Data updated: May 26, 2026
DANOCRINE (danazol)
Trial Activity: Declining 1 active trials
Women's Health
Approved 1976-06-21
Development Insights
National Heart, Lung, and Blood Institute (NHLBI) conducting 2 trials (14%)
20 indications explored (Broad Platform)
→ telomere disease (2 trials)
→ endometriosis (2 trials)
→ dyskeratosis congenita (2 trials)
3
Indications
--
Phase 3 Trials
3
Priority Reviews
49
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-06-21
- Routes
- ORAL
- Dosage Forms
- CAPSULE
DANOCRINE Approval History
1977
1978
1979
1980
1981
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1994
1995
1996
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2025
2026
Original
New Indication
New Form
Label Update
93 FDA actions from 1976 to 2011 · 2 indication expansions
Dec 1996 SUPPL Priority
Mfg · Manufacturing (CMC)
Aug 1995 SUPPL Priority
Mfg · Manufacturing (CMC)
May 1994 SUPPL Priority
Label
Jan 1994 SUPPL Priority
Label
Mar 1993 SUPPL Priority
Label
Jul 1990 SUPPL Priority
Label
May 1988 SUPPL Priority
Mfg
Mar 1986 SUPPL Priority
Label
Jan 1985 SUPPL Priority
Label
Aug 1984 SUPPL Priority
Label
Nov 1982 SUPPL Priority
Label
Jan 1982 SUPPL Priority
Mfg
May 1981 SUPPL Priority
Efficacy
Nov 1980 SUPPL Priority
Label
Sep 1980 SUPPL Priority
Efficacy
Jun 1980 SUPPL Priority
Mfg
May 1980 SUPPL Priority
Mfg
Mar 1980 SUPPL Priority
Mfg
Oct 1979 SUPPL Priority
Mfg
May 1978 SUPPL Priority
Mfg
Mar 1978 SUPPL Priority
Mfg
Mar 1978 SUPPL Priority
Label
Sep 1976 SUPPL Priority
Label
Jun 1976 ORIGINAL Priority
New Drug
What DANOCRINE Treats
3 FDA approvalsOriginally approved for its first indication in 1976 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Jun 1976) Priority
- • Approved indication (Sep 1980) Priority
- • Approved indication (May 1981) Priority
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Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03312400 | 180004 18-H-0004 | Ph 2 | recruiting | Low-Dose Danazol for the Treatment of Telomere Related Diseases |
| NCT07183787 LET-DAN RCT | SMDC/SMRC/79-18 | Ph 2 | completed | Letrozole vs Danazol for Endometriosis-Related Pain: Randomized Trial |
| NCT04638517 | TELO-SCOPE | Ph 2 | terminated | The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis |
| NCT00953771 TTP results posted | GCO 16-2608 055-08 | Ph 2 | terminated | Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura (TTP) |
| NCT04173494 results posted | SRA-MMB-301 | Ph 3 | completed | A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) |
| NCT04757532 ESPAMA | IMIMFTCL/ESPAMA | Ph 1 | completed | Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers. |
| NCT01001598 results posted | 09-03-0131 | Ph 1, Ph 2 | terminated | Safety and Efficacy Trial of Danazol in Patients With Fanconi Anemia or Dyskeratosis Congenita |
| NCT01441037 results posted | 110209 11-H-0209 | Ph 1, Ph 2 | completed | Danazol for Genetic Bone Marrow and Lung Disorders |
| NCT03563664 | RIF-Danazol | Ph 3 | completed | Effect of Danazol on Endometrial αvβ3 Integrin Expression in Patients With Unexplained Recurrent Implantation Failure |
| NCT01732445 results posted | MC1283 NCI-2012-02201, MC1283 | Ph 2 | completed | Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis |
| NCT01667263 | U1111-1132-6877 Z111107058811024 | Ph 2 | completed | The Combination of ATRA and Danazol as Second-line Treatment in Adult Immune Thrombocytopenia |
| NCT01779232 | CR-09-2013 | Ph 4 | completed | Danazol Treatment in Endometriosis Women Before IVF |
| NCT02002403 | DMILS-RX09-001 | Ph 2 | completed | Efficacy and Safety Study to Evaluate Two Doses of Oral DMI-5207 in Adult Subjects With Diabetic Macular Edema |
| NCT01105793 | FP1198-002 | Ph 2 | completed | An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DANOCRINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment