Danazol

Overview

A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders.

Indication

For the treatment of endometriosis and fibrocystic breast disease (in patients unresponsive to simple measures). Also used for the prophylactic treatment of all types of hereditary angioedema in males and females.

Associated Conditions

Endometriosis
Fibrocystic Disease of Breast
Hereditary Angioedema (HAE)
Refractory immune thrombocytopenia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia	2023/12/20	NCT06176911	Phase 2	Recruiting	Peking University People's Hospital
Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia	2023/05/10	NCT05852847	Phase 2	Recruiting	Peking University People's Hospital
Comparisons of the Therapeutic Effects of Dienogest and Danazol on Endometriosis	2023/01/26	NCT05697471	Phase 3	Recruiting	Far Eastern Memorial Hospital
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia	2022/08/09	NCT05494307	Phase 2	UNKNOWN	Peking University People's Hospital
The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	2022/07/22	NCT05471050	Phase 2	UNKNOWN	Peking University People's Hospital
The Combination of Sitagliptin and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	2022/04/29	NCT05353673	Phase 2	UNKNOWN	Peking University People's Hospital
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia	2022/03/15	NCT05281068	Phase 2	UNKNOWN	Peking University People's Hospital
Repurposed Drugs to Improve Haematological Responses in Myelodysplastic Syndromes	2021/08/10	NCT04997811	Phase 2	Recruiting	Prof. Janet Dunn
Danazol for Treatment of Cytopenias in Patients With Cirrhosis	2021/05/05	NCT04873102	Phase 2	Recruiting	University of Southern California
PRETELL: PREvention of TELomere-related Complications After Lung Transplant	2021/03/19	NCT04807309	Phase 1	Withdrawn	Brigham and Women's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Danazol	Teva Pharmaceuticals USA, Inc.	0555-0634	ORAL	100 mg in 1 1	11/18/2022
Danazol	Lannett Company, Inc.	0527-1392	ORAL	50 mg in 1 1	4/30/2020
Danazol	Chartwell RX, LLC.	62135-476	ORAL	100 mg in 1 1	6/22/2023
Danazol	Teva Pharmaceuticals USA, Inc.	0555-0635	ORAL	200 mg in 1 1	11/18/2022
Danazol	Teva Pharmaceuticals USA, Inc.	0555-0633	ORAL	50 mg in 1 1	11/18/2022
Danazol	Chartwell RX, LLC.	62135-477	ORAL	200 mg in 1 1	6/22/2023
Danazol	Proficient Rx LP	71205-861	ORAL	100 mg in 1 1	4/1/2022
Danazol	Lannett Company, Inc.	0527-1369	ORAL	200 mg in 1 1	4/30/2020
Danazol	Carilion Materials Management	68151-2298	ORAL	200 mg in 1 1	1/26/2012
Danazol	Lannett Company, Inc.	0527-1368	ORAL	100 mg in 1 1	4/30/2020

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
NAZOL CAPSULE 200 mg	DUOPHARMA (M) SDN BHD	SIN03932P	CAPSULE	200 mg	3/1/1990

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
CYCLOMEN	sanofi-aventis canada inc	02018160	Capsule - Oral	200 MG	12/31/1972
CYCLOMEN	sanofi-aventis canada inc	02018152	Capsule - Oral	100 MG	12/31/1976
CYCLOMEN	sanofi-aventis canada inc	02018144	Capsule - Oral	50 MG	12/31/1980

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DANATROL 50 mg CAPSULAS	Laboratorios Fidia Farmaceutica S.L.	56255	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
DANATROL 100 mg CAPSULAS	Laboratorios Fidia Farmaceutica S.L.	56256	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized
DANATROL 200 mg CAPSULAS	Laboratorios Fidia Farmaceutica S.L.	55580	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	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.

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