Product Description
Flutamide is a nonsteroidal antiandrogen that competitively binds androgen receptors throughout the body. This binding inhibits cell growth in prostate cancer by inhibiting testosterone's stimulatory effects. The drug has a half-life of 6 hours, meaning dosing will have to occur a minimum of 3 times a day to maintain adequate serum levels. Flutamide is used in the management and treatment of androgen-dependent tumors like prostate cancer and conditions associated with hyperandrogenism like polycystic ovarian syndrome (PCOS). It is a prototypical drug of the anti-androgen class of medications. (Sourced from: https://www.ncbi.nlm.nih.gov/books/NBK482215/)
Mechanisms of Action: GnRH Agonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Denmark | Dominican Republic | Ecuador | Egypt | Finland | France | Germany | Greece | Hong Kong | India | Ireland | Italy | Jordan | Latvia | Luxembourg | Malaysia | Malta | Mexico | Morocco | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Serbia | Slovenia | South Africa | Spain | Sweden | Taiwan | Thailand | Turkey | Ukraine | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: NRG Oncology
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, United States
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Adenocarcinoma|Prostate Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05050084 |
GUIDANCE | P3 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2026-11-11 |
2025-03-18 |
Primary Endpoints |
|
NCT04513717 |
PREDICT-RT* | P3 |
Active, not recruiting |
Prostate Cancer|Adenocarcinoma |
2033-12-31 |
2025-09-12 |
Primary Endpoints |