Eulexin

(Flutamide)

ApprovedSmall molecule

Flutamide is used to treat prostate cancer by blocking male hormones that help cancer cells grow. It's often combined with other prostate cancer treatments.[2] Eulexin is currently approved and in use across 5 indications[4].[1]

Eulexin is one of 189 small molecule programs targeting Metabolic Syndrome. It is currently in Approved.

Indications

Total Trials

Active Trials

188

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Metabolic SyndromeActive, not recruiting

Prostate AdenocarcinomaActive, not recruiting

Prostate CarcinomaActive, not recruiting

Prostate CancerCompleted

Head and Neck Squamous Cell CarcinomaApproved

Metabolic SyndromePreclinical

Active, not recruiting

Prostate AdenocarcinomaPhase 3

Active, not recruiting

Prostate CarcinomaApproved

Active, not recruiting

Prostate CancerApproved

Completed

Head and Neck Squamous Cell CarcinomaApproved

Approved

Competition

Competitive Landscape

314 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Eulexin

SSchering-Plough

Approved

34 2

Opdivo

Bristol-Myers Squibb

Phase 3

21 3

Keytruda

Merck & Co.

Phase 3

21 4

Lupron

EEastern Cooperative Oncology Group

Phase 3

53 5

Rubraca

Bristol-Myers Squibb

Phase 3

9 6

Orgovyx

Sumitomo Pharma America, Inc.

Phase 3

12 7

Piflufolastat F 18

Novartis

Phase 3

1 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Prostate Adenocarcinoma

NCT01786265

Q4 2030

PreclinicalActive, not recruiting

Prostate Adenocarcinoma

NCT03070886

Q4 2031

Phase 3Active, not recruiting

Prostate Adenocarcinoma

NCT05050084

Q4 2036

Phase 3Recruiting

Castration Levels of Testosterone

NCT03678025

Clinical

Trials by Indication[1]

Prostate Cancer34 trials

Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00004054·397 enrolled

Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00002633·361 enrolled

Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00002855·306 enrolled

Show 31 more trials

Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00023829·67 enrolled

Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

Completed· Astellas logo

Astellas·Phase 4·NCT02918968·206 enrolled

Randomized Trial of Adjuvant Hormonal Therapy in Surgically Treated Prostate Cancer Patients at High Risk for Recurrence

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00003645·64 enrolled

Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00002597·2,028 enrolled

Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Completed·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 3·NCT00003026·966 enrolled

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

Terminated·NNCIC Clinical Trials Group·Phase 3·NCT00651326·48 enrolled

Hormone Therapy and OGX-011 Before Radical Prostatectomy in Treating Patients With Prostate Cancer

Completed·NNCIC Clinical Trials Group·Phase 1·NCT00054106·25 enrolled

Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer

Unknown status·—·Phase 3·NCT00003734·276 enrolled

Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00003653·1,386 enrolled

Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

Completed·MMayo Clinic·Phase 2·NCT00170157·112 enrolled

Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00002889·180 enrolled

Comparative Study of Alternative Antiandrogen (AA) Therapy and Early Initiating of Enzalutamide for Castration-resistant Prostate Cancer (CRPC) After Combined Androgen Blockade (CAB) Therapy.

Completed·TTaro Iguchi, MD, PHD·Phase 2·NCT02346578·104 enrolled

Flutamide, Suramin, and Hydrocortisone in Treating Patients With Prostate Cancer

Completed·EEastern Cooperative Oncology Group·Phase 3·NCT00002881

SU5416 Plus Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

Completed·UUniversity of Chicago·Phase 1·NCT00026377·3 enrolled

Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00767286

Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00006214·63 enrolled

Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

Withdrawn·—·Phase 2·NCT00003517

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00388804·39 enrolled

Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.

Completed·EEnte Ospedaliero Ospedali Galliera·Phase 2/3·NCT06601205·125 enrolled

Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00936390·1,538 enrolled

Hormone Therapy Plus Radiation Therapy in Treating Patients With Prostate Cancer

Completed·HHerbert Irving Comprehensive Cancer Center·Phase 2·NCT00003124·105 enrolled

Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00769548·1,322 enrolled

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00512668·24 enrolled

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2·NCT00528866·80 enrolled

Vaccine Therapy With PROSTVAC/TRICOM and Flutamide Versus Flutamide Alone to Treat Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00450463·64 enrolled

Hormone Therapy in Treating Patients With Prostate Cancer

Completed·AAlliance for Clinical Trials in Oncology·Phase 2·NCT00003323·101 enrolled

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 3·NCT00030654·21 enrolled

Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer

Completed·UUniversity of Washington·Phase 2·NCT00223665·102 enrolled

Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

Completed·UUNICANCER·Phase 3·NCT00104741·378 enrolled

Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

Unknown status·WWonju Severance Christian Hospital·Phase 4·NCT04248621·164 enrolled

Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT01122121·273 enrolled

Prostate Adenocarcinoma5 trials

Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma

Completed· Takeda logo

Takeda·Phase 3·NCT01011751·311 enrolled

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

Active, not recruiting·NNRG Oncology·Preclinical·NCT03070886·612 enrolled

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Active, not recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

Show 2 more trials

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01786265·310 enrolled

Polycystic Ovary Syndrome2 trials

Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome

Terminated·VVirginia Commonwealth University·N/A·NCT00729560·8 enrolled

Effect of High Testosterone on Sleep-associated Slowing of Follicular Luteinizing Hormone (LH) Frequency in Polycystic Ovary Syndrome

Unknown status·UUniversity of Virginia·Phase 1·NCT00930228·72 enrolled

Progesterone2 trials

Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone

Terminated·UUniversity of Virginia·N/A·NCT01428193·4 enrolled

Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion

Unknown status·UUniversity of Virginia·Phase 1·NCT04597099·10 enrolled

Effectiveness1 trial

Effectiveness of Flutamide in Treating Women With Premenstrual Dysphoric Disorder

Completed·WWeill Medical College of Cornell University·Phase 4·NCT00611923·115 enrolled

9 more indications

Ovarian Cancer1 trial

Effect of Flutamide on Biomarkers in Blood and Tissue Samples From Patients at High Risk of Ovarian Cancer

Completed·UUniversity of Arizona·Phase 2·NCT00699907·127 enrolled

Treatment1 trial

Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

Completed· Takeda logo

Takeda·Phase 2·NCT00817739·341 enrolled

Congenital Adrenal Hyperplasia1 trial

Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 3·NCT00001521·66 enrolled

Androgen Deprivation Therapy1 trial

Androgen Deprivation Therapy or Androgen Deprivation Therapy Plus Definitive Treatment (Radiation or Surgery)

Unknown status·FFudan University·Phase 2·NCT02742675·200 enrolled

ART1 trial

Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT03507608·25 enrolled

Function1 trial

Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women

Completed·UUniversity of California, Los Angeles·Phase 2·NCT01889199·23 enrolled

Metabolic Syndrome1 trial

Metabolic Syndrome in PCOS: Precursors and Interventions

Completed·NNorthwestern University·N/A·NCT00442689·97 enrolled

Metastatic Prostate Cancer1 trial

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT00028769·41 enrolled

Castration Levels of Testosterone1 trial

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

Recruiting·SSWOG Cancer Research Network·Phase 3·NCT03678025·1,273 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 27, 1989

EULEXIN

NDA NDA018554

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Flutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Eulexin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Flutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Flutamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018554). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Schering-Plough company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSchering-Plough

Eulexin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2030

Q4 2031

Q4 2036

Trials by Indication[1]

Prostate Cancer34 trials

Prostate Adenocarcinoma5 trials

Polycystic Ovary Syndrome2 trials

Progesterone2 trials

Effectiveness1 trial

Ovarian Cancer1 trial

Treatment1 trial

Congenital Adrenal Hyperplasia1 trial

Androgen Deprivation Therapy1 trial

ART1 trial

Function1 trial

Metabolic Syndrome1 trial

Metastatic Prostate Cancer1 trial

Castration Levels of Testosterone1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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