X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
EU WC
0
Listed 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:
EPI-7386 (masofaniten) is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. It is currently being studied in Combination with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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 18, 2023
Details:
ESSA will conduct a Phase 1 trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetate plus prednisone in patients with prostate cancer.
Lead Product(s): Masofaniten,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 12, 2023
Details:
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. It is currently being studied for CRPC whose tumors have progressed on standard-of-care therapies.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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 13, 2023
Details:
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is being studied in men with castration-resistant prostate cancer ("CRPC") whose tumors have progressed on standard-of-care therapies.
Lead Product(s): Masofaniten,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2022
Details:
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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 26, 2022
Details:
The initial data from 36 patients demonstrate that EPI-7386 was well-tolerated, exhibited a favorable pharmacokinetic profile, and demonstrated initial anti-tumor activity in a heavily pretreated group of patients.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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 24, 2022
Details:
The preclinical results for EPI-7386, demonstrated that ANITAC degraders utilize the ubiquitin proteasome system and can degrade many forms of AR including full length, mutant and splice variants which are often expressed in CRPC patients.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 April 08, 2022
Details:
Results from the research indicated that EPI-7386 has an IC50 of 421 nM in LNCaP reporter assays, which is a range that is comparable to most LBD inhibitors; however, this agent differs from known agents in that its antitumor activity was maintained in CRPC models.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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 08, 2022
Details:
EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 October 28, 2021
Details:
Under the terms of the agreement, ESSA will utilize liquid biopsies, including longitudinal data from serial samples, to better characterize the tumor biological profiles of patients in the ongoing monotherapy clinical trial of EPI-7386 in mCRPC patients.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Caris Life Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 07, 2021
Details:
EPI-7386 is currently being studied in a Phase 1 clinical trial in men with metastatic castration-resistant prostate cancer ("mCRPC") whose tumors have progressed on current standard-of-care therapies.
Lead Product(s): Masofaniten,Darolutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2021
Details:
Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety, pharmacokinetics and efficacy of the combination of EPI-7386 and darolutamide in mCRPC patients. ESSA will supply EPI-7386 for the trial and will retain all rights to EPI-7386.
Lead Product(s): Masofaniten,Darolutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bayer AG
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 28, 2021
Details:
ESSA intends to use the net proceeds from the Offering to fund clinical activities, chemistry, manufacturing and controls, and research and development, as well as working capital and general corporate purposes.
Lead Product(s): Masofaniten,Anti-androgens therapy
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies and Piper Sandler
Deal Size: $130.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 22, 2021
Details:
In this initial cohort of patients receiving the 200 mg once-daily dose, EPI-7386 was well-tolerated with no SAEs observed. The results from this cohort support ESSA's preclinical projections regarding the pharmacologic properties of EPI-7386 in patients.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 February 11, 2021
Details:
Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the combination of EPI-7386 and apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed second-generation antiandrogen therapy.
Lead Product(s): Masofaniten,Apalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 13, 2021
Details:
ESSA Pharma is developing novel and proprietary therapies which include EPI-7386, for the treatment of patients with prostate cancer.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Financing January 12, 2021
Details:
The studies highlight new information about EPI-7386. In an in vitro cellular thermal shift assay (CETSA), EPI-7386 was shown to physically interact with the both the full-length and the splice variant (AR-V7) form of the androgen receptor.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 October 24, 2020
Details:
Abstract titled, EPI-7386, a potent N-terminal domain androgen receptor inhibitor, with a favorable preclinical safety and superior in vitro/in vivo profile, in clinical development for prostate cancer.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 October 19, 2020
Details:
In an in vitro VCaP model, combination treatment of EPI-7386 with enzalutamide, apalutamide or darolutamide display broader and deeper inhibition of ARassociated transcriptional activity than higher doses of each single agent alone.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 September 17, 2020
Details:
The Phase 1 clinical trial will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 September 14, 2020
Details:
ESSA intends to use the net proceeds of the Offering for pre-clinical and clinical activities, chemistry, manufacturing and controls, research and development, as well as working capital and general corporate purposes.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies
Deal Size: $39.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 28, 2020
Details:
First patient dosed in a Phase 1 clinical trial designed to demonstrate the safety and tolerability of EPI-7386 in metastatic castration-resistant prostate cancer patients who failed standard of care treatments, including second generation anti-androgens.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: EPI-7386
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 July 15, 2020
Details:
The study highlighted full-length AR target engagement by EPI-7386, Its In vitro cellular gene expression analyses, Toxicology studies evaluating the safety profile of EPI-7386 and its starting clinical dose.
Lead Product(s): Masofaniten,Enzalutamide
Therapeutic Area: Oncology Product Name: EPI-7386
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:
In an oral poster presentation a more in-depth preclinical characterization of EPI-7386 including gene expression analyses and the toxicologic profile was presented.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
Phase 1 clinical trial will evaluate safety and tolerability of EPI-7386 for the treatment of metastatic castration-resistant prostate cancer.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
Details:
ESSA Pharma has submitted an Investigational New Drug application to the U.S. FDA to evaluate its lead clinical candidate, EPI-7386, in a Phase 1 clinical study for the treatment of metastatic mCRPC.
Lead Product(s): Masofaniten
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 31, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
