TheraRadar
Data updated: May 26, 2026

Cuvitru (immune globulin subcutaneous (human), 20% solution)

Approved 2016-09-12
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-09-12
Routes
Subcutaneous
Dosage Forms
Injection

Companies

Takeda
Active Ingredient: Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution , Immune Globulin Subcutaneous (Human), 20% Solution

Cuvitru Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2016 to 2016
Sep 2016 ORIGINAL
Update · CBER biologic (Purple Book)

What Cuvitru Treats

1 FDA approvals

Originally approved for its first indication in 2016 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03116347 results posted 161504 2016-003438-26 Ph 4 completed Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
NCT01218438 results posted 170904 Ph 2, Ph 3 completed Phase 2/3 Study of IGSC, 20% in PIDD
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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.

Cuvitru FDA Label Details

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Data Sources

FDA Approval: BLA125596 → Trials: ClinicalTrials.gov →

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