X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
Details:
Estelle (estetrol monohydrate) is an estrogen receptor agonist small molecule drug candidate, which is currently being evaluated in combination with drospirenone for contraception for 12 to 17 years aged females.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle
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 December 20, 2023
Details:
Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, in Japan and ASEAN.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fuji Pharma
Deal Size: $45.4 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 23, 2023
Details:
Under the agreements, Fuji Pharma obtains the rights to commercialize and advance the develoopment of Estelle, Mithra’s oral contraceptive product candidate based on Estetrol, for the treatment of Japanese patients with dysmenorrhea or endometriosis, in Japan and ASEAN.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Fuji Pharma
Deal Size: $45.4 million Upfront Cash: $29.0 million
Deal Type: Licensing Agreement August 03, 2023
Details:
Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle
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 10, 2023
Details:
NEXTSTELLIS (drospirenone and estetrol tablets) indicated for use by females of reproductive potential to prevent pregnancy. Nextstellis® has been granted marketing exclusivity as a new chemical entity from the US Food and Drug Administration (FDA).
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mithra Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
NEXTSTELLIS is the first contraceptive pill containing E4, a new naturally occurring estrogen with a unique mechanism of action that offers potential advantages over other estrogens.
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2021
Details:
New data shows treatment with NEXTSTELLIS®,1 a novel, investigational combined oral contraceptive containing drospirenone and estetrol, resulted in less changes in endocrine markers, including lower increases in hormone binding globulins vs COCs based on ethinyl-estradiol.
Lead Product(s): Drospirenone,Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Nextstellis
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mithra Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2021
Details:
Using its AI-based drug discovery platforms, Ennaid's scientific research team at the Universidad Catolica de Murcia (UCAM), in south-eastern Spain, identified the drug Drospirenone , as a solid therapeutic candidate showing significant antiviral activity against COVID-19.
Lead Product(s): Drospirenone
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2020
Details:
New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: E4/DRSP
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 24, 2020
Details:
Health Canada has accepted Searchlight Pharma's New Drug Submission for a novel combined oral contraceptive (COC) product. Innovative product candidate developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP).
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) 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 20, 2020
Details:
Mayne Pharma has submitted a New Drug Application to the US FDA, seeking marketing authorisation for E4/DRSP.
Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) 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 16, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
