TheraRadar
Data updated: May 26, 2026

CORTROSYN (cosyntropin)

Trial Activity: Declining
Endocrine Approved 1970-04-22

CORTROSYN is indicated for the treatment of Adrenocortical Insufficiency.

Source: FDA Label • AMPHASTAR PHARMS INC

Development Insights

University of Virginia conducting 1 trials (20%)
8 indications explored (Moderate)
adrenal insufficiency (2 trials)
cirrhosis (1 trials)
spur cell anemia (1 trials)
1
Indication
--
Phase 3 Trials
56
Years on Market

Details

Status
Prescription
First Approved
1970-04-22
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: COSYNTROPIN

CORTROSYN Approval History

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Original
New Indication
New Form
Label Update
20 FDA actions from 1970 to 2023
Dec 2023 SUPPL
Label · Labeling
Dec 2021 SUPPL
Label · Labeling
Sep 2014 SUPPL
Mfg · Manufacturing (CMC)

What CORTROSYN Treats

1 indications

CORTROSYN is approved for 1 conditions since its original approval in 1970. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Adrenocortical Insufficiency
Source: FDA Label

CORTROSYN Competitive Set

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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

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALKINDI SPRINKLE
HYDROCORTISONE
1 shared
ETON
Shared indications:
Adrenocortical Insufficiency
CORTEF
HYDROCORTISONE
1 shared
PHARMACIA AND UPJOHN
Shared indications:
Adrenocortical Insufficiency
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
DEXAMETHASONE SODIUM PHOSPHATE
1 shared
AMNEAL
Shared indications:
Adrenocortical Insufficiency
📋

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NCT03752190 IRB00193457 Ph 4 withdrawn Comparison of Intramuscular and Intravenous ACTH Stimulation Test in Normal Volunteers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

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

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