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Data updated: May 26, 2026

Hyqvia (immune globulin infusion (human), 10% with recombinant human hyaluronidase)

Approved 2014-09-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-09-11
Patent Cliff
2031

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Routes
Subcutaneous
Dosage Forms
Injection

Companies

Takeda
Active Ingredient: Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase

Hyqvia Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Sep 2014 ORIGINAL
Update · CBER biologic (Purple Book)

What Hyqvia Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT06895967 results posted TAK-881-1002 Ph 1 completed A Study of TAK-881 and HyQvia in Healthy Adults
NCT05755035 TAK-881-3001 2022-502095-23-01 Ph 2, Ph 3 completed A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
NCT06747351 TAK-881-3003 2024-517450-95-00, jRCT2041250014 Ph 3 recruiting A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT02955355 results posted 161505 2016-000374-37 Ph 3 completed Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP
NCT04578535 results posted TAK-771-1001 Ph 1 completed A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
NCT03277313 results posted 161503 Ph 3 completed Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects
NCT02549170 results posted 161403 2014-005496-87 Ph 3 completed A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
NCT03116347 results posted 161504 2016-003438-26 Ph 4 completed Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects
NCT02556437 RH-2015-200 Ph 2 completed Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)
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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.

Hyqvia FDA Label Details

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Data Sources

FDA Approval: BLA125402 → Trials: ClinicalTrials.gov →

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