MedPath

Savolitinib

Generic Name
Savolitinib
Drug Type
Small Molecule
Chemical Formula
C17H15N9
CAS Number
1313725-88-0
Unique Ingredient Identifier
2A2DA6857R

Overview

Savolitinib has been used in trials studying the treatment and health services research of Tumor, Food Effect, Gastric Cancer, Health Subjects, and Colorectal Cancer, among others.

Indication

用于含铂化疗后疾病进展或不耐受标准含铂化疗的、具有间质-上皮转化因子(MET)外显子14跳变的局部晚期或转移性非小细胞肺癌成人患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/11/18
Phase 2
Not yet recruiting
Peking University Shenzhen Hospital
2024/08/21
Phase 2
Recruiting
Sun Yat-sen University
2024/04/04
Phase 1
Completed
2023/06/05
Phase 1
Completed
2023/03/21
Phase 1
Recruiting
The First Affiliated Hospital of Guangzhou Medical University
2023/03/14
Phase 1
Completed
2022/11/17
Phase 2
Recruiting
Jeeyun Lee
2022/05/16
Phase 2
Active, not recruiting
2022/03/02
Phase 3
Recruiting
2021/12/20
Phase 2
Active, not recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Savolitinib Tablets
国药准字H20210027
化学药品
片剂
6/22/2021
Savolitinib Tablets
国药准字H20210026
化学药品
片剂
6/22/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
♐♇ ORPATHYS TABLETS 100MG
N/A
N/A
N/A
2/19/2025
♐♇ ORPATHYS TABLETS 200MG
N/A
N/A
N/A
2/19/2025

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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