Nilutamide

Overview

Nilutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Nilutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Nilutamide blocks the action of androgens of adrenal and testicular origin that stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.

Indication

用于已转移的前列腺癌，可与手术或化学去势合用。

Associated Conditions

Metastatic Prostate Cancer

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	2018/09/19	NCT03678025	Phase 3	Recruiting	SWOG Cancer Research Network
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery	2017/03/06	NCT03070886	Phase 2	Active, not recruiting	NRG Oncology
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer	2013/02/07	NCT01786265	Phase 2	Active, not recruiting	M.D. Anderson Cancer Center
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer	2009/06/11	NCT00918385	Phase 2	Terminated	Duke University
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer	2007/08/08	NCT00512668	Phase 1	Terminated	National Cancer Institute (NCI)
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer	2003/01/27	NCT00002855	Phase 3	Completed	M.D. Anderson Cancer Center
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer	2003/01/27	NCT00020254	Phase 2	Completed	National Cancer Institute (NCI)
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer	2003/01/27	NCT00028769	Phase 2	Completed	SWOG Cancer Research Network
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	2003/01/27	NCT00002633	Phase 3	Completed	NCIC Clinical Trials Group
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer	2003/01/27	NCT00003653	Phase 3	Completed	NCIC Clinical Trials Group

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nilutamide	Prasco Laboratories	66993-212	ORAL	150 mg in 1 1	11/22/2019
Nilutamide	ANI Pharmaceuticals, Inc.	62559-173	ORAL	150 mg in 1 1	9/18/2020
Nilandron	Concordia Pharmaceuticals Inc.	59212-111	ORAL	150 mg in 1 1	7/8/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ANANDRON TAB 50MG	roussel canada inc.	00863890	Tablet - Oral	50 MG / TAB	12/31/1992
ANANDRON - TAB 100MG	aventis pharma inc	02221888	Tablet - Oral	100 MG	8/20/1997
ANANDRON TAB 50MG	hoechst roussel canada inc.	01989642	Tablet - Oral	50 MG / TAB	12/31/1994
ANANDRON TAB 100MG	roussel canada inc.	00863904	Tablet - Oral	100 MG / TAB	12/31/1992
ANANDRON TAB 100MG	hoechst roussel canada inc.	01989650	Tablet - Oral	100 MG / TAB	12/31/1992
ANANDRON	Cheplapharm Arzneimittel Gmbh	02221861	Tablet - Oral	50 MG	8/20/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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