TheraRadar
Data updated: May 26, 2026

Cutaquig (immune globulin subcutaneous (human)-hipp)

Approved 2018-12-11
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-12-11
Routes
Subcutaneous
Dosage Forms
Solution

Companies

Octapharma
Active Ingredient: Immune Globulin Subcutaneous (Human)-hipp , Immune Globulin Subcutaneous (Human)-hipp , Immune Globulin Subcutaneous (Human)-hipp , Immune Globulin Subcutaneous (Human)-hipp , Immune Globulin Subcutaneous (Human)-hipp , Immune Globulin Subcutaneous (Human)-hipp

Cutaquig Approval History

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

What Cutaquig Treats

1 FDA approvals

Originally approved for its first indication in 2018 .

  • Other (1)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03939533 results posted SCGAM-06 Ph 3 completed Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases
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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.

Cutaquig FDA Label Details

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Data Sources

FDA Approval: BLA125668 → Trials: ClinicalTrials.gov →

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