[Translation] A multicenter, randomized, double-blind, parallel controlled clinical trial to evaluate the safety and efficacy of oral taremide sodium tablets in patients with systemic lupus erythematosus

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

[Translation]

1. To explore the safety and efficacy of oral taremide sodium tablets at different doses for the treatment of patients with systemic lupus erythematosus under multiple administration conditions 2. To explore the steady-state blood drug concentration and in vivo exposure 3. To explore the relevant pharmacodynamic (PD) biomarkers of systemic lupus erythematosus 4. To provide a basis for determining the dosing regimen and dosage for Phase III clinical trials

Start Date14 May 2019

Sponsor / Collaborator

Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

[+2]

CTR20150314

/ CompletedPhase 1

泰瑞米特钠片与来氟米特片的口服相对生物利用度研究

[Translation] Study on the relative oral bioavailability of teremide sodium tablets and leflunomide tablets

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。

[Translation]

1) To study the time course of plasma tetamide concentration and urinary excretion of tetamide and its metabolites in healthy subjects after a single oral administration of tetamide sodium tablets and leflunomide tablets, so as to determine the pharmacokinetic characteristics of tetamide and provide a basis for determining the clinical dosage of tetamide sodium tablets; 2) To evaluate the oral relative bioavailability of tetamide sodium tablets and leflunomide tablets; 3) To evaluate the safety and tolerability of tetamide sodium tablets and leflunomide tablets after a single oral administration.

Start Date27 May 2015

Sponsor / Collaborator

Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.

[+2]

100 Clinical Results associated with Teriflunomide Sodium

100 Translational Medicine associated with Teriflunomide Sodium

100 Patents (Medical) associated with Teriflunomide Sodium

868

Literatures (Medical) associated with Teriflunomide Sodium

01 Mar 2025·Fluid Phase Equilibria

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

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

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.

01 Mar 2025·Journal of Neuroimmunology

Endocrine disrupting chemicals in early MS disease activity

Article

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

BACKGROUND AND OBJECTIVESEpidemiological 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.METHODSThis 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.RESULTS68 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.CONCLUSIONThis 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.

20 Feb 2025·Chinese Medical Journal

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

Article

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

AbstractBackground: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 Deals associated with Teriflunomide Sodium

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	China	Xinkaiyiyao Science & Technology Shanghai Co. Ltd.	14 May 2019
Systemic Lupus Erythematosus	Phase 2	China	Xinkai Medicine and Chemical Intermediates (Shanghai) Co., Ltd.	14 May 2019

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