API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
GMI-1687 is a highly potent E-selectin antagonist that is bioavailable after subcutaneous administration. It is under phase 1 clinical development for the treatment of sickle cell disease.
Lead Product(s): Uproleselan
Therapeutic Area: Hematology Product Name: GMI-1687
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
APL-106 (uproleselan) is an investigational, first-in-class E-selectin antagonist, which is under phase 3 clinical development for the treatment of of adults with relapsed or refractory acute myeloid leukemia (relapsed/refractory AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
Details:
GMI-1271 (uproleselan) is designed to bind to E-selection and block the normal processes controlled by E-selectin. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2023
Details:
Completion of enrollment of GMI-1271 (Uproleselan), sets the stage for planned interim analysis evaluating potential for regulatory filings, improves overall survival in newly diagnosed patients 60 years or older with acute myeloid leukemia.
Lead Product(s): Uproleselan,Daunorubicin,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
The primary endpoint of APL-106 is overall survival and Secondary outcome measures the rate and duration of remission, and whether APL-106 can reduce the rate of oral mucositis, a chemotherapy-related side effect.
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
APL-106 (uproleselan injection) is an innovative drug discovered and developed by GlycoMimetics. Apollomics licensed uproleselan from GlycoMimetics, and Apollomics has the rights to clinical development, production and commercial sales in the Greater China market.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2021
Details:
Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2021
Details:
The combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
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 September 23, 2021
Details:
The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML.
Lead Product(s): Uproleselan,Cladribine,Cytarabine
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: The University of Texas MD Anderson Cancer Center
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2021
Details:
The Phase 1 clinical trial in China is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: GlycoMimetics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 04, 2021
Details:
APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 07, 2021
Details:
Uproleselan, when added to a combination therapy of venetoclax, was shown to break chemoresistance by dramatically and significantly reducing tumor burden as detected by circulating human AML cells after three weeks of treatment, and by significantly increasing survival rate.
Lead Product(s): Uproleselan,Venetoclax,Hypomethylating agent
Therapeutic Area: Oncology Product Name: GMI-1271
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 05, 2020
Details:
This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).
Lead Product(s): Uproleselan,Mitoxantrone,Etoposide
Therapeutic Area: Oncology Product Name: APL-106
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GlycoMimetics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2020
Details:
GlycoMimetics will present preclinical data that support the potential of the Company’s compounds (uproleselan and GMI-1359) to be used in the treatment of acute myeloid leukemia (AML) as well as in the setting of stem cell transplantation.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
The paper outlines how uproleselan, targeted inhibitor of E-selectin, can reduce chemoresistance in acute myeloid leukemia (AML) through the key mechanism of targeted E-selectin inhibition.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
Details:
Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization of uproleselan and GMI-1687 in Greater China.
Lead Product(s): Uproleselan
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Apollomics Inc
Deal Size: $180.0 million Upfront Cash: $9.0 million
Deal Type: Collaboration January 06, 2020