X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
Details:
Orgovyx (relugolix) is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors. It is launched in Canada for testosterone suppression in patients with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
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 12, 2024
Details:
Rexigo (relugolix) is a nonpeptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors. It is launched in India for testosterone suppression in patients with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Rexigo
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, 2024
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:
ORGOVYX (relugolix), is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
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 24, 2023
Details:
Orogvyx (relugolix), is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
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 23, 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:
Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition March 10, 2023
Details:
Orgovyx (relugolix), was granted approval by the European Medicines Agency (EMA) in April 2022 for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2022
Details:
Sumitovant and Myovant will strengthen Myovant's two products, Orgovyx® (relugolix) and Myfembree® capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women's health.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: $1,700.0 million Upfront Cash: $1,700.0 million
Deal Type: Acquisition October 23, 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:
ORGOVYX® (relugolix), is the first and only oral androgen deprivation therapy for an oral medication used to treat adult patients with advanced hormone-sensitive prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Myovant Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 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:
ORGOVYX® (relugolix), which is a gonadotropin-releasing hormone (GnRH) antagonist that is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced prostate cancer.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Myovant Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 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:
Myovant will continue to lead the global development of Orgovyx (relugolix) and provide product supply to Accord. Accord will be responsible for certain local clinical development, commercialization for its territories, and has the option to manufacture relugolix in future.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Accord healthcare
Deal Size: $140.5 million Upfront Cash: $50.0 million
Deal Type: Licensing Agreement 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:
In HERO study, ORGOVYX met primary endpoint and achieved sustained testosterone suppression to castrate levels through 48 weeks in 96.7% of men, compared with 88.8% of men receiving leuprolide acetate injections, current standard of care.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
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 29, 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:
CHMP positive opinion recommending approval is supported by efficacy and safety data from Phase 3 HERO study, designed to evaluate safety and efficacy of ORGOVY (relugolix), an oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
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 25, 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:
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:
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:
Myovant and Pfizer will jointly develop and commercialize ORGOVYX™ (Relugolix) in advanced prostate cancer and, if approved, relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: $4,200.0 million Upfront Cash: $650.0 million
Deal Type: Collaboration December 28, 2020
Details:
ORGOVYX demonstrated a 96.7% response rate in testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in the Phase 3 HERO study.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: Orgovyx
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 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:
Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.
Lead Product(s): Relugolix
Therapeutic Area: Oncology 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 September 29, 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:
Myovant has entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals for services to support the planned commercialization of investigational drug candidate relugolix.
Lead Product(s): Relugolix
Therapeutic Area: Oncology Product Name: MVT-601
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 05, 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:
Myovant announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA).
Lead Product(s): Relugolix
Therapeutic Area: Oncology 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 June 22, 2020
Details:
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year.
Lead Product(s): Relugolix
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 June 01, 2020
Details:
Presentation expands on previous results demonstrating superiority of relugolix to leuprolide acetate, with additional data on testosterone suppression and recovery, prostate-specific antigen (PSA) response, and cardiovascular safety in advanced prostrate cancer patients.
Lead Product(s): Relugolix
Therapeutic Area: Oncology 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 29, 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:
Treatment with relugolix combination therapy resulted in significant improvements in pain and quality of life in women with heavy menstrual bleeding associated with uterine fibroids.
Lead Product(s): Relugolix
Therapeutic Area: Oncology 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 April 27, 2020
Details:
The NDA submission is supported by positive results from the Phase 3 HERO study, a randomized pivotal study comparing relugolix versus leuprolide acetate.
Lead Product(s): Relugolix
Therapeutic Area: Oncology 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 April 21, 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:
Primary efficacy endpoint met with 87.7% response rate at one year; women experienced, on average, an 89.9% reduction in menstrual blood loss
Lead Product(s): Relugolix
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 February 10, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
