Data updated: Mar 10, 2026
OMONTYS
PEGINESATIDE ACETATE
Approved 2012-03-27
1
Indication
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-03-27
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
OMONTYS Approval History
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What OMONTYS Treats
1 FDA approvalsOriginally approved for its first indication in 2012 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
OMONTYS FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.