A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the NOX1/4 Inhibitor Setanaxib in Patients With Alport Syndrome

The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study.
Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function.
The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period.

开始日期2023-11-27

申办/合作机构

Calliditas Therapeutics AB

NCT05323656 / Active, not recruiting临床2期

A Phase 2, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Setanaxib, When Administered With Pembrolizumab, in Patients With Recurrent or Metastatic SCCHN

The primary objective of this study is to compare the change in tumour size per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in recurrent or metastatic SCCHN patients treated with setanaxib and pembrolizumab versus patients treated with placebo and pembrolizumab.

开始日期2022-04-06

申办/合作机构-

EUCTR2021-004627-33-ES / Unknown status临床2期

A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability, and Effects on Tumour Biomarkers of the NOX1/4 Inhibitor Setanaxib, when Administered with the PD-1 Inhibitor Pembrolizumab, in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

开始日期2022-03-08

申办/合作机构-

100 项与 Setanaxib 相关的临床结果

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100 项与 Setanaxib 相关的转化医学

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100 项与 Setanaxib 相关的专利（医药）

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项与 Setanaxib 相关的文献（医药）

2024-05-01·European journal of pharmacology

Inhibition of both NOX and TNF-α exerts substantial renoprotective effects in renal ischemia reperfusion injury rat model

Article

作者: Mahmoud, Mona F ; Elbatreek, Mahmoud H ; Ibrahim, Islam A A E-H ; Ahmad, Enssaf Ahmad ; Bayoumi, Amina A

BACKGROUND AND AIMS:

Acute kidney injury (AKI) due to renal ischemia-reperfusion injury (RIRI) is associated with high morbidity and mortality, with no renoprotective drug available. Previous research focused on single drug targets, yet this approach has not reached translational success. Given the complexity of this condition, we aimed to identify a disease module and apply a multitarget network pharmacology approach.

METHODS:

Identification of a disease module with potential drug targets was performed utilizing Disease Module Detection algorithm using NADPH oxidases (NOXs) as seeds. We then assessed the protective effect of a multitarget network pharmacology targeting the identified module in a rat model of RIRI. Rats were divided into five groups; sham, RIRI, and RIRI treated with setanaxib (NOX inhibitor, 10 mg/kg), etanercept (TNF-α inhibitor, 10 mg/kg), and setanaxib and etanercept (5 mg/kg each). Kidney functions, histopathological changes and oxidative stress markers (MDA and reduced GSH) were assessed. Immunohistochemistry of inflammatory (TNF-α, NF-κB) apoptotic (cCasp-3, Bax/Bcl 2), fibrotic (α-SMA) and proteolysis (MMP-9) markers was performed.

RESULTS:

Our in-silico analysis yielded a disease module with TNF receptor 1 (TNFR1A) as the closest target to both NOX1 and NOX2. Targeting this module by a low-dose combination of setanaxib, and etanercept, resulted in a synergistic effect and ameliorated ischemic AKI in rats. This was evidenced by improved kidney function and reduced expression of inflammatory, apoptotic, proteolytic and fibrotic markers.

CONCLUSIONS:

Our findings show that applying a multitarget network pharmacology approach allows synergistic renoprotective effect in ischemic AKI and might pave the way towards translational success.

2024-04-29·Journal of leukocyte biology

GKT137831 in combination with adipose-derived stem cells alleviates high glucose–induced inflammaging and improves diabetic wound healing

Article

作者: Li, Fangwei ; Tang, Bing ; Wang, Haibin ; Lv, Dongming ; Zhang, Youliang ; Dong, Yunxian ; Luo, Shengkang

Abstract:

Adipose-derived stem cells (ADSCs) have been proven to promote healing in diabetic wounds, which are one of the most serious chronic refractory wounds. However, reactive oxygen species (ROS) induced by high glucose (HG) lead to oxidative stress and aging in ADSCs, which limits the therapeutic effect of ADSCs. In this study, we investigated the role of GKT137831, a NOX1/4 inhibitor that can reduce ROS production, in protecting ADSCs from hyperglycemia and in diabetic wound healing. In vitro, ROS levels and NOX4 expression were increased after HG treatment of ADSCs, while the oxidative stress marker malondialdehyde was increased; mitochondrial membrane potential was decreased; inflammatory aging–related indicators such as p16, p21, matrix metalloproteinase-1 (MMP1), MMP3, interleukin-6, and β-galactosidase were increased; and migration was weakened. In vivo, we constructed a diabetic mouse wound model and found that the combination of ADSCs and GKT137831 synergistically promoted the 21-day wound healing rate, increased the expression of collagen and hydroxyproline, increased the number of blood vessels and the expression of CD31, and reduced the expression of interleukin-6, MMP1, MMP3, and p21. These results suggest that GKT137831 could protect ADSCs from oxidative stress and aging induced by HG and enhance the therapeutic effect of ADSCs on diabetic wounds.

2024-04-01·Free radical biology & medicine

Reactive oxygen species augment contractile responses of saphenous artery in 10-15-day-old but not adult rats: Substantial role of NADPH oxidases

Article

作者: Makukha, Yulia A ; Gaynullina, Dina K ; Shateeva, Valentina S ; Shvetsova, Anastasia A ; Borzykh, Anna A ; Khlystova, Margarita A ; Tarasova, Olga S

Reactive oxygen species (ROS) produced by NADPH oxidases (NOX, a key source of ROS in vascular cells) are involved in the regulation of vascular tone, but this has been explored mainly for adult organisms. Importantly, the mechanisms of vascular tone regulation differ significantly in early postnatal ontogenesis and adulthood, while the vasomotor role of ROS in immature systemic arteries is poorly understood. We tested the hypothesis that the functional contribution of NADPH oxidase-derived ROS to the regulation of peripheral arterial tone is higher in the early postnatal period than in adulthood. We studied saphenous arteries from 10- to 15-day-old ("young") and 3- to 4-month-old ("adult") male rats using lucigenin-enhanced chemiluminescence, quantitative PCR, Western blotting, and isometric myography. We demonstrated that both basal and NADPH-stimulated superoxide anion radical (O₂^•-) production was significantly higher in the arteries from young in comparison to adult rats. Importantly, pan-inhibitor of NADPH oxidase VAS2870 (10 μM) reduced NADPH-induced O₂^•- production in arteries of young rats. Saphenous arteries of both young and adult rats demonstrated high levels of Nox2 and Nox4 mRNAs, while Nox1 and Nox3 mRNAs were not detected. The protein contents of NOX2 and NOX4 were significantly higher in arterial tissue of young compared to adult animals. Moreover, VAS2870 (10 μM) had no effect on methoxamine-induced contractile responses of adult arteries but decreased them significantly in young arteries; such effect of VAS2870 persisted after removal of the endothelium. Finally, NOX2 inhibitor GSK2795039 (10 μM), but not NOX1/4 inhibitor GKT137831 (10 μM) weakened methoxamine-induced contractile responses of arteries from young rats. Thus, ROS produced by NOX2 have a pronounced contractile influence in saphenous artery smooth muscle cells of young, but not adult rats, which is associated with the increased vascular content of NOX2 protein at this age.

项与 Setanaxib 相关的新闻（医药）

2024-08-16

·药明康德

全球首批！治疗致命性肝病，FDA加速批准吉利德小分子疗法

吉利德科学（Gilead Sciences）今天宣布，美国FDA已加速批准Livdelzi（seladelpar）与熊去氧胆酸（UDCA）联合用于治疗对UDCA应答不足的原发性胆汁性肝硬化（PBC）成人患者，或作为单药治疗对UDCA不耐受的患者，但不建议患有或发展为失代偿性肝硬化的患者使用Livdelzi。根据新闻稿，Livdelzi是在碱性磷酸酶（ALP）正常化、关键生物标志物和瘙痒控制方面，与安慰剂相比表现出统计学显著改善的首个疗法。目前英国药品和健康产品管理局（MHRA）和欧洲药品管理局（EMA）正在评估Livdelzi的上市申请。原发性胆汁性胆管炎是一种有潜在生命危险的肝脏自身免疫性疾病。由于免疫系统持续攻击胆管，胆汁流动受阻而淤积，毒性胆汁酸在肝内留存，可发展为肝纤维化、肝硬化和肝功能衰竭。其他临床症状还包括疲劳和瘙痒。在40岁以上的女性中，有千分之一患有PBC。这次的加速批准主要基于关键安慰剂对照3期RESPONSE研究的数据。在该研究中，62%接受每日一次口服Livdelzi的受试者在第12个月达到了综合生化应答的主要终点，而此数值在安慰剂组中只有20%。使用Livdelzi治疗后，25%的患者在第12个月时ALP值恢复正常，而安慰剂组中的患者均未出现这种变化。ALP是一种胆汁淤积标志物，可预测肝移植和死亡的风险。第6个月时瘙痒评分相对于基线的变化是试验的关键次要终点。与安慰剂组相比，Livdelzi组患者的瘙痒症状显著减少。根据新闻稿，Livdelzi是在3期试验中，证明能够显著、持久改善瘙痒和胆汁淤积标志物的首个药物，这些标志物与疾病进展风险相关。最常见的不良事件（≥5% Livdelzi组患者报告，且高于安慰剂组）是头痛、腹痛、恶心、腹胀和头晕，没有观察到与治疗相关的严重不良事件（SAE）。目前为止，Livdelzi已在RESPONSE以及其他试验（包括长期开放标签ASSURE研究和之前的早期研究）中超过500名PBC患者中受检视。进行中的研究包括验证性3期AFFIRM研究，这是一项随机、安慰剂对照的验证性研究，旨在评估Livdelzi对因PBC导致的代偿性肝硬化患者的临床结果的影响。 Livdelzi为一款口服的强效选择性过氧化物酶体增殖物活化受体δ（PPAR δ）激动剂。PPARδ表达在肝脏的多种细胞类型中，临床前数据表明，它对调控胆汁酸合成、炎症、纤维化过程的多种基因有调节作用。该药物曾于2019年2月获得美国FDA授予突破性疗法认定，用以治疗PBC。该疗法原由CymaBay公司所研发，吉利德科学在2024年2月与该公司达成总金额达43亿美元的收购协议，进而囊获此款疗法。今年6月美国FDA加速批准益普生（Ipsen）的Iqirvo（elafibranor）80毫克片剂与UDCA联合用于治疗对UDCA应答不足的成人PBC患者，或作为单药疗法治疗对UDCA不耐受的患者。Iqirvo是一种每日一次、口服、“first-in-class"的PPAR α/δ激动剂，同时靶向活化PPAR α/δ可潜在治疗PBC的炎症、胆汁淤积和纤维化。根据新闻稿，Iqirvo是近十年来首个获批用于治疗罕见肝病原发性胆汁性胆管炎的新药。除了Livdelzi与Iqirvo，目前开发用以治疗PBC的疗法还有由GSK开发、目前处于3期阶段的回肠胆汁酸转运体（IBAT）口服小分子抑制剂linerixibat，其3期试验已募集238位患者，预计今年10月会有初步结果。而由Calliditas Therapeutics开发的NOX1/4抑制剂setanaxib也在近期完成临床2期试验，预计在今年下半年公布完整试验结果。该疗法曾获EMA与美国FDA授予孤儿药资格，并获FDA授予快速通道资格，用以治疗PBC。Mirum Pharmaceuticals也正在开发选择性ASBT小分子抑制剂volixibat用于PBC治疗，目前该疗法的2期试验正在进行患者招募，预计在明年12月会有初步结果。同样地，凯思凯迪（Cascade Pharmaceuticals）开发的FXR靶向激动剂linafexor（CS0159）的2期试验也正在招募患者，初步结果预计在今年10月公布。参考资料： [1] Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA. Retrieved August 14, 2024 from https://www.gilead.com/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-seladelpar-granted-accelerated-approval-for-primary-biliary-cholangitis-by-us-fda [2] Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN). Retrieved August 14, 2024 from https://clinicaltrials.gov/study/NCT04950127?term=Primary%20Biliary%20Cholangitis%20%5C(PBC%5C)&intr=linerixibat&rank=2 [3] A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM). Retrieved August 14, 2024 from https://clinicaltrials.gov/study/NCT05014672?term=Primary%20Biliary%20Cholangitis%20&intr=setanaxib&rank=1 [4] A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis (VANTAGE). Retrieved August 14, 2024 from https://clinicaltrials.gov/study/NCT05050136?term=Primary%20Biliary%20Cholangitis%20&intr=volixibat%20&rank=1 [5] CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis). Retrieved August 14, 2024 from https://clinicaltrials.gov/study/NCT05896124?term=Primary%20Biliary%20Cholangitis%20&intr=CS-0159&rank=3 内容来源于网络，如有侵权，请联系删除。

加速审批突破性疗法上市批准临床结果

2024-08-13

·PRNewswire

Calliditas Interim Report January to June 2024

STOCKHOLM, Aug. 13, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) : April to June 2024 (compared to April to June 2023) Net sales amounted to SEK 559.8 million, of which TARPEYO® net sales amounted to SEK 493.4 million, for the three months ended June 30, 2024. For the three months ended June 30, 2023, net sales amounted to SEK 269.4 million, of which TARPEYO net sales amounted to SEK 259.2 million. Operating loss amounted to SEK 31.5 million and SEK 75.2 million for the three months ended June 30, 2024, and 2023, respectively. However, expenses related to the Asahi Kasei offer and expenses related to provisions for social security contribution for incentive programs were included in the second quarter, totaling SEK 101.7 million. Excluding these expenses, the adjusted operating profit1 amounted to SEK 70.2 million for the three months ended June 30, 2024. Loss per share before and after dilution amounted to SEK 0.88 and SEK 1.71 for the three months ended June 30, 2024, and 2023, respectively. Cash amounted to SEK 797.3 million and SEK 866.2 million as of June 30, 2024, and 2023, respectively. January to June 2024 (compared to January to June 2023) Net sales amounted to SEK 855.3 million, of which TARPEYO® net sales amounted to SEK 771.6 million, for the six months ended June 30, 2024. For the six months ended June 30, 2023, net sales amounted to SEK 460.7 million, of which TARPEYO net sales amounted to SEK 444.9 million. Operating loss amounted to SEK 235.3 million and SEK 255.2 million for the six months ended June 30, 2024, and 2023, respectively. However, expenses related to the Asahi Kasei offer and expenses related to provisions for social security contribution for incentive programs were included in the second quarter, totaling SEK 101.7 million. Excluding these expenses the adjusted operating loss1 amounted to SEK 133.6 million for the six months ended June 30, 2024. Loss per share before and after dilution amounted to SEK 5.47 and SEK 5.21 for the six months ended June 30, 2024, and 2023, respectively. Key takeaways from Q2, 2024 In April, Calliditas read out positive data from the Nefecon Open Label Phase 3 Extension trial. In May, Calliditas read out positive topline results from the setanaxib Phase 2 trial in head and neck cancer. In May, Calliditas' partner Everest Medicines announced the commercial launch of Nefecon in China. In May, Calliditas' partner STADA received a positive CHMP opinion recommending full approval for Kinpeygo® in EU for the treatment of IgA nephropathy. In June, Calliditas announced the issuance by the United States Patent and Trademark Office (USPTO) of a new patent for setanaxib for treatment of cancer. The patent will have an expiration date in 2039. Key events after the reporting period In July, Calliditas partner STADA received European Commission decision for full approval of Kinpeygo® for the treatment of IgA Nephropathy. In July, Calliditas announced positive TRANSFORM Phase 2b topline data in primary biliary cholangitis. Asahi Kasei Offer Asahi Kasei Corporation announced on May 28, 2024, a public cash offer to acquire all shares in Calliditas for SEK 208 in cash per share (SEK 416 in cash per ADS). The Offer represents a premium of 83 per cent compared to the closing price of the Shares on Nasdaq Stockholm on May 27, 2024. The acceptance period of the offer commenced on July 18, 2024, and expires on August 30, 2024, subject to any extensions. Outlook 2024: Updated Calliditas expects continued revenue growth: Total net sales from the Nefecon franchise, including milestones, are estimated to be USD 165-185 million for the year ending December 31, 2024. Investor Presentation Today, 13 August at 2.30 p.m. CET Link to webcast: To participate via conference call register via this link: After registration, you will receive a phone number and a conference ID to log in to the conference call. There will be no Q&A following the presentation. For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: [email protected] The information in the report is information that Calliditas is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Market Act. The information was sent for publication, through the agency of the contact person set out above, on August 13, 2024, at 7:00 a.m. CET. 1Management uses and presents IFRS results as well as the non-IFRS measure of adjusted operating profit to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Calliditas's current performance, performance trends, and financial condition. Adjusted operating profit is defined as IFRS operating profit (loss), less provisions for social security contributions for incentive programs and advisor fees for the Asahi Kasei public offer. A reconciliation of adjusted operating profit to operating profit (loss), which is the most directly comparable IFRS measure, is set forth on page 31 of the attached report. About Calliditas Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Calliditas' common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT). Visit Calliditas.com for further information. Forward Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas' strategy, business plans, revenue and other financial projections, and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words. Any forward-looking statements in this Press Release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this Press Release, including, without limitation, any related to Calliditas' business, operations, commercialization of TARPEYO, Kinpeygo and Nefecon, clinical trials, supply chain, strategy, goals and anticipated timelines for development and potential approvals, competition from other biopharmaceutical companies, revenue and product sales projections or forecasts, including 2024 total net sales guidance and cash runway, all statements regarding the public offer by Asahi Kasei Corporation, profitability and other risks identified in the section entitled "Risk Factors" in Calliditas' reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this Press Release represent Calliditas' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. This information was brought to you by Cision The following files are available for download:

临床结果上市批准临床3期财报临床2期

2024-07-29

·药明康德

治疗肝脏疾病，小分子疗法达到2b期临床主要终点

▎药明康德内容团队编辑 Calliditas Therapeutics日前宣布，其2b期临床试验TRANSFORM试验达到了主要终点，显示出在两种剂量下，在研疗法setanaxib与安慰剂组相比，显著改善患有原发性胆汁性胆管炎（PBC）且肝硬度增加的患者的碱性磷酸酶（ALP）水平。 TRANSFORM试验是一项随机双盲、含安慰剂对照的2b期研究，调查了剂量为1200 mg或1600 mg的setanaxib在24周中的治疗效果。分析基础数据集包括76名患有PBC且肝硬度增加的患者。试验中超过40%的患者同时接受了至少两种背景治疗。接受setanaxib治疗的患者在主要终点ALP上显示出显著的改善，在1600 mg组中为19%，在1200 mg组中为14%，并且在24周时在FibroScan评估的肝硬度上显示出积极趋势。Setanaxib治疗总体上耐受性良好，治疗出现不良事件（TEAE）以及严重TEAE的数量在治疗组和安慰剂组之间相似。因不良事件导致研究中止的频率在接受setanaxib治疗的患者中高于安慰剂组。 ▲Setanaxib的临床开发项目（图片来源：Calliditas Therapeutics官网） Setanaxib是一种NOX1/4抑制剂。NOX1和NOX4是产生活性氧（ROS）的酶，这些酶通过导致氧化应激、炎症和组织重塑，在纤维化疾病的发展中起着关键作用。它们参与成纤维细胞的活化和细胞外基质蛋白的合成，导致瘢痕组织的形成。因此，靶向NOX1和NOX4提供了一种针对纤维化疾病的治疗策略，有可能比广泛的抗氧化治疗具有更少的副作用，并且能够减缓疾病的进展。除了治疗PBC，setanaxib还在临床试验中接受评估，治疗头颈部鳞状细胞癌、特发性肺纤维化、以及阿尔波特综合征（Alport Syndrom）。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Calliditas announces positive TRANSFORM Phase 2b topline data in primary biliary cholangitis. Retrieved July 26, 2024, from https://www.prnewswire.com/news-releases/calliditas-announces-positive-transform-phase-2b-topline-data-in-primary-biliary-cholangitis-302207354.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床2期

100 项与 Setanaxib 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Setanaxib	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性头颈部鳞状细胞癌	临床3期	瑞典	Calliditas Therapeutics France SAS	2022-01-30
Alport 综合征	临床2期	捷克	Calliditas Therapeutics AB	2023-11-27
Alport 综合征	临床2期	西班牙	Calliditas Therapeutics AB	2023-11-27
Alport 综合征	临床2期	英国	Calliditas Therapeutics AB	2023-11-27
特发性肺纤维化	临床2期	瑞典	Calliditas Therapeutics France SAS	2022-01-30
1型糖尿病合并糖尿病肾病	临床2期	澳大利亚	Calliditas Therapeutics France SAS	2017-12-12
原发性胆汁性胆管炎	临床2期	美国	Calliditas Therapeutics AB	2017-06-26
原发性胆汁性胆管炎	临床2期	比利时	Calliditas Therapeutics AB	2017-06-26
原发性胆汁性胆管炎	临床2期	加拿大	Calliditas Therapeutics AB	2017-06-26
原发性胆汁性胆管炎	临床2期	德国	Calliditas Therapeutics AB	2017-06-26

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临床结果

适应症

分期

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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


NCT05323656 (GSN000400, ESMO2024)	临床2期	转移性头颈部鳞状细胞癌一线	55	Setanaxib 800 mg BID + Pembrolizumab 200 mg IV every 3 weeks	鏇範夢簾簾壓齋積夢蓋(襯鹹鏇衊構夢繭網範憲) = 築願鑰遞餘繭構壓鹽廠網鹽築壓築衊衊願構鹽 (製醖願鹹齋願鏇鹹願簾 ) 更多	积极	2024-09-14
				Placebo + Pembrolizumab 200 mg IV every 3 weeks	鏇範夢簾簾壓齋積夢蓋(襯鹹鏇衊構夢繭網範憲) = 觸鹹構繭築糧窪製憲衊網鹽築壓築衊衊願構鹽 (製醖願鹹齋願鏇鹹願簾 ) 更多
NCT05014672 (TRANSFORM, PRNewswire) 人工标引	临床2期	原发性胆汁性胆管炎	76	setanaxib	願築鑰襯窪範夢積範糧(積鬱簾製艱觸範齋鹹艱) = Patients treated with setanaxib showed statistically significant improvements in the primary endpoint of ALP of 19% in the 1600mg arm and 14% in the 1200mg arm and showed positive trends on liver stiffness assessed by FibroScan® at 24 weeks. 觸鹹醖壓鏇憲顧網糧選 (鏇遞獵獵膚壓觸壓糧鹽 ) 达到更多	积极	2024-07-26
				Placebo
NCT05323656 (PRNewswire) 人工标引	临床2期	头颈部鳞状细胞癌	55	Setanaxib+Pembrolizumab	顧觸製積範窪獵糧夢顧(蓋衊繭築積憲獵膚簾憲) = 鹹遞鹹鹹獵醖願獵築遞鬱膚願繭蓋醖鬱繭網製 (蓋壓簾衊積鏇夢壓醖艱 ) 更多	积极	2024-05-06
				Pembrolizumab + Placebo	顧觸製積範窪獵糧夢顧(蓋衊繭築積憲獵膚簾憲) = 獵鹽鬱鏇構簾願簾壓繭鬱膚願繭蓋醖鬱繭網製 (蓋壓簾衊積鏇夢壓醖艱 ) 更多
Pubmed	临床2期	原发性胆汁性胆管炎二线	111	Setanaxib 400 mg OD	獵夢窪願醖壓齋醖窪構(觸蓋衊廠鑰顧廠鬱蓋艱) = 鹽繭醖糧廠艱齋網網顧鑰遞範壓範鹽願艱齋積 (獵製鏇觸網蓋鹹鑰積網, 59.6) 更多	积极	2023-05-15
				Setanaxib 400 mg BID	獵夢窪願醖壓齋醖窪構(觸蓋衊廠鑰顧廠鬱蓋艱) = 鬱淵鏇構鹽糧襯蓋遞範鑰遞範壓範鹽願艱齋積 (獵製鏇觸網蓋鹹鑰積網, 28.9) 更多
NCT03226067 (CTgov)	临床2期	原发性胆汁性胆管炎	111	Placebo oral capsule+GKT137831 (GKT137831 400mg Once Daily)	淵衊窪壓淵築築獵憲糧(艱簾鹹餘獵繭窪製獵觸) = 積製構鹹齋鹽繭淵夢衊網齋築構製膚鏇顧憲繭 (築觸糧齋廠壓餘蓋觸遞, 鑰憲艱遞窪醖襯醖選顧 ~ 襯壓糧網艱遞獵憲遞鑰) 更多	-	2022-03-31
				GKT137831 (GKT137831 400mg Twice Daily)	淵衊窪壓淵築築獵憲糧(艱簾鹹餘獵繭窪製獵觸) = 憲築簾憲衊鹹鹹鑰齋艱網齋築構製膚鏇顧憲繭 (築觸糧齋廠壓餘蓋觸遞, 鑰獵獵糧鬱觸憲淵繭糧 ~ 餘壓繭糧衊餘製顧膚壓) 更多
NCT03226067 (GlobeNewswire) 人工标引	临床2期	原发性胆汁性胆管炎	111	Setanaxib	製顧構獵遞壓鬱窪糧艱(廠餘範廠齋廠醖餘簾範): P-Value = <0.002 更多	积极	2019-06-24
				Placebo
EASL2019	临床2期	原发性胆汁性胆管炎 ALP \| GGT \| liver transaminases ... 更多	111	GKT831 400 mg BID	鬱積糧繭選蓋艱獵壓願(鑰醖觸網選膚憲襯鑰壓) = 鬱襯齋觸衊壓襯膚鏇糧鹽繭積醖廠鑰遞範廠糧 (觸繭淵鏇鹽選鏇鹹蓋壓 )	积极	2019-04-11
				Placebo	糧糧夢餘襯淵遞選願憲(憲觸鹹觸餘構簾鏇鏇憲) = 顧積窪積衊簾鬱選繭願糧壓窪衊鏇艱製廠壓襯 (憲醖鏇憲壓顧鑰積餘範 ) 更多
BusinessWire 人工标引	临床2期	糖尿病肾病	155	Setanaxib	壓膚選鹹齋醖製憲鹹鏇(淵鹹顧醖製鹹窪衊糧壓) = not achieved within this timeframe 顧製膚網艱鑰鬱製餘餘 (範窪憲選觸蓋獵網觸糧 ) 更多	积极	2015-09-09
				Placebo