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nilutamide

Generic: NILUTAMIDE·Brand: NILANDRON, NILUTAMIDE, Nilandron

nilutamide: sourced relationships with 1 company · 3 clinical trials tracked · 1 FDA decision.

nilutamide evidence translation

What we can confirm

1 FDA record · 3 tracked trials

What it means

Source-backed records connect nilutamide to ANIP; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could nilutamide → ANIP affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Dated Pipeline Records (1)
CompanyDated record stage
ANI PHARMACEUTICALS INC (ANIP)
Reported 2016-07-15 · Current development: unknownSource
Approved
Clinical Trial Registry Records (3)

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

NCT03678025Registry updated 2026-10-08·Phase 3
Recruiting

Primary endpoint: Overall survival (OS)

InterventionalRandomizedopen1,273 targetStarted 2018-09Completion 2036-10338 sites · Chile, Colombia, Mexico, Switzerland…SWOG Cancer Research Network

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

NCT03070886Registry updated 2026-09-14·Phase 2/Phase 3
Active, not recruiting

Primary endpoint: Freedom from progression (FFP) (Phase II)

InterventionalRandomizedopen612 enrolledStarted 2017-04Completion 2030-1050 sites · United StatesNRG Oncology

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

NCT01786265Registry updated 2026-02-20·Phase 2
Active, not recruiting

Primary endpoint: Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)

InterventionalRandomizedopen310 targetStarted 2013-02Completion 2027-021 site · United StatesM.D. Anderson Cancer Center
FDA Decisions1 records
ANDA207631UNKNOWNStandardOralTablet

Frequently asked questions

Which companies have sourced relationships with nilutamide?

nilutamide has dated SEC/FDA relationship records for ANI PHARMACEUTICALS INC.

How many clinical trials involve nilutamide?

BioSniper tracks 3 clinical trials involving nilutamide.

What is nilutamide's latest FDA decision?

The most recent tracked FDA decision for nilutamide is Approval, dated July 15, 2016.