[{"orgOrder":0,"company":"Knight Therapeutics","sponsor":"TherapeuticsMD","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Knight and TherapeuticsMD Announce Health Canada Approval of BIJUVA\u00ae","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"SIFI","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SIFI Initiates Patient Enrollment in Phase II Trial evaluating Pro-Ocular in Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"MedinCell","sponsor":"Bill & Melinda Gates Foundation","pharmaFlowCategory":"D","amount":"$22.5 million","upfrontCash":"Undisclosed","newsHeadline":"Additional US$ 4 Million Received for Next Development Steps of MedinCell's 6-Month Active Injectable Bioresorbable Subcutaneous Contraceptive","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dare Bioscience Initiates Phase 1\/2 Clinical Study of DARE-HRT1","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Pfizer CentreOne","sponsor":"Effik","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer CenterOne\u2019s Enviero\u00ae Receives First EU Authorization As Part of ESTIMA\u00ae (progesterone) Product Approval","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Positive Efficacy Results from the DARE-HRT1 Phase 1 \/ 2 Study","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Positive Pharmacokinetic (PK) Results from the DARE-HRT1 Phase 1 \/ 2 Study that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for Both Vasomotor and Vaginal Symptoms of Menopause","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1 Trial of DARE-HRT1 that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for MolPort-001-794-643
Enviero is first-of-its-kind, a green-chemistry progesterone that represents a step change in progesterone API synthesis, is manufactured via a proprietary biocatalytic process based on plant sterols that reduce waste, greenhouse gas emissions and use of hazardous solvents.
DARE-HRT1 (estradiol) acts on the on the estrogen receptors to relieve vasomotor systems (such as hot flashes) and urogenital symptoms (such as vaginal dryness and dyspareunia).
DARE-HRT1 (estradiol), is an investigational intravaginal ring, delivers bio-identical 17β-estradiol and bio-identical progesterone continuously for 28-day period. It has shown potential monthly-therapy for vasomotor and vaginal symptoms of menopause.
The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide.
DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format.
DARE-HRT1 is a novel intravaginal ring designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen to treat vasomotor symptoms and genitourinary syndrome associated with menopause.
ProGIFT is a multicenter, randomized, double-masked, placebo-controlled Phase II clinical trial comparing different concentrations of Pro-ocular (1% and 0.5%) versus placebo.
BIJUVA is a once-daily combination of estradiol and progesterone in a single oral capsule that will be available in two strengths in Canada indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus.