TheraRadar
Data updated: Nov 8, 2026

BRAVNETSA (lutetium lu-177 dotatate) · LANTHEUS MEDICAL

Approved 2026-09-21

BRAVNETSA is FDA-approved to treat 1 condition (same as LUTATHERA).

Source: FDA Label
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-09-21
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: LUTETIUM LU-177 DOTATATE

BRAVNETSA Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL
Update

What BRAVNETSA Treats

1 indications

BRAVNETSA is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gastroenteropancreatic Neuroendocrine Tumors

Same approved indications as LUTATHERA (same active ingredient).

Source: FDA Label
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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

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.

BRAVNETSA FDA Label Details

Indications & Usage

BRAVNETSA is FDA-approved to treat 1 condition — same approved indications as LUTATHERA.

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Data Sources

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