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Drug

C1 esterase inhibitor (recombinant)

In clinical development
Emerging researchLate-stage development
Also known as CONESTAT ALFA, Complement C1 esterase inhibitor, Ruconest, C1 Inhibitor (Recombinant)+11 more

CONESTAT ALFA, Complement C1 esterase inhibitor, Ruconest, C1 Inhibitor (Recombinant), C1 esterase inhibitor, recombinant, C1-esterase inhibitor (recombinant), Human C1-inhibitor (recombinant, rabbit derived), Recombinant C1 esterase inhibitor, Recombinant complement C1 esterase inhibitor, Recombinant human C1 inhibitor, Recombinant human C1-INH, Recombinant human C1-esterase inhibitor, Recombinant human C1-inhibitor, Recombinant human C1-inhibitor rabbit milk derived, complement C1 esterase inhibitor (recombinant).

RxNorm1599831UNII5QS67N4551
2
Research papers
1
Active clinical trials
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).

Clinical trial2026-01-05Completed · ClinicalTrials.gov

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Conestat Alfa As a Treatment for Angiotensin-Converting Enzyme-Inhibitor-Induced Angioedema

Clinical trial2025-12-01Primary completion · ClinicalTrials.gov

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

Clinical trial2021-09-15Terminated · ClinicalTrials.gov

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Contrast-induced Nephropathy in High-risk Subjects (PROTECT): a Randomized, Placebo-controlled, Double-blind Single-center Trial

Clinical trial2018-07-01Completed · ClinicalTrials.gov

An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")

Clinical trial2018-06-26Results posted · ClinicalTrials.gov

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Efficacy and Safety of Recombinant Human C1 Inhibitor in the Prophylaxis of Angioedema Attacks in Patients With Hereditary Angioedema (HAE)

Clinical trial2017-12-08Results posted · ClinicalTrials.gov

A Randomized, Placebo-controlled, Double Blind Phase II/III Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Clinical trial2013-02-22Results posted · ClinicalTrials.gov

A Randomized, Placebo-controlled, Double-blind Phase III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Clinical trial2012-10-02Results posted · ClinicalTrials.gov

Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study.

Research2012-06-01Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology

Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema.

Research2010-10-01The Journal of allergy and clinical immunology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
C1 esterase inhibitor (recombinant)
Aliases & brands
CONESTAT ALFAComplement C1 esterase inhibitorRuconestC1 Inhibitor (Recombinant)C1 esterase inhibitor, recombinantC1-esterase inhibitor (recombinant)Human C1-inhibitor (recombinant, rabbit derived)Recombinant C1 esterase inhibitorRecombinant complement C1 esterase inhibitorRecombinant human C1 inhibitorRecombinant human C1-INHRecombinant human C1-esterase inhibitorRecombinant human C1-inhibitorRecombinant human C1-inhibitor rabbit milk derivedcomplement C1 esterase inhibitor (recombinant)
RxNorm CUI
1599831
UNII
5QS67N4551

Clinical trials

8 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
8
registered trials across all phases
LATEST COMPLETION 2026
1
Active studies
1
Recruiting
3
Late-stage (III+)
6
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 8
Phase 25Phase 2 / 31Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Study Evaluating the Safety and Efficacy of Conestat Alfa As a Treatment for Angiotensin-Converting Enzyme-Inhibitor-Induced Angioedema

Not yet recruitingPH IIIUniversity of Cincinnatin=242025

A Randomized, Placebo-controlled, Double Blind Phase II/III Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

CompletedPH II/IIIPharming Technologies B.V.n=772010

A Randomized, Placebo-controlled, Double-blind Phase III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

CompletedPH IIIPharming Technologies B.V.n=752009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).

CompletedPH IIUniversity Hospital, Basel, Switzerlandn=1412026

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Contrast-induced Nephropathy in High-risk Subjects (PROTECT): a Randomized, Placebo-controlled, Double-blind Single-center Trial

CompletedPH IIUniversity Hospital, Basel, Switzerlandn=802018

A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Efficacy and Safety of Recombinant Human C1 Inhibitor in the Prophylaxis of Angioedema Attacks in Patients With Hereditary Angioedema (HAE)

CompletedPH IIPharming Technologies B.V.n=322016

An Open-label Exploratory Phase II Study of the Safety and Immunogenicity of Repeated "rhC1INH" Administration of 50 U/Kg in Patients With Hereditary C1 Inhibitor Deficiency ("HAE")

CompletedPH IIPharming Technologies B.V.n=252010

A Randomized, Placebo-controlled, Double Blind Phase II/III Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

CompletedPH II/IIIPharming Technologies B.V.n=772010

A Randomized, Placebo-controlled, Double-blind Phase III Study of the Efficacy and Safety of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

CompletedPH IIIPharming Technologies B.V.n=752009

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102012
Most influential

Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema.

The Journal of allergy and clinical immunology · 2010 · 137 cites

Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study.

Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2012 · 36 cites
Recent papers

Efficacy and safety of recombinant human C1-inhibitor for the treatment of attacks of hereditary angioedema: European open-label extension study.

Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2012 · 36 cites

Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema.

The Journal of allergy and clinical immunology · 2010 · 137 cites
Journals, researchers & institutions
Top journals
  • Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology1
  • The Journal of allergy and clinical immunology1
Leading researchers
  • Cicardi M2
  • Relan A2
  • Visscher S2
  • Cancian M1
  • Cillari E1
  • Fabiani J1
  • Haase G1
  • Hack CE1
Leading institutions
free-text, unnormalised
  • Mures County Hospital1
  • University of California San Diego and San Diego VA Healthcare1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials