TheraRadar
Data updated: May 26, 2026

Nuwiq (antihemophilic factor (recombinant))

Approved 2015-09-03
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2015-09-03
Routes
Intravenous
Dosage Forms
For Injection

Companies

Octapharma
Active Ingredient: Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant) , Antihemophilic Factor (Recombinant)

Nuwiq 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
Sep 2015 ORIGINAL
Update · CBER biologic (Purple Book)

What Nuwiq Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
📋

Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT05936580 GENA-23 Ph 4 recruiting Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery
NCT05935358 NuPOWER GENA-22 Ph 4 recruiting Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
NCT02932618 071102 2016-001477-33, 2023-509769-18-00 Ph 3 completed A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
NCT02973087 results posted 071301 2016-001478-14 Ph 3 completed rVWF IN PROPHYLAXIS
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

Nuwiq FDA Label Details

Track Nuwiq with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: BLA125555 → Trials: ClinicalTrials.gov →

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