A Phase II Prospective, Randomized, Double-Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Ophthalmic Suspension Compared to Placebo for the Treatment of Dry Eye Disease

To investigate the safety and efficacy of DE-101 to improve the signs and symptoms in dry-eye disease.

开始日期2011-10-01

申办/合作机构

Santen Pharmaceutical Co., Ltd.

NCT01118754 / Completed临床1/2期

Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease

The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.

开始日期2010-04-01

申办/合作机构

Santen Pharmaceutical Co., Ltd.

NCT00571519 / Terminated临床3期

A Randomized, Double-blind, Placebo, and Active Comparator-controlled, Parallel-group Study of the Efficacy and Safety of Rivoglitazone as Monotherapy Treatment of Type 2 Diabetes Mellitus

This is a 26-week, multicenter, randomized, double-blind, placebo and active comparator-controlled, parallel-group study in participants with type 2 diabetes currently sub-optimally controlled by diet and exercise or with non-thiazolidinedione antihyperglycemic monotherapy. Pioglitazone is used as active comparator. The total duration of a participant's participation will be approximately 30 weeks, including a 2-week placebo lead-in period, a 26-week double-blind treatment period, and a 2-week post-treatment follow-up period. Participants who complete the randomized portion of the study per protocol may have the opportunity to continue in a long-term extension study of active treatments.

开始日期2007-11-14

申办/合作机构

Daiichi Sankyo Co., Ltd.

100 项与利格列酮相关的临床结果

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100 项与利格列酮相关的专利（医药）

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项与利格列酮相关的文献（医药）

2024-01-01·Therapeutic advances in gastroenterology

The emerging therapies are reshaping the first-line treatment for advanced hepatocellular carcinoma: a systematic review and network meta-analysis

Article

作者: Chen, Jinbin ; Hu, Dandan ; Pan, Yangxun ; Zhou, Zhongguo ; Yang, Zhoutian ; Fang, Aiping ; Xu, Li ; Peng, Wei ; Xie, Lan ; Ye, Zhiwei ; Zhang, Yaojun ; Chen, Minshan ; Wang, Juncheng

Background::

Given the superior performance of various therapies over sorafenib in advanced hepatocellular carcinoma (HCC) and the absence of direct comparisons, it is crucial to explore the efficacy of these treatments in phase III randomized clinical trials.

Objectives::

The goal is to identify which patients are most likely to benefit significantly from these emerging therapies, contributing to more personalized and informed clinical decision-making.

Design::

Systematic review and network meta-analysis

Data sources and methods::

PubMed, Embase, ClinicalTrials.gov, and international conference databases have been searched from 1 January 2010 to 1 December 2023.

Results::

After screening, 17 phase III trials encompassing 18 treatments were included. In the whole-population network meta-analysis, the newly first-line tremelimumab plus durvalumab (Tre + Du) was found to be comparable with atezolizumab plus bevacizumab (Atezo + Beva) in providing the best overall survival (OS) benefit [hazard ratio (HR) 1.35, 95% confidence interval (CI): 0.93–1.92]. Concerning OS benefits, sintilimab plus bevacizumab biosimilar (Sint + Beva), camrelizumab plus rivoceranib (Camre + Rivo), and lenvatinib plus pembrolizumab (Lenva + Pemb) appear to exhibit similar effects to Tre + Du and Atezo + Beva. In the context of progression-free survival, Atezo + Beva seemed to outperform Tre + Du (HR: 0.66 CI: 0.49–0.87), while the effects are comparable to Sint + Beva, Camre + Rivo, and Lenva + Pemb. Upon comparison between Asia-Pacific and non-Asia-Pacific cohorts, as well as between hepatitis B virus (HBV)-infected and non-HBV-infected populations, immune checkpoint inhibitor (ICI)-based treatments seemed to exhibit heightened efficacy in the Asia-Pacific group and among individuals with HBV infection. However, combined ICI-based therapies did not show more effectiveness than molecular-targeted drugs in patients without macrovascular invasion and/or extrahepatic spread. As for grades 3–5 adverse events, combined therapies showed comparable safety to sorafenib and lenvatinib.

Conclusion::

Compared with sorafenib and lenvatinib, combination therapies based on ICIs significantly improved the prognosis of advanced HCC and demonstrated similar safety. At the same time, the optimal treatment approach should be tailored to individual patient characteristics, such as etiology, tumor staging, and serum alpha-fetoprotein levels. With lower incidence rates of treatment-related adverse events and non-inferior efficacy compared to sorafenib, ICI monotherapies should be prioritized as a first-line treatment approach for patients who are not suitable candidates for ICI-combined therapies.

Trial registration::

PROSPERO, CRD42022288172.

2023-07-01·Indian journal of endocrinology and metabolism

Efficacy and Safety of Novel Thiazolidinedione Rivoglitazone in Type-2 Diabetes a Meta-Analysis

Article

作者: Kadian, Jyoti ; Maisnam, Indira ; Kumar, Ashok ; Sharma, Meha ; Dutta, Deep ; Bhattacharya, Saptarshi

No meta-analysis has analyzed the safety and efficacy of rivoglitazone in type-2 diabetes (T2DM). We undertook this meta-analysis to address this knowledge gap. Electronic databases were searched for RCTs involving T2DM patients receiving rivoglitazone in the intervention arm, and placebo/active comparator in the control arm. The primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in glucose, lipids, and adverse events. From initially screened 24 articles, data from 3 RCTs (3591 patients) that fulfilled all criteria was analzsed. HbA1c was significantly lower with standard-dose (1 mg/d) [MD-0.86% (95%CI:-1.11–-0.61); P < 0.01; I2 = 87%] and high-dose (1.5-2 mg/d) [MD-0.97%(95%CI:-1.03–-0.90); P < 0.01; I2 = 19%] rivoglitazone compared to placebo. When compared to pioglitazone (30-45 mg/d), HbA1c lowering was comparable with standard-dose [MD 0.05%(95%CI:-0.01 – 0.11); P = 0.08; I2 = 11%], but superior with high-dose [MD -0.11%(95%CI:-0.18– -0.04); P < 0.01; I2 = 0%] rivoglitazone. Triglycerides were significantly lower with standard-dose [MD-17.95 mg/dl (95%CI:-34.23–-1.66); P = 0.03; I2 = 0%] and high-dose [MD-40.41 mg/dl (95%CI:-72.90– -7.93);P = 0.01;I2 = 71%] rivoglitazone compared to placebo. Adiponectin significantly improved with standard-dose [MD 7.94 ng/ml (95%CI: 5.48–10.39); P < 0.01;I2 = 98%] and high-dose [MD 13.82 ng/ml (95%CI: 8.16–19.48); P < 0.01; I2 = 100%] rivoglitazone compared to placebo. hsCRP was significantly lower with standard-dose [MD -1.00 mg/L (95% CI: -1.20 – -0.80); P < 0.01; I2 = 6%] and high-dose [MD -1.50 mg/L (95%CI:-1.59– -1.40); P < 0.01; I2 = 0%] rivoglitazone compared to placebo. Treatment-emergent adverse events with standard-dose [Risk ratio (RR) 1.16 (95%CI: 0.84 –1.60); P = 0.38; I2 = 0%] and high-dose [RR1.34 (95%CI: 0.99–1.83); P = 0.06; I2 = 0%] rivoglitazone was comparable to placebo. Severe adverse events with standard-dose [RR1.88 (95%CI: 0.69–5.12);P = 0.22;I2 = 0%] and high-dose [RR 1.27 (95% CI: 0.45 – 3.59); P = 0.68; I2 = 0%] rivoglitazone was comparable to placebo. This meta-analysis highlights the good glycaemic efficacy and safety of both standard and high-dose rivoglitazone, and appears to be better than lobeglitazone in T2DM.

2022-09-01·Animal : an international journal of animal bioscience

The amino acid profile of Camelina sativa seeds correlates with the strongest immune response in dairy ewes

Article

作者: Tedeschi, T ; Christodoulou, C ; Sforza, S ; Mavrommatis, A ; Prandi, B ; Tsiplakou, E ; Simoni, M ; Righi, F

Camelina sativa is an alternative protein source (with a specific amino acid profile) rich also in bioactive compounds (such as polyunsaturated fatty acids and antioxidants), which have immunomodulatory properties. This study aimed to assess the impact of the dietary inclusion level of Camelina seeds, on the expression levels of key genes involved in ewes' innate immunity. Forty-eight dairy ewes were assigned into four homogenous groups of 12 animals that were fed individually with alfalfa hay, wheat straw, and concentrate. The concentrate of the control group (CON) had no Camelina seeds, while in the treated groups, Camelina seeds (CSs) were incorporated at 6 (CS6), 11 (CS11), and 16% (CS16) in the concentrates, respectively, as partial substitution of both soybean meal and maize grain. The relative transcript levels of the immune-related genes were determined using a real-time PCR platform. The relative transcript levels of toll-interleukin receptor-domain-containing adapter-inducing interferon-β, tumour necrosis factor receptor-associated factor 3, Interferon regulatory factor 5, and Mitogen-activated protein kinase were upregulated in monocytes of the CS11-fed ewes. Furthermore, in the CS6-fed ewes, the relative transcript levels of Interleukin-1 beta (IL1B) were upregulated in monocytes compared to the CON, while those of IL1B, Interleukin-8, and Interleukin-10 were upregulated in neutrophils compared to the CON and the CS11-fed ewes. The highest inclusion level of CS (CS16) did not have a negative impact on ewes' innate immunity. The response of monocytes on dietary amino acid (mainly threonine, tyrosine, serine, and lysine) changes related to Camelina inclusion is different from that of neutrophils. The observed responses need to be further investigated.

项与利格列酮相关的新闻（医药）

2024-09-12

·GlobeNewswire-Health Care

Elevar Therapeutics Reports Advances in HCC and Other Oncology Clinical Programs for Rivoceranib Plus Camrelizumab at the European Society for Medical Oncology Congress 2024

FORT LEE, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the presentation of three posters at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, Sept. 13-17. “The results to be presented at ESMO continue to support the safety and efficacy of rivoceranib in combination with camrelizumab as a first-line systemic treatment option for patients with hepatocellular carcinoma; as well as the potential of combining rivoceranib with other immune checkpoint inhibitors as a therapeutic option for many types of solid tumors,” commented Chris Galloway, M.D., senior vice president of clinical and medical affairs at Elevar Therapeutics. Camrelizumab and rivoceranib were granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medical Association. ESMO Presentation 985P (Abstract 5451): Analysis of antidrug antibodies (ADA) to camrelizumab in CARES-310: The pivotal phase III study of camrelizumab + rivoceranib in unresectable hepatocellular carcinoma (uHCC) The poster reports an analysis of antidrug antibodies (ADAs) in the CARES-310 (NCT03764293) Phase 3 clinical study for the treatment of unresectable hepatocellular carcinoma (uHCC). There was minimal impact of ADAs on PK, efficacy and safety. Therefore, follow-up monitoring of ADAs to cam is not warranted. CARES-310 was the first trial to demonstrate significant progression-free survival (PFS) and overall survival benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as a first-line treatment for uHCC. Speaker: Ahmed O. Kaseb (Houston, United States of America)Onsite poster display date: Mon., Sept. 16Link to Abstract 5451 / Presentation 985P ESMO Presentation 963P (Abstract 5635): Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis to assess the impact of treatment with camrelizumab + rivoceranib (cam+rivo) on quality-of-life vs sorafenib (sora) in patients (pts) with unresectable hepatocellular carcinoma (uHCC): Study CARES-310 The poster reports results from Phase 3 CARES-310 study, concluding cam + rivo had clinically meaningful quality-adjusted survival benefits over sorafenib. The higher incidence of adverse effects in patients treated with cam + rivo was likely due to longer time on treatment versus sorafenib. Speaker: Andrew Moon (Chapel Hill, United States of America)Onsite poster display date: Mon., Sept. 16Link to Abstract 5635 / Presentation 963P ESMO Presentation 1013P (Abstract 2318): A phase I study of rivoceranib combined with nivolumab in patients with unresectable or metastatic cancer The poster reports results from Phase 1 (NCT03396211) clinical study of rivoceranib plus nivolumab (rivo + nivo) in patients with advanced metastatic solid tumors. The study concluded that rivo + nivo demonstrated a manageable safety profile and promising antitumor efficacy across many solid tumors as measured by reduction in tumor burden over time. Further studies are needed to confirm the safety and efficacy of rivo + nivo therapy. Speaker: Neal S. Chawla (Duarte, United States of America)Onsite poster display date: Sat., Sept. 14Link to Abstract 2318 / Presentation 1013P About Hepatocellular Carcinoma More than 800,000 people worldwide are diagnosed with liver cancer each year. Liver cancer is a leading cause of cancer accounting for more than 700,000 deaths annually.[i] Hepatocellular Carcinoma (HCC) is the most common type of primary liver cancer. It most frequently develops in people with chronic underlying liver inflammation which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf®). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese -territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan®. About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa®, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. Media Contact Jeanette Bressi Head, Corporate Communications, Elevar Therapeutics jbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade SmithChief Financial & Business Officer, Elevar Therapeuticswsmith@elevartherapeutics.com [i] Key Statistics About Liver Cancer | American Cancer Society

临床结果免疫疗法临床3期孤儿药临床1期

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KEGG	Wiki	ATC	Drug Bank
-	利格列酮	-	DB09200

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
2型糖尿病	临床3期	波多黎各	Daiichi Sankyo Co., Ltd.	2007-04-01
干眼综合征	临床2期	美国	Santen Pharmaceutical Co., Ltd.	2011-10-01

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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


NCT00484198 (CTgov)	临床3期	2型糖尿病	1,912	placebo+Rivoglitazone+Pioglitazone (Placebo)	鏇窪築築顧遞觸廠鬱鑰(襯範範餘糧窪鹽範淵積) = 窪簾顧築願製鑰構蓋鑰構鬱膚鏇鑰醖壓鏇艱鏇 (選鏇繭餘鹹窪醖餘廠鬱, 夢簾構觸淵餘淵膚廠築 ~ 顧膚廠鑰鹹廠觸網壓製) 更多	-	2021-07-27
				Rivoglitazone (Rivoglitazone 1.0 mg)	鏇窪築築顧遞觸廠鬱鑰(襯範範餘糧窪鹽範淵積) = 範獵夢糧製齋觸膚窪壓構鬱膚鏇鑰醖壓鏇艱鏇 (選鏇繭餘鹹窪醖餘廠鬱, 願獵齋廠壓網觸網膚壓 ~ 鬱鏇鏇鏇範積膚衊構蓋) 更多
NCT00571519 (CTgov)	临床3期	2型糖尿病	94	placebo+Rivoglitazone+Pioglitazone (Placebo)	廠夢顧餘願觸網齋鹽構(膚顧衊獵選遞鏇獵醖簾) = 願繭蓋顧醖積鏇繭觸鹹廠衊簾蓋艱範齋艱繭鬱 (獵夢襯繭醖壓觸鏇範鑰, 鑰範獵艱範夢選願製簾 ~ 衊襯願積鑰鏇蓋餘憲艱) 更多	-	2021-02-26
				Rivoglitazone (Rivoglitazone 0.5mg)	廠夢顧餘願觸網齋鹽構(膚顧衊獵選遞鏇獵醖簾) = 蓋觸築顧餘襯襯齋觸積廠衊簾蓋艱範齋艱繭鬱 (獵夢襯繭醖壓觸鏇範鑰, 簾願壓衊鬱窪範選壓鑰 ~ 積範鹹廠夢築網醖齋繭) 更多