泰瑞米特钠(Teriflunomide Sodium) - 药物靶点：DHODH_在研适应症：系统性红斑狼疮_专利_临床

概要

基本信息

药物类型

小分子化药

别名

CK8

靶点

DHODH

作用方式

抑制剂

作用机制

DHODH抑制剂(双氢乳清酸酯脱氢酶抑制剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

系统性红斑狼疮

非在研适应症-

原研机构

欣凯医药科技（上海）有限公司

在研机构

欣凯医药科技（上海）有限公司欣凯医药化工中间体（上海）有限公司

非在研机构-

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评特殊审批 (中国)

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结构/序列

分子式C12H9F3N2NaO2

InChIKeyJPMWNACBXMNYHH-VEZAGKLZSA-N

CAS号1260213-11-3

关联

2

项与泰瑞米特钠相关的临床试验

CTR20180837

/ Recruiting临床2期

评估系统性红斑狼疮患者口服泰瑞米特钠片的安全性及有效性的多中心、随机、双盲、平行对照临床试验

1.探索口服不同剂量泰瑞米特钠片多次给药条件下，用于治疗系统性红斑狼疮患者的安全性及有效性 2.探索稳态血药浓度及体内暴露量 3.探索系统性红斑狼疮的相关药效动力学（PD）生物标记物 4.为III期临床试验确定给药方案和用药剂量提供依据

开始日期2019-05-14

申办/合作机构

欣凯医药化工中间体（上海）有限公司

[+2]

CTR20150314

/ Completed临床1期

泰瑞米特钠片与来氟米特片的口服相对生物利用度研究

1）研究健康受试者单次口服泰瑞米特钠片和来氟米特片后血浆泰瑞米特浓度的经时过程和尿中泰瑞米特及其代谢产物的排泄量，以此确定泰瑞米特的药代动力学特征，为确定泰瑞米特钠片的临床使用剂量提供依据；2）评价泰瑞米特钠片与来氟米特片的口服相对生物利用度；3）评价单次口服泰瑞米特钠片和来氟米特片后的安全性和耐受性。

开始日期2015-05-27

申办/合作机构

欣凯医药化工中间体（上海）有限公司

[+2]

100 项与泰瑞米特钠相关的临床结果

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100 项与泰瑞米特钠相关的转化医学

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100 项与泰瑞米特钠相关的专利（医药）

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857

项与泰瑞米特钠相关的文献（医药）

2025-03-01·FLUID PHASE EQUILIBRIA

Solubility of teriflunomide in supercritical carbon dioxide and co-solvent investigation

作者: Esfandiari, Nadia ; Honarvar, Bizhan ; Askarizadeh, Mahshid ; Azdarpour, Amin ; Sajadian, Seyed Ali

The solubility of Teriflunomide in supercritical CO₂ at 338, 328, 318, and 308 K temperatures was investigated with and without a Co-solvent.Ethanol was also tested as a Co-solvent.Semi-empirical and empirical methods were used to model the data obtained from the experimentsIn both the binary and ternary systems, Teriflunomide's solubility values ranged from 0.54 x 10^-4 to 0.64 x 10^-3 and 0.705 x 10^-3 to 2.78 x 10^-3, resp.The solubility was addnl. examined using the PR-EoS along with the vdW2 mixing rule for both systems.Teriflunomide's solubility was considerably enhanced by the addition of ethanol, according to the findings.The highest solubility of Teriflunomide was observed in the Teriflunomide -Ethanol- CO₂ system at 338 K and 12 MPa, which was about 13.99 times greater than its solubility in supercritical carbon dioxide alone under the same conditions.The best correlation with AARD% and AICc for binary and ternary methods, resp., was demonstrated by the models put out by Jouyban et al. and the Sodeifian-Sajadian models.

2025-03-01·JOURNAL OF NEUROIMMUNOLOGY

Endocrine disrupting chemicals in early MS disease activity

Article

作者: Saxena, Shrishti ; Chitnis, Tanuja ; Corbali, Osman ; Chuang, Tzu-Ying ; Feldman, Talia B ; LaBarre, Brenna A ; Saraceno, Taylor J ; Healy, Brian C ; Sanon, Eunnindy

BACKGROUND AND OBJECTIVES:

Epidemiological data shows that the prevalence of multiple sclerosis (MS) and the female-to-male sex ratio among MS patients are increasing over time. Endocrine disrupting chemicals (EDCs) are ubiquitous and increasingly recognized for effects on estrogen signaling. This study aimed to determine whether there was an association between EDC levels and disease severity in newly diagnosed, female MS patients.

METHODS:

This exploratory observational cohort study enrolled female patients, ages 18-60, via written informed consent from the Brigham MS Center. Enrollment criteria included diagnosis with MS within the past 5 years and completion of a questionnaire about potential EDC exposures. Exclusion criteria were intravenous steroids in the past 30 days. Collection processes and materials were designed to avoid EDC contamination. Urine samples were analyzed by NSF International (Ann Arbor, Michigan). Primary outcome measures were MRI parameters and clinical disease activity, including multivariable analysis adjusting for MS treatment types. Spearman correlation test was used for analysis and between group comparisons were conducted with one-way ANOVA.

RESULTS:

68 patients with MS were enrolled. In the phthalates, mEOHP was negatively correlated with T2 lesion volume over time (R value = -0.522, p-value = 0.002, Bonferroni adjusted p = 0.03). For the phenols, triclocarban was negatively associated with cheese consumption (R value = -0.402, p = 0.001, Bonferroni adjusted p = 0.012) There was no association between EDCs and disease activity or demographic factors, nor significant correlation with exposure to household plastics.

CONCLUSION:

This exploratory study identified a negative correlation between triclocarban and cheese consumption. Longitudinally, phthalate metabolite mEOHP was negatively correlated with T2 lesion volume over time. Exposure to EDCs may affect the early disease course in MS, and expansion of research efforts is warranted.

2025-02-20·Chinese medical journal

Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study

Article

作者: Wang, Jiawei ; Zhang, Baorong ; Zhou, Hongyu ; Bu, Bitao ; Jin, Tao ; Zhang, Xinghu ; Dong, Huiqing ; Zhang, Hua ; Liu, Jue ; Zhang, Meini ; Chen, Yueting ; Quan, Chao ; Qiu, Wei ; Yang, Huan ; Hu, Xueqiang ; Qin, Xinyue ; Gao, Feng ; Tan, Guojun ; Li, Chunyang ; Jiao, Zheng ; Xue, Qun ; Shi, Fudong

Abstract:

Background::

Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.

Methods::

This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.

Results::

Eighty-two patients were assigned to variant (n = 42) and wild type groups (n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUCtau) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.

Conclusion::

ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.

Registration::

NCT04410965, https://clinicaltrials.gov.

100 项与泰瑞米特钠相关的药物交易

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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
系统性红斑狼疮	临床2期	中国	欣凯医药科技（上海）有限公司	2019-05-14
系统性红斑狼疮	临床2期	中国	欣凯医药化工中间体（上海）有限公司	2019-05-14