TheraRadar
Data updated: May 26, 2026

OSVYRTI (denosumab-desu)

Musculoskeletal Approved 2025-10-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-10-29
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

ACCORD BIOPHARMA INC.
Active Ingredient: denosumab-desu

OSVYRTI Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Oct 2025 ORIGINAL
Update
FDA Letter Label

What OSVYRTI Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
Auto-substitute OK for Prolia

Pharmacists can substitute OSVYRTI for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

OSVYRTI FDA Label Details

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Data Sources

FDA Approval: BLA761424 → Trials: ClinicalTrials.gov →

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