Danazol - PharmaKB

Danazol

Danazol (danazol) is a small molecule pharmaceutical. Danazol was first approved as Danocrine on 1982-01-01. It is used to treat endometriosis and fibrocystic breast disease in the USA. The pharmaceutical is active against androgen receptor.

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Therapeutic Areas

Therapeutic Area	MeSH
urogenital diseases	D000091642
skin and connective tissue diseases	D017437

Trade Name

FDA

EMA

Danazol (discontinued: Danazol, Danocrine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Danazol

Tradename	Company	Number	Date	Products
DANOCRINE	Sanofi	N-017557 DISCN	1982-01-01	3 products

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FDA

EMA

Brand Name	Status	Last Update
danazol	ANDA	2024-10-10

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
endometriosis	EFO_0001065	D004715	N80
fibrocystic breast disease	—	D005348	N60

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

G: Genito urinary system and sex hormones

— G03: Sex hormones and modulators of the genital system

— G03X: Other sex hormones and modulators of the genital system in atc

— G03XA: Antigonadotropins and similar agents

— G03XA01: Danazol

HCPCS

Code	Description
G9507	Documentation that the patient is on a statin medication or has documentation of a valid contraindication or exception to statin medications; contraindications/exceptions that can be defined by diagnosis codes include pregnancy during the measurement period, active liver disease, rhabdomyolysis, end stage renal disease on dialysis and heart failure; provider documented contraindications/exceptions include breastfeeding during the measurement period, woman of child-bearing age not actively taking birth control, allergy to statin, drug interaction (hiv protease inhibitors, nefazodone, cyclosporine, gemfibrozil, and danazol) and intolerance (with supporting documentation of trying a statin at least once within the last 5 years or diagnosis codes for myostitis or toxic myopathy related to drugs)

Code

Description

G9507

Documentation that the patient is on a statin medication or has documentation of a valid contraindication or exception to statin medications; contraindications/exceptions that can be defined by diagnosis codes include pregnancy during the measurement period, active liver disease, rhabdomyolysis, end stage renal disease on dialysis and heart failure; provider documented contraindications/exceptions include breastfeeding during the measurement period, woman of child-bearing age not actively taking birth control, allergy to statin, drug interaction (hiv protease inhibitors, nefazodone, cyclosporine, gemfibrozil, and danazol) and intolerance (with supporting documentation of trying a statin at least once within the last 5 years or diagnosis codes for myostitis or toxic myopathy related to drugs)

Clinical

Clinical Trials

41 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Endometriosis	D004715	EFO_0001065	N80	—	2	1	1	—	4
Infertility	D007246	HP_0000789	—	—	—	1	1	—	2
Ovarian cysts	D010048	HP_0000138	N83.1	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Thrombocytopenia	D013921	HP_0001873	D69.6	1	13	2	—	—	14
Thrombocytopenic purpura idiopathic	D016553	EFO_0007160	D69.3	1	11	2	—	—	13
Primary myelofibrosis	D055728	—	D47.4	—	1	3	—	—	4
Thrombocytopenic purpura	D011696	—	—	—	1	1	—	—	2
Purpura	D011693	HP_0000979	D69.2	—	1	1	—	—	2
Essential thrombocythemia	D013920	—	D47.3	—	—	2	—	—	2
Polycythemia vera	D011087	—	D45	—	—	2	—	—	2
Thrombocytosis	D013922	HP_0001894	D75.83	—	—	2	—	—	2
Polycythemia	D011086	EFO_0005804	D75.1	—	—	2	—	—	2

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Anemia	D000740	HP_0001903	D64.9	1	3	—	—	1	4
Macular edema	D008269	—	—	—	2	—	—	—	2
Edema	D004487	HP_0000969	R60.9	—	2	—	—	—	2
Fibrosis	D005355	—	—	—	2	—	—	—	2
Dyskeratosis congenita	D019871	—	—	1	2	—	—	—	2
Telomere shortening	D059506	—	—	1	2	—	—	—	2
Aplastic anemia	D000741	HP_0001915	D61.9	1	1	—	—	1	2
Myeloproliferative disorders	D009196	—	D47.1	—	1	—	—	—	1
Lung transplantation	D016040	—	—	1	1	—	—	—	1
Pulmonary fibrosis	D011658	—	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ovarian reserve	D065851	EFO_0004770	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Danazol
INN	danazol
Description	Danazol is a 17beta-hydroxy steroid and a terminal acetylenic compound. It has a role as an anti-estrogen, an estrogen antagonist and a geroprotector. It derives from a hydride of a pregnane.
Classification	Small molecule
Drug class	Androgen; Anabolic steroid; Progestogen; Progestin; Antigonadotropin; Steroidogenesis inhibitor; Antiestrogen
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C#C[C@]1(O)CC[C@H]2[C@@H]3CCC4=Cc5oncc5C[C@]4(C)[C@H]3CC[C@@]21C