TheraRadar
Data updated: May 26, 2026

ZINBRYTA (daclizumab)

Priority Review
Immunology Approved 2016-05-27
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-05-27
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Biogen
Active Ingredient: DACLIZUMAB

ZINBRYTA Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2016 to 2017 · 1 indication expansions
Nov 2017 SUPPL
Update · REMS
FDA Letter
Aug 2017 SUPPL
Label · Labeling
FDA Letter Label
May 2017 SUPPL
Efficacy
FDA Letter Label

What ZINBRYTA Treats

2 FDA approvals

Originally approved for its first indication in 2016 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02881567 SUSTAIN results posted 205MS305 2016-002820-10 Ph 3 terminated Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
NCT00790439 DAIT CIT-01B CIT-01B Ph 2 withdrawn Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant
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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.

ZINBRYTA FDA Label Details

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Data Sources

FDA Approval: BLA761029 → Trials: ClinicalTrials.gov →

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