Data updated: Jun 17, 2026
EULEXIN (flutamide)
Trial Activity: Expansion 4 active trials
Oncology
Approved 1989-01-27
Development Insights
NRG Oncology conducting 3 trials (27%)
14 indications explored (Broad Platform)
→ prostate cancer (4 trials)
→ prostate adenocarcinoma (3 trials)
→ stage iva prostate cancer ajcc v8 (2 trials)
2
Indications
--
Phase 3 Trials
1
Priority Reviews
37
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1989-01-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE
EULEXIN Approval History
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 1989 to 2001 · 1 indication expansions
Mar 2001 SUPPL Priority
Mfg
Jan 2001 SUPPL Priority
Mfg
Jan 2000 SUPPL Priority
Mfg
Aug 1999 SUPPL
Label
May 1998 SUPPL Priority
Mfg
Nov 1997 SUPPL Priority
Mfg
Aug 1996 SUPPL Priority
Mfg
Jun 1996 SUPPL
Efficacy
Nov 1995 SUPPL Priority
Mfg
Sep 1995 SUPPL
Label
Oct 1994 SUPPL
Label
Jul 1993 SUPPL Priority
Mfg
Jul 1992 SUPPL Priority
Mfg
May 1992 SUPPL Priority
Mfg
Sep 1991 SUPPL
Label
May 1991 SUPPL Priority
Mfg
Sep 1990 SUPPL
Label
Oct 1989 SUPPL
Label
Jan 1989 ORIGINAL Priority
New Drug
What EULEXIN Treats
2 FDA approvalsOriginally approved for its first indication in 1989 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jan 1989) Priority
- • Approved indication (Jun 1996)
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
ENFLONSIA
2025 CLESROVIMAB-CFOR
1 designation
KEYTRUDA QLEX
2025 PEMBROLIZUMAB
1 designation
OHTUVAYRE
2024 ENSIFENTRINE
WINREVAIR
2024 SOTATERCEPT-CSRK
4 designations
VTAMA
2022 TAPINAROF
1 designation
VERQUVO
2021 VERICIGUAT
3 designations
WELIREG
2021 BELZUTIFAN
3 designations
RECARBRIO
2019 CILASTATIN SODIUM
2 designations
PIFELTRO
2018 DORAVIRINE
PREVYMIS
2017 LETERMOVIR
5 designations
STEGLATRO
2017 ERTUGLIFLOZIN
ZEPATIER
2016 ELBASVIR
3 designations
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Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | completed | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT05050084 | NRG-GU010 NCI-2021-08760, NRG-GU010 | Ph 3 | active not recruiting | Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial |
| NCT04513717 | NRG-GU009 NCI-2020-04705, NRG-GU009 | Ph 3 | active not recruiting | Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial |
| NCT00936390 results posted | RTOG 0815 CDR0000648194, NCI-2011-01948 | Ph 3 | completed | Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer |
| NCT01786265 | 2012-0993 NCI-2018-01856, 2012-0993 | Ph 2 | active not recruiting | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer |
| NCT03678025 | S1802 NCI-2018-01738, S1802 | Ph 3 | recruiting | Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer |
| NCT01889199 results posted | UCLA IRB #12-001780 | Ph 2 | completed | Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women |
| NCT02918968 results posted | 9785-MA-3051 | Ph 4 | completed | Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer |
| NCT00651326 DART | PR12 CAN-NCIC-PR12, CDR0000589247 | Ph 3 | terminated | Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer |
| NCT02346578 | OCUU-CRPC | Ph 2 | completed | Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy. |
| NCT00528866 results posted | RTOG-0621 CDR0000563917, NCI-2009-00740 | Ph 2 | completed | Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
EULEXIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment