CORTROSYN (cosyntropin)
CORTROSYN is indicated for the treatment of Adrenocortical Insufficiency.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1970-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CORTROSYN Approval History
What CORTROSYN Treats
1 indicationsCORTROSYN is approved for 1 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
CORTROSYN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CORTROSYN
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03368066 results posted | 20212 | Ph 3 | completed | Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients? |
| NCT03752190 | IRB00193457 | Ph 4 | withdrawn | Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers |
| NCT01673087 | 1R01MH093486-01A1 | Ph 1 | completed | Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures |
| NCT02394457 PDPH results posted | NMCSD.2006.0026 | Ph 4 | completed | Cosyntropin Versus Epidural Blood Patch (EBP) for Treatment of Treatment of Post Dural Puncture Headache |
| NCT01839812 | 08-001638 | Ph 1 | completed | Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CORTROSYN FDA Label Details
Indications & Usage
FDA Label (PDF)CORTROSYN is indicated for the treatment of Adrenocortical Insufficiency.
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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