Product Description
Mechanisms of Action: CYP3A4 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Jordan | Korea | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Turkey | Ukraine | United Arab Emirates | United Kingdom | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Organon
Company Location: JERSEY CITY NJ 07302
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 4: Depressive Disorder|Menopause|Bone Diseases, Metabolic|Osteoporosis
Phase 3: Breast Cancer|Osteoporosis, Postmenopausal|Other|Osteoporosis|Menopause
Phase 2: Menopause|Osteoporosis, Postmenopausal|Breast Cancer|Bone Cancer
Phase 1: Depressive Disorder, Treatment-Resistant|Depressive Disorder, Major|Menopause
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| eTAPE | N/A |
Withdrawn |
Myofibroma|Leiomyoma|Endometriosis |
2026-04-01 |
|
| ChiCTR2300069429 | N/A |
Recruiting |
Endometriosis |
2024-02-29 |
|
| NCT01470092 | P4 |
Completed |
Depressive Disorder |
2017-12-01 |
|
| ACTRN12615000521527 | P1 |
Completed |
Menopause |
2016-07-19 |