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Details:
Alora® (Estradiol transdermal system) used for Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause, Vulvar and Vaginal Atrophy due to Menopause, Hypoestrogenism Primary Ovarian Failure and Postmenopausal Osteoporosis.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Alora
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Divestment March 16, 2021
Iran Expo
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Details:
Ryeqo (relugolix, estradiol, and norethisterone acetate) receives approval from EU in for the adjuvant treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ryeqo
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 02, 2023
Details:
Myfembree (relugolix, estradiol, and norethindrone acetate) has received a dual indication approval, making it the first Health Canada-approved oral treatment to manage uterine fibroids and endometriosis.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2023
Details:
Ryeqo (relugolix, estradiol, and norethisterone acetate) receives positive opinion by CHMP recommending approval in for the adjuvant treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ryeqo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2023
Details:
Estradiol tablets for oral administration, which is indicated for the treatment of moderate to severe vasomotor symptoms associated with the menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estrace-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2023
Details:
Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel®, an estrogen hormone therapy used to treat moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Divigel-Generic
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 28, 2023
Details:
Estradiol transdermal system is indicated for prevention of postmenopausal osteoporosis, it has the ability to reduce the elevated levels of these hormones seen in postmenopausal women.
Lead Product(s): Estradiol
Therapeutic Area: Musculoskeletal Product Name: Menostar-Generic
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 18, 2023
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:
Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mayne Pharma
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Licensing Agreement January 03, 2023
Details:
Imvexxy (estradiol vaginal inserts) is approved in the U.S. for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: TherapeuticsMD
Deal Size: $225.7 million Upfront Cash: $140.0 million
Deal Type: Agreement December 04, 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:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is a once-daily oral treatment approved by the U.S. Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first and only once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by USFDA with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2022
Details:
The sNDA proposes updates to MYFEMBREE (Relugolix) based on safety and efficacy data from the Phase 3 LIBERTY randomized withdrawal study of MYFEMBREE in premenopausal women with heavy menstrual bleeding associated with uterine fibroids for up to two years.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
Results demonstrated that OBE-2109 (linzagolix) has potential to balance safety, efficacy, and address wide-ranging symptoms of uterine fibroids also showed promise in delivering sustained clinical benefit.
Lead Product(s): Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE-2109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 09, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. FDA, with a treatment duration of up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 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:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by U.S. Food and Drug Administration, with a treatment duration of upto 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Details:
MYFEMBREE (relugolix, estradiol, and norethindrone acetate) is the first once-daily oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women approved by the U.S. Food and Drug Administration, with treatment duration up to 24 months.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Details:
Both DYS and NMPP showed rapid reductions compared to placebo (after 1 and 2 months of treatment), with continued reduction up to 6 months of treatment and with higher reductions with linzagolix, an oral GnRH antagonist, 200 mg + ABT compared to linzagolix 75 mg.
Lead Product(s): Linzagolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE-2109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
Relugolix is oral gonadotropin-releasing hormone (GnRH) receptor antagonis used as combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in premenopausal women with uterine fibroids and in women with endometriosis pain.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
The real world PRO-E2 safety study confirmed that the risk of venous thromboembolism is at least as low with Zoely (NOMAC-E2) as with levonorgestrel-containing combined oral contraceptives. NOMAC-E2 is only monophasic contraceptive pill using body-identical 17B-estradiol.
Lead Product(s): Nomegestrol Acetate,Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Zoely
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, 2021
Details:
RYEQO (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is approved for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ryeqo
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 20, 2021
Details:
Estradiol, also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles.
Lead Product(s): Estradiol,Dydrogesterone
Therapeutic Area: Musculoskeletal Product Name: Femoston
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 15, 2021
Details:
MYFEMBREE® approval is supported by efficacy and safety data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies. MYFEMBREE® is first once-daily treatment for management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Myfembree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2021
Details:
The CHMP’s positive opinion further validates RYEQO’s potential to effectively address heavy menstrual bleeding and pain associated with uterine fibroids and serve as an important new treatment option for patients and physicians.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ryeqo
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2021
Details:
The relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) will be evaluated in healthy women aged 18-35 years who are at risk for pregnancy.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Myovant Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2021
Details:
78.4% of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment at Week 52.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity).
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 11, 2021
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products which includes IMVEXXY®, BIJUVA® and ANNOVERA®, and for working capital and general corporate purposes.
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cantor Fitzgerald
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering November 10, 2020
Details:
Company to present data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and in women with uterine fibroids at the ASRM 2020 Virtual Congress.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
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
Details:
In Canada, IMVEXXY is approved for the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA).
Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
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, 2020
Details:
Myovant's NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the U.S. Food and Drug Administration (FDA).
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
Data from Phase 3 LIBERTY program show improvement in patient-reported outcomes in addition to improvement in hemoglobin levels in anemic women after administration of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg).
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: TAK-385
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
Co-primary endpoints and six key secondary endpoints met in Phase 3 SPIRIT 2 study in women with endometriosis, with results from the Phase 3 SPIRIT 1 study expected this year.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Gedeon Richter will commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, Russia, Latin America, Australia, and New Zealand.
Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gedeon Richter
Deal Size: $80.0 million Upfront Cash: $40.0 million
Deal Type: Licensing Agreement March 31, 2020
Details:
Theramex currently markets Zoely® in eleven European countries, and this transaction will bring the total number of more than 50 on a global basis. MSD retains rights in the United States and Canada.
Lead Product(s): Estradiol,Nomegestrol Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 22, 2020
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