TAS-102

Overview

TAS-102 (Taiho Pharma USA, Inc.) is an anti-cancer drug under development and in stage 3 clinical trials for the treatment of colorectal cancer. It is composed of the thymidine phosphorylase inhibitor (TPI) tipiracil and the cytotoxin trifluridine. Trifluridine inhibits tumor growth by being incorporated into DNA during DNA synthesis. Tipiracil prevents trifluridine from being broken down when taken orally.

Indication

用于治疗曾经接受氟嘧啶，奥沙利铂和伊立替康为基础的化疗，抗VEGF生物治疗和抗EGFR治疗（如果是RAS野生型）无效的转移性结直肠癌患者。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2	2024/04/04	NCT06346392	Phase 3	Recruiting	AstraZeneca
Phase 2 Study of CA102N Combined With TAS-102 Compared to Bevacizumab Combined With TAS-102 in Subjects With Relapsed and/or Refractory Metastatic Colorectal Cancer	2023/09/15	NCT06039202	Phase 2	Not yet recruiting	Holy Stone Healthcare Co., Ltd
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer	2023/05/11	NCT05854498	Phase 2	Active, not recruiting	University of Wisconsin, Madison
An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions	2023/05/03	NCT05839951	N/A	Active, not recruiting	Bayer
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)-China Extension Study	2022/10/31	NCT05600309	Phase 3	Completed	Merck Sharp & Dohme LLC
Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer	2022/08/01	NCT05481463	Phase 2	Completed	Sun Yat-sen University
Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study	2022/05/02	NCT05356897	Phase 2	Withdrawn	Academic and Community Cancer Research United
TAS-102 in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy	2022/04/25	NCT05343013	Phase 2	Suspended	M.D. Anderson Cancer Center
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer	2022/04/14	NCT05328908	Phase 3	Active, not recruiting	Bristol-Myers Squibb
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer	2022/04/06	NCT05314101	Phase 2	UNKNOWN	Fujian Cancer Hospital

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
Trifluridine and Tipiracil Hydrochloride Tablets	正大天晴药业集团股份有限公司	国药准字H20213714	化学药品	片剂	9/13/2021
Trifluridine and Tipiracil Hydrochloride Tablets	江苏奥赛康药业有限公司	国药准字H20253171	化学药品	片剂	1/14/2025
Trifluridine and Tipiracil Hydrochloride Tablets	江苏奥赛康药业有限公司	国药准字H20253172	化学药品	片剂	1/14/2025
Trifluridine and Tipiracil Hydrochloride Tablets	山东新时代药业有限公司	国药准字H20253846	化学药品	片剂	4/8/2025
Trifluridine and Tipiracil Hydrochloride Tablets	山东新时代药业有限公司	国药准字H20253847	化学药品	片剂	4/8/2025
Trifluridine and Tipiracil Hydrochloride Tablets	国药一心制药有限公司	国药准字H20253942	化学药品	片剂	4/15/2025
Trifluridine and Tipiracil Hydrochloride Tablets	国药一心制药有限公司	国药准字H20253941	化学药品	片剂	4/15/2025
Trifluridine and Tipiracil Hydrochloride Tablets	山东齐鲁制药有限公司	国药准字H20203731	化学药品	片剂	12/29/2020
Trifluridine and Tipiracil Hydrochloride Tablets	正大天晴药业集团股份有限公司	国药准字H20213715	化学药品	片剂	9/13/2021
Trifluridine and Tipiracil Hydrochloride Tablets	山东齐鲁制药有限公司	国药准字H20203732	化学药品	片剂	12/29/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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

Related News

Third-Line mCRC Treatment Landscape Evolves with Multiple Sequential Options Offering Modest Survival Benefits

14 days ago

The management of treatment-refractory metastatic colorectal cancer has evolved with three distinct therapeutic options, each offering modest but meaningful survival benefits of 2-6 months progression-free survival and 2-4 months overall survival improvements.

NCCN Awards Three Research Grants to Advance Gastrointestinal Cancer Treatments with Taiho Oncology

5 months ago

• The National Comprehensive Cancer Network has awarded three research grants to investigate tipiracil/trifluridine and futibatinib in gastrointestinal cancers, funded through collaboration with Taiho Oncology, Inc. • Selected research projects will explore novel treatment combinations including TAS-102 with PARP inhibition for pancreatic cancer, futibatinib with paclitaxel/ramucirumab for gastroesophageal cancer, and trifluridine/tipiracil plus oxaliplatin for biliary tract cancer. • The two-year research initiative aims to address significant unmet needs in gastrointestinal cancer treatment, particularly focusing on advanced-stage patients with limited therapeutic options.

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