Delving into the Latest Updates on Fopitasvir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

SKLB-79, SKLB-HCV-79

Target

NS5A

Mechanism

NS5A inhibitors(Nonstructural protein 5A inhibitors)

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Sichuan University

Active Organization-

Inactive Organization-

Drug Highest Phase-

First Approval Date-

Regulation-

Structure

Molecular FormulaC18H21ClN4O2S

InChIKeySBAKTYOQFNXYGD-UHFFFAOYSA-N

CAS Registry1673547-18-6

To evaluate the tolerability of multiple-dose, single-dose and multiple-dose fobitasvir tablets in patients with chronic hepatitis C; To evaluate the pharmacokinetic study of multiple-dose, single-dose and multiple-dose fobitasvir tablets in patients with chronic hepatitis C; To evaluate the antiviral activity of multiple-dose, single-dose and multiple-dose fobitasvir tablets in patients with chronic hepatitis C.

Start Date25 Dec 2016

Sponsor / Collaborator

Changzhou Yinsheng Pharmaceutical Co., Ltd

[+1]

CTR20170077 / CompletedNot Applicable

福比他韦片在健康受试者中的多剂量单次、多次给药的耐受性、药代动力学Ⅰa期临床试验

[Translation] Phase Ia clinical trial of tolerability and pharmacokinetics of single and multiple doses of fobitasvir tablets in healthy subjects

评价福比他韦片在健康受试者中多剂量、单次、多次给药耐受性研究；评价福比他韦片在健康受试者中多剂量、单次、多次给药药代动力学研究；评价福比他韦片药物代谢转化研究；评价食物对福比他韦片药代动力学的影响。

[Translation]

To evaluate the tolerance of Fobitasvir tablets in healthy subjects after multiple doses, single doses and multiple administrations; To evaluate the pharmacokinetics of Fobitasvir tablets in healthy subjects after multiple doses, single doses and multiple administrations; To evaluate the drug metabolism and transformation studies of Fobitasvir tablets; To evaluate the effect of food on the pharmacokinetics of Fobitasvir tablets.

Start Date12 Jul 2016

Sponsor / Collaborator

Changzhou Yinsheng Pharmaceutical Co., Ltd

[+1]

100 Clinical Results associated with Fopitasvir

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100 Translational Medicine associated with Fopitasvir

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100 Patents (Medical) associated with Fopitasvir

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Literatures (Medical) associated with Fopitasvir

01 Aug 2021·Die PharmazieQ4 · MEDICINE

A novel fixed-dose combination treatment for chronic hepatitis C, based on NS5A inhibitor fopitasvir and NS5B inhibitor sofosbuvir.

Q4 · MEDICINE

Article

Author: Yu, Luo-Ting ; Zhou, Shu-Yan ; Wang, Ning-Yu ; Chen, Yan ; Tao, Xin ; Chen, Xin-Yi ; Meng, Na-Na ; Liu, Zhi-Hao ; He, Hua-Long

Drug resistance caused by the extreme genetic variability of zhe hepatitis C virus has rendered effective combinations of drugs indispensable in the treatment of chronic hepatitis C (CHC). Herein, we developed a fixed-dose combination (FDC) treatment containing the NS5B inhibitor sofosbuvir (SOF) and the NS5A inhibitor fopitasvir (FOP). Then the dissolution behavior of FOP in FOP/SOF FDC was improved by co-micronizing FOP with lactose. The enhanced dissolution rate of FOP in the FDC was in good agreement with the behavior of the FOP singledrug tablet. In addition, pharmacokinetic studies showed that both FOP and SOF in the FDC exhibited similar characteristics (area under the curve, C_max, T_max, and T_1/2) as those of tablets containing FOP or SOF alone. These results revealed that the FOP/SOF FDC represents a potential therapeutic option for the treatment of CHC.

100 Deals associated with Fopitasvir

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