Sold as Danocrine. Every FDA application for this active ingredient: 1 branded and 4 generic.
As of Nov 13, 2026, FDA lists 5 applications for Danazol (sold as Danocrine), first approved Jun 21, 1976, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Danazol | Part D | $1.7M | -10% | 1,569 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-ThalassemiaBeta-Thalassemia, Thalassemia · Khyber Medical University Peshawar | Phase 3 | Recruiting | Oct 21, 2026 |
| Danazol for Treatment of Cytopenias in Patients With CirrhosisCirrhosis, Liver, Cytopenia · University of Southern California | Phase 2 | Recruiting | May 5, 2021 |
| A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor TreatmentMyelofibrosis · Geron Corporation | Phase 3 | Active, not recruiting | Oct 6, 2020 |
| A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia MyelofibrosisPrimary Myelofibrosis, Post-polycythemia Vera Myelofibrosis · Swedish Orphan Biovitrum | Phase 3 | Active, not recruiting | May 24, 2017 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 21, 1976 | DanocrineNDA 17557 · New molecular entity | Sanofi Aventis US | 30 | Discontinued |
| Aug 9, 1996 | DanazolANDA 74582 | Barr | 11 | Marketed |
| Sep 28, 2005 | DanazolANDA 77246 | Lannett Co Inc | 3 | Marketed |
| Apr 19, 2007 | DanazolANDA 78214 | Lannett | 2 | Marketed |
| — | DanazolANDA 71569 | Am Therap | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
