X
[{"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":"Mithra Pharmaceuticals","sponsor":"Farmitalia ","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Signs LSA for Commercialization of Myring\u2122 in Italy, the Third Biggest Worldwide Market","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Gynial","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Pharmaceuticals and Gynial Sign Commercialization Agreement for Myring\u2122 in Switzerland","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2020","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 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":"Mithra Pharmaceuticals","sponsor":"Spirig Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Mithra Signs LSA for Commercialization of Tibelia\u00ae in Liechtenstein and Switzerland","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Zentiva","pharmaFlowCategory":"D","amount":"$2.2 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra to Commercialize Myring In France, Poland And UK","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Mayne Pharma","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":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Mayne Pharma","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":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Mithra CDMO","sponsor":"Mithra Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ExeVir and Mithra Announce Manufacturing Collaboration for Innovative Covid-19 Treatments","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"BELGIUM","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"BCI Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"BCI Pharma Enters Into Strategic Partnership with Mithra to Identify Novel Therapy for Endometriosis and Cancer in Women","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"BELGIUM","productType":"Small molecule","productStatus":"Undisclosed","date":"December 2021","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"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":"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":"BCI Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces New Positive Preclinical Data from CSF-1R Inhibitor Program","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"BELGIUM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"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"}]
Find Clinical Drug Pipeline Developments & Deals by Mithra Pharmaceuticals
Filters
Companies By Therapeutic Area
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:
Colony-stimulating factor 1 receptor (CSF-1R) is a cell-surface tyrosine kinase receptor and a key regulator of macrophage biology and homeostasis andpromising therapeutic strategy for cancer treatment.
Lead Product(s):
Undisclosed
Therapeutic Area: Obstetrics/Gynecology (Women’s Health)
Product Name: Undisclosed
Highest Development Status: Preclinical
Product Type: Small molecule
Partner/Sponsor/Collaborator:
BCI Pharma
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 15, 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
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 II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
January 14, 2022
Details:
Mithra acquired a purchase option on the rights to two development programs in innovative CSF1R kinase inhibitors, led by BCI Pharma. Under the terms of the contract, Mithra has the possibility to buy the rights to a development program on inhibitors.
Lead Product(s):
Undisclosed
Therapeutic Area: Obstetrics/Gynecology (Women’s Health)
Product Name: Undisclosed
Highest Development Status: Preclinical
Product Type: Small molecule
Recipient:
BCI Pharma
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Collaboration
December 16, 2021
Details:
XVR011 is a single domain-based anti-SARS-CoV-2 antibody (llama-derived VHH-Fc) optimized for stability, safety, broad neutralizing capability and excellent manufacturability.
Lead Product(s):
llama-derived VHH-Fc Antibody
Therapeutic Area: Infections and Infectious Diseases
Product Name: XVR011
Highest Development Status: Phase I/ Phase II
Product Type: Large molecule
Recipient:
Mithra Pharmaceuticals
Deal Size: Undisclosed
Upfront Cash: Undisclosed
Deal Type: Collaboration
July 15, 2021
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
Recipient:
Mayne Pharma
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 27, 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
Recipient:
Mayne Pharma
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
March 06, 2021