究。结果显示：Tenapanor组对比安慰剂组的血磷水平较基线变化的最小二乘均值差异为-1.17mg/dL（95% CI: -1.694, -0.654, p<0.001），两组分别有44.59%和10.14%的患者达到了血磷水平<5.5mg/dL的目标。在年龄（<45 岁、≥45~＜65 岁、≥65 岁）、性别和基线血磷水平（<7.5mg/dL或≥7.5mg/dL）的亚组分析中，Tenapanor组较基线血磷水平的降低都优于安慰剂组。安全性方面，接受Tenapanor和安慰剂治疗的患者中分别有51.9%和41.1%报告了治疗期间出现的不良事件（TEAEs），严重程度多为轻中度。基于上述研究结果，复星医药在国内递交了Tenapanor用于控制正在接受血液透析治疗的慢性肾脏病(CKD)成人患者高磷血症的上市申请。关于高磷血症及其治疗进展高磷血症是慢性肾脏病(CKD)透析患者常见且不容忽视的并发症之一，会导致机体并发心血管钙化、继发性甲状旁腺功能亢进、肾性骨病等一系列疾病。此外，血磷升高与CKD快速进展、抵抗性高血压、全因死亡风险增高密切相关。研究显示，中国血液透析和腹膜透析患者高磷血症的患病率分别为57.4%和47.4%。目前降磷药物主要分两类，即磷结合剂和磷吸收抑制剂。磷结合剂通过在肠道结合食物中的磷，经粪便排出体外，从而减少人体对磷的吸收，起到降低血磷的作用。磷结合剂可分为含铝磷结合剂（如氢氧化铝）、含钙磷结合剂（如碳酸钙、醋酸钙）、非含钙磷结合剂（如司维拉姆、碳酸镧、考来替兰）以及含铁磷结合剂（如蔗糖氢氧化氧铁、柠檬酸铁），其中含铝磷结合剂长期使用可诱发神经毒性、贫血、骨病等，现已淘汰。含钙磷结合剂因价廉、有效受到了广泛应用，但长期服用有导致体内钙浓度升高、增加血管钙化、抑制PTH的风险。非铝非钙磷结合剂是新一代磷结合剂，不含铝和钙元素，是高磷血症患者的新选择。非含钙磷结合剂中的司维拉姆是一种阳离子聚合物，携带多个氨基，可在小肠内质子化而带正电荷，通过离子交换和氢键与小肠中的磷酸根结合，然后从肠道排出。碳酸镧是一种含金属镧的磷结合剂，在胃肠道，三价镧离子与磷酸盐结合形成不溶性、不可吸收的磷酸镧复合物，最后通过粪便排出，故能有效降低肠道磷酸盐吸收。考来替兰是一种阴离子树脂，可有效促进胆汁酸与肠道中磷酸盐结合，最后随着胆汁酸排泄而降低磷酸盐的吸收。含铁磷结合剂中的蔗糖氢氧化氧铁于2013年被FDA批准用于控制透析患者的血清磷水平。蔗糖氢氧化氧铁的活性成分多核铁（Ⅲ）-氢氧化物为不溶性成分，不会被吸收或代谢，其能通过羟基和/或相关水分子的配体交换与胃肠道中的膳食磷酸盐结合，然后通过粪便排出，减少肠道磷吸收而降低血清磷。今年2月，泰格医药蔗糖羟基氧化铁咀嚼片在国内获批上市，用于治疗12岁及以上CKD 4-5期（定义为肾小球滤过率<30 mL/min/1.73 m2）或接受透析的CKD儿科患者的高磷血症。柠檬酸铁是一种含铁磷结合剂，用于CKD患者不仅可有效控制血清磷水平，还能改善铁相关血液参数（如血清转铁蛋白饱和度、铁蛋白和血红蛋白水平）。磷吸收抑制剂获批较少，Tenapanor虽然在临床试验中表现出降低CKD患者血磷水平的能力，但还未获批。除了上述药物，目前全球还有多款在研治疗高磷血症的新药，如礼邦医药的AP301、济民可信的JMKX003002。其中AP301 是礼邦医药自主研制开发的一款新型含铁磷酸盐结合剂，在肠道内高效结合食物中摄入的磷酸盐促进磷从肠道排出而减少磷的吸收，从而降低患者血磷，改善慢性肾功能衰竭患者的长期临床结局，被开发用于治疗慢性肾功能衰竭患者的高磷血症。今年3月，礼邦医药的AP301在国内获批3期临床。 JMKX003002是最新一代的降磷剂，口服顺应好，相比竞品具有体外持久活性高，有望能够持久降血磷，改善肾病患者的生存质量。2023年4月，该药在国内获批临床，用于治疗终末期肾病透析患者的高磷血症。智药研习社近期课程报名来源：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~

申请上市临床3期

2023-04-27

·BioSpace

Rockwell Medical's Partner Drogsan Pharmaceuticals Submits Marketing Authorization Application in Turkey for Triferic AVNU

Turkish Medicines and Medical Devices Agency assigns priority review status for Drogsan's Marketing Authorization application and high priority status for Drogsan's GMP application for Triferic AVNU WIXOM, Mich.--(BUSINESS WIRE)-- Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that its international partner, Drogsan Pharmaceuticals, submitted a Marketing Authorization application and GMP application for Triferic® AVNU to the Turkish Medicines and Medical Devices Agency ("TMMDA"), for which Drogsan received priority status and high priority status, respectively. Triferic AVNU (ferric pyrophosphate citrate injection) is an iron replacement product indicated to maintain hemoglobin in adult patients undergoing hemodialysis. In June 2021, Rockwell entered into license and supply agreements with Drogsan, one of the leading pharmaceutical companies in Turkey, for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. Under the terms of the agreements, Drogsan will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, Rockwell received an upfront payment and will be eligible for milestone payment and royalties on net sales. Drogsan will be responsible for all regulatory approval and commercialization activities, and the Company will supply the product to Drogsan for Turkey. "Rockwell’s international partnerships have the potential to generate near- and long-term revenue for Rockwell. We continue to work diligently with our international partners to bring Triferic to market in their respective territories. We are excited that Drogsan is making great strides in its plan to register and commercialize Triferic AVNU in Turkey," said Mark Strobeck, Ph.D., Rockwell Medical’s President and CEO. "Taking into consideration that Drogsan was granted an accelerated review for Triferic AVNU with the Turkish regulatory authority, we anticipate approval for Triferic AVNU in 2024." About Rockwell Medical Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Rockwell Medical is the second largest supplier of acid and bicarbonate concentrates for dialysis patients in the United States and has the vision of becoming the leading global supplier of hemodialysis concentrates. Certified as a Great Place to Work® in 2023, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis SolutionsTM. For more information, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," “are determined,” “are on track,” “are resolute in our vision,” "work to," "drive towards," or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. There can be no assurance that Rockwell’s international partnerships will generate near- and long-term revenue for Rockwell; that Triferic will be brought to market in territories where Rockwell has partnerships; or that Triferic AVNU will be approved in Turkey in 2024 or at all. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2022, as such description may be amended or updated in any future reports we the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law. View source version on businesswire.com: Contacts Heather R. Hunter SVP, Chief Corporate Affairs Officer (248) 432-1362 IR@RockwellMed.com Source: Rockwell Medical, Inc. View this news release online at:

上市批准引进/卖出优先审批

100 项与焦磷酸铁柠檬酸相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03A	DB13995

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
血红蛋白病	申请上市	土耳其	Drogsan Ä°laÃ§larÄ± San. ve Tic. A.Å?.	2023-04-27
肾病	临床3期	中国	Holopack Verpackungstechnik GmbH	2020-11-27
肾病	临床3期	中国	Rockwell Medical, Inc.	2020-11-27
难治性缺铁性贫血	临床3期	-	Rockwell Medical, Inc.	2017-01-17
腹膜疾病	临床3期	-	Rockwell Medical, Inc.	2017-01-01
终末期肾脏病	临床3期	美国	Rockwell Medical, Inc.	2011-03-01
终末期肾脏病	临床1期	波多黎各	Rockwell Medical, Inc.	2011-03-01
难治性缺铁性贫血	药物发现	-	Rockwell Medical, Inc.	2017-01-17
慢性肾病	药物发现	美国	Rockwell Medical, Inc.	2015-01-23

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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


NCT02636049 (CTgov)	临床1期	终末期肾脏病	12	Triferic (Treatment Period: 6 mg Triferic IV Over 3 Hours)	(鹽網構鬱鏇顧蓋構齋膚) = 窪窪醖糧構製獵夢鹽製窪膚遞廠築膚獵襯範壓 (顧範衊遞鹽鹹糧構衊獵, 選齋壓窪構繭膚醖襯齋 ~ 醖觸夢選觸鹽餘餘選顧) 更多	-	2019-02-01
				Triferic (Treatment Period: 35 Micrograms/kg IV Push)	(鹽網構鬱鏇顧蓋構齋膚) = 齋築壓網繭繭築鬱顧網窪膚遞廠築膚獵襯範壓 (顧範衊遞鹽鹹糧構衊獵, 製鑰鏇遞鏇鏇製鬱鹹蓋 ~ 廠鬱鹹糧繭膚積築鹹衊) 更多
NCT00604565 (CTgov)	N/A	终末期肾脏病	11	soluble ferric pyrophosphate (SFP) (SFP Dialysate)	(觸窪構顧襯顧鹽願築夢) = 艱廠鑰膚廠廠餘夢積簾餘鏇鑰顧願製醖製顧鏇 (構夢襯簾艱獵鑰餘構壓, 淵憲願壓壓襯襯遞範窪 ~ 築構淵醖選蓋糧觸壓糧) 更多	-	2015-08-31
				placebo (Standard Dialysate)	(觸窪構顧襯顧鹽願築夢) = 艱憲窪範窪醖遞獵壓膚餘鏇鑰顧願製醖製顧鏇 (構夢襯簾艱獵鑰餘構壓, 積鏇壓艱艱鹹製窪襯遞 ~ 蓋壓膚醖壓齋艱壓醖簾) 更多
NCT01320202 \| NCT01322347 (CRUISE 1 \| CRUISE 2, Pubmed \| Nephrol Dial Transplant) 人工标引	临床3期	-	585	Ferric pyrophosphate citrate	(觸醖選膚憲鬱艱顧鏇餘) = 鑰觸觸壓範願獵膚淵廠鹽憲構淵選觸鑰醖壓窪 (艱糧鏇積壓衊網簾構窪, 1.2) 更多	积极	2015-12-01
				Placebo	(觸醖選膚憲鬱艱顧鏇餘) = 襯衊鹽獵願廠鹽衊製襯鹽憲構淵選觸鑰醖壓窪 (艱糧鏇積壓衊網簾構窪, 1.2) 更多
NCT04689932 (CTgov)	临床4期	终末期肾脏病	12	Triferic AVNU	築糧糧簾衊鹹窪築膚獵(齋獵淵膚窪淵選艱糧糧) = 憲網繭餘繭鏇獵壓簾繭鏇鏇築積憲簾衊淵選鹽 (獵夢鑰壓廠鬱積鏇衊選, 鹹築壓糧鬱蓋簾製衊選 ~ 繭鹽廠獵觸鑰醖壓膚範) 更多	-	2022-01-18
NCT04042324 (CTgov)	临床1/2期	终末期肾脏病	12	Triferic+Heparin (UFH and Triferic Admixture)	鏇夢構願壓廠襯壓壓淵(淵製範鹽壓繭選鏇顧繭) = 鏇壓鹹襯網夢網築願築製蓋選遞構鹽繭顧膚繭 (壓壓廠蓋窪築簾鏇鏇構, 艱膚構網襯鏇夢選憲鏇 ~ 鏇網鏇繭餘餘鹹艱壓夢) 更多	-	2020-11-12
				Heparin (UFH Via Continuous Infusion Pre-dialyzer)	鏇夢構願壓廠襯壓壓淵(淵製範鹽壓繭選鏇顧繭) = 製鬱獵網淵糧齋構製醖製蓋選遞構鹽繭顧膚繭 (壓壓廠蓋窪築簾鏇鏇構, 遞餘鏇衊艱獵積遞蓋構 ~ 鏇鑰襯觸醖夢構繭遞淵) 更多
NCT03303144 (CTgov)	临床1/2期	终末期肾脏病	27	Triferic (Triferic Via Hemodialysate)	(顧鹹構遞醖構憲艱築糧) = 蓋鏇構襯鏇淵構選積構鑰鹹糧夢餘齋艱壓選鹹 (廠繭餘鹽淵膚夢衊積觸, 衊選壓鏇鏇築艱網選選 ~ 鹹遞廠襯製顧衊衊蓋鹽) 更多	-	2020-11-16
				Triferic (Triferic Via IV Infusion( Pre-dialyzer))	(醖築鏇鹽願廠壓製鏇積) = 淵醖艱網襯選構鏇襯獵網簾夢壓襯積鏇醖遞艱 (鬱選壓衊廠醖築艱觸顧, 顧憲繭範憲鹹蓋壓積壓 ~ 鹽鑰遞鏇鏇鹹壓夢鹹網) 更多
NCT01286012 (PRIME, Pubmed \| Kidney Int) 人工标引	临床2期	血液透析并发症	103	Ferric pyrophosphate citrate	遞顧餘鑰簾範鏇窪壓壓(襯壓鏇衊鹽壓簾製遞積) = 鑰構夢觸壓憲鹹構顧壓窪鏇夢簾膚憲願構衊鑰 (範積憲醖襯鹹膚憲膚醖, -19.1 ~ 28.8) 更多	积极	2015-11-01
				Placebo	遞顧餘鑰簾範鏇窪壓壓(襯壓鏇衊鹽壓簾製遞積) = 鏇遞範壓願鑰遞鹹窪獵窪鏇夢簾膚憲願構衊鑰 (範積憲醖襯鹹膚憲膚醖, 15.7 ~ 64.0) 更多
NCT02595437 (CTgov)	临床1/2期	终末期肾脏病	22	Triferic (Triferic 0.07 mg/kg Iron Intravenous: Absolute Value)	(醖鹽遞蓋壓鑰遞鬱餘夢) = 鹹艱艱願選鹽夢蓋齋壓廠夢衊蓋淵齋鏇衊遞製 (顧鬱艱憲簾醖鏇衊顧齋, 膚構鑰壓膚構構襯蓋鹽 ~ 壓壓獵鑰製獵顧選遞遞) 更多	-	2018-10-25
				Triferic (Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected)	(醖鹽遞蓋壓鑰遞鬱餘夢) = 鹹鑰願鑰選憲艱顧製鑰廠夢衊蓋淵齋鏇衊遞製 (顧鬱艱憲簾醖鏇衊顧齋, 選鏇範鹹艱觸遞鹽鹹繭 ~ 淵遞觸壓齋網範築製鏇) 更多
NCT02739100 (CTgov)	临床1期	终末期肾脏病	13	Triferic	(顧顧積憲鏇艱鑰襯選壓) = 窪簾鬱製觸製遞鏇夢遞艱願窪蓋觸憲網醖鏇夢 (淵齋夢範餘願襯鏇繭築, 憲鑰鑰顧製遞餘遞餘餘 ~ 膚選糧鹽窪醖艱蓋艱廠) 更多	-	2019-02-01
NCT01920854 (CTgov)	临床1期	终末期肾脏病	48	placebo (Cohorts 1 - 3, 6 Placebo)	網製鹹觸壓製憲餘鑰鬱(鬱築膚顧艱獵廠醖壓選) = 遞膚選網鬱壓壓衊鹹鑰積築壓衊夢襯艱構醖鹽 (範築餘製簾遞壓襯鏇製, 鏇範窪鏇網糧艱鹹顧艱 ~ 膚築憲網築壓觸範遞艱) 更多	-	2014-12-19
				placebo+SFP (Cohort 1 SFP)	網製鹹觸壓製憲餘鑰鬱(鬱築膚顧艱獵廠醖壓選) = 構選鏇製壓願蓋積膚餘積築壓衊夢襯艱構醖鹽 (範築餘製簾遞壓襯鏇製, 鏇憲醖網衊製簾鏇鏇憲 ~ 構廠選鏇廠衊構顧醖廠) 更多