X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
Details:
Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor. It is being developed for the treatment of NTRK-positive locally advanced or metastatic solid tumors.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: Augtyro
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2024
Details:
TPX-0005 (repotrectinib) is an oral ROS1/TKI inhibitor which is under phase 1/2 clinical development for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer and NTRK-positive solid tumors.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Turning Point Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2024
Details:
Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer (NSCLC).
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: Augtyro
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2023
Details:
TPX-0005 (repotrectinib) is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of advanced solid tumors, including NSCLC.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2023
Details:
TPX-0005/BMS-986472 (repotrectinib) is a oral next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting ROS1- or NTRK-positive locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC).
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2023
Details:
TPX-0005/BMS-986472 (repotrectinib) is a oral next-generation, potential best-in-class tyrosine kinase inhibitor (TKI) targeting ROS1- or NTRK-positive locally advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC).
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2023
Details:
Bristol Myers Squibb gains a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis, including TPX-0005 (repotrectinib).
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bristol Myers Squibb
Deal Size: $4,100.0 million Upfront Cash: $4,100.0 million
Deal Type: Acquisition August 17, 2022
Details:
TPX-0005 (repotrectinib) is small macrocyclic tyrosine kinase inhibitor of ROS1, TRK and ALK. Repotrectinib was designed to efficiently bind with the active kinase conformation and avoid steric interference from a variety of clinically resistant mutations.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zai Lab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2022
Details:
TPX-0005 (repotrectinib), is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2022
Details:
In TKI-naive patients for repotrectinib, in 71 total patients, there was a cORR of 79% across global trial. Ten of 11 patients responded within China for a cORR of 91% and DOR ranged from 3.6+ to 7.5+ months with a median duration of follow-up of 3.7 months.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zai Lab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 28, 2022
Details:
Enrollment target of 40 patients achieved for expansion cohort 6 (EXP-6) for TPX-0005 (repotrectinib), a next-generation kinase inhibitor targeting the ROS1 and TRK in NTRK-positive TKI-pretreated advanced solid tumors.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2022
Details:
The primary objective of the Phase 2 portion of the study is to determine the anti-tumor activity of repotrectinib in pediatric and young adult patients less than 25 years old.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2021
Details:
Repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. TRIDENT-1 study showed Repotrectinib was most potent inhibitor of wild-type TRKA/B/C fusions than selitrectinib.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2021
Details:
Repotrectinib is a small (low molecular weight), macrocyclic tyrosine kinase inhibitor of ROS1, TRK and ALK being evaluated TRIDENT-1 trial for both TKI-naïve and TKI-pretreated patients with ROS1+ advanced non-small cell lung cancer and NTRK+ advanced solid tumors.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The Phase 1b portion of the study will examine the safety, tolerability, pharmacokinetics, and any early signals of efficacy of repotrectinib in combination with trametinib in patients with KRAS G12D mutated advanced solid tumors.
Lead Product(s): Repotrectinib,Trametinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 16, 2021
Details:
Phase 2 Confirmed Objective Response Rate is 93%. Repotrectinib was generally well tolerated in 185 patients treated in the Phase 1 and Phase 2 portions of the study.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2021
Details:
Repotrectinib, has been granted breakthrough therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2020
Details:
Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
The early interim data from the Phase 2 TRIDENT-1 study reaffirm that repotrectinib has the potential to be the best-in-class treatment for patients with ROS1- or NTRK-driven tumors, including patients who are TKI-naïve and TKI-pretreated.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 19, 2020
Details:
Under the terms of the agreement, Zai Lab will obtain exclusive rights to develop and commercialize repotrectinib in Greater China.
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zai Lab
Deal Size: $176.0 million Upfront Cash: $25.0 million
Deal Type: Licensing Agreement July 07, 2020
Details:
The preclinical antitumor activities of repotrectinib in combination with proxy molecules for AMG510, an investigational KRAS-G12C inhibitor, and trametinib, an approved MEK inhibitor were highlighted for the first time in two poster presentations.
Lead Product(s): Repotrectinib,Sotorasib
Therapeutic Area: Oncology Product Name: TPX-0005
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2020
Details:
Repotrectinib demonstrated potent in vitro and in vivo activity in patient-derived preclinical models compared with proxy chemical compounds for other tyrosine kinase inhibitors (TKIs).
Lead Product(s): Repotrectinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
