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  • CAPSULE;ORAL - 100MG
  • CAPSULE;ORAL - 200MG
  • GEL;VAGINAL - 4%
  • GEL;VAGINAL - 8%
  • CAPSULE;ORAL - 0.5MG;100MG
  • CAPSULE;ORAL - 1MG;100MG

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

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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

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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

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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

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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

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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

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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

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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

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