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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 hazardous solvents.
Lead Product(s): Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estima
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Effik
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
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).
Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2023
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.
Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
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.
Lead Product(s): Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Bill & Melinda Gates Foundation
Deal Size: $22.5 million Upfront Cash: Undisclosed
Deal Type: Funding November 30, 2022
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.
Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2022
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 associated with menopause.
Lead Product(s): Progesterone,Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
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.
Lead Product(s): Progesterone
Therapeutic Area: Ophthalmology Product Name: Pro-ocular
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2021
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 intact uterus.
Lead Product(s): Estradiol,Progesterone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Bijuva
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: TherapeuticsMD
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2020