Data updated: Sep 20, 2026
Advate (antihemophilic factor (recombinant), plasma/albumin free method) · Takeda
Approved 2003-07-24
1
Indication
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Prescription
- First Approved
- 2003-07-24
- Revenue
- $174M (Q3-FY2025)
- Routes
- Intravenous
- Dosage Forms
- For Injection
Companies
Active Ingredient: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method , Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method
Website: ↗
Advate Approval History
2004
2005
2006
2007
2008
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 2003 to 2003
Jul 2003 ORIGINAL
Update · CBER biologic (Purple Book)
What Advate Treats
1 FDA approvalsOriginally approved for its first indication in 2003 .
- Other (1)
Other
(1 approval)- • Approved indication (Jul 2003)
Takeda's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07129343 | TAK-577-3002 | Ph 3 | recruiting | A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD) |
| NCT05582993 | TAK-577-3001 2023-509877-22-00, 2023 | Ph 3 | recruiting | A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) |
| NCT04985682 results posted | TAK-761-4009 2022-004149-11 | Ph 4 | completed | A Study of ADVATE in People With Hemophilia A in India |
| NCT04864743 | CTR20210830 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection |
| NCT05251090 | CTR20220279 | Ph 1 | completed | A Study to Evaluate the Safety and Pharmacokinetic of Recombinant Human Coagulation Factor VIII ，Fc Fusion Protein for Injection |
| NCT02306694 results posted | e11104 | Ph 3 | completed | Prospective Biomarkers of Bone Metabolism in Hemophilia A |
| NCT02483208 | 17608 2014-005173-36 | Ph 1 | completed | Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate |
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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.
Advate FDA Label Details
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Deep insights for Advate
Revenue Insights
- • Q3-FY2025: $174M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • 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.