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:
Amcenestrant (SAR439859) is an orally bioavailable SERD that demonstrates pure ER antagonism in vivo. Compared with other SERD agents, amcenestrant provides optimal ER antagonism and degradation.
Lead Product(s): Amcenestrant,Letrozole
Therapeutic Area: Oncology Product Name: SAR439859
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 August 17, 2022
Details:
The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint of improving progression-free survival, in patients with breast cancer.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: SAR439859
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 March 14, 2022
Details:
Early clinical data for investigational oral selective estrogen receptor (SERD), amcenestrant, show potential to become a new endocrine backbone therapy in ER+ HER2- breast cancer.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: SAR439859
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 19, 2021
Details:
The pivotal study (AMEERA-3) of amcenestrant versus physician’s choice in locally advanced or metastatic estrogen receptor-positive (ER+) breast cancer is fully recruited; readout expected in H2 2021.
Lead Product(s): Amcenestrant,Palbociclib
Therapeutic Area: Oncology Product Name: SAR439859
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 19, 2021
Details:
Preclinical data for Sanofi's investigational compounds in breast, lung, multiple myeloma and other cancers will be featured at the American Academy of Cancer Research (AACR) Virtual Annual Meeting II on June 22-24.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: Undisclosed
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 June 15, 2020
Details:
The four areas of strategic focus within oncology, including multiple myeloma, skin, lung, and breast cancers. Sanofi’s four anchor oncology treatments include Sarclisa® (isatuximab-irfc) and Libtayo® (cemiplimab-nwlc), and the pipeline programs.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: Undisclosed
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 June 02, 2020
Details:
Company going to present clinical data on its oncology portfolio including data on its Phase 1/2 study of SAR439859, an oral selective estrogen receptor degrader (SERD), in estrogen receptor-positive (ER+)/HER2- metastatic breast cancer.
Lead Product(s): Amcenestrant,Palbociclib
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 May 13, 2020
Details:
Phase 3 AMEERA-6 study expected to be the first pivotal trial of an oral selective estrogen receptor degrader (SERD) in the adjuvant setting and will evaluate the safety and efficacy of Sanofi’s amcenestrant in ER+ patients who prematurely discontinue standard therapy.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: SAR439859
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sanofi
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 04, 2021
Details:
The EOP study will use an oral SERD as the endocrine therapy backbone. Sanofi's SAR439859 is a potent, orally bioavailable, and selective estrogen receptor (ER) inhibitor that belongs to the selective estrogen receptor degrader (SERD) class of compounds.
Lead Product(s): Amcenestrant
Therapeutic Area: Oncology Product Name: Undisclosed
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 June 08, 2020