TheraRadar
Data updated: May 26, 2026

PONLIMSI (denosumab-adet)

Approved 2026-03-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-03-27
Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Teva
Active Ingredient: DENOSUMAB-ADET

PONLIMSI Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Mar 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What PONLIMSI Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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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.

PONLIMSI FDA Label Details

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Data Sources

FDA Approval: BLA761385 → Trials: ClinicalTrials.gov →

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