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Details:
DARE-LARC1 is an investigational, drug delivery platform designed to store and precisely deliver levonorgestrel therapeutic doses over months or years through a single device.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-LARC1
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2024
Details:
The funding will be used to advance the development of Daré’s investigational contraceptive DARE-LARC1, an investigational, pre-clinical stage contraceptive implant delivering levonorgestrel, through nonclinical proof of principle studies.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-LARC1
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: NICHD
Deal Size: $49.0 million Upfront Cash: Undisclosed
Deal Type: Funding September 21, 2023
Details:
Opill (norgestrel) tablet for nonprescription use to prevent pregnancy the first daily oral contraceptive approved for use in the U.S. without a prescription.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Opill
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 13, 2023
Details:
The net proceeds will be used for the Twirla (levonorgestrel and ethinyl estradiol), the first and only combined hormonal once-weekly birth control patch delivering a low dose of estrogen.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $7.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering July 03, 2023
Details:
The agreement aims to expand patient access and streamline fulfillment for Twirla (levonorgestrel ethinyl estradiol) transdermal system, a once-weekly combined hormonal contraceptive (CHC) patch, indicated for use as a method of contraception by women.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: vitaCare Prescription Services
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 13, 2023
Details:
Opill (norgestrel) is a progestin-only daily oral contraceptive, available for over-the-counter (OTC) is used by females of reproductive potential to prevent pregnancy.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Opill
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2023
Details:
Opill® is a progestin-only daily oral birth control pill (also referred to as a mini pill or non-estrogen pill), which prevents conception by suppressing ovulation.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Opill
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2023
Details:
TWIRLA is a combination of levonorgestrel, a progestin, ethinyl estradiol and estrogen. It is a hormonal contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2023
Details:
LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 8 years. The system should be replaced after eight years if continued use is desired.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Liletta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
Opill® is a progestin-only daily birth control pill (also referred to as a mini pill or non-estrogen pill). If approved, Opill® would be the first ever daily birth control pill available OTC—without a prescription—in the U.S.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Opill
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
Julie emergency contraception offers Levonorgestrel 1.5mg, an FDA-approved, progestin-only emergency contraceptive that helps prevent pregnancy by temporarily delaying or stopping ovulation.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Julie
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aurobindo Pharma Limited
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2022
Details:
Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 18, 2022
Details:
Approval of Twirla (levonorgestrel) was based on SECURE study, which demonstrated safety in a large diverse group of women in a clinical trial setting.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is combined hormonal contraceptive patch, indicated for use as a method of contraception by women of reproductive potential with a body mass index < 30 kg/m2.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2022
Details:
This strategic agreement with Afaxys, a recognized leader in the public health system, will help ensure that Twirla is available, accessible and affordable to a much broader group of patients who can benefit from it.
Lead Product(s): Levonorgestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Twirla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Agile Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 10, 2022
Details:
FDA approves extension of Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg for up to seven years of pregnancy prevention.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2021
Details:
This new submission will seek to extend the indication another year for up to seven years of pregnancy prevention based on results from a Phase 3 extension trial evaluating the efficacy and safety of Mirena.
Lead Product(s): Levonorgestrel
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Mirena
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
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