API Suppliers
US DMFs Filed
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:
ONA-XR (onapristone) is a selective progesterone receptor (PR) antagonist designed to block both ligand dependent and ligand-independent activity of PR which downregulates cancer stem cellmobilization, and blocking immune evasion.
Lead Product(s): Onapristone,Anastrozole
Therapeutic Area: Oncology Product Name: ONA-XR
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 February 06, 2023
Details:
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. Currently, there are no approved therapies that selectively target PR+ cancers.
Lead Product(s): Onapristone,Fulvestrant
Therapeutic Area: Oncology Product Name: ONA-XR
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 December 08, 2022
Details:
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. Preclinical and clinical data suggest that ONA-XR has anticancer activity by inhibiting progesterone receptor binding to chromatin.
Lead Product(s): Onapristone,Fulvestrant
Therapeutic Area: Oncology Product Name: ONA-XR
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 November 21, 2022
Details:
ONA-XR (onapristone extended release) is a potent and specific antagonist of the progesterone receptor (PR) that is orally administered. ONA-XR is an investigational drug that has not been approved for marketing by any regulatory authority.
Lead Product(s): Onapristone,Letrozole,Palbociclib
Therapeutic Area: Oncology Product Name: ONA-XR
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: The Menarini Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 02, 2022
Details:
Lead clinical-stage oral progesterone receptor (PR) antagonist ONA-XR (onapristone extended release) demonstrates monotherapy clinical activity in advanced granulosa cell tumor of the ovary.
Lead Product(s): Onapristone,Anastrozole
Therapeutic Area: Oncology Product Name: ONA-XR
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 May 05, 2022
Details:
ONA-XR is a novel, first-in-class small molecule under development as a potent and specific antagonist of PR, a key unchecked mechanism in hormone-driven women’s cancers.The preclinical data for onapristone (ONA-XR) support it as a potent progesterone receptor antagonist.
Lead Product(s): Onapristone
Therapeutic Area: Oncology Product Name: ONA-XR
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 April 11, 2022
Details:
ONA-XR (onapristone extended release), a potent, specific progesterone receptor (PR) antagonist being evaluated for PR+ breast, ovarian and endometrial cancer, and our preclinical anti-claudin 6 (CLDN6) bispecific monoclonal antibody (BsMAb) for gynecologic cancer therapy.
Lead Product(s): Onapristone
Therapeutic Area: Oncology Product Name: ONA-XR
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 March 08, 2022
Details:
Data demonstrated ONA-XR (Onapristone extended release) decreased proliferation in tumors with high PR+ at baseline in early breast cancer.
Lead Product(s): Onapristone
Therapeutic Area: Oncology Product Name: ONA-XR
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 December 09, 2021
Details:
In the Phase 1-2 trials, ONA-ER at escalating doses of 10 mg to 50 mg twice-a-day had a favorable safety and tolerability profile at all doses.
Lead Product(s): Onapristone
Therapeutic Area: Oncology Product Name: ONA-ER
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 29, 2020
Details:
Tyligand will be solely responsible for the design and optimization of a novel manufacturing process for onapristone ER to meet Context’s development and future commercialization needs.
Lead Product(s): Onapristone
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Context Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 12, 2020