TheraRadar
Data updated: May 26, 2026

METYROSINE

Catecholamine Synthesis Inhibitors
Endocrine Approved 2020-07-24

METYROSINE is indicated for the treatment of Pheochromocytoma.

Source: FDA Label • LEADING
3
Indications
--
Phase 3 Trials
5
Years on Market

Details

Status
Prescription
First Approved
2020-07-24
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: METYROSINE

METYROSINE Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2020 to 2025
Apr 2025 ORIGINAL
Update
Sep 2024 ORIGINAL
Update
Jul 2020 ORIGINAL
Update

What METYROSINE Treats

1 indications

METYROSINE is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Pheochromocytoma
Source: FDA Label

METYROSINE 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 METYROSINE

3 of 5

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

ADREVIEW
IOBENGUANE SULFATE I-123
1 shared
GE HEALTHCARE
Shared indications:
Pheochromocytoma
DEMSER
METYROSINE
1 shared
BAUSCH
Shared indications:
Pheochromocytoma
PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
1 shared
Aurobindo Pharma
Shared indications:
Pheochromocytoma
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01127503 results posted 09-MET-101 Ph 2 terminated Metyrosine (Demser®) for the Treatment of Psychotic Disorders in Patients With Velocardiofacial Syndrome
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Active Pipeline

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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.

METYROSINE FDA Label Details

Indications & Usage

METYROSINE is indicated for the treatment of Pheochromocytoma.

Looking for the branded version?

DEMSER

Full clinical data, patents, trials, and competitive landscape for metyrosine.

See DEMSER

Data Sources

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