[{"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":"","productType":"Small molecule","productStatus":"Approved","date":"September 2020","year":"2020","type":"Not Applicable","leadProduct":"Estradiol","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Knight Therapeutics","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"Hormone","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Knight Therapeutics \/ TherapeuticsMD","highestDevelopmentStatusID":"12","companyTruncated":"Knight Therapeutics \/ TherapeuticsMD"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"April 2021","year":"2021","type":"Not Applicable","leadProduct":"Progesterone","moa":"","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II","graph3":"SIFI","amount2":0,"therapeuticAreaNew":"Ophthalmology","highestDevelopmentStatusNew":"Phase II","highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Ophthalmology","productSubType":"Hormone","amount2New":0,"dosageForm":"Topical Gel","sponsorNew":"SIFI \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"SIFI \/ Not Applicable"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"April 2022","year":"2022","type":"Not Applicable","leadProduct":"Progesterone","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II","graph3":"Dar\u00e9 Bioscience","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0,"dosageForm":"Ring","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"November 2020","year":"2020","type":"Not Applicable","leadProduct":"Progesterone","moa":"PR","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved","graph3":"Pfizer CentreOne","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"Hormone","amount2New":0,"dosageForm":"Capsule","sponsorNew":"Pfizer CentreOne \/ Effik","highestDevelopmentStatusID":"12","companyTruncated":"Pfizer CentreOne \/ Effik"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"October 2022","year":"2022","type":"Not Applicable","leadProduct":"Estradiol","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II","graph3":"Dar\u00e9 Bioscience","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0,"dosageForm":"Ring","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"November 2022","year":"2022","type":"Funding","leadProduct":"Progesterone","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical","graph3":"MedinCell","amount2":0.02,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Preclinical","highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0.02,"dosageForm":"Injectable\/Injection","sponsorNew":"MedinCell \/ Bill & Melinda Gates Foundation","highestDevelopmentStatusID":"4","companyTruncated":"MedinCell \/ Bill & Melinda Gates Foundation"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"January 2023","year":"2023","type":"Not Applicable","leadProduct":"Estradiol","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II","graph3":"Dar\u00e9 Bioscience","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0,"dosageForm":"Ring","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"},{"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":"","productType":"Small molecule","productStatus":"Approved","date":"January 2023","year":"2023","type":"Not Applicable","leadProduct":"Estradiol","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II","graph3":"Dar\u00e9 Bioscience","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0,"dosageForm":"Ring","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for Tox21_300307

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                          01

                          Lead Product(s) : Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Study Phase : Approved

                          Sponsor : Effik

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : 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...

                          Brand Name : Estima

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 18, 2020

                          Lead Product(s) : Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Approved

                          Sponsor : Effik

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Pfizer centreOne

                          02

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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).

                          Brand Name : DARE-HRT1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          January 26, 2023

                          Lead Product(s) : Estradiol,Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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.

                          Brand Name : DARE-HRT1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          January 09, 2023

                          Lead Product(s) : Estradiol,Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          November 30, 2022

                          Lead Product(s) : Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Preclinical

                          Sponsor : Bill & Melinda Gates Foundation

                          Deal Size : $22.5 million

                          Deal Type : Funding

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                          05

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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.

                          Brand Name : DARE-HRT1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 17, 2022

                          Lead Product(s) : Estradiol,Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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 associate...

                          Brand Name : DARE-HRT1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 12, 2022

                          Lead Product(s) : Progesterone,Estradiol

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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.

                          Brand Name : Pro-ocular

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 27, 2021

                          Lead Product(s) : Progesterone

                          Therapeutic Area : Ophthalmology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          08

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : 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 in...

                          Brand Name : Bijuva

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 21, 2020

                          Lead Product(s) : Estradiol,Progesterone

                          Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

                          Highest Development Status : Approved

                          Sponsor : TherapeuticsMD

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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