TheraRadar
Data updated: May 26, 2026

JUBEREQ (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

JUBEREQ 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 JUBEREQ Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

JUBEREQ FDA Label Details

Track JUBEREQ with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: BLA761424 → Trials: ClinicalTrials.gov →

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