Drugs / Danazol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | DANOCRINE | — | 1980-09-02 – 1981-05-18 | fda.gov ↗ |
| Approved | US (FDA) | DANOCRINE | — | 1976-06-21 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04757532 | Dec 2020 → Mar 2021 | — | Parc de Salut Mar | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT03710356 | Oct 2018 → Oct 2021 | telomere syndrome | Assistance Publique - Hôpitaux de Paris | Unknown | No outcome recorded |
| Phase 1/2 | NCT03460808 | Mar 2018 → Jan 2020 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT01441037 | Jul 2011 → Nov 2016 | aplastic anemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1/2 | NCT01001598 | Nov 2009 → May 2014 | Fanconi anemia, dyskeratosis congenita | Boston Children's Hospital | Terminated | No outcome recorded Stop: Enrollment |
| Phase 220 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04873102 | Aug 2024 → Aug 2027 expected | cirrhosis of liver | University of Southern California | Recruiting | No outcome recorded |
| Phase 2 | NCT06176911 | Dec 2023 → Dec 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05852847 | May 2023 → Nov 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05494307 | Sep 2022 → Sep 2023 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05471050 | Mar 2022 → Mar 2023 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04997811 | Dec 2021 → Jan 2025 | myelodysplastic syndrome | Prof. Janet Dunn | Unknown | No outcome recorded |
| Phase 2 | NCT05281068 | Sep 2021 → Sep 2023 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05353673 | Jun 2021 → Dec 2022 | autoimmune thrombocytopenia, blood coagulation disease | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04481282 | Jul 2020 → Mar 2021 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04289207 | Mar → Sep 2020 | autoimmune thrombocytopenia | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03352076 | Dec 2017 → Oct 2019 | endometriosis | Viramal Limited | Completed | No outcome recorded |
| Phase 2 | NCT03909763 | Jan 2016 → Dec 2020 | — | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01732445 | Apr 2013 → Jul 2016 | myelofibrosis, primary myelofibrosis | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT01821677 | Feb 2013 → Oct 2014 | diabetic macular edema | Ampio Pharmaceuticals. Inc. | Completed | Missed primary |
| Phase 2 | NCT01667263 | Jun 2012 → Jul 2016 | autoimmune thrombocytopenia | Peking University People's Hospital | Completed | Met primary |
| Phase 2 | NCT02002403 | Jan 2011 → Apr 2012 | diabetic macular edema | Unity Health Toronto | Completed | No outcome recorded |
| Phase 2 | NCT01105793 | Jun 2010 → Jun 2011 | breast fibrocystic disease | FemmePharma Global Healthcare, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00953771 | Oct 2008 → Nov 2015 | thrombotic thrombocytopenic purpura | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00758953 | Feb 2007 → Jan 2009 | endometriosis | Lumara Health, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00003946 | Aug 1999 → Jun 2003 | endometrial cancer | Gynecologic Oncology Group | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03563664 | Aug 2015 → Aug 2017 | infertility disorder | Ain Shams University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04058678 | Jan 2020 → Dec 2021 | ovarian dysfunction | IVI Madrid | Completed | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1/2 | NCT04807309 Comparator | Jan → Nov 2021 | telomere syndrome | Brigham and Women's Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04638517 Comparator | Sep 2021 → Jan 2025 | dyskeratosis congenita, pulmonary fibrosis, telomere syndrome | The University of Queensland | Terminated | No outcome recorded |
| Phase 2 | NCT07183787 Comparator | Apr → Oct 2019 | endometriosis | Sidra Salman | Completed | No outcome recorded |
| Phase 2 | NCT03312400 Comparator | Feb 2018 → Oct 2025 | telomere syndrome | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00744276 Comparator | Jan 2007 → Apr 2009 | breast fibrocystic disease | FemmePharma Global Healthcare, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT04324060 Comparator | Mar 2020 → Mar 2022 | myelodysplastic syndrome | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05697471 Comparator | Feb 2023 → Dec 2025 | endometriosis | Far Eastern Memorial Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04576156 Comparator | Apr 2021 → Jun 2028 expected | myelofibrosis | Geron Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04173494 Comparator | Feb 2020 → Dec 2021 | myelofibrosis, primary myelofibrosis | Sierra Oncology LLC - a GSK company | Completed | Met primary |
| Phase 3 | NCT03165734 Comparator | Jun 2017 → Oct 2026 expected | myelofibrosis, primary myelofibrosis | Swedish Orphan Biovitrum | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01779232 Comparator | Oct 2012 → Aug 2015 | endometriosis, infertility disorder, ovarian cyst | Centre for Endocrinology and Reproductive Medicine, Italy | Completed | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 39 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | danazol | “which may include but is not limited to hydroxyurea, thalidomide or an analog of thalidomide, interferon, danazol, hypomethylating agents, chemotherapy or radiotherapy.” NCT04576156 ↗37“corticosteroids, hydroxyurea, danazol, or low-dose ruxolitinib” NCT03165734 ↗ |
| Known as | Danatrol | “Danazol treatment administered as an oral capsule (Danatrol)” NCT03352076 ↗ |
| Known as | Danocrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1479 ↗ |
| Known as | Danol | “Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in daily dosage of 400 mg for 12 weeks.” NCT03563664 ↗ |
| Known as | NSC-270916 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1479 ↗ |
| Known as | Optina | “The drug being tested in this study is low doses of Optina (formerly known as Danazol)” NCT02002403 ↗ |
| Known as | VML-0501 | “VML-0501 (100 mg Danazol)” NCT03352076 ↗ |
| Known as | WIN 17,757 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1479 ↗ |
| Action | Activate | “Progesterone receptor agonist” CHEMBL1479 ↗1“Androgen Receptor agonist” CHEMBL1479 ↗ |
| Action | Inhibit | “It suppresses the pituitary-ovarian axis by inhibiting the pituitary output of gonadotropins.” NCT04873102 ↗ |
| Modality | Other / unclassified | “Danazol is a synthetic steroid hormone structurally resembling a group of natural hormones (androgens)found in the body.” NCT00953771 ↗ |
| Route | Oral | “Patients receive oral danazol 4 times per day for at least 4 weeks.” NCT00003946 ↗ |
| Target | AR | “Androgen Receptor agonist” CHEMBL1479 ↗ |
| Target | PGR | “Progesterone receptor agonist” CHEMBL1479 ↗ |