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[{"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":"Ennaid Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ennaid Therapeutics Discovers Orally Deliverable Generic COVID-19 Drug","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"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":"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":"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":"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 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"}]
Find Clinical Drug Pipeline Developments & Deals for Drospirenone
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Companies By Therapeutic Area
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 ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableDecember 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: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator:
Fuji Pharma
Deal Size: $45.4 millionUpfront Cash: Undisclosed
Deal Type: Licensing AgreementOctober 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: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator:
Fuji Pharma
Deal Size: $45.4 millionUpfront Cash: $29.0 million
Deal Type: Licensing AgreementAugust 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 III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMay 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: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator:
Mithra Pharmaceuticals
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMay 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: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableApril 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: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator:
Mithra Pharmaceuticals
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMarch 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: Preclinical Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 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 III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJune 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 III Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableMay 20, 2020
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