Flutamide

Overview

An antiandrogen with about the same potency as cyproterone in rodent and canine species.

Indication

For the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate

Associated Conditions

Stage B2-C metastatic Carcinoma of the Prostate
Stage D2 metastatic Carcinoma of the Prostate

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Finasteride and Flutamide in Pre-surgical Trial in Prostate Cancer.	2024/09/19	NCT06601205	Phase 2	Completed	Ente Ospedaliero Ospedali Galliera
Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris	2022/07/28	NCT05478330	Not Applicable	Completed	Zagazig University
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	2021/09/20	NCT05050084	Phase 3	Recruiting	NRG Oncology
Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion	2020/10/22	NCT04597099	Early Phase 1	Recruiting	University of Virginia
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	2020/08/14	NCT04513717	Phase 3	Recruiting	NRG Oncology
Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients	2020/01/30	NCT04248621	Phase 4	UNKNOWN	Wonju Severance Christian Hospital
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
Assessing Induction of Double Strand Breaks With Androgen Receptor Partial Agonist in Patients on Androgen Suppression	2018/04/25	NCT03507608	Early Phase 1	Active, not recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer	2016/09/29	NCT02918968	Phase 4	Completed	Astellas Pharma Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
FLUTAMIDE	Cipla USA Inc.	69097-915	ORAL	125 mg in 1 1	11/29/2018
Eulexin	Waylis Therapeutics LLC	80725-600	ORAL	125 mg in 1 1	1/13/2022

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
APO-FLUTAMIDE TAB 250MG	N/A	HIND WING COMPANY LIMITED	N/A	N/A	10/14/2007

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FLUTAMIN flutamide 250mg tablet blister pack	65675	Alphapharm Pty Ltd	Medicine	A	3/24/1999

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-FLUTAMIDE TABLETS	nu-pharm inc	02239082	Tablet - Oral	250 MG / TAB	N/A
FLUTAMIDE	schering-plough canada inc	02059673	Tablet - Oral	250 MG	12/31/1996
DOM-FLUTAMIDE	dominion pharmacal	02230524	Tablet - Oral	250 MG / TAB	N/A
FLUTAMIDE	Pharmascience Inc	02230875	Tablet - Oral	250 MG	10/31/1997
EUFLEX	Merck Canada Inc	00637726	Tablet - Oral	250 MG	12/31/1984
FLUTAMIDE-250	PRO DOC LIMITEE	02239388	Tablet - Oral	250 MG / TAB	2/22/1999
PENTA-FLUTAMIDE	pentapharm ltd.	02233019	Tablet - Oral	250 MG / TAB	N/A
TEVA-FLUTAMIDE	teva canada limited	02230089	Tablet - Oral	250 MG	1/16/1997
FLUTAMIDE	aa pharma inc	02238560	Tablet - Oral	250 MG	10/8/1998
FLUTAMIDE	pharmel inc	02239045	Tablet - Oral	250 MG	12/1/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
GRISETIN 250 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Faes Farma S.A.	59594	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
FLUTAMIDA CINFA 250 mg COMPRIMIDOS EFG	Laboratorios Cinfa S.A.	62912	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
PROSTACUR COMPRIMIDOS	Mylan Pharmaceuticals S.L.	59593	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Not Commercialized

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.

Related News

Studies Reveal Quality of Life Trade-offs with Androgen Deprivation Therapy in Prostate Cancer Treatment

7 months ago

New research from ASCO GU Symposium demonstrates that both continuous and intermittent androgen deprivation therapy (ADT) show comparable survival rates but significant quality of life impacts in prostate cancer patients.

Short-Term ADT Plus High-Dose Radiotherapy Improves Outcomes in Localized Prostate Cancer

a year ago

A phase 3 trial (GETUG 14) reveals that combining short-term androgen deprivation therapy (ADT) with high-dose radiotherapy improves disease-free survival in localized prostate cancer patients.

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