Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Self-administered Subcutaneous Selatogrel for Prevention of All-cause Death and Treatment of Acute Myocardial Infarction in Subjects With a Recent History of Acute Myocardial Infarction

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

开始日期2021-08-14

申办/合作机构

Idorsia Pharmaceuticals Ltd.

NCT04557280

/ Completed临床1期

A Randomized, Open-label, 3-period Cross-over Study to Assess the Pharmacokinetics of Selatogrel (ACT-246475) in Healthy Subjects After Subcutaneous Administration by Syringe and Auto-injector

The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.

开始日期2020-11-06

申办/合作机构

Idorsia Pharmaceuticals Ltd.

100 项与 Selatogrel 相关的临床结果

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100 项与 Selatogrel 相关的转化医学

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100 项与 Selatogrel 相关的专利（医药）

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项与 Selatogrel 相关的文献（医药）

2024-11-01·Journal of Computational Biophysics and Chemistry

Molecular Docking, Quantum Mechanics and Molecular Dynamics Simulation of Anti-CAD Drugs Against High-Risk Xanthine Dehydrogenase Variants Associated with Oxidative Stress Pathways

作者: Sudhan, M. ; Ahmed, Shiek S. S. J. ; Emran, Talha Bin ; Attia, Sabry M. ; Ahmad, Sheikh F. ; Janakiraman, V.

Xanthine dehydrogenase (XDH) contributes significantly to generating reactive oxygen species in coronary artery disease (CAD). XDH has been proposed as a therapeutic target, but its genetic variants could affect protein structure and drug response. We aimed to assess protein structure modification occur due to genetic variants and to screen 215 CAD drugs for their utility in personalized CAD treatment against the XDH variants. A series of computational methods were implemented to identify pathogenic variants that cause XDH structure instability localized at the con served regions contributing to functional significance. Then, the XDH structures with the pathogenic variants were modeled using two different approaches to select the best models for docking with the CAD drugs. Finally, the stability of the docked complexes and their ability to transfer electrons were evaluated using molecular dynamics (MD) simulations and quantum mechanics/molecular mechanics (QM/MM) calculation. Among 751 variants examined; R149C and Q919R showed high pathogenicity, localized in conserved regions could alter protein structure and function. Further, docking of CAD drugs against XDH (native, R149C and Q919R) showed vericiguat with higher affinity, ranging from −7.95 kcal/mol to −10.41 kcal/mol, than the well-known XDH inhibitor (febuxostat, −5.73 kcal/mol to −8.35 kcal/mol). This indicates that vericiguat will be effective in CAD treatment, regardless of the XDH variants. Additionally, MD simulation and QM/MM confirmed vericiguat stability and electron transfer ability to form hydrogen bonds with the XDH protein. In conclusion, vericiguat will be beneficial for the personalized treatment of CAD by inhibiting XDH variants. Additional clinical studies are necessary to confirm our findings.

2023-11-01·Journal of thrombosis and thrombolysis

Comparison of the effects of the GPIIb-IIIa antagonist Zalunfiban and the P2Y12 antagonist Selatogrel on Platelet Aggregation.

Article

作者: Rikken, A O F Sem ; van 't Hof, Arnoud W J ; Ten Berg, Jurriën M ; Gibson, C Michael ; Jennings, Lisa K ; Granger, Christopher B ; Curry, Benjamin J

Understanding the pharmacodynamic effects of platelet inhibitors is standard for developing more effective antithrombotic therapies. An example is the antithrombotic treatment of acute coronary syndrome (ACS), in particular ST-elevated myocardial infarction (STEMI) patients who are in need for rapid acting strong antithrombotic therapy despite the use of aspirin and oral P2Y12-inhibitors. In this study, we evaluated two injectable platelet inhibitors under clinical development (the P2Y12 antagonist selatogrel and the GPIIb-IIIa antagonist zalunfiban) that may be amenable to pre-hospital treatment of STEMI patients. Platelet reactivity was assessed at inhibitor concentrations that represent clinically relevant levels of platelet inhibition (IC20-50%, 1/2Cmax, and Cmax). Light transmission aggregometry (LTA), was used to evaluate the initial rate of aggregation (primary slope, PS) and maximal aggregation (MA). Both adenosine diphosphate (ADP) and thrombin receptor agonist peptide (TRAP) were used as agonists. Zalunfiban demonstrated similar inhibition of platelet aggregation when blood was collected in PPACK or TSC, whereas selatogrel demonstrated greater inhibition in PPACK. In this study, using PPACK anticoagulant, selatogrel and zalunfiban affected PS in response to ADP equivalently at all drug concentrations tested. In contrast, zalunfiban had significantly greater potency at its Cmax concentration compared to selatogrel using TRAP as agonist. Upon evaluation of MA responses at lower doses, selatogrel had greater inhibition of MA in response to ADP than zalunfiban; however, at concentrations that represent Cmax, the drugs were equivalent. Zalunfiban also had greater inhibition of MA in response to TRAP at the Cmax dose. These data suggest that zalunfiban may provide greater protection in reducing thrombus formation than selatogrel, especially since thrombin is an early, key primary agonist in the pathophysiology of thrombotic events.

2023-10-03·Expert opinion on drug metabolism & toxicology

Clinical pharmacology of selatogrel for self-administration by patients with suspected acute myocardial infarction

Review

作者: Dingemanse, Jasper ; Gehin, Martine ; Storey, Robert F. ; Bernaud, Corine

INTRODUCTION:

P2Y12 receptor antagonists (P2Y12 inhibitors) are well established for the treatment of coronary artery disease. The P2Y12 inhibitors currently commercially available present either pharmacokinetic limitations (due to delayed absorption, bioactivation requirement via CYP enzymes, or need of intravenous administration), pharmacodynamic (PD) limitations (limited % inhibition of platelet aggregation (IPA) or relevant PD interactions) or safety limitations (major bleeding in specific populations).

AREAS COVERED:

Selatogrel, a 2-phenylpyrimidine-4-carboxamide analog, is a potent, reversible, and selective P2Y12 inhibitor administered subcutaneously that is under development for the treatment of acute myocardial infarction (AMI) in patients with a recent history of AMI. In this review, the authors summarize the results from preclinical, phase 1, and phase 2 trials which showed that selatogrel provides rapid, pronounced, and reversible P2Y12 receptor inhibition with a favorable safety profile.

EXPERT OPINION:

These unique characteristics added to the limited potential to interact with co-medications and manageable PD interactions with other P2Y12 inhibitors provide a clear rationale for investigating the benefit of selatogrel as an emergency treatment to improve clinical outcomes in patients with AMI.

项与 Selatogrel 相关的新闻（医药）

2024-12-24

·药时代

晖致印度工厂暴雷！

当地时间2024年12月23日，仿制药巨头晖致表示，因违规，其位于印度印多尔的口服制剂工厂经FDA检查后，收到一封警告信。详细信息显示，FDA还同时发布了对其印度工厂生产的11种产品的进口禁令，并表示在警告信解除之前这些产品将不再被允许进入美国。不过基于药品短缺担忧，警告表示将对其中四种产品进行了例外处理，但仍需满足特定条件。目前，晖致在新闻稿件中表示，其目前正在进行全面整改，已经启动相应整改计划，涵盖必要的纠正和预防措施，包括对相关人员采取的行动。此外，还聘请了独立的第三方专家来协助并确保整改措施的有效实施。并表明将在规定期限内提交对警告信和进口警报的回复。图片来源：晖致官网 “瘦身”后的晖致情况如何？ 2020年11月，迈蓝（Mylan）和辉瑞旗下的非专利品牌和仿制药部门普强（Upjohn）成功合并，晖致自此成立。得益于迈蓝和普强的强大根基，晖致在成立后的第一个完整财年就成功超越了梯瓦和山德士，以178亿美元的年营收登顶仿制药领域TOP 1。不过这家因强强联合而诞生的新公司自成立起便不断改革，持续传来工厂关闭、大幅度裁员及业务剥离的消息。据悉，其成立后第一个月就关闭了15家工厂，裁员约20%。的确，自成立起晖致就一直在对其“继承”来的资产进行精简。其备受关注的两次大规模业务剥离，一次发生在2022年，另一次是在2023年。 2022年2月，晖致宣布将以约33亿美元的价格，将其生物类似药业务出售给印度药厂Biocon Biologics Ltd.（BBL）。十几个月后，2023年10月，晖致发布新闻稿，宣布已收到Cooper Consumer Health的收购要约，将出售其大部分非处方药业务，包括其位于法国和意大利的两个制造基地以及位于意大利的一个研发基地。此次剥离中，晖致另签订了其他几项协议。一是将其在印度的API业务出售给IQuest Enterprises，二是将其主要涉及口服和注射避孕药的女性保健业务出售给西班牙领先的跨国制药公司 Insud Pharma；三是其对女性保健产品 Duphaston®和Femoston®的权利转让给 Theramex；四是剥离与普强合并后某些非核心市场的商业化权利。据悉，2023年的这次剥离总计涉及12家工厂和全球6000名员工，是一次极致的“瘦身”。 2023年，受长期“瘦身”影响，晖致丢失仿制药TOP 1宝座，以4亿美元的差距让位梯瓦。据悉，梯瓦2023年营收约158亿美元，晖致约154亿美元。其中梯瓦年营收同比增长约7%，晖致同比下降约5.5%。晖致信息指出，其已于2024年中完成了此前公布的所有剥离计划，开启新征程。 2024年是晖致在2023年底大刀阔斧的瘦身改革后恢复公司增长战略的第一阶段，对晖致而言至关重要。根据晖致2024 Q3财报信息，目前受到业务剥离影响，其2024年Q3营收同比下降约5%，不过经业务剥离调整后仍同比增长3%。其实如果仅看晖致业务剥离调整后的业绩，其已经实现连续6各季度的业绩增长，并且无论是品牌药还是仿制药，业务均处于稳健的增长状态。另外，晖致财报分享文件指出，其2024Q3新产品营收共1.55亿美元，2024三季度的累计新产品营收已经达到4.97亿美元，明显高于去年全年的新产品营收。图片来源：晖致官网就创新产品管线而言，其接下来将重点推进此前与Idorsia合作引入的心血管产品selatogrel。据悉，Selatogrel是一种强效、速效、可逆和高选择性的P2Y12抑制剂，拟用于治疗有既往病史的急性心肌梗死（AMI）。2024年初，晖致与Idorsia达成合作，引入了Selatogrel和另一款治疗系统性红斑狼疮药物的全球开发和商业化权利。根据晖致披露信息，Selatogrel被设计为皮下给药，患者可在出现AMI早期症状后，及时使用自动注射器自主给药，达到保护心肌防止早期死亡的目的。值得注意的是，目前全球并未有相同功效的产品获批上市，Selatogrel有可能成为首个治疗复发性急性心肌梗死的自控药物，有望填补临床空白。小结对于晖致这样曾手握上千款产品的仿制药巨头，诸如今日这样因工厂违规而收到FDA警告信的情况并不常见。但当大家看到工厂的地址是在印度时，又不会觉得意外。有外媒信息显示，晖致在印度经营有4家工厂，主要生产用于抗菌、糖尿病和心血管等疾病领域的的片剂/胶囊。晖致在此次新闻稿中指出，这次事件并不会影响其2024年财务增长情况。且其目前正在与监管机构以及客户进行沟通，减轻任何可能的供应链中断。参考资料： 1.公司官网 2.US FDA restricts imports of some Viatris drugs made at India facility - CNBC TV18 3.其他公开资料封面图来源：自制往期推荐医保药品目录解读重点列举的新cGVHD疗法，创新价值体现在哪里？一起穿越生物医药的炎夏和寒冬！——全球知名投资机构Atlas Venture 2018至2024年年度演讲荟萃又一MASH FIC新药III期临床失败！股价一夜腰斩版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击，查看更多精彩!

并购生物类似药

2024-12-20

·GlobeNewswire-Health Care

Idorsia provides update on the exclusive negotiations for the global rights to aprocitentan

Ad hoc announcement pursuant to Art. 53 LR Company announces delay to the targeted timeline for signing a binding agreementCompany in discussions with bondholders to restructure the company’s outstanding debt and extend the operational cash runway Allschwil, Switzerland – December 20, 2024Idorsia Ltd (SIX: IDIA) today provided an update on the ongoing exclusive negotiations for the global rights to aprocitentan. On November 27, 2024, the company announced that it had entered exclusive negotiations with an undisclosed party for global rights to aprocitentan that resulted in an exclusivity fee of USD 35 million paid in early December. At that time, the company was targeting signing an agreement before the end of 2024 and closing in early 2025, with more details to be shared should a final agreement be signed. In addition, the company announced plans to streamline its business to reduce costs and restructure its outstanding debt. Idorsia believes signing will not be achieved in 2024. Negotiations with the undisclosed party continue, however the company cannot guarantee that an agreement can be reached. As a result, the company is considering options to extend the company’s operational cash runway to bridge to a potential binding offer, as well as all strategic options. André C. Muller, CEO of Idorsia, commented: “Signing the agreement for aprocitentan is a crucial first step to ensure the future of Idorsia. Based on our current liquidity forecasts, there are additional prerequisites to allow the company to continue to operate, which include the completion of the recently announced company restructuring; the restructuring of the company’s outstanding debt, including the 2025 and 2028 convertible bonds; and raising additional funding. As a result of these constraints and the delay to the completion of the aprocitentan agreement, we are also considering all strategic options beyond a deal for aprocitentan.” Convertible Bond restructuringThe company has issued two convertible bonds which rank pari-passu, the first with a nominal value of CHF 200 million and a conversion price of CHF 6.00 per Idorsia share, maturing on January 17, 2025 (CB 2025), the second with a nominal value of CHF 600 million and a conversion price of CHF 31.54, maturing on August 4, 2028, although investors may request redemption of the bonds as of August 4, 2026 (CB 2028). Given the near-term maturity and the inability of the company to repay the bonds at this time, an extension to the CB 2025 is required whatever the outcome of the ongoing negotiation regarding the rights to aprocitentan. The company is in discussions with certain holders of the CB 2025 and the CB 2028 to amend the terms of both instruments following an extension of the CB 2025. Company restructuringFollowing a consultation process with employee representatives at headquarters a reduction of approximately 250 positions globally is anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. Additional fundingIdorsia expects to close 2024 with cash of at least CHF 70 million including the USD 35 million exclusivity fee. The company could end 2024 with cash of around CHF 100 million, should an additional deal close in the coming days. Should the potential agreement for the rights to aprocitentan conclude in a timely manner, in-line with the upfront payment anticipated in the non-binding offer, and subject to the CB 2025 restructuring, Idorsia would be funded until mid-2025. The company is diligently seeking additional funding of at least CHF 200 million to extend its operational cash runway into at least 2026. Updated guidance for 2024For 2024 – excluding unforeseen events and broadly in-line with previously issued guidance – the company expects QUVIVIQ net sales of around CHF 55 million, SG&A expenses of around CHF 265 million, R&D expense of around CHF 130 million for Idorsia-led pipeline assets, leading to non-GAAP operating expenses around CHF 400 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 350 million. The company expects a US GAAP operating loss for 2024 of around CHF 260 million which includes a one-off benefit of CHF 125 million from the agreement with Viatris on selatogrel and cenerimod and an estimated restructuring charge of CHF 10 million. Guidance for 2024 in CHF million* Idorsia-led business Partner-led business Global BusinessREVENUE 55 50 105COGS -10 -30 -40SG&A OPEX -265 – -265R&D OPEX -130 0 -130Non-GAAP EBIT -350 20 -330D&A -30 – -30SBC -15 – -15Other -10 125 115US-GAAP EBIT -405 145 -260 *Excluding unforeseen events Notes to the editor About the 2025 convertible bondOn July 17, 2018, Idorsia raised CHF 200 million through the issuance of convertible bonds to fund the Phase 3 development of aprocitentan, clazosentan, lucerastat and daridorexant, as well as the early-stage and preclinical pipeline. The bonds initially had a term of six years, maturing on July 17, 2024. On May 6, 2024, a bondholders’ meeting approved modifications to the terms of the convertible bonds to, among others, amend the conversion price to CHF 6.00 per Idorsia share (from CHF 33.95) and extend the maturity date by six months to January 17, 2025. About the 2028 convertible bondOn August 4, 2021, Idorsia raised CHF 600 million through the issuance of convertible bonds to support the commercial product launches in several key markets and to fund the further development of the late-stage pipeline. The bonds have a conversion price of CHF 31.54 and a term of seven years, maturing on August 4, 2028. Investors may request redemption of the bonds as of the 5th anniversary of the settlement date. About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 (0)58 844 10 10investor.relations@idorsia.commedia.relations@idorsia.com www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

财报

2024-11-19

·PRNewswire

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 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期临床2期快速通道细胞疗法

100 项与 Selatogrel 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15163

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
急性心肌梗塞	临床3期	美国	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	奥地利	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	比利时	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	巴西	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	保加利亚	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	加拿大	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	智利	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	哥伦比亚	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	捷克	Idorsia Pharmaceuticals Ltd.	2021-08-14
急性心肌梗塞	临床3期	丹麦	Idorsia Pharmaceuticals Ltd.	2021-08-14

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临床结果

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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


NCT04557280 (Pubmed \| Clin Pharmacokinet)	临床1期	-	24	Phase III liquid formulation by autoinjector	願獵網襯積願獵廠選鹽(簾鹽簾鬱選齋範襯膚鹽) = 餘鹽觸簾廠糧鹽構夢鏇範構繭遞膚繭窪襯廠衊 (觸鏇顧觸壓製鹹築醖鬱 )	-	2021-12-28
				Phase I/II reconstituted lyophilizate-based formulation by syringe	願獵網襯積願獵廠選鹽(簾鹽簾鬱選齋範襯膚鹽) = 夢範艱壓積餘壓鬱艱繭範構繭遞膚繭窪襯廠衊 (觸鏇顧觸壓製鹹築醖鬱 )
NCT03487445 (CTgov)	临床2期	急性心肌梗塞	48	Selatogrel 8 mg (Selatogrel 8 mg)	襯淵範醖範壓憲獵鹹齋(蓋窪觸夢鑰繭鏇淵壓繭) = 憲構鹽積網醖觸鏇鹹壓築鏇窪糧憲鏇構衊膚鬱 (積齋簾夢衊積蓋夢糧觸, 選願範願製壓廠膚簾淵 ~ 願築壓築蓋顧夢鏇範衊) 更多	-	2021-08-25
				Selatogrel 16 mg (Selatogrel 16 mg)	襯淵範醖範壓憲獵鹹齋(蓋窪觸夢鑰繭鏇淵壓繭) = 遞鹹窪積衊繭壓鹹鏇醖築鏇窪糧憲鏇構衊膚鬱 (積齋簾夢衊積蓋夢糧觸, 衊衊襯艱鏇餘築遞鹹網 ~ 夢壓窪壓鬱壓鏇繭願觸) 更多
NCT03487445 (Pubmed \| J Am Coll Cardiol) 人工标引	临床2期	急性心肌梗塞	47	Selatogrel (a single subcutaneous dose of selatogrel of 8mg)	醖淵糧構齋壓願襯製齋(窪齋蓋鬱壓鑰窪繭廠齋) = 遞構鑰餘積積窪範獵繭鑰夢觸餘觸醖餘淵鏇獵 (選簾齋鹹膚夢淵齋鹽鏇, 80 ~ 100) 更多	积极	2020-05-26
				Selatogrel (a single subcutaneous dose of selatogrel of 16mg)	醖淵糧構齋壓願襯製齋(窪齋蓋鬱壓鑰窪繭廠齋) = 餘醖襯鏇顧簾鬱構鹽鑰鑰夢觸餘觸醖餘淵鏇獵 (選簾齋鹹膚夢淵齋鹽鏇, 87 ~ 100) 更多
NCT03593278 (Pubmed \| Xenobiotica) 人工标引	临床1期	-	6	selatogrel	淵鬱製艱艱簾製積醖遞(積遞選醖選觸觸築夢醖) = 94.9%, of which 92.5% was recovered in faeces and 2.4% in urine 觸膚窪艱構鑰糧廠構構 (選築繭製鏇艱窪壓觸鏇 )	积极	2020-04-01
NCT03384966 (Pubmed \| Eur Heart J)	临床2期	-	345	Selatogrel 8mg	衊襯築願鏇壓範範繭廠(選艱壓繭鬱構積築鹹簾) = Transient dyspnoea occurring overall in 7% (16/229) of patients 鏇鬱鬱蓋膚獵淵膚構壓 (衊顧簾願憲壓蓋廠鏇簾 )	-	2019-11-14
				Selatogrel 16mg
ESC2019	N/A	冠状动脉疾病	345	Selatogrel 8 mg	糧願觸願鏇膚衊觸顧積(鏇蓋獵憲獵繭鬱壓鏇願) = 膚淵遞製觸廠築簾鑰廠遞憲窪壓窪襯繭廠積醖 (糧築範鬱遞鹽蓋淵衊糧 ) 更多	-	2019-09-01
				Selatogrel 16 mg	糧願觸願鏇膚衊觸顧積(鏇蓋獵憲獵繭鬱壓鏇願) = 廠鹽醖蓋鹽構鏇顧齋廠遞憲窪壓窪襯繭廠積醖 (糧築範鬱遞鹽蓋淵衊糧 ) 更多