LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise. LGM Pharma API Sourcing. CDMO Services, Regulatory Expertise.

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Health)","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Outside the US Bayer Extends Development Program for Investigational Product Elinzanetant With Phase III Study in Breast Cancer Patients With Vasomotor Symptoms Caused by Endocrine Therapy","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"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":"Small molecule","graph2":"Mithra Pharmaceuticals"}]

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            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

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            ESN364 (fezolinetant) works by blocking NKB binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the hypothalamus to reduce the frequency and severity of moderate to severe VMS due to menopause.

            Lead Product(s): Fezolinetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364

            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 February 20, 2023

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            BAY3427080 (elinzanetant) is an oral, once-daily, non-hormonal, selective neurokinin-1,3 (NK-1,3) receptor antagonist that is being studied for the reduction of vasomotor symptoms (VMS).

            Lead Product(s): Elinzanetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: BAY3427080

            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 February 02, 2023

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            BAY3427080 (elinzanetant) is a non-hormonal, orally administered, dual neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause.

            Lead Product(s): Elinzanetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: BAY3427080

            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 November 07, 2022

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            Elinzanetant is a first-in-class, non-hormonal, orally administered, dual neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause.

            Lead Product(s): Elinzanetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: BAY3427080

            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 October 17, 2022

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            Nolasiban (OBE001), an oral oxytocin receptor antagonist with the potential to decrease contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation. This increases the chance of successful pregnancy and live-birth.

            Lead Product(s): Nolasiban

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE001

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Yuyuan Bioscience

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 13, 2022

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            Fezolinetant is an investigational selective NK3 receptor antagonist and is not approved for use anywhere in the world. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolinetant-treated patients.

            Lead Product(s): Fezolinetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364

            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 October 12, 2022

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            Details:

            Results from the SKYLIGHT 1™ and SKYLIGHT 2™ pivotal trials characterize the efficacy and safety of ESN364 (fezolinetant) for the treatment of moderate to severe VMS associated with menopause.

            Lead Product(s): Fezolinetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364

            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 September 30, 2022

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            Details:

            ESN364 (fezolinetant) is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause.

            Lead Product(s): Fezolinetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364

            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 September 05, 2022

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            APL-1702 (trade name: Cevira®), a drug-device combination photodynamic therapy product for non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL) caused by any HPV subtypes.

            Lead Product(s): APL-1702

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

            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 August 25, 2022

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