[{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eli Lilly's Abemaciclib Improves OS In Combination With Tamoxifen In HR-Positive, HER2-Negative Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"September 2020","year":"2020","type":"Not Applicable","leadProduct":"Abemaciclib","moa":"CDK6","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Eli Lilly","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Oral","sponsorNew":"Eli Lilly \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Eli Lilly \/ Not Applicable"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Kisqali Receives Highest Rating of any CDK4\/6 Inhibitor on the ESMO Magnitude of Clinical Benefit Scale","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"","productType":"Small molecule","productStatus":"Approved","date":"September 2020","year":"2020","type":"Not Applicable","leadProduct":"Ribociclib","moa":"CDK4\/CDK6","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Novartis Pharmaceuticals Corporation","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Novartis Pharmaceuticals Corporation \/ Astex Pharmaceuticals","highestDevelopmentStatusID":"12","companyTruncated":"Novartis Pharmaceuticals Corporation \/ Astex Pharmaceuticals"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Astex Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis' KISQALI\u00ae (ribociclib) UPs Overall Survival in Pre- and Perimenopausal Women with HR+\/HER2- Advanced Breast Cancer Fran\u00e7ais","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"November 2020","year":"2020","type":"Not Applicable","leadProduct":"Ribociclib","moa":"CDK4\/CDK6","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Novartis Pharmaceuticals 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Applicable","leadProduct":"Leuprolide Acetate","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Takeda Pharmaceutical","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Subcutaneous Injection","sponsorNew":"Takeda Pharmaceutical \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Takeda Pharmaceutical \/ Not Applicable"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Initiates Phase 1\/2 Clinical Study of DARE-VVA1, Intravaginal Tamoxifen for the Treatment of Vulvar and Vaginal Atrophy","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"September 2021","year":"2021","type":"Not Applicable","leadProduct":"Tamoxifen Citrate","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":"Vaginal Insert","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data from Verzenio\u00ae (abemaciclib) monarchE Study to Be Featured in ESMO Virtual Plenary","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"Approved","date":"September 2021","year":"2021","type":"Not Applicable","leadProduct":"Abemaciclib","moa":"CDK6","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Eli Lilly","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Eli Lilly \/ Not Applicable","highestDevelopmentStatusID":"12","companyTruncated":"Eli Lilly \/ Not Applicable"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Agilent Technologies","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Verzenio\u00ae (abemaciclib) as the First and Only CDK4\/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"","productType":"Small molecule","productStatus":"Approved","date":"October 2021","year":"2021","type":"Not Applicable","leadProduct":"Abemaciclib","moa":"CDK6","url1":"","url2":"","graph1":"Oncology","graph2":"Approved","graph3":"Eli Lilly","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Approved","highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Oncology","productSubType":"Small molecule","amount2New":0,"dosageForm":"Tablet","sponsorNew":"Eli Lilly \/ Agilent","highestDevelopmentStatusID":"12","companyTruncated":"Eli Lilly \/ Agilent"},{"orgOrder":0,"company":"Eli Lilly","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Additional Verzenio\u00ae (Abemaciclib) Phase 3 monarchE Trial Data Published in the Annals of 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Study","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"November 2022","year":"2022","type":"Not Applicable","leadProduct":"Tamoxifen Citrate","moa":"17-Beta estradiol","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II","graph3":"Dar\u00e9 Bioscience","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"Insert","sponsorNew":"Dar\u00e9 Bioscience \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Dar\u00e9 Bioscience \/ Not Applicable"},{"orgOrder":0,"company":"Diaccurate","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diaccurate Announces Updated Data on its Novel PAM Pathway Inhibitor DIACC3010 in Patients with ER+ HER2- Metastatic Breast Cancer to be Presented at AACR 2023","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","year":"2023","type":"Not Applicable","leadProduct":"DIACC3010","moa":"","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I","graph3":"Diaccurate","amount2":0,"therapeuticAreaNew":"Oncology","highestDevelopmentStatusNew":"Phase I","highestDevelopmentShortName":"Ph I","therapeuticAreaShortName":"Oncology","productSubType":"","amount2New":0,"dosageForm":"","sponsorNew":"Diaccurate \/ Not Applicable","highestDevelopmentStatusID":"6","companyTruncated":"Diaccurate \/ Not Applicable"},{"orgOrder":0,"company":"DARA BIOSCIENCES","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"December 2023","year":"2023","type":"Not Applicable","leadProduct":"Tamoxifen Citrate","moa":"","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II","graph3":"DARA BIOSCIENCES","amount2":0,"therapeuticAreaNew":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatusNew":"Phase I\/ Phase II","highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Gynecology\/Obstetrics","productSubType":"","amount2New":0,"dosageForm":"Insert","sponsorNew":"DARA BIOSCIENCES \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"DARA BIOSCIENCES \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals for NCGC00024928-06

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                          01

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : DARE-VVA1 (tamoxifen) is a small molecule vaginal insert acting as an Estrogen receptor modulator, which is being investigated for the treatment of moderate to severe dyspareunia.

                          Brand Name : DARE-VVA1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 07, 2023

                          Lead Product(s) : Tamoxifen Citrate

                          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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                          02

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : DIACC3010 was well tolerated in monotherapy and potential biomarkers of pharmacological activity were seen in peripheral blood mononuclear cells and tumor tissues.

                          Brand Name : DIACC3010

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 06, 2023

                          Lead Product(s) : DIACC3010,Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase I

                          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-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 14, 2022

                          Lead Product(s) : Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          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 : Verzenio® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).

                          Brand Name : Verzenio

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 28, 2021

                          Lead Product(s) : Abemaciclib,Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : Based on results, Verzenio may require dose modification. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Advise patients of potential risk to a fetus and to use effective contraception.

                          Brand Name : Verzenio

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          October 13, 2021

                          Lead Product(s) : Abemaciclib,Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          Sponsor : Agilent Technologies

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : Data from monarchE study for Verzenio® (abemaciclib), CDK)4/6 inhibitor used in combination with endocrine therapy used in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) high risk early breast can...

                          Brand Name : Verzenio

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 27, 2021

                          Lead Product(s) : Abemaciclib,Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          Highest Development Status : Phase III

                          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 : DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.

                          Brand Name : DARE-VVA1

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 23, 2021

                          Lead Product(s) : Tamoxifen Citrate

                          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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                          08

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and advanced breast cancer, which is the most common cancer in women globally.

                          Brand Name : PROSTAP 3 DCS

                          Molecule Type : Peptide

                          Upfront Cash : Not Applicable

                          February 09, 2021

                          Lead Product(s) : Leuprolide Acetate,Tamoxifen Citrate

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.

                          Brand Name : Kisqali

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 09, 2020

                          Lead Product(s) : Ribociclib,Tamoxifen Citrate,Letrozole

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Astex Pharmaceuticals

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          AAPS 2024
                          Not Confirmed
                          AAPS 2024
                          Not Confirmed

                          Details : KISQALI® is the first CDK4/6 inhibitor to show statistically significant improvement in overall survival (key secondary endpoint) in advanced breast cancer in pre- and perimenopausal women.

                          Brand Name : Kisqali

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 02, 2020

                          Lead Product(s) : Ribociclib,Tamoxifen Citrate,Goserelin Acetate

                          Therapeutic Area : Oncology

                          Highest Development Status : Approved

                          Sponsor : Astex Pharmaceuticals

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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