A Multicentric, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke.

Extensive research is being conducted in search of neuroprotective agents for possible use in the acute phase of stroke and agents that can be used for neurorepair in later stages of stroke. Several trials have been conducted and are in progress using different pharmacological agents, but none of the studies involve the stimulation of ETB receptors to treat cerebral ischemic stroke. Sovateltide (IRL-1620, PMZ-1620) has been effective in animal models of cerebral ischemic stroke. Its safety and tolerability have been demonstrated in a human phase I study with 7 subjects. Clinical phase II and III results indicate that sovateltide is a novel, first-in-class, highly effective drug candidate for treating cerebral ischemic stroke. Safety and significant efficacy in improving the National Institutes of Health Stroke Scale (NIHSS), Modified Rankin scale (mRS), and Barthel index (BI) obtained in phase II and III studies in patients with cerebral ischemic stroke in India are convincing and encouraged us to investigate its safety and efficacy in cerebral ischemic stroke patients in the United States. Therefore, the plan is to conduct a phase III clinical study to evaluate the safety and efficacy of sovateltide therapy along with standard of care in patients of acute ischemic stroke.

开始日期2025-07-24

申办/合作机构

Pharmazz, Inc.

CTRI/2024/07/070459

/ Not yet recruiting临床4期

Safety and efficacy of sovateltide in acute cerebral ischemic stroke patients at a tertiary care centre-a double blinded block randomised placebo controlled study - NIL

开始日期2024-07-22

申办/合作机构

Pondicherry Institute of Medical Sciences

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100 项与 Sovateltide 相关的专利（医药）

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310

项与 Sovateltide 相关的文献（医药）

2026-02-20·MEDICINE

Real-world functional outcomes of sovateltide as an adjunct to standard therapy in acute ischemic stroke: A prospective observational study

Article

作者: Kandasamy, Geetha ; Aldahish, Afaf Ahmed ; Prabahar, Kousalya ; Orayj, Khalid ; Almanasef, Mona ; Mani, Vasudevan ; Saravanan, Abishek ; Hmlan, Amjad ; Asiri, Rayah ; Selvaraj, Lavanya

Acute ischemic stroke (AIS) remains a leading cause of long-term disability and mortality worldwide. Current therapeutic strategies primarily focus on reperfusion, with limited options to enhance neuroregeneration and functional recovery. Sovateltide, a selective endothelin-B receptor agonist, has demonstrated neuroprotective and neurorestorative potential in preclinical and early clinical studies. This study aimed to assess real-world neurological and functional outcomes in AIS patients receiving standard therapy, with a subgroup additionally receiving sovateltide as part of routine clinical care. A prospective real-world observational study was conducted over 6 months (April–September 2025) in the Neurology Department of PSG Hospitals, Coimbatore. During routine clinical care, patients presenting with AIS within 24 hours of symptom onset were consecutively identified. Based on the treatment they naturally received as part of standard clinical decision-making, patients were classified into 2 groups: standard therapy alone (n = 40) or standard therapy plus intravenous sovateltide (n = 40). Sovateltide (0.3 µg/kg) was administered as part of routine care in 3 doses on Days 1, 3, and 6. Neurological and functional outcomes were assessed using the NIH Stroke Scale (NIHSS), Barthel Index (BI), and modified Rankin Scale (mRS) at baseline and at 90-day follow-up by trained outcome assessors blinded to treatment classification. A total of 80 patients were included, with 40 receiving standard therapy and 40 receiving adjuvant therapy with sovateltide. Stroke severity assessed by the NIHSS was comparable between groups at baseline. Across follow-up, NIHSS scores decreased in both groups, with the sovateltide group showing greater numerical reductions at 60 days ( P = .040) and 90 days ( P = .006). Functional recovery patterns assessed using the BI indicated higher median scores in the sovateltide group at 30 days ( P = .0429), 60 days ( P = .0350), and 90 days ( P = .0376). mRS scores also declined over time in both groups, with the sovateltide group demonstrating more favorable distributions at 30 days ( P = .0413), 60 days ( P = .0246), and 90 days ( P = .0064). Within-group analyses showed significant improvements in NIHSS, BI, and mRS across all time points for both cohorts ( P < .0001). These findings represent observed differences only and do not indicate causality. In this real-world observational study, patients who received sovateltide as part of routine care showed more favorable trends in neurological and functional outcomes over 90 days compared with those receiving standard therapy alone. These findings represent associations only and do not establish causality. The results offer preliminary real-world insights into the use of sovateltide in AIS, and larger randomized controlled trials are required to determine its independent therapeutic role and to confirm these observations.

2025-03-01·EXPERIMENTAL NEUROLOGY

Microglial cell proliferation is regulated, in part, by reactive astrocyte ETBR signaling after ischemic stroke

Article

作者: Torsney, Emily E ; LeComte, Matthew D ; Del Rio-Guerra, Roxana ; Poynter, Matthew E ; Spees, Jeffrey L ; McInnis, John J ; Reed, Leah F

Reciprocal communication between reactive astrocytes and microglial cells provides local, coordinated control over critical processes such as neuroinflammation, neuroprotection, and scar formation after CNS injury, but is poorly understood. The vasoactive peptide hormone endothelin (ET) is released and/or secreted by endothelial cells, microglial cells and astrocytes early after ischemic stroke and other forms of brain injury. To better understand glial cell communication after stroke, we sought to identify paracrine effectors produced and secreted downstream of astroglial endothelin receptor B (ETB_R) signaling. Using a genetic loss-of-function screen, we identified angiopoietin-2 (Ang-2) as a factor produced by reactive astrocytes in response to ET. In experiments with primary adult astrocytes stimulated by IRL1620, a specific ETB_R agonist, we found that ERK1/2 and NFkB mediated the effects of ET on Ang-2 production. To determine astroglial Ang-2 levels in vivo, reactive astrocytes expressing the high affinity glutamate transporter (GLAST, EAAT1) were isolated by magnetic-activated cell sorting 3 days after stroke. Astrocytes obtained from the ipsilateral hemisphere expressed significantly more Ang-2 compared with astrocytes isolated from the contralateral hemisphere, or from cortices of sham-operated (control) mice. Notably, analysis of microglia sorted from CX3CR1-eGFP mice demonstrated increased cell surface expression of Tie-2, the Ang-2 receptor, on cells obtained from ipsilateral versus contralateral tissue. Addition of recombinant Ang-2 to astrocyte-conditioned medium significantly increased the number of SIM-A9 murine microglial cells cultured under hypoxic conditions (1 % oxygen for 48 h). In transgenic GFAP-CreER™-EDNRB-^fl/fl mice with stroke, conditional knockout of astroglial ETB_R significantly decreased the number of proliferating cells in the peri-infarct area with a microglial phenotype (Ki67⁺/CD11b⁺). Our results indicate that Ang-2, and possibly other paracrine effectors functioning downstream of astroglial ETB_R signaling, are important mediators of microglial cell dynamics after stroke.

2024-10-01·Neurocritical care

Sovateltide (ILR-1620) Improves Motor Function and Reduces Hyperalgesia in a Rat Model of Spinal Cord Injury

Article

作者: Karampela, Eleftheria ; Xanthos, Theodoros ; Mavridi, Artemis ; Gkiokas, George ; Iacovidou, Nicoletta ; Galanos, Antonis ; Mavridis, Theodoros

BACKGROUND:

Spinal cord injury (SCI) presents a major global health challenge, with rising incidence rates and substantial disability. Although progress has been made in understanding SCI's pathophysiology and early management, there is still a lack of effective treatments to mitigate long-term consequences. This study investigates the potential of sovateltide, a selective endothelin B receptor agonist, in improving clinical outcomes in an acute SCI rat model.

METHODS:

Thirty male Sprague-Dawley rats underwent sham surgery (group A) or SCI and treated with vehicle (group B) or sovateltide (group C). Clinical tests, including Basso, Beattie, and Bresnahan scoring, inclined plane, and allodynia testing with von Frey hair, were performed at various time points. Statistical analyses assessed treatment effects.

RESULTS:

Sovateltide administration significantly improved motor function, reducing neurological deficits and enhancing locomotor recovery compared with vehicle-treated rats, starting from day 7 post injury. Additionally, the allodynic threshold improved, suggesting antinociceptive properties. Notably, the sovateltide group demonstrated sustained recovery, and even reached preinjury performance levels, whereas the vehicle group plateaued.

CONCLUSIONS:

This study suggests that sovateltide may offer neuroprotective effects, enhancing neurogenesis and angiogenesis. Furthermore, it may possess anti-inflammatory and antinociceptive properties. Future clinical trials are needed to validate these findings, but sovateltide shows promise as a potential therapeutic strategy to improve functional outcomes in SCI. Sovateltide, an endothelin B receptor agonist, exhibits neuroprotective properties, enhancing motor recovery and ameliorating hyperalgesia in a rat SCI model. These findings could pave the way for innovative pharmacological interventions for SCI in clinical settings.

项与 Sovateltide 相关的新闻（医药）

2026-02-11

·肽研社

Tides | 药王易主，诺和诺德不得不All In Wegovy

温馨提示肽研社建读者交流群啦~ 行业交流、商务合作、报告咨询请添加小编微信，后续入群哦👇 研究进展 01 Ayrmid 2026-02-04爱尔兰，Ayrmid公布的真实世界研究数据显示，其长效 CXCR4 抑制肽药物 motixafortide 在镰状细胞病和 β-地中海贫血患者中展现出显著的造血干细胞（HSC）动员能力，为基因治疗的实施扫清了关键障碍。相关研究结果已在 2026 年 TANDEM（ASTCT® 与 CIBMTR® 联合年会）上发布。 Motixafortide 是一种结构优化的 CXCR4 拮抗肽分子，目前已获 FDA 批准，与 G-CSF（filgrastim）联用用于多发性骨髓瘤的干细胞动员。其独特的药代动力学特征和持久 CXCR4 阻断能力，使其在传统动员方案效果受限的遗传性血液病患者中受到关注，尤其是在镰状细胞病这一干细胞采集长期受限的治疗场景中。本次来自五个治疗中心的真实世界研究共纳入 15 名 14–50 岁患者。结果显示，73% 的患者（11/15）成功采集到足量 HSC 以进入基因治疗生产阶段，其中 5 名患者已完成基因治疗并实现成功植入，另有 5 名患者的治疗产品正在生产中。值得注意的是，这 11 名成功动员的患者此前均曾在 plerixafor 动员方案下采集失败，凸显了 motixafortide 作为 CXCR4 靶向肽类动员剂在困难人群中的临床价值。此外，还有 3 名患者将 motixafortide 作为一线动员方案，同样实现了有效采集。在已完成或正在进行的治疗中，患者接受了包括 Casgevy、Lyfgenia 和 Zynteglo 在内的多种基因治疗产品，显示由 motixafortide 动员获得的干细胞可适配不同的基因治疗制造平台，进一步验证了其临床通用性和技术兼容性。 02 Pharmazz 2026-02-04，Pharmazz在2026年国际卒中大会（ISC 2026）上公布其内皮素B（ET-B）受体激动剂 sovateltide（Tycamzzi®）治疗急性缺血性脑卒中的IV期临床研究中期分析结果。数据显示，该药物在功能恢复方面展现出显著疗效，并保持良好的安全性。该项IV期研究（NCT05955326）为一项在印度开展的多中心随机对照试验，旨在评估sovateltide在卒中发病24小时内给药的真实世界疗效与安全性。在研究设计方面，入组对象为18–78岁、影像学确诊缺血性脑卒中且NIHSS评分≥6分的患者。受试者随机接受sovateltide（0.3 μg/kg）或生理盐水对照治疗。药物于第1、3、6天分别给药，每次给药包含3次静脉推注，间隔3±1小时。主要终点为第90天mRS功能评分。中期分析共纳入80例完成90天随访的患者，其中39例接受sovateltide治疗，41例为对照组。结果显示： - 92.3%的sovateltide治疗患者在第90天达到改良Rankin量表（mRS）0–2分，而对照组为58.5%（OR=8.50，p=0.0005） - 有利功能结局绝对提高33% - 84.6%的治疗组患者mRS评分改善≥2分，对照组为51.2%（p=0.0014） - 两组患者基线特征（年龄、NIHSS评分、治疗时间窗等）均具有可比性 - 未观察到药物相关不良事件，整体安全性与既往研究一致 Sovateltide是一种全球first-in-class高选择性ET-B受体激动剂，可通过神经保护、促血管生成以及促进神经再生发挥作用。该药物已于2023年在印度获批上市，迄今累计治疗患者超过10万人。目前，Pharmazz正在推进全球III期随机双盲安慰剂对照研究RESPECT-ETB（NCT05691244），该研究计划在美国、欧洲、英国及澳大利亚入组超过500例急性缺血性脑卒中患者。 03 先为达 2026-02-05，先为达的XW014片获得CDE临床默示许可，用于肥胖或超重合并至少一种体重相关合并症人群的体重管理。 04 甘李药业 2026-02-06，甘李药业的注射用GLR1059临床申请获得CDE受理（CXSL2600182）。 05 Novo Nordisk 2026-02-09，根据Clinicaltrials官网显示，Novo Nordisk注册了UBT251用于治疗肥胖的全球二期临床试验。该候选药物为联邦制药自主研发的GLP-1/GIP/GCG受体激动剂。根据2024年披露的一期临床数据，半衰期为136-170小时，支持每周一次给药，1.0-4.5mg剂量范围内，体重下降幅度为3.19-2.80kg，明显优于安慰剂对照组。2025年3月，联邦制药宣布将该分子的大中华区外全球权益授权给Novo Nordisk，后者支付2亿美元预付款、18亿美元里程碑金额，以及一定比例的销售分成。 06 先为达 2026-02-10，先为达的埃诺格鲁肽注射液临床申请获得CDE受理。 07 MannKind 2026-02-10美国，MannKind宣布其针对新诊断儿童及青少年 1 型糖尿病患者的临床研究 INHALE-1ST 已完成首例受试者入组。该研究旨在评估在确诊初期即启动 Afrezza® 吸入式人胰岛素治疗，在10至未满18岁青少年患者中的安全性、有效性及治疗体验。MannKind 是一家专注于心代谢及罕见肺部疾病的生物制药公司，此项研究由 Jaeb Center for Health Research 牵头开展。 INHALE-1ST 研究设计为单臂、多中心临床研究，评估 Afrezza 联合每日一次皮下注射基础胰岛素用于新诊断 1 型糖尿病青少年患者的治疗效果。研究不仅关注血糖控制等临床终点，还将系统评估患者及照护者在疾病早期使用吸入式胰岛素进行餐时血糖管理的满意度与体验。研究计划在美国约 10 家临床中心入组约 100 名患者，首例患者已在科罗拉多州奥罗拉的 Barbara Davis 糖尿病中心完成入组。该研究主阶段为期 13 周，随后设有可选延展阶段，允许持续使用 Afrezza 联合基础胰岛素治疗最长 26 周。主要终点为在第 13 周访视前 14 天内，佩戴连续血糖监测仪（CGM）的受试者中，血糖处于 70–180 mg/dL 目标范围（TIR）时间比例达到或超过 70% 的患者比例。相关研究信息已在 ClinicalTrials.gov 登记（NCT07224321）。在监管进展方面，MannKind于2025年10月向 FDA 递交的 Afrezza 儿科适应症补充生物制品许可申请（sBLA）已获受理，PDUFA 目标审评日期为2026-05-29。若获批准，Afrezza有望成为 100 多年来首个适用于儿童和青少年患者的无针胰岛素治疗选择。注册获批 01 银诺医药 2026-02-04，银诺医药（02591.HK）宣布其核心产品依苏帕格鲁肽 α 用于治疗宠物糖尿病的新兽药临床试验申请已获农业部正式受理，预计将于 2026Q1开始 I 期临床试验。紧接着2月6日，公司宣布成立宠物事业部，将战略性布局宠物用创新药领域。依托其在代谢性疾病领域的核心技术积淀，充分复用在GLP-1领域的技术积累与产业化经验，针对性治疗宠物糖尿病、肥胖等宠物常见病症。 2025 年 1 月，依苏帕格鲁肽 α 在国内获批上市，用于成人 2 型糖尿病治疗，包括单药以及接受二甲双胍药物治疗血糖仍控制不佳的患者，每周皮下注射一次。同年，该产品还通过谈判顺利进入了医保目录，其减重适应症也正在申请中。 02 Insulet Corporation 2026-02-05，Insulet Corporation (NASDAQ: PODD) 宣布其Omnipod 5自动化胰岛素输注系统（AID）已在中东多个核心市场实现商业化落地，包括沙特阿拉伯、科威特、卡塔尔和阿联酋。该系统可与雅培FreeStyle Libre 2 Plus及Dexcom G7连续血糖监测（CGM）传感器兼容。相关进展于迪拜举行的第16届阿联酋糖尿病与内分泌大会（EDEC）期间正式发布。 Omnipod 5是一款无管路（tubeless）自动化胰岛素输注系统，通过每5分钟自动调节胰岛素给药，实现全天候动态控糖，减少多次每日注射（MDI）的负担。临床数据显示，该系统可显著改善血糖达标时间（Time in Range）并降低HbA1c水平。其防水、隐蔽、可穿戴的设计，使其成为目前首个可与CGM联动、主动纠正高血糖并预防低血糖的无管路AID系统。在适应症方面，Omnipod 5适用于2岁及以上1型糖尿病患者。在沙特、科威特和阿联酋，该系统可同时兼容雅培FreeStyle Libre 2 Plus和Dexcom G7传感器；在卡塔尔则兼容Dexcom G7传感器。与此同时，Insulet还在上述中东市场首次推出Omnipod Discover数据管理平台。该平台是一款基于网络的回顾性数据分析与报告工具，面向患者、照护者及医疗专业人员，旨在整合血糖与胰岛素输注数据，将复杂的糖尿病管理信息转化为清晰、可操作的趋势和洞察。Omnipod Discover可直观展示Omnipod 5算法如何自动调整胰岛素给药，帮助医生和患者更高效地理解数据、优化决策，从而降低临床管理和日常使用负担。 Insulet表示，Omnipod Discover将以中东市场作为首发区域，未来计划扩展至其他已上市Omnipod 5的国家和地区。随着此次中东市场的拓展，Omnipod 5目前已在全球19个国家实现商业化。公司预计将于2026年进入西班牙市场，并计划在2027年上半年陆续在希腊和克罗地亚上市。 03 南京海融制药 2026-02-06，南京海融制药的注射用醋酸西曲瑞克获得NMPA批准（国药准字H20263289）。 04 Ascendis 2026-02-06加拿大，Pendopharm（Pharmascience旗下部门）宣布，加拿大卫生部（Health Canada）已批准 Yorvipath®（palopegteriparatide 注射液）在加拿大上市，用于治疗成人慢性甲状旁腺功能减退症。Yorvipath® 是一种甲状旁腺激素（PTH）替代治疗方案，由 Ascendis开发。此次获批标志着该创新疗法正式进入加拿大市场，为长期缺乏新治疗选择的患者提供了新的疾病管理手段。此次监管批准基于 Pendopharm 与 Ascendis 于 2024 年 7 月签署的加拿大独家分销协议。根据该协议，Pendopharm 负责 Yorvipath® 在加拿大的注册、商业化及市场推广工作。该产品此前已在美国、欧盟、英国、澳大利亚、瑞士、以色列和日本获批，并正在其他全球市场推进注册或开发。Pendopharm 表示，目前正与多方关键合作伙伴紧密协作，推进产品顺利上市，并同步开展公共和私人医保体系的准入与报销谈判。 Yorvipath® 的获批进一步巩固了 Ascendis 基于 TransCon® 技术平台在内分泌罕见病领域的布局，也凸显了 Pendopharm 在加拿大引入创新专科药物、解决未满足医疗需求方面的能力与执行力。市场营销 01 Novo Nordisk 2026-02-08美国，Novo Nordisk在“超级碗”赛事期间，首次发布品牌重磅广告，正式向大众介绍Wegovy®（司美格鲁肽）口服片剂25mg。该产品为目前美国唯一获FDA批准、用于体重管理的口服GLP-1受体激动剂，适用于肥胖成人，或伴有体重相关合并症的超重成人，在控制热量摄入和增加运动的基础上，用于减重及维持体重。此次名为 “A New Way to Wegovy®” 的传播活动，通过轻松幽默的方式，尝试打破公众对减重药物“走捷径”的刻板印象，将讨论重点从羞耻感和犹豫，转向基于医学与科学证据的体重管理选择。在商业可及性方面，Wegovy®口服片剂已在美国7万多家药房广泛上市，包括CVS、Costco等连锁药房，并通过Ro、LifeMD、Weight Watchers等部分远程医疗平台，以及NovoCare® Pharmacy和GoodRx等渠道提供。对于自费患者，起始剂量（1.5 mg）可通过官方渠道以每月$149的价格获得；符合条件的商业保险患者，在优惠计划下最低可支付每月$25。目前，美国已有超过5500万人享有FDA批准的肥胖治疗药物保险覆盖。 02 Novo Nordisk 2026-02-09美国&丹麦，Novo Nordisk宣布已正式对远程医疗公司 Hims & Hers提起诉讼，指控其在美国市场销售的复方司美格鲁肽产品侵犯了Novo Nordisk的美国专利 US 8,129,343，并通过大规模营销未经FDA批准的产品误导患者和医疗专业人士，对公共健康构成严重风险。 Novo Nordisk表示，Hims & Hers长期开展针对复方司美格鲁肽产品的推广活动，夸大其临床获益和安全性，使消费者和医务人员误以为这些未经批准的产品与原研药具有同等质量与疗效。公司特别指出，Hims & Hers在Novo Nordisk推出全球首款、也是唯一获得FDA批准的GLP-1减重口服药 Wegovy® pill 后不久，曾高调推出所谓“复方GLP-1口服片”，但仅两天后即匆忙下架；与此同时，Hims & Hers仍在继续非法大规模复方配制并销售注射用司美格鲁肽产品，其所使用的API并非正品来源，存在严重安全隐患。诉讼中，Novo Nordisk请求法院永久禁止Hims & Hers销售侵犯其专利的未经批准复方药物，并追究其造成的经济损失。公司同时警告称，Hims & Hers与部分复方药房的大规模营销行为已导致市场充斥Wegovy®和Ozempic®的“仿制品”。这些复方司美格鲁肽产品可能含有危险杂质或错误剂量的活性成分，从而引发严重免疫反应、住院治疗、严重药物相互作用甚至过量用药等风险。根据Novo Nordisk的检测结果，由复方药房配制的注射用司美格鲁肽产品中，杂质含量最高可达86%，而口服复方司美格鲁肽产品中的杂质比例最高可达75%。即使是少量杂质，也可能对药物的安全性和有效性产生重大不利影响，包括诱发过敏性休克等严重免疫反应。 Hims & Hers于上周四正式推出其所谓的“司美格鲁肽口服片”，初期促销价为每月49美元，随后上调至99美元；相比之下，Novo Nordisk的原研产品 Wegovy® pill 起始价为149美元，常规月费为199美元。然而，在面临司法部潜在调查风险及Novo Nordisk明确的法律行动威胁后，Hims & Hers在产品上市仅几天后便宣布停止提供该治疗方案。Hims & Hers于2月8日在X平台发布简短声明称，公司已与行业相关方进行了“建设性沟通”，并据此决定下架该产品。该消息发布后，Hims & Hers股价在盘后交易中一度下跌近16%。就在上周，美国FDA也再次明确指出，包括Hims & Hers在内的复方药房所大规模销售的GLP-1类产品属于“FDA无法核实其质量、安全性或有效性的药物”。美国医学会（AMA）、美国糖尿病协会（ADA）及内分泌学会等权威医学组织也多次对GLP-1仿制产品表达担忧。ADA明确建议不要使用此类产品，原因在于其成分、安全性、质量一致性和疗效均存在高度不确定性。此次诉讼是Novo Nordisk多年持续行动的一部分，旨在保护患者免受不安全复方产品的侵害。此前，公司已发起包括“Check Before You Inject”和“Choose The Real Thing”在内的多项公众教育活动，提醒患者警惕使用来源不明、含有境外非正品API的未经批准药物。企业发展 01 Lilly 2026-02-04美国，Lilly公布了2025年全年财务业绩——在GLP-1产品持续放量的推动下实现强劲增长。Mounjaro（替尔泊肽降糖适应症）全年销售额$22965Mn（增长99%），Zepbound（替尔泊肽减重适应症）全年销售额$13542Mn（增长175%），替尔泊肽累计2025年销售额达到$36507Mn。 02 OPKO Health & Entera Bio 2026-02-04美国，OPKO Health（NASDAQ: OPK）通过其全资子公司 OPKO Biologics，与口服肽与蛋白替代疗法领域的领先企业 Entera Bio（NASDAQ: ENTX）宣布，双方将扩展于2025年签署的合作与许可协议，推进全球首个口服长效甲状旁腺激素（LA-PTH）肽类似物，用于甲状旁腺功能减退症患者的一日一次口服给药治疗。该新增项目将 OPKO 专有的长效PTH肽变体与 Entera 的 N-Tab® 口服肽递送平台相结合。这是双方第三个成功整合口服肽技术与先进蛋白/肽工程能力的研发项目。基于2025年12月公布的积极PK/PD数据，双方决定加速该项目开发，预计将于2026H2向美国FDA提交IND申请。根据扩展后的合作协议，OPKO 与 Entera 将以 50:50 的比例共同持有 LA-PTH 项目的权益，并各自承担一半的研发费用；而在另一条口服胃泌酸调节素（OXM）肽项目中，双方仍维持此前公布的 OPKO 60%、Entera 40% 的权益与成本分担结构。在管线进展方面，双方正同步推进可注射与口服两种剂型的OXM项目。OXM 是一种天然存在的GLP-1 / 胰高血糖素双重激动肽，在体重管理、代谢性疾病及抗纤维化领域具有潜在优势。注射型OXM的一期临床初步数据预计将于2026年末公布，随后口服OXM肽制剂将进入临床阶段。目前，全球尚无获批的GLP-1/胰高血糖素双重激动剂。 03 云顶新耀 & 麦科奥特 2026-02-05，云顶新耀（HKEX 1952.HK），一家专注于创新药研发、临床开发、制造及商业化的生物制药公司宣布与麦科奥特签署独家商业化许可协议，获得MT1013在中国及亚太区（日本除外）的独家商业化授权。MT1013为全球首创的双靶点受体激动剂多肽，可同时靶向钙敏感受体(CaSR)及成骨生长肽(OGP)受体，开发主要用于治疗继发性甲状旁腺功能亢进症(SHPT)。此次战略合作将与云顶新耀现有肾科管线形成协同效应，强化产品布局，巩固公司在亚洲肾脏及自身免疫疾病领域的领导地位，并将产品覆盖从IgA肾病拓展至更广泛的慢性肾脏病领域。根据协议，云顶新耀将向麦科奥特支付人民币2亿元首付款，以及最高不超过人民币10.40亿元的潜在监管及商业里程碑付款。中国III期临床研究正在进行中，相关临床开发费用将由麦科奥特承担。 MT1013是由麦科奥特自主研发的全球首创双靶点多肽新药，2025年获美国肾脏病学会（ASN）年会“Late-Breaking”收录。其开创性地融合了“钙敏感受体（CaSR）+成骨生长肽（OGP）模拟”双重作用机制，解决了PTH、钙、磷代谢平衡的问题，这一全新设计使其在治疗继发性甲状旁腺功能亢进（SHPT）及相关骨代谢疾病时，首次创造性的从源头上控制病情，且能通过直接激活成骨通路，主动促进骨形成与修复，实现从“间接抑制骨吸收”到“主动促进骨生成”的治疗创新升级。临床研究证实，MT1013在慢性肾病接受维持性血液透析伴继发性甲状旁腺功能亢进患者中，起效迅速、效力强且持久，安全性良好，在综合达标率（iPTH，血钙，血磷均达标）、血钙钙化指标的控制及心血管获益前景上均展示出超越现有疗法的潜力。目前，MT1013正在中国开展针对该患者群体的III期临床研究，已入组超50%。 MT1013已完成关键II期临床研究，数据显示，MT1013在维持性血液透析伴SHPT患者中，展现出强效且持久的iPTH抑制能力，并在与依特卡肽头对头比较中实现了综合管理的优势——其iPTH、血钙、血磷三项同时达标率更高，降磷及降低心血管风险标志物FGF-23的优势更强，加之MT1013在长达52周的治疗中也为患者人群带来了显著的骨密度提升及骨代谢标志物改善，逐步验证了其独特的双重机制在SHPT患者中综合管理及改善骨骼健康方面的潜在临床获益。目前MT1013已进入以西那卡塞为阳性对照的确证性III期临床试验。该III期试验已在全国范围内启动超过100家研究中心，计划招募约424名患者，主要针对慢性肾脏病维持性血液透析伴SHPT的患者群体。 2026-02-05，云顶新耀（HKEX 1952.HK），一家专注于创新药研发、临床开发、制造及商业化的生物制药公司宣布与麦科奥特签署独家商业化许可协议，获得MT1013在中国及亚太区（日本除外）的独家商业化授权。MT1013为全球首创的双靶点受体激动剂多肽，可同时靶向钙敏感受体(CaSR)及成骨生长肽(OGP)受体，开发主要用于治疗继发性甲状旁腺功能亢进症(SHPT)。此次战略合作将与云顶新耀现有肾科管线形成协同效应，强化产品布局，巩固公司在亚洲肾脏及自身免疫疾病领域的领导地位，并将产品覆盖从IgA肾病拓展至更广泛的慢性肾脏病领域。根据协议，云顶新耀将向麦科奥特支付人民币2亿元首付款，以及最高不超过人民币10.40亿元的潜在监管及商业里程碑付款。中国III期临床研究正在进行中，相关临床开发费用将由麦科奥特承担。 MT1013是由麦科奥特自主研发的全球首创双靶点多肽新药，2025年获美国肾脏病学会（ASN）年会“Late-Breaking”收录。其开创性地融合了“钙敏感受体（CaSR）+成骨生长肽（OGP）模拟”双重作用机制，解决了PTH、钙、磷代谢平衡的问题，这一全新设计使其在治疗继发性甲状旁腺功能亢进（SHPT）及相关骨代谢疾病时，首次创造性的从源头上控制病情，且能通过直接激活成骨通路，主动促进骨形成与修复，实现从“间接抑制骨吸收”到“主动促进骨生成”的治疗创新升级。临床研究证实，MT1013在慢性肾病接受维持性血液透析伴继发性甲状旁腺功能亢进患者中，起效迅速、效力强且持久，安全性良好，在综合达标率（iPTH，血钙，血磷均达标）、血钙钙化指标的控制及心血管获益前景上均展示出超越现有疗法的潜力。目前，MT1013正在中国开展针对该患者群体的III期临床研究，已入组超50%。 MT1013已完成关键II期临床研究，数据显示，MT1013在维持性血液透析伴SHPT患者中，展现出强效且持久的iPTH抑制能力，并在与依特卡肽头对头比较中实现了综合管理的优势——其iPTH、血钙、血磷三项同时达标率更高，降磷及降低心血管风险标志物FGF-23的优势更强，加之MT1013在长达52周的治疗中也为患者人群带来了显著的骨密度提升及骨代谢标志物改善，逐步验证了其独特的双重机制在SHPT患者中综合管理及改善骨骼健康方面的潜在临床获益。目前MT1013已进入以西那卡塞为阳性对照的确证性III期临床试验。该III期试验已在全国范围内启动超过100家研究中心，计划招募约424名患者，主要针对慢性肾脏病维持性血液透析伴SHPT的患者群体。 04 LIR 2026-02-05加拿大，LIR Life Sciences宣布已根据现有服务协议，正式与 Neuland Laboratories启动 Project Phase 2肽设计工作，进一步推进其用于经皮递送平台的新一代细胞穿透肽（CPP）研发。本次二期项目在一期肽合成工作成功完成的基础上展开，核心聚焦于构效（SAR）分析，旨在设计并优化第三代肽候选物，以在保持强经皮转运能力的同时，提升可合成性、工艺效率及制剂灵活性，为后续规模化生产奠定基础。 Project Phase 2 将系统性探索一系列源自 LIR 铅型鱼精蛋白（protamine-based）序列的合成变体，通过理性设计筛选在经皮递送性能与制造可行性之间实现更优平衡的候选肽分子。LIR 与 Neuland 将协同推进代表性肽结构的优化，并确定后续优先合成与评估的目标序列。该阶段产生的结果将为未来的肽合成、制剂开发及生物学验证提供关键决策依据。 LIR Life Sciences 专注于通过创新递送方式开发可规模化、可负担的肥胖治疗方案，目前正推进基于 GLP-1 作用机制的经皮贴剂及其他非注射递送系统，目标是在全球范围内提升治疗可及性、依从性与成本效率。 05 Kashiv BioSciences 2026-02-10美国，Kashiv BioSciences宣布已与印度领先的跨国制药公司 Intas Pharmaceuticals 达成一项独家许可及供货协议，双方将就一款复杂肽类产品展开合作。根据协议安排，该产品将在印度由 Intas 负责商业化，在欧洲及英国市场则由其全资子公司 Accord Healthcare 进行推广和销售，合作范围覆盖泛欧洲、英国及印度市场。按照协议条款，Kashiv 将负责该产品的注册申报、生产制造及全球供应，而 Accord 将主导欧洲及英国地区的商业化和分销工作。Kashiv 表示，此次合作将借助 Intas 及 Accord 在欧洲市场成熟而广泛的商业化网络，进一步拓展公司在欧洲、英国及印度等关键市场的布局，并持续强化其区域产品组合。 Kashiv BioSciences 是一家总部位于美国的垂直整合型生物制药公司，拥有多项已商业化及处于临床后期阶段的产品管线，并跻身少数同时具备生物类似药生产能力并获得多项上市许可的美国企业之列。公司通过其在美国及印度的业务布局，形成了覆盖研发、临床、生产、注册及知识产权的全球化能力体系，持续推动重要药物的可及性与患者获益。部分图文来源于网络，如有侵权，请联系删除旗舰报告专栏推荐肽研社生物医药 · 美妆个护 · 营养健康动物健康 · 绿色农业 · 生物材料专业专注 | 成就客户 | 共生成长

2026-02-06

·GlobeNewswire-Health Care

Pharmazz Presents Positive Phase IV Interim Analysis of Sovateltide for Acute Ischemic Stroke at the International Stroke Conference 2026

Feb. 04, 2026 -- Pharmazz, Inc. today announced the presentation of positive interim results from its ongoing Phase IV clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke at the International Stroke Conference (ISC) 2026 in New Orleans. The Phase IV study (NCT05955326) is a multicenter, randomized, controlled trial being conducted in India to further evaluate the real-world safety and effectiveness of sovateltide, a first-in-class, highly selective endothelin-B (ET-B) receptor agonist, when administered within 24 hours of stroke onset. The interim analysis included 80 patients (39 sovateltide; 41 control) who completed 90-day follow-up assessments. Results demonstrated a clinically and statistically significant improvement in functional outcomes among patients treated with sovateltide: • 92.3% of sovateltide-treated patients achieved a modified Rankin Scale (mRS) score of 0–2 at Day 90, compared with 58.5% in the control group (Odds Ratio 8.50; 95% CI 2.44–29.01; p=0.0005) • An absolute 33% increase in favorable functional outcomes (mRS 0–2) was observed with sovateltide treatment • 84.6% of sovateltide-treated patients achieved an improvement of ≥2 points on the mRS, compared with 51.2% in controls (p=0.0014) • Baseline characteristics, including age, NIHSS score, and time from stroke onset to treatment, were comparable between groups • No drug-related adverse events were observed, and safety outcomes were consistent with prior studies Patients aged 18–78 years with radiologically confirmed ischemic stroke and NIHSS ≥6 were randomized to receive either sovateltide (0.3 µg/kg) or saline placebo. The study drug was administered as three intravenous bolus doses over one minute at 3±1 hour intervals on Days 1, 3, and 6. Outcomes were assessed at Day 90 using the modified Rankin Scale. Sovateltide is approved for marketing in India and was launched in September 2023. To date, over 100,000 patients have been treated. The drug has demonstrated neuroprotective, pro-angiogenic, and neurogenic effects across preclinical and clinical studies, with a favorable safety profile. A global Phase III randomized, double-blind, placebo-controlled trial (RESPECT-ETB; NCT05691244) is currently underway across the United States, Europe, the United Kingdom, and Australia, evaluating sovateltide in more than 500 patients with acute ischemic stroke. Pharmazz, Inc. is a biopharmaceutical company focused on developing novel therapies for critical care and neurological disorders. Its lead programs target conditions with high unmet medical need, including acute ischemic stroke and hypovolemic shock. The content above comes from the network. if any infringement, please contact us to modify.

临床结果上市批准

2025-07-29

·PipelineReview

Pharmazz Inc. Announces Enrollment of First Patient in Phase 3 Clinical Trial of Sovateltide for Treating Patients with Cerebral Ischemic Stroke

The Phase 3 clinical trial of sovateltide, RESPECT-ETB, is expected to enroll over 500 patients with a primary endpoint of proportion of patients demonstrating functional independence at 90 days and is being conducted under a Special Protocol Assessment (SPA) with the FDA. Sovateltide, a potential first-in-class, highly selective endothelin-B (ETB) receptor agonist, has previously demonstrated significant improvement in stroke patients compared to standard of care in a Phase 3 trial that served as the basis for regulatory approval in India. Recent $25 million equity investment from Sun Pharmaceutical Industries Limited, provides sufficient capital to complete the Phase 3 trial. WILLOWBROOK, IL, USA I July 29, 2025 I Pharmazz, Inc. (“Pharmazz” or the “Company”), a late-stage biopharmaceutical company developing innovative therapies for unmet medical needs in critical care and neurology, today announced that the first patient has been enrolled and treated in the pivotal Phase 3 RESPECT-ETB clinical trial assessing the safety and efficacy of sovateltide for the treatment of acute cerebral ischemic stroke ( NCT05691244 ). Sovateltide represents a potential breakthrough as a first-in-class endothelin-B receptor agonist, uniquely promoting neurovascular remodeling—generating new neurons (neurogenesis), blood vessels (angiogenesis), and enhancing mitochondrial function. “There has not been a new FDA approved non-thrombolytic therapy for stroke in over 30 years. We have already shown promising results in our previous Phase 3 study, which showed that sovateltide could be a meaningful advance over standard of care to promote a fast recovery and improve neurological outcomes in cerebral ischemic stroke patients,” said Emeritus Prof. Anil Gulati, CEO and Founder of Pharmazz. “We have now treated the first patient in our US-based Phase 3 clinical trial and have sufficient capital to complete this study to further cement the potential for sovateltide to transform the treatment of cerebral ischemic stroke.” “There is a massive and ongoing medical burden associated with ischemic stroke, which continues to be a leading cause of long-term disability, affecting hundreds of thousands of patients each year,” said Dr. Thomas Devlin, MD, PhD, FSVIN, physician executive of Neurosciences and medical director at CHI Memorial Stroke and Neuroscience Center, and principal investigator of the Phase 3 trial. “Current treatment options remain limited, underscoring the critical need for novel therapies. Given the promising results already demonstrated with sovateltide, this rigorous Phase 3 study represents an important step toward addressing this urgent unmet medical need.” Phase 3 Trial of Sovateltide for Stroke Covered by Special Protocol Assessment Sovateltide is a first-in-class endothelin-B receptor (ETBR) agonist to treat acute cerebral ischemic stroke that can be administered up to 24 hours after the onset of symptoms. Pharmazz has received agreement from the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of sovateltide for the treatment of acute cerebral ischemic stroke patients. Pharmazz has now enrolled and treated the first patient in its Phase 3 trial, RESPECT-ETB (ClinicalTrials.gov ID: NCT05691244 ). The Phase 3 clinical trial is designed to enroll a total of 514 stroke patients at 65 sites in the US, Germany, Spain, and the UK. The primary endpoint is the proportion of patients demonstrating functional independence post-stroke, defined as a modified Rankin Scale (mRS) score of 0–2 at 90 days after stroke onset. About Sovateltide and Stroke Stroke is a leading cause of long-term disability in the United States, affecting more than 795,000 people each year, and reduces mobility in more than half of stroke survivors over the age of 65 1 . Sovateltide is a first-in-class drug to treat acute cerebral ischemic stroke, a condition in which the loss of blood supply to the brain prevents brain tissue from receiving oxygen and nutrients, resulting in potential brain damage, neurological deficits, or death. Sovateltide is unique because its action site is the neural progenitor cells. Sovateltide promotes neurovascular remodeling by inducing the formation of new neurons (neurogenesis) and blood vessels (angiogenesis). Sovateltide also protects neural mitochondria and enhances their biogenesis. The Phase 3 trial that served as the basis for approval in India was published in 2024 and showed that the sovateltide group (n=80) had a significantly greater number of cerebral ischemic stroke patients with lower mRS and NIHSS scores at 90 days post-treatment than the control group (n=78). 2 About Pharmazz, Inc. Pharmazz is a privately held company developing novel products in critical care medicine. Pharmazz, Inc. has obtained marketing authorization for two of its first-in-class drug molecules, centhaquine and sovateltide, for the treatment of hypovolemic shock and ischemic stroke, respectively, in India. In addition, the US Food and Drug Administration (FDA) has approved two phase III INDs for centhaquine as an agent for hypovolemic shock and sovateltide for cerebral ischemic stroke. Additional information may be found on the Company’s website, www.pharmazz.com . SOURCE: Pharmazz

临床3期上市批准

100 项与 Sovateltide 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB06138

研发状态

批准上市

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适应症	国家/地区	公司	日期
急性缺血性卒中	印度	Pharmazz, Inc.	2023-05-31

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床3期	印度	Pharmazz, Inc.	2022-08-23
脑梗塞	临床3期	印度	Pharmazz, Inc.	2019-11-10
新生儿窒息	临床2期	印度	Pharmazz, Inc.	2023-09-06
缺氧缺血性脑病	临床2期	印度	Pharmazz, Inc.	2023-09-06
新生儿脑病	临床2期	印度	Pharmazz, Inc.	2023-09-06
窒息	临床2期	美国	Pharmazz, Inc.	2022-08-23
窒息	临床2期	印度	Pharmazz, Inc.	2022-08-23
急性脊髓损伤	临床2期	印度	Pharmazz, Inc.	2019-01-10
非小细胞肺癌	临床2期	美国	Spectrum Pharmaceuticals, Inc.	2013-05-01
晚期胆管癌	临床2期	美国	Spectrum Pharmaceuticals, Inc.	2013-04-01

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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


NCT04047563 (CTRI/2019/09/021373, Pubmed \| Drugs) 人工标引	临床3期	急性缺血性卒中	158	Sovateltide	醖築窪獵襯鑰鏇鹽醖選(築鑰鹽鬱積網鹹壓顧製) = 窪網顧鹹蓋鬱淵淵顧鏇鏇簾壓築遞築願鑰鹽構 (顧蓋襯艱窪遞鑰觸鬱憲 ) 更多	积极	2024-11-15
				Control (Placebo)	範選淵壓衊簾鹹簾廠鑰(選獵積廠襯膚構獵積網) = 鬱壓淵獵製構簾糧醖網獵憲廠製願夢鹹願壓壓 (觸願壓餘願蓋範艱窪壓 ) 更多
NCT04047563 (GlobeNewswire) 人工标引	临床3期	急性缺血性卒中	158	Sovateltide	選餘遞壓蓋製醖齋糧餘(鏇齋膚糧鹽餘繭餘鹽鑰) = 憲艱繭鹽憲製膚淵壓窪築觸積積簾憲鹹鬱築獵 (襯選憲憲齋齋網顧夢窪 ) 更多	积极	2022-10-31
				Placebo	選餘遞壓蓋製醖齋糧餘(鏇齋膚糧鹽餘繭餘鹽鑰) = 醖築醖憲願夢繭艱醖壓築觸積積簾憲鹹鬱築獵 (襯選憲憲齋齋網顧夢窪 ) 更多
NCT04047563 (Biospace) 人工标引	临床3期	急性缺血性卒中	158	standard of care+Sovateltide	願醖鑰製鏇壓壓築積艱(壓餘獵餘餘齋願齋糧窪) = improvement of ≥6 points on NIHSS 壓醖鏇窪壓壓齋遞糧夢 (選醖壓遞襯獵憲範憲鏇 ) 更多	积极	2022-05-25
				standard of care+Placebo
NCT04052737 (PRNewswire) 人工标引	临床2期	阿尔茨海默症	62	sovateltide	齋鑰壓構顧觸觸觸壓製(淵鬱壓簾繭糧膚遞築醖) = 繭築窪襯鏇觸膚範鏇願壓鹽醖積選夢夢膚廠淵 (繭製鏇衊獵淵鬱膚鹹艱, 0.955) 更多	积极	2021-06-10
				Placebo	齋鑰壓構顧觸觸觸壓製(淵鬱壓簾繭糧膚遞築醖) = 鏇構網齋夢壓窪顧糧艱壓鹽醖積選夢夢膚廠淵 (繭製鏇衊獵淵鬱膚鹹艱, 0.920) 更多
NCT04046484 (Pubmed \| CNS Drugs) 人工标引	临床2期	缺血性卒中	36	Sovateltide	齋憲憲選糧廠鏇顧憲願(遞觸範繭衊淵壓繭願範) = 築願選鬱衊窪夢蓋窪窪鹽簾顧積衊壓獵衊範鹹 (膚醖顧醖簾膚憲選鑰製 ) 更多	积极	2021-01-01
				Placebo	齋憲憲選糧廠鏇顧憲願(遞觸範繭衊淵壓繭願範) = 憲簾願鏇獵願選獵鹹鹹鹽簾顧積衊壓獵衊範鹹 (膚醖顧醖簾膚憲選鑰製 ) 更多
NCT05691244 (Pubmed \| Brain Res)	临床3期	脑缺血	-	IRL-1620	窪壓廠獵築鏇夢網觸積(壓夢繭簾鹹齋築製餘憲) = 膚醖網顧顧齋衊繭範醖鹹壓餘築廠膚鑰願構鏇 (蓋艱網網鏇獵艱艱艱製 )	-	2012-06-29
				Vehicle	窪壓廠獵築鏇夢網觸積(壓夢繭簾鹹齋築製餘憲) = 顧齋艱鏇壓鏇憲廠鏇膚鹹壓餘築廠膚鑰願構鏇 (蓋艱網網鏇獵艱艱艱製 )
NCT05691244 (Pubmed \| Brain Res)	临床3期	大脑中动脉梗塞	-	IRL-1620	鹽廠憲淵築衊顧齋糧齋(範憲糧選製簾淵餘範遞) = 憲鏇構鬱繭範齋築鏇獵積餘構顧顧遞顧鹹繭衊 (壓齋範淵憲夢艱衊選顧 )	-	2011-10-28
				BQ788	鹽廠憲淵築衊顧齋糧齋(範憲糧選製簾淵餘範遞) = 淵鹽簾憲廠簾範觸淵簾積餘構顧顧遞顧鹹繭衊 (壓齋範淵憲夢艱衊選顧 )