What is Ruconest used for?

Ruconest is indicated for Hereditary C1 esterase inhibitor deficiency - deficient factor.

Ruconest is developed by Pharming Group N.V..

What development phase is Ruconest in?

Ruconest is FDA-approved (marketed).

What are the side effects of Ruconest?

Common side effects include Headache, Nausea, Diarrhea, Anaphylactic reaction, Abdominal pain, Rash.

What is the generic name of Ruconest?

CONESTAT ALFA is the generic (nonproprietary) name of Ruconest.

Last reviewed 2026-05-13 · How we verify

Ruconest (CONESTAT ALFA)

Pharming Group N.V. · FDA-approved approved Recombinant protein Quality 35/100

At a glance

Generic name	CONESTAT ALFA
Sponsor	Pharming Group N.V.
Modality	Recombinant protein
Therapeutic area	Other
Phase	FDA-approved
First approval	2010

Approved indications

Hereditary C1 esterase inhibitor deficiency - deficient factor

Common side effects

Headache
Nausea
Diarrhea
Anaphylactic reaction
Abdominal pain
Rash
Sneezing
Angioedema
Erythema marginatum
Skin burning sensation
Back pain
C-reactive protein increased

Key clinical trials

Improving Deceased-Donor Kidney Transplant Outcomes Via a Single Intragraft Injection of C1 Esterase Inhibitor (IMPROVE TRIAL) (PHASE2)
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection (PHASE2)
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation (PHASE2)
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH) (PHASE2)
Berinert (C1INH) vs Placebo for DGF/IRI (PHASE1,PHASE2)
Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest) (PHASE4)
Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
FDA label	Mechanism, indications, dosing, boxed warnings, drug interactions
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Ruconest CI brief — competitive landscape report
Ruconest updates RSS · CI watch RSS
Pharming Group N.V. portfolio CI