Data updated: May 26, 2026
Adynovate (antihemophilic factor (recombinant), pegylated)
Approved 2015-11-12
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-11-12
- Routes
- Intravenous
- Dosage Forms
- For Injection
Companies
Active Ingredient: Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated , Antihemophilic Factor (Recombinant), PEGylated
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Adynovate Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
Nov 2015 ORIGINAL
Update · CBER biologic (Purple Book)
What Adynovate Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 2015)
📋
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04690322 | STU-2020-1378 | Ph 4 | withdrawn | POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies |
| NCT05707351 results posted | TAK-660-3001 2023-000502-26 | Ph 3 | completed | A Study of Adynovate in Previously Treated Chinese Teenagers and Adults With Severe Hemophilia A |
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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.
Adynovate FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.