TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DEMSER

METYROSINE Catecholamine Synthesis Inhibitors
Oncology Approved 1979-10-03
1
Indication
--
Phase 3 Trials
1
Priority Reviews
46
Years on Market

Details

Status
Prescription
First Approved
1979-10-03
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: METYROSINE

DEMSER Approval History

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What DEMSER Treats

2 indications

DEMSER is approved for 2 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pheochromocytoma
  • Malignant Pheochromocytoma
Source: FDA Label
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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.

DEMSER FDA Label Details

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Indications & Usage

DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.