TheraRadar
Data updated: May 30, 2026

HEPCLUDEX (bulevirtide-gmod)

Approved 2026-05-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2026-05-22
Routes
POWDER,FOR SOLUTION
Dosage Forms
INJECTION

Companies

Gilead Sciences
Active Ingredient: BULEVIRTIDE-GMOD

HEPCLUDEX Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
May 2026 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What HEPCLUDEX 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.

HEPCLUDEX FDA Label Details

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Data Sources

FDA Approval: BLA761468 → Trials: ClinicalTrials.gov →

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