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[{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Pharmaceuticals Delays Recruitment In Donesta Phase III Clinical Programme","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Submits New Drug Application for E4\/DRSP to the FDA","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra and Searchlight Pharma Announce Filing of New Drug Submission for Estelle\u00ae in Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4\/DRSP in the US","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"AUSTRALIA","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Show NEXTSTELLIS\u00ae Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Efficacy Data Reinforces NEXTSTELLIS\u00ae Benefits Across Patient Populations","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mayne Pharma","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nextstellis\u00ae Receives FDA Marketing Exclusivity and Phase III Data Published","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces Positive Top-Line Results from Donesta\u00ae Phase 3 Studies in Menopausal Women","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase II","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"SEARCHLIGHT PHARMA INC","pharmaFlowCategory":"D","amount":"$18.7 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra and Searchlight Pharma Announce Donesta\u00ae Licensing Agreement for Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","amount":"$45.4 million","upfrontCash":"$29.0 million","newsHeadline":"Mithra Receives EUR 1.25 Million Milestone Payment from Fuji Pharma Under Estelle\u00ae Licensing Agreement","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"H.C. Wainwright & Co.","pharmaFlowCategory":"D","amount":"$70.1 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra Prices Private Placement to Raise EUR 20 Million in Equity","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase II","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Fuji Pharma","pharmaFlowCategory":"D","amount":"$45.4 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra to Receive EUR 2.5 Million Milestone Payment from Fuji Pharma under ESTELLE\u00ae Licensing Agreement","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"SEARCHLIGHT PHARMA INC","pharmaFlowCategory":"D","amount":"$17.9 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra and Searchlight Pharma Sign DONESTA\u00ae Licensing Agreement for Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Receives Guidance From the FDA for the DONESTA\u00ae NDA Marketing Authorization Filing in The United States","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Receives Positive DSMB Opinion on DONESTA\u00ae European Phase 3 Trial","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Completes Pediatric Study of ESTELLE\u00ae in Adolescent Patients","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"DONESTA\u00ae Safety Study for Menopause Completes Treatment Phase and Advances to Data Management & Reporting Phase","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Estetrol
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Companies By Therapeutic Area
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 III
Product 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 III
Product 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 III
Product 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 III
Product 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 III
Product 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: Approved
Product 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 II
Product 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: Approved
Product 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 III
Product 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 III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 10, 2023