TheraRadar
Data updated: May 26, 2026

DEMSER (metyrosine)

Catecholamine Synthesis Inhibitors
Endocrine Approved 1979-10-03

DEMSER is indicated for the treatment of Pheochromocytoma; Malignant Pheochromocytoma.

Source: FDA Label • BAUSCH
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
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

BAUSCH
Active Ingredient: METYROSINE

DEMSER Approval History

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Original
New Indication
New Form
Label Update
12 FDA actions from 1979 to 2014
Jul 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
Nov 2013 SUPPL Priority
Mfg · Manufacturing (CMC)
May 2003 SUPPL
Label · Labeling
FDA Letter

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

DEMSER Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

WELIREG
Merck
2021 6 indic.
PHENOXYBENZAMINE HYDROCHLORIDE
Aurobindo Pharma
2012 2 indic.
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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 DEMSER

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
METYROSINE
METYROSINE
1 shared
LEADING
Shared indications:
Pheochromocytoma
PHENOXYBENZAMINE HYDROCHLORIDE
PHENOXYBENZAMINE HYDROCHLORIDE
1 shared
Aurobindo Pharma
Shared indications:
Pheochromocytoma
View all 5 similar drugs Pro
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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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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

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

DEMSER is indicated for the treatment of Pheochromocytoma; Malignant Pheochromocytoma.

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Data Sources

FDA Approval: NDA017871 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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