Nilandron

(nilutamide)

Phase 3Small molecule

AAdvanz Pharma

Nilandron is one of 86 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Prostate AdenocarcinomaActive, not recruiting

Metastatic Prostate CancerRecruiting

Prostate AdenocarcinomaPhase 2

Active, not recruiting

Metastatic Prostate CancerPhase 3

Recruiting

Competition

Competitive Landscape

75 competitors in Metastatic Prostate Cancer

#DrugCompanyPhaseTrials

Zytiga

Johnson & Johnson

Phase 3

21 2

Xtandi

Astellas

Phase 3

18 3

Taxotere

AAvyxa

Phase 3

42 4

Erleada

Johnson & Johnson

Phase 3

14 5

Nubeqa

Bayer

Phase 3

7 6

Rayos

RRoxane Laboratories

Phase 3

19 7

Jevtana

Sanofi

Phase 3

5 8

Lupron

EEastern Cooperative Oncology Group

Phase 3

9 9

Zoladex

TTerSera Therapeutics LLC

Phase 3

7 10

Paraplatin

AAvyxa

Phase 3

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 3Recruiting

Metastatic Prostate Cancer

NCT03678025

Clinical

Trials by Indication[1]

Prostate Cancer6 trials

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

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

Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer

Terminated·—·Phase 2·NCT00918385·57 enrolled

Show 3 more trials

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

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

Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00020254

Metastatic Prostate Cancer2 trials

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

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

Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

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

Prostate Adenocarcinoma2 trials

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

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

Regulatory

FDA Approval Timeline[4]

Sep 19, 1996

NILANDRON

NDA NDA020169

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for nilutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — nilutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for nilutamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020169). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Advanz Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAdvanz Pharma

Nilandron

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2030

Q4 2031

Trials by Indication[1]

Prostate Cancer6 trials

Metastatic Prostate Cancer2 trials

Prostate Adenocarcinoma2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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