TheraRadar
Data updated: May 26, 2026

Heplisav-B (hepatitis b vaccine (recombinant), adjuvanted)

Approved 2017-11-08
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-11-08
Routes
Intramuscular
Dosage Forms
Injection

Companies

Dynavax Technologies Corporation
Active Ingredient: Hepatitis B Vaccine (Recombinant), Adjuvanted

Heplisav-B Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017
Nov 2017 ORIGINAL
Update · CBER biologic (Purple Book)

What Heplisav-B Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
📋

Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT04193189 BEe-HIVe results posted ACTG A5379 38569 Ph 3 completed B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
NCT04199715 IND 18850 Ph 1 completed Safety and Efficacy of a Hepatitis B Vaccine in Immunosuppressed Patients
NCT03685708 results posted 180145 18-H-0145 Ph 2 completed HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I)
NCT00985426 results posted DV2-HBV-17 2009-015877-11 Ph 3 completed Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
🔬

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.

Heplisav-B FDA Label Details

Track Heplisav-B with TheraRadar Pro

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

Upgrade to Pro

Data Sources

FDA Approval: BLA125428 → Trials: ClinicalTrials.gov →

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