Data updated: Sep 20, 2026
Cinryze (c1 esterase inhibitor (human)) · Takeda
Approved 2008-10-09
1
Indication
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Prescription
- First Approved
- 2008-10-09
- Patent Cliff
- 2025
- Revenue
- $22M (Q3-FY2025)
- Routes
- Intravenous
- Dosage Forms
- For Injection
Cinryze Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2008 to 2008
Oct 2008 ORIGINAL
Update · CBER biologic (Purple Book)
What Cinryze Treats
1 FDA approvalsOriginally approved for its first indication in 2008 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2008)
Takeda's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01095497 results posted | 0624-200 SPD616-200 | Ph 2 | completed | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration |
| NCT01147302 results posted | 0624-201 2012-000441-12 | Ph 2 | completed | A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection |
| NCT01095510 results posted | 0624-203 2011-000369-11 | Ph 2 | completed | CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 |
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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.
Cinryze FDA Label Details
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Deep insights for Cinryze
Revenue Insights
- • Q3-FY2025: $22M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2025
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.