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Details:
Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
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 February 29, 2024
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:
Donesta (estetrol) is a next generation orally administered Estetrol (E4)-based hormone therapy product, which is under phase 3 clinical development for the treatment of the symptoms of menopause.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
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 18, 2023
Details:
Donesta (estetrol) is a hormone capsule formulation acting as an Estrogen receptor agonist, approved for the treatment of alleviating symptoms of menopause.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
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 30, 2023
Details:
Under the terms of the agreement, Searchlight will have sales and marketing rights for DONESTA® in Canada. DONESTA (estetrol) phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms compared to placebo.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC
Deal Size: $17.9 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 26, 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:
The proceeds will support the NDA filing of Donesta, a next generation Estetrol-based hormone therapy, and to support differentiation for treatment of menopause symptoms related to hair, skin and sexual desire, and for the development of Estetrol and Zoreline.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $70.1 million Upfront Cash: Undisclosed
Deal Type: Private Placement August 24, 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:
Under the agreement, Searchlight will have the Canadian rights to Donesta, a next generation orally administered Estetrol (E4)-based hormone therapy product, for the treatment of the symptoms of menopause.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC
Deal Size: $18.7 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 31, 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:
Donesta (Estetrol), a next generation estetrol (E4)-based hormone therapy product candidate, demonstrated a meaningful reduction in vasomotor symptoms from baseline and compared to placebo in Phase 3 pivotal “E4 Comfort” clinical trial for treatment of VMS in postmenopausal women.
Lead Product(s): Estetrol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta
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 January 14, 2022
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:
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
Details:
In light of covid-19 crisis, Mithra confirms that E4 Comfort studies are still ongoing at this time, but that current patient recruitment has been delayed or put on hold in some countries.
Lead Product(s): Estetrol
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 01, 2020
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