TheraRadar
Data updated: May 26, 2026

VANTAS (histrelin acetate)

Endocrine Approved 2004-10-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
21
Years on Market

Details

Status
Discontinued
First Approved
2004-10-12
Routes
SUBCUTANEOUS
Dosage Forms
IMPLANT

Companies

ENDO OPERATIONS
Active Ingredient: HISTRELIN ACETATE

VANTAS Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2004 to 2026
May 2026 SUPPL
Label · Labeling
FDA Letter Label
Sep 2025 SUPPL
Label · Labeling
FDA Letter Label
Aug 2022 SUPPL
Label · Labeling
FDA Letter Label

What VANTAS Treats

1 FDA approvals

Originally approved for its first indication in 2004 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03678025 S1802 NCI-2018-01738, S1802 Ph 3 recruiting Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT02278185 results posted 14-0909.cc NCI-2014-02219 Ph 2 completed Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer
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Active Pipeline

Pro

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.

VANTAS FDA Label Details

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Data Sources

FDA Approval: NDA021732 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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