TheraRadar
Data updated: May 26, 2026

ADAGEN (pegademase bovine)

Rare Disease Approved 1990-03-21
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
36
Years on Market

Details

Status
Discontinued
First Approved
1990-03-21
Patent Cliff
1997

Pro Metrics

Patent cliff and revenue data

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Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

LEADIANT BIOSCI INC
Active Ingredient: PEGADEMASE BOVINE

ADAGEN Approval History

1991
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Original
New Indication
New Form
Label Update
26 FDA actions from 1990 to 2015
Dec 2015 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 2014 SUPPL Priority
Mfg · Manufacturing (CMC)
Jun 2014 SUPPL
Label · Labeling
FDA Letter Label

What ADAGEN Treats

1 FDA approvals

Originally approved for its first indication in 1990 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01420627 results posted STP-2279-002 Ph 3 completed EZN-2279 in Patients With ADA-SCID
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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.

ADAGEN FDA Label Details

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Data Sources

FDA Approval: BLA019818 → Trials: ClinicalTrials.gov →

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