预约演示
更新于：2025-02-13
Insulin (Oramed)
重组人胰岛素（Oramed）
更新于：2025-02-13
概要
基本信息
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评- |
登录后查看时间轴
关联
18
项与 重组人胰岛素（Oramed） 相关的临床试验NCT06731075
A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One to Three Glucose-lowering Agents
ORA-013-3 is a randomized, controlled study to test the efficacy and safety of an oral capsule of ORMD-0801 at several doses in patients with Type 2 Diabetes Mellitus (T2DM) who have not responded well to other glucose-lowering medications. A total of three hundred subjects will be enrolled in this study and will be required to complete this thirty-four-week clinical trial.
开始日期2025-03-15 |
申办/合作机构 Oramed Ltd. [+1] |
CTR20244337
一项开放、随机、两周期、两交叉、评价人胰岛素肠溶胶囊在中国健康男性受试者中的药效动力学、药代动力学及相对生物有效性、相对生物利用度研究
主要目的：
本研究采用高胰岛素-正葡萄糖钳夹技术作为测试方法，对人胰岛素肠溶胶囊进行药效动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物有效性。
次要目的：
对人胰岛素肠溶胶囊进行药代动力学研究，对比人胰岛素肠溶胶囊与人胰岛素注射液(天麦霖® R)的相对生物利用度。
开始日期2024-07-17 |
申办/合作机构 Israel Oramd Co Ltd [+3] |
EUCTR2021-004226-30-HU
A Double-Blinded, Placebo-controlled, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Glucose-lowering Agents as Monotherapy.
开始日期2022-03-22 |
申办/合作机构 |
100 项与 重组人胰岛素（Oramed） 相关的临床结果
登录后查看更多信息
100 项与 重组人胰岛素（Oramed） 相关的转化医学
登录后查看更多信息
100 项与 重组人胰岛素（Oramed） 相关的专利（医药）
登录后查看更多信息
4
项与 重组人胰岛素（Oramed） 相关的文献（医药）2023-04-01·Diabetes, obesity & metabolism
Oral insulin (ORMD ‐0801) in type 2 diabetes mellitus: A dose‐finding 12‐week randomized placebo‐controlled study
Article
作者: Neutel, Joel ; Kidron, Miriam ; Fleming, Alexander ; Homer, Kenneth ; Eldor, Roy ; Rosenstock, Julio ; Francis, Bruce H.
Abstract:
Aims:
To assess the safety and efficacy of multiple daily doses of oral insulin (ORMD‐0801) in subjects with type 2 diabetes (T2DM) over 12 weeks.
Materials and Methods:
Participants with T2DM on metformin or combination oral therapy with glycated haemoglobin (HbA1c) levels ≥ 7.5% (58 mmol/mol) were randomized to receive ORMD‐0801 8 mg or 16 mg once (QD) or twice (BID) daily, or 32 mg QD, BID or three times daily (TID) over a 12‐week period.
Results:
A total of 373 subjects were randomized to active treatment or placebo (~60% male, age ~ 56 years, HbA1c 9%‐9.8%; 75‐84 mmol/mol). Placebo‐adjusted HbA1c changes from baseline to Week 12 were observed with ORMD‐0801 8 mg BID (−7.15 ± 3.57 mmol/mol [−0.65% ± 0.33%]; P = 0.046). However, a significant site interaction was observed in two sites. After excluding these, HbA1c reduction was observed with 8 mg QD (−0.81 ± 0.37%; −8.89 ± 4.01 mmol/mol; P = 0.028, n = 15), 8 mg BID (−0.82 ± 0.37%; −8.95 ± 4.08 mmol/mol; P = 0.029, n = 17), 32 mg QD (−0.54 ± 0.26%; −5.89 ± 2.78 mmol/mol;P = 0.036, n = 69) and 32 mg BID (−0.53 ± 0.26%; −5.80 ± 2.83 mmol/mol; P = 0.042, n = 68). No effect was observed with 16 mg QD (0.25 ± 0.37%; 2.76 ± 3.99 mmol/mol; P = 0.48, n = 18), 16 mg BID (−0.36 ± 0.40%; −3.97 ± P = 0.36, n = 15) or 32 mg TID (−0.45 ± 0.27%, −4.89 ± 2.90 mmol/mol; P = 0.093, n = 69). Continuous glucose monitor and serum glucose measurements showed similar trends but were not significant. ORMD‐0801 was safe, well tolerated and not associated with weight gain or hypoglycaemia.
Conclusions:
Oral insulin (ORMD‐0801) induced greater reductions in HbA1c when compared to placebo, and was safe and well tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support continued development of the 8‐mg dose at bedtime, which is currently being evaluated in two Phase 3 trials.
2022-05-01·Clinical pharmacology in drug development
Safety, Pharmacokinetics, and Pharmacodynamics of Oral Insulin Administration in Healthy Subjects: A Randomized, Double‐Blind, Phase 1 Trial
Article
作者: Ning, Guang ; Sheng, Haiyuan ; Zhang, Yifei ; Huang, Xing ; Lang, Liqun ; Shen, Liyun ; Wang, Weiqing ; Zhou, Weiwei
Abstract:
Oral delivery is an ideal method of insulin administration and is currently a promising research field. Here, we evaluated the safety, pharmacokinetic, and pharmacodynamic characteristics of oral administration of an insulin capsule (ORMD‐0801) with 2 different sources of recombinant human insulin. This was a single‐center, randomized, double‐blind, placebo‐controlled, dose‐escalating phase 1 trial. Single dosing of the oral insulin capsule was administered in 70 healthy Chinese subjects. In stage 1, four dose groups (8, 16, 32, and 48 mg) for capsules containing Sanofi insulin and in stage 2, three dose groups (8, 32, and 48 mg) containing Hefei Tianmai insulin were evaluated consequently. The results showed that the oral insulin formulations with either source in the dose range 8 to 48 mg were safe, and no serious adverse events were observed. After a standard breakfast 45 minutes after dosing, the area under the concentration‐time curve (AUC) from time 0 to time t and AUC from time 0 to infinity for insulin in the 8‐mg and 48‐mg dose groups in stage 1 and for 8‐ to 48‐mg groups in stage 2 were slightly increased compared with placebo, but no significant dose‐related changes in the pharmacokinetic parameters were observed for either stage. The peak‐valley difference and the change in value of the AUC for glucose from baseline showed a dose‐related increase in the dose range from 8 to 48 mg in both stages. Together, this study indicated that in healthy Chinese subjects, this oral capsule containing 2 different insulin formulations was safe and well tolerated after a single‐dose administration.
2021-11-01·Diabetes, obesity & metabolism2区 · 医学
Efficacy and safety of 28‐day treatment with oral insulin (ORMD ‐0801) in patients with type 2 diabetes: A randomized, placebo‐controlled trial
2区 · 医学
Article
作者: Neutel, Joel ; Kidron, Miriam ; Eldor, Roy ; Homer, Kenneth
Abstract:
Aim:
To assess the safety and efficacy of oral insulin (ORMD‐0801) in patients with type 2 diabetes (T2D).
Materials and Methods:
After a 2‐week washout of other medications, adult metformin‐treated patients with T2D were randomized to receive placebo or 16 or 24 mg ORMD‐0801, once daily, at bedtime, for 28 days. The mean change from baseline weighted mean night‐time glucose levels was determined from 2 nights of continuous glucose monitoring (CGM) recordings during the placebo run‐in and last week of treatment.
Results:
In total, 188 patients (HbA1c: 7.82% ± 0.88% [placebo] and 8.08% ± 1.11% [pooled ORMD‐0801 group]) were enrolled. In the placebo group, mean night‐time CGM increased from baseline by 13.7 ± 26.1 mg/dL, whereas the increase was significantly smaller in the pooled ORMD‐0801 group (1.7 ± 23.5 mg/dL, P = .0120). Glycaemic control variables (24‐hour, fasting and daytime CGM glucose) also displayed smaller increases with ORMD‐0801 versus placebo. Change from baseline HbA1c was −0.01% in the pooled ORMD‐0801 group versus +0.20% in the placebo group (P = .0149). ORMD‐0801 was well tolerated, with similar adverse event and hypoglycaemia rates as placebo.
Conclusions:
In patients with T2D, bedtime ORMD‐0801 curbed increases in night‐time glycaemia, 24‐hour glycaemia and HbA1c, without increasing the risk of hypoglycaemia or safety events compared with the control arm.
61
项与 重组人胰岛素（Oramed） 相关的新闻（医药）2025-02-11
New Standalone Company, OraTech Pharmaceuticals Inc., to Focus on Oral Drug Delivery with Strategic Investment and Advanced Manufacturing Capabilities
Oramed shareholders to receive the right to a direct stake in OraTech, expected to go public on Nasdaq.
OraTech will have global marketing rights to Oramed's POD™ oral protein delivery technology.
HTIT to invest $60 million, Oramed to invest $15 million into OraTech.
HTIT to provide a supply agreement for oral insulin capsules.
New Phase 3 trial in the U.S. with a revised protocol expected to begin this quarter.
OraTech to advance registration of oral insulin in the U.S. and other countries.
OraTech to receive royalty payments from sales of oral insulin in China, where a Marketing Authorization Application has been submitted, and commercialization preparations are underway by HTIT.
NEW YORK, Feb. 11, 2025 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) ("Oramed"), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced that it has entered into definitive agreements to spin off its Protein Oral Delivery (POD™) technology into a newly formed joint venture, OraTech Pharmaceuticals Inc. ("OraTech"), with Hefei Tianhui Biotech Co., Ltd. ("HTIT"). This transaction is designed to accelerate the development and commercialization of Oramed's ORMD-0801 oral insulin and other POD™-based innovative oral drug delivery technologies, reinforcing Oramed's vision of revolutionizing diabetes and chronic disease treatments.
As part of the transaction, Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, into OraTech. The definitive agreements call for Oramed shareholders to receive a majority of Oramed's equity interest in the new entity, allowing them to directly participate in its future success. Additionally, under the agreements, Oramed and HTIT will contribute a combined $75 million in capital, some of which will be allocated for services rendered via a supply agreement. This financial backing will provide substantial resources to drive development, commercialization, and clinical advancement.
"We are excited to launch OraTech, a company that brings together Oramed's technology and clinical development expertise with HTIT's state-of-the-art manufacturing capabilities," said Nadav Kidron, Chief Executive Officer of Oramed. "OraTech will be singularly focused on bringing oral insulin to market and unlocking the broader potential of oral drug delivery for additional therapeutic targets. With strong capital investment, an experienced leadership team, and world-class manufacturing support from HTIT, the company is uniquely positioned to advance its programs, including the planned reinitiation of a pivotal Phase 3 clinical trial in the United States."
OraTech will leverage HTIT's expertise in capsule production and cost-efficient manufacturing, ensuring a robust, reliable, and scalable supply chain to support clinical trials and commercialization efforts.
With a clear focus on development and commercialization, strong financial backing, and a pipeline poised for clinical and regulatory advancements, OraTech is potentially set to redefine diabetes care and transform the future of oral biologics and chronic disease management.
Further details on Oramed's plans and initiatives will be provided in a shareholder letter in the coming weeks.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. The Company's novel Protein Oral Delivery (POD™) technology is designed to protect drug integrity and increase absorption. Oramed has offices in the United States and Israel. For more information, please visit .
About HTIT
Hefei Tianhui Biotechnology Co., Ltd. (HTIT) owns and operates a state-of-the-art manufacturing facility in Hefei, China. HTIT is a biotech company focused on biopharmaceutical product manufacturing and R&D with an emphasis on the oral delivery of therapeutic macromolecules.
Forward-looking statements: This press release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions and include statements that OraTech is designed to accelerate the development and commercialization of Oramed's ORMD-0801 oral insulin and other POD™-based innovative oral drug delivery technologies, Oramed's vision of revolutionizing diabetes and chronic disease treatments, that Oramed will transfer its proprietary oral insulin and POD™ technology, along with other pipeline assets, into OraTech, that Oramed shareholders will receive a majority of Oramed's holdings in OraTech, allowing them to directly participate in its future success, that Oramed and HTIT will contribute a combined $75 million in capital, the focus of OraTech, planned reinitiation of a Phase 3 clinical trial in the United States, and OraTech's plan to redefine diabetes care and transform the future of oral biologics and chronic disease management. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, uncertainties in satisfaction of closing conditions for the contemplated transactions, risks and uncertainties discussed in the Company's most recent annual and quarterly reports and detailed from time to time in the Company's other filings with the Securities and Exchange Commission, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. These forward-looking statements speak only as of the date hereof. Oramed undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof or to reflect actual outcomes, unless required by law.
Company Contact:
+1-844-9-ORAMED
[email protected]
Logo -
SOURCE Oramed Pharmaceuticals Inc.
WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?
440k+
Newsrooms &
Influencers
9k+
Digital Media
Outlets
270k+
Journalists
Opted In
GET STARTED
临床3期引进/卖出
2024-12-14
·医药魔方
12月12日，美国临床试验收录网站Clinicaltrials显示，Oramed公司就口服胰岛素胶囊ORMD-0801启动了一项新的III期研究（ORA-D-013-3）。
该研究是一项随机、双盲、双模拟、安慰剂对照临床试验（n=300），旨在评估ORMD-0801（8mg，每日1次或每日2次）治疗糖化血红蛋白（HbA1c）水平为7.2%-10.0%、年龄≥50岁、体重指数（BMI）≤28kg/m2、估算肾小球滤过率（eGFR）≥30ml/min且接受过1-3种降糖药（二甲双胍、磺酰脲类药物、DPP-4抑制剂、SGLT-2抑制剂、噻唑烷二酮、胰岛素促分泌剂、口服或注射GLP-1受体激动剂、葡萄糖苷酶抑制剂或普兰林肽，不包括胰岛素）治疗的2型糖尿病患者的疗效和安全性。
入组患者将被分为4个队列：
①ORMD-0801（8mg，每日1次）：20:00-24:00服用1粒8mg ORMD-0801+3粒安慰剂；
②ORMD-0801（8mg，每日2次）：早餐前服用1粒8mg ORMD-0801，睡前服用1粒8mg ORMD-0801+1粒安慰剂；
③ORMD-0801（16mg，每日1次）：早上服用1粒安慰剂，20:00-24:00服用2粒8mg ORMD-0801；
④安慰剂。
研究的主要终点是第26周患者的HbA1c水平相较于基线的变化，次要终点是第26周达到HbA1c水平<7%的患者比例、第26周空腹血糖相较于基线的变化、安全性。
值得注意的是，Oramed强调了将设置性别（男性、女性）、年龄（≤60岁、>60岁）、基线HbA1c水平（≤9.0%、>9.0%）、人种、种族亚组进行主要终点和次要终点分析。
这项研究的入组限制条件如此细致，像是Oramed公司试图挽救ORMD-0801的拼死一搏。
ORMD-0801是Oramed利用其专有的口服递送技术平台PODTM开发的一款口服胰岛素胶囊，由肠溶包衣、蛋白酶抑制剂、吸收促进剂和胰岛素4部分组成。肠溶包衣对pH敏感，可避免胶囊在胃部被强酸环境破坏，从而使内容物在进入小肠之前保持完整；蛋白酶抑制剂可以减少胃肠道中的蛋白酶对胰岛素的降解；吸收促进剂可以增强小肠壁对胰岛素的吸收。合肥天麦生物拥有该药物的中国（包括香港和澳门）权益。
ORMD-0801的组成成分（来源：Oramed官网）
ORMD-0801在2009年进入临床研究阶段，历时11年之久才进入III期阶段。如此长的研发周期并没有换来上市的坦途。2023年1月，Oramed公司遗憾宣布ORMD-0801治疗2型糖尿病的III期ORA-D-013-1研究未达到主要终点和次要终点。当时，Oramed公司决定终止开发ORMD-0801的2型糖尿病适应症，并决定终止同期在开展的III期ORA-D-013-2研究。但在对数据进行详细分析后，Oramed公司从中找到了最后一丝希望。
Oramed公司并未公布全人群的分析数据，仅公布了对特定参数（如BMI、基线HbA1c水平、年龄、性别）进行亚组人群的回顾性分析数据。结果显示，年龄>54岁且BMI<31kg/m2的患者HbA1c降幅最大，P<0.002。
鉴于ORMD-0801还是可能有效的可能性，Oramed公司与FDA就在细分人群中开展全新的III期研究进行了讨论。由此有了ORA-D-013-3研究。
虽然ORMD-0801的海外III期研究取得了阴性的结果，但是合肥天麦生物就ORMD-0801开展的中国降糖III期研究（ORA-D-CN-005）顺利完成。合肥天麦生物并未公布研究数据，但Oramed公司在回顾性分析中提及，将ORA-D-013-1研究亚组患者与ORA-D-CN-005研究患者的基线BMI对齐时，可以得到HbA1c水平显著降低的结果。从这一点来看，合肥天麦生物开展的ORA-D-CN-005研究取得的结果还是有效的。这一点也支持其提交的ORMD-0801的上市申请。
距离国家药监局受理ORMD-0801的上市申请已经过去20个月的时间，其受理号的审评状态已在今年11月12日更新为【新报任务已完成审评】。
期待糖尿病领域可以迎来新的治疗变革。
Copyright © 2024 PHARMCUBE. All Rights Reserved.
欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。
免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。
临床3期临床结果临床2期临床成功
2024-04-09
·药融圈
▲5月30-31日 第八届广州生物医药创新者峰会 扫码立即报名 注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。本期开始将推送大家关于多肽口服中领域先进的Pipeline技术与进展（上&下）。1990年FDA批准了全球第一个口服多肽药物（环状肽）药物环孢素A（Cyclosporin A，1200kDa）。这是一种免疫抑制剂，用于预防移植排斥反应和治疗自身免疫性疾病。经过了三十年的发展，目前已有多款口服肽类药物上市。表1：上市口服多肽产品多肽领域是目前资本寒冬下为数不多的一抹绿意。图1：蛋白口服药物发展历程口服药物递送的生化和物理屏障是“肽肽们”逆袭之路上的障碍，药品口服后会经过胃和小肠，这里环境的酸碱度、酶环境和黏液层等都是蛋白类药物需要解决的障碍（见药事纵横2023-11-27推文链接：多肽口服---“肽肽们”的逆袭之路https://mp.weixin.qq.com/s/NzRfl9LoHY5bchouQ2Bgfw）。过五关，斩六将，略显英雄本色。图2：口服药物递送的生化和物理屏障，以及具有主要肠细胞类型的肠粘膜结构口服Rybelsus和Mycapssa已经将司美格鲁肽（semaglutide音译，同索马鲁肽）和奥曲肽（Mycapssa）（分子量均大于1000Da）暴露于体循环中吸收，代表了口服可吸收肽制剂开发的重大成就。但是，口服生物利用度仍然只有1%左右。口服多肽大分子吸收的挑战仍未被有效解决。表2：司美格鲁肽（Rybelsus）和奥曲肽（Mycapssa）新药方式口服生物利用度差的原因可以用Lipinski的五法则（分子量（MW）≤500，氢键供体（HBD）的数量≤5，氢键受体（HBAs）的数量≤10，辛醇-水分配系数（LogP）≤5）以及可旋转键的数量应小于 10 个，拓扑极表面积（TPSA）应小于 140 Å 2）来解释，事实上，大多数新药模式都属于中大分子的范畴，因此往往缺乏口服生物利用度（口服生物利用度高是小分子药物的最大优势之一）。奥曲肽的化学结构和理化性质见下图，显然有悖于Lipinski的五法则。图3：奥曲肽的化学结构以及理化性质2019 年，FDA 批准了用于治疗 2 型糖尿病的口服司美格鲁肽制剂。临床研究结果表明，口服40mg剂量与皮下注射1mg剂量的结局相似（NCT01923181），口服生物利用度仍的挑战仍未被有效解决。尽管司美格鲁肽和奥曲肽利用度低，但也是目前上市口服多肽药物的集大成者。Rybelsus 是第一个基于促渗透策略的口服肽药物，以SNAC作为促渗透剂。SNAC由Emisphere的Eligen™技术开发（见下文）（第一个使用SNAC商业化的产品是2015年被FDA批准上市的Eligen B12（维生素B12））。与针对胃吸收的 Rybelsus 不同，Mycapssa 针对小肠中的药物吸收。Mycapssa胶囊涂覆甲基丙烯酸酯来防止奥曲肽在胃中的分解，胶囊中促渗剂主要是C8，辅以高浓度的附加添加剂（如PVP、单辛酸甘油酯和聚山梨醇酯80）来增加促渗透效应。不同于Rybelsus ，Mycapssa是基于C8的TPE平台技术而来的重磅产品（见下文）。针对口服生物利用度低的问题，主要的药物策略旨在增强肽和蛋白质的稳定性和吸收，包括修饰、改进配方以及采用贴片微针等一系列方式。下图是目前多肽递送中先进的技术汇总。图4：多肽口服递送策略的示意图。（a）蛋白酶抑制剂、渗透增强剂和微针对肽的口服递送有效。（b）渗透增强剂成功地用于口服给药，如SNAC、胆盐和辛酸钠（它们使分子能够通过粘液层、细胞膜和紧密连接）。（c）化学修饰和环化是用于调节肽的理化性质的合适工具。Oramed Pharmaceuticals Inc.开发了蛋白质口服递送（POD™）。在这个系统中，不同的策略共存于同一配方中：封装、渗透增强剂、螯合剂和蛋白酶抑制剂。Oramed的技术基于旨在通过胃肠道和增强吸收的组件。乙二胺四乙酸钠（EDTA）和胆盐可作为渗透增强剂。胶囊可保护胰岛素在胃中不被水解，而蛋白酶抑制剂（如大豆胰蛋白酶抑制剂和抑肽酶）可保护胰岛素免受蛋白酶降解，尤其是在小肠中。图5：Oramed Pharmaceuticals Inc.的口服递送技术平台Oramed公司目前有三条主要管线。图6：Oramed Pharmaceuticals目前管线（官网）Oramed公司应用POD技术开发的ORMD-0901（GLP-1类似物，将EDTA作为吸收促进剂使用）在模型猪及模型犬中均表现出良好的耐受性，且降血糖作用显著。Oramed在临床上使用酶抑制剂方法进展最快是口服胰岛素ORMD-0801项目，Ⅲ期多中心临床试验结果表明，没有达到主要终点和次要终点便停止其后续的临床研究。图7：Oramed Pharmaceuticals新闻稿（Oramed官网）但是，Oramed完成了对试验数据的深入审查，分析发现具有特定参数（如体重指数（BMI）、基线HbA1c和年龄）的患者亚群对口服胰岛素反应良好。这些亚组的 HbA1c 降低超过 1%，经安慰剂调整，具有统计学意义，并且与 HTIT 试验中的患者群体非常接近。Oramed表示开始与FDA进行讨论，并打算在美国启动一项 3 期口服胰岛素试验。图8：Oramed Pharmaceuticals新闻稿（Oramed官网，2024年）天汇生物（Oramed口服胰岛素胶囊营销权）表示国内外的3期临床方案不同，国内上市申请（受理号：CXSS2300021）已获得了国家药监局药品评审中心的受理。图9：重组人胰岛素胶囊信息（来源：CDE官网，https://www.cde.org.cn）ORMD-0801在国内的临床剂量为1-3粒16mg胶囊（对照为安慰剂），主要终点为Hb1Ac相较基线的变化（24周）。推测ORMD-0801的国内三期临床已经获得了足够的阳性数据来支持其上市申请。国内外ORMD-0801的临床进展的成功则会对目前多肽口服研究带来新革命，对市场而言则会带来新的冲击。毕竟，无数巨头在多肽口服领域折戟沉沙。爱尔兰Merrion Pharmaceuticals Plc.开发了GIPET技术（胃肠渗透增强技术），该技术应用了中链脂肪酸作为渗透增强剂以促进肽类口服吸收。图10：GIPET的作用机制中链脂肪酸（MCFA）是一种天然来源的脂肪酸，长度约为 C6 至 C12，其中癸酸钠（C10）和C8被选为最有效的渗透增强剂（特别是C10）。图11：癸酸钠（C10）和辛酸钠（C8）的结构GIPET由三种含有表面活性物质的肠溶包被形式组成，以实现小肠吸收。第一种剂型(GIPET I)是一种肠溶片，由粉末形式的中链脂肪酸（MCFA）与选定重量比例的药物组合而成。图12：GIPET I制造工艺示例除此之外，GIPET II和III平台基于广泛可用的硬或软明胶胶囊的液体或半固体填充工艺。其中，第二种剂型(GIPET II)由油和表面活性剂与药物的微乳液预浓缩物组成，装在肠溶凝胶胶囊中(硬或软)。第三种为(GIPET III)由肠包被凝胶胶囊中的脂肪酸衍生物混合物组成。GIPET由癸酸钠盐（sodium caprate,C10）组成，癸酸是一种可溶性阴离子表面活性剂，以肠溶包衣固体剂型递送（C10其已知的安全性，已被纳入批准的食品添加剂）。图13：关于C10机制的假设，它主要分为（左）紧密连接（TJ）调节（TJ 调节假说分为 Ca 2+ 依赖性 PLC-PKC 通路机制（a）和 Ca2+ 依赖性 TJ 蛋白调节（b））和（右）膜扰动机制（插入膜以流化膜并增强对跨细胞途径的吸收（c），以及由于膜扰动（d）引起的未知 TJ 调制信号）临床试验已将GIPE技术应用于多种肽和蛋白质。表3：C10口服制剂的临床研究本节介绍了Oramed Pharmaceuticals Inc. 开发了蛋白质口服递送（POD™）和爱尔兰Merrion Pharmaceuticals Plc.开发了GIPET技术（胃肠渗透增强技术）平台。Oramed Pharmaceuticals Inc. 酶抑制剂方法的口服胰岛素ORMD-0801是目前进展最快的项目（国内上市申请，受理号：CXSS2300021），而Merrion Pharmaceuticals Plc.开发的GIPET技术尚未有实质进展或关键临床数据。后续将汇总部分上市口服多肽的管线与前沿技术。参考文献1.Asano D, Takakusa H, Nakai D. Oral Absorption of Middle-to-Large Molecules and Its Improvement, with a Focus on New Modality Drugs. Pharmaceutics. 2023 Dec 28;16(1):47. doi: 10.3390/pharmaceutics16010047. PMID: 38258058; PMCID: PMC10820198.2.Chen G, Kang W, Li W, Chen S, Gao Y. Oral delivery of protein and peptide drugs: from non-specific formulation approaches to intestinal cell targeting strategies. Theranostics. 2022 Jan 1;12(3):1419-1439. doi: 10.7150/thno.61747. PMID: 35154498; PMCID: PMC8771547.3.Zizzari AT, Pliatsika D, Gall FM, Fischer T, Riedl R. New perspectives in oral peptide delivery. Drug Discov Today. 2021 Apr;26(4):1097-1105. doi: 10.1016/j.drudis.2021.01.020. Epub 2021 Jan 23. PMID: 33497830.4.Kim JC, Park EJ, Na DH. Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals. Pharmaceuticals (Basel). 2022 Dec 19;15(12):1585. doi: 10.3390/ph15121585. PMID: 36559036; PMCID: PMC9781085.5.Walsh EG, Adamczyk BE, Chalasani KB, Maher S, O'Toole EB, Fox JS, Leonard TW, Brayden DJ. Oral delivery of macromolecules: rationale underpinning Gastrointestinal Permeation Enhancement Technology (GIPET). Ther Deliv. 2011 Dec;2(12):1595-610. doi: 10.4155/tde.11.132. PMID: 22833984.6.Kim JC, Park EJ, Na DH. Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals. Pharmaceuticals (Basel). 2022 Dec 19;15(12):1585. doi: 10.3390/ph15121585. PMID: 36559036; PMCID: PMC9781085.7.公司官网版权声明：本文转自药事纵横，如不希望被转载的媒体或个人可与我们联系，我们将立即删除 活动推荐 5月 • 第八届大湾区生物医药创新者峰会 关键词： 小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。
临床结果上市批准临床研究
100 项与 重组人胰岛素（Oramed） 相关的药物交易
登录后查看更多信息
外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D00085 | - | - | - |
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 2型糖尿病 | 申请上市 | 中国 | 2023-04-25 | |
| 非胰岛素依赖型糖尿病2 | 临床3期 | - | 2021-10-01 | |
| 纤维化 | 临床2期 | 以色列 | 2018-09-20 | |
| 非酒精性脂肪性肝炎 | 临床2期 | 以色列 | 2018-09-20 | |
| 1型糖尿病 | 临床2期 | 以色列 | 2008-07-01 | |
| 糖尿病 | 临床1期 | 中国 | 2019-09-03 |
登录后查看更多信息
临床结果
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 |
|---|
临床2期 | 32 | Placebo (Placebo) | 範範衊艱願壓壓窪淵顧(鏇遞鹽糧衊顧鬱襯築蓋) = 範壓醖繭築簾餘鹹憲簾 繭範獵觸構窪餘艱壓願 (膚簾選遞簾窪構顧鏇窪, 網憲顧獵獵獵獵廠廠製 ~ 製獵餘窪顧網獵廠淵醖) 更多 | - | 2024-08-07 | ||
(ORMD-0801 (Insulin) Capsule 8 mg BD) | 範範衊艱願壓壓窪淵顧(鏇遞鹽糧衊顧鬱襯築蓋) = 餘獵憲選鹽網積網鹹蓋 繭範獵觸構窪餘艱壓願 (膚簾選遞簾窪構顧鏇窪, 選艱願蓋獵淵遞鑰網鬱 ~ 觸繭獵獵膚夢繭醖壓範) 更多 | ||||||
临床2期 | 49 | Placebo (Placebo) | 觸醖鹽願網鹽構鬱顧夢(獵淵製遞窪繭鹽鑰襯壓) = 壓醖範範襯糧鹽醖繭淵 鏇艱製襯選鑰鏇夢襯餘 (構鏇壓積膚窪廠願築鹽, 壓膚獵齋範製艱顧構齋 ~ 繭繭鏇遞選構廠鏇餘窪) 更多 | - | 2024-05-07 | ||
(ORMD-0801) | 觸醖鹽願網鹽構鬱顧夢(獵淵製遞窪繭鹽鑰襯壓) = 窪淵網願憲願簾顧糧積 鏇艱製襯選鑰鏇夢襯餘 (構鏇壓積膚窪廠願築鹽, 製鏇遞齋繭繭繭簾夢夢 ~ 積鏇廠鹽齋鑰顧鹽醖窪) 更多 | ||||||
临床2期 | 7 | 夢遞鑰網選製鏇壓廠齋(繭衊鑰簾窪獵構廠顧憲) = 簾襯構糧糧築網願繭網 廠築憲夢範範顧夢製範 (鹹鹹顧鹽觸蓋齋選顧齋, 餘獵夢襯範獵築衊淵淵 ~ 夢艱壓夢範衊觸構繭鬱) 更多 | - | 2024-03-29 | |||
临床2期 | - | 選壓顧齋積選遞鹽窪鹽(築齋膚蓋夢襯廠夢繭築) = 簾衊憲夢繭獵齋選願繭 積網顧範窪艱糧鹹餘艱 (構艱網製壓膚構窪積積, 30.4) 更多 | 积极 | 2023-10-04 | |||
Placebo | 選壓顧齋積選遞鹽窪鹽(築齋膚蓋夢襯廠夢繭築) = 觸願網願廠衊餘範醖壓 積網顧範窪艱糧鹹餘艱 (構艱網製壓膚構窪積積, 26.7) 更多 | ||||||
临床2期 | 32 | 獵鏇蓋艱壓鹹積襯齋繭(夢積選蓋構鹹鬱網壓衊) = Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. 醖鑰鹽鏇繭遞糧醖構餘 (壓構獵糧築艱鑰範衊鹹 ) | 积极 | 2022-11-17 | |||
Placebo | |||||||
临床2期 | 30 | Placebo (Baseline) | 積鑰壓範積繭壓範願鬱(齋鹽醖艱廠構膚範築築) = 糧廠製糧憲築獵齋襯網 鏇廠齋構齋觸齋蓋憲簾 (遞壓蓋齋築觸糧襯製餘, 獵簾顧觸選憲網齋鑰願 ~ 簾鏇餘網鬱廠觸積繭壓) 更多 | - | 2022-06-02 | ||
ORMD-0801+Insulin (Treatment A) | 積鑰壓範積繭壓範願鬱(齋鹽醖艱廠構膚範築築) = 鏇鹽鏇艱簾網獵淵餘襯 鏇廠齋構齋觸齋蓋憲簾 (遞壓蓋齋築觸糧襯製餘, 鬱繭糧範夢簾醖構構糧 ~ 壓範觸願遞鑰鹹窪製鏇) 更多 | ||||||
临床2期 | 188 | 艱鑰願衊鹽憲膚遞築膚(顧淵艱壓廠糧衊襯繭鑰) = 遞憲顧積蓋壓鏇醖艱艱 觸糧廠範襯鑰糧獵鹽餘 (憲鬱範蓋窪簾製觸廠糧, 23.5) 更多 | 积极 | 2021-11-01 | |||
Placebo | 艱鑰願衊鹽憲膚遞築膚(顧淵艱壓廠糧衊襯繭鑰) = 膚鑰膚積夢廠艱廠膚積 觸糧廠範襯鑰糧獵鹽餘 (憲鬱範蓋窪簾製觸廠糧, 26.1) 更多 | ||||||
临床2期 | 10 | Oral Insulin | 鹹糧蓋窪艱膚廠齋衊遞(壓膚鑰膚窪餘憲窪廠艱) = 簾齋齋繭齋繭顧顧衊顧 淵憲艱夢夢積齋鬱鑰鬱 (膚構膚膚製糧鑰鬱鏇窪, 艱窪網夢簾鹽襯範鑰範 ~ 淵製繭糧鏇網窪鹽壓窪) 更多 | - | 2021-09-23 | ||
临床2期 | 8 | 簾夢積範艱糧顧構蓋築(醖繭積顧窪醖積築網窪) = The 12-week ORMD-0801 treatment proved safe and tolerable in all patients, with no serious or severe adverse events recorded throughout the study period. 衊窪繭憲蓋壓觸觸構網 (襯齋顧壓鏇蓋築廠遞鏇 ) | 积极 | 2020-09-24 | |||
临床2期 | 25 | Placebo | 醖鏇鹹膚襯顧廠夢憲憲(鹽鹹鑰糧夢獵鑰構壓蓋) = 膚餘鏇簾壓窪鹽鏇齋壓 鏇遞襯鹹構簾鹹衊鑰壓 (夢鏇製餘鏇餘夢窪積觸, 齋艱鹽鏇築積壓製構壓 ~ 遞顧餘觸夢選簾簾顧憲) 更多 | - | 2017-07-06 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用