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 |
|---|---|---|---|---|---|
2023/12/20 | Phase 2 | Recruiting | |||
2023/05/10 | Phase 2 | Recruiting | |||
2023/01/26 | Phase 3 | Recruiting | |||
2022/08/09 | Phase 2 | UNKNOWN | |||
2022/07/22 | Phase 2 | UNKNOWN | |||
2022/04/29 | Phase 2 | UNKNOWN | |||
2022/03/15 | Phase 2 | UNKNOWN | |||
2021/08/10 | Phase 2 | Recruiting | Prof. Janet Dunn | ||
2021/05/05 | Phase 2 | Recruiting | |||
2021/03/19 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0555-0634 | ORAL | 100 mg in 1 1 | 11/18/2022 | |
| Lannett Company, Inc. | 0527-1392 | ORAL | 50 mg in 1 1 | 4/30/2020 | |
| Chartwell RX, LLC. | 62135-476 | ORAL | 100 mg in 1 1 | 6/22/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0635 | ORAL | 200 mg in 1 1 | 11/18/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0555-0633 | ORAL | 50 mg in 1 1 | 11/18/2022 | |
| Chartwell RX, LLC. | 62135-477 | ORAL | 200 mg in 1 1 | 6/22/2023 | |
| Proficient Rx LP | 71205-861 | ORAL | 100 mg in 1 1 | 4/1/2022 | |
| Lannett Company, Inc. | 0527-1369 | ORAL | 200 mg in 1 1 | 4/30/2020 | |
| Carilion Materials Management | 68151-2298 | ORAL | 200 mg in 1 1 | 1/26/2012 | |
| 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 | SIN03932P | CAPSULE | 200 mg | 3/1/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Danazol Suppository | 国药准字H19990236 | 化学药品 | 栓剂 | 8/10/2020 | |
| Danazol Soft Capsules | 国药准字H20060604 | 化学药品 | 胶囊剂 | 7/29/2021 | |
| Danazol Capsules | 国药准字H33021094 | 化学药品 | 胶囊剂 | 5/26/2020 | |
| Danazol Capsules | 国药准字H44020421 | 化学药品 | 胶囊剂 | 5/15/2020 | |
| Danazol Capsules | 国药准字H33022461 | 化学药品 | 胶囊剂 | 5/22/2020 | |
| Danazol Capsules | 国药准字H20023742 | 化学药品 | 胶囊剂 | 11/22/2019 | |
| Danazol Capsules | 国药准字H19994122 | 化学药品 | 胶囊剂 | 8/30/2021 | |
| Danazol Capsules | 国药准字H11020261 | 化学药品 | 胶囊剂 | 12/8/2020 | |
| Danazol Capsules | 国药准字H32022729 | 化学药品 | 胶囊剂 | 8/10/2020 | |
| Danazol Capsules | 国药准字H20023116 | 化学药品 | 胶囊剂 | 8/10/2020 |
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. | |||||
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