Stem definition | Drug id | CAS RN |
---|---|---|
5432 | 737789-87-6 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 16, 2021 | EMA | Gedeon Richter Plc. | |
Dec. 18, 2020 | FDA | MYOVANT SCIENCES | |
Aug. 1, 2019 | PMDA | Takeda Pharmaceutical Company Limited |
None
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Therapy interrupted | 470.92 | 56.70 | 84 | 299 | 10512 | 31686449 |
Hot flush | 92.37 | 56.70 | 24 | 359 | 16172 | 31680789 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Therapy interrupted | 116.68 | 57.71 | 24 | 184 | 24778 | 70903458 |
Prostate cancer | 67.36 | 57.71 | 16 | 192 | 31147 | 70897089 |
None
Source | Code | Description |
---|---|---|
ATC | H01CC54 | SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Anti-gonadotropin-releasing hormones |
ATC | L02BX04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ENDOCRINE THERAPY HORMONE ANTAGONISTS AND RELATED AGENTS Other hormone antagonists and related agents |
FDA PE | N0000008638 | Decreased GnRH Secretion |
FDA MoA | N0000175084 | Gonadotropin Releasing Hormone Receptor Antagonists |
MeSH PA | D000726 | Androgen Antagonists |
MeSH PA | D006727 | Hormone Antagonists |
FDA EPC | N0000175839 | Gonadotropin Releasing Hormone Receptor Antagonist |
FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
FDA MoA | N0000187064 | Cytochrome P450 2B6 Inducers |
FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
FDA MoA | N0000190118 | Cytochrome P450 3A Inducers |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Lower abdominal pain | indication | 54586004 | |
Uterine fibroids | indication | 95315005 | DOID:13223 |
Pain associated with endometriosis | indication | 129103003 | |
Menorrhagia | indication | 386692008 | |
Malignant tumor of prostate | indication | 399068003 | DOID:10283 |
Abnormal uterine bleeding due to uterine fibroid | indication | 16754891000119106 |
None
None
None
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
120MG | ORGOVYX | MYOVANT SCIENCES | N214621 | Dec. 18, 2020 | RX | TABLET | ORAL | 8735401 | Feb. 4, 2024 | TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER THAT IS SEX-HORMONE-DEPENDENT |
1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | 9346822 | Feb. 17, 2024 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
120MG | ORGOVYX | MYOVANT SCIENCES | N214621 | Dec. 18, 2020 | RX | TABLET | ORAL | 10449191 | Sept. 29, 2037 | TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER |
120MG | ORGOVYX | MYOVANT SCIENCES | N214621 | Dec. 18, 2020 | RX | TABLET | ORAL | 10786501 | Sept. 29, 2037 | TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER |
1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | 11033551 | Sept. 29, 2037 | MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | May 26, 2024 | NEW PRODUCT |
1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | Aug. 5, 2025 | FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS |
120MG | ORGOVYX | MYOVANT SCIENCES | N214621 | Dec. 18, 2020 | RX | TABLET | ORAL | Dec. 18, 2025 | NEW CHEMICAL ENTITY |
1MG;0.5MG;40MG | MYFEMBREE | MYOVANT SCIENCES | N214846 | May 26, 2021 | RX | TABLET | ORAL | Dec. 18, 2025 | NEW CHEMICAL ENTITY |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Gonadotropin-releasing hormone receptor | GPCR | ANTAGONIST | IC50 | 9.92 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Gonadotropin-releasing hormone receptor | GPCR | ANTAGONIST | IC50 | 9.48 | IUPHAR |
ID | Source |
---|---|
D10888 | KEGG_DRUG |
P76B05O5V6 | UNII |
C3896936 | UMLSCUI |
CHEMBL1800159 | ChEMBL_ID |
10348973 | PUBCHEM_CID |
DB11853 | DRUGBANK_ID |
5586 | IUPHAR_LIGAND_ID |
342118 | MMSL |
39104 | MMSL |
d09698 | MMSL |
4039939 | VANDF |
018596 | NDDF |
1144477009 | SNOMEDCT_US |
1144510001 | SNOMEDCT_US |
C561634 | MESH_SUPPLEMENTAL_RECORD_UI |
9628 | INN_ID |
2472778 | RXNORM |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Orgovyx | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72974-120 | TABLET, FILM COATED | 120 mg | ORAL | NDA | 30 sections |
Orgovyx | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72974-120 | TABLET, FILM COATED | 120 mg | ORAL | NDA | 30 sections |
Myfembree | HUMAN PRESCRIPTION DRUG LABEL | 3 | 72974-415 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 33 sections |
Myfembree | HUMAN PRESCRIPTION DRUG LABEL | 3 | 72974-415 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 33 sections |