Data updated: May 26, 2026
Xembify (immune globulin subcutaneous, human-klhw)
Approved 2019-07-02
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-07-02
- Routes
- Subcutaneous
- Dosage Forms
- Injection
Companies
Active Ingredient: immune globulin subcutaneous, human-klhw , immune globulin subcutaneous, human-klhw , immune globulin subcutaneous, human-klhw , immune globulin subcutaneous, human-klhw
Website: ↗
Xembify Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2019 to 2019
Jul 2019 ORIGINAL
Update · CBER biologic (Purple Book)
What Xembify Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2019)
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07540221 XPERT | GC2402 | Ph 3 | recruiting | A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy |
| NCT05645107 EXCELL | GC2202 XEMBIFY® - CLL, MM, and NHL, 2022-502193-16-00 | Ph 3 | recruiting | A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
Xembify FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.