TheraRadar
Data updated: May 26, 2026

Ruconest (c1 esterase inhibitor (recombinant))

Approved 2014-07-15
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Prescription
First Approved
2014-07-15
Patent Cliff
2026

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Routes
Intravenous
Dosage Forms
For Injection

Companies

Pharming Americas BV
Active Ingredient: C1 Esterase Inhibitor (Recombinant)

Ruconest Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2014 to 2014
Jul 2014 ORIGINAL
Update · CBER biologic (Purple Book)

What Ruconest Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04705831 IIS202001-Neuroimmune Ph 2 completed Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
NCT06690047 Ruc01 Ph 4 completed Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)
NCT04530136 results posted C1 6201 Ph 2 completed Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

Ruconest FDA Label Details

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Data Sources

FDA Approval: BLA125495 → Trials: ClinicalTrials.gov →

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