Drugs / recombinant human C1 inhibitor
recombinant human C1 inhibitor
also known as
conestat alfa · Ruconest · C1 Esterase Inhibitor · ConA · Recombinant Human C1 Esterase Inhibitor
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ruconest | — | 2010-10-28 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Rhucin | — | 2008-05-22 | europa.eu ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT04530136 | Nov 2020 → Sep 2021 | COVID-19 | Pharming Technologies B.V. | Completed | Met primary |
| Phase 2 | NCT02247739 | Dec 2014 → May 2016 | hereditary angioedema | Pharming Technologies B.V. | Completed | Met primary |
| Phase 2 | NCT00851409 | Jun 2009 → Mar 2010 | hereditary angioedema | Pharming Technologies B.V. | Completed | No outcome recorded |
| Phase 2 | NCT00261053 | Jun 2003 → Sep 2005 | disease of genetic or genomic mechanism | Pharming Technologies B.V. | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT00225147 | Jul 2005 → Oct 2009 | hereditary angioedema | Pharming Technologies B.V. | Completed | Met primary |
| Phase 2/3 | NCT00262288 | Apr 2004 → Jan 2007 | disease of genetic or genomic mechanism | Pharming Technologies B.V. | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT00262301 | Jun 2004 → Jul 2009 | hereditary angioedema | Pharming Technologies B.V. | Completed | Met primary |
| Comparator or background therapy7 trials | ||||||
| Phase 2 | NCT05145283 Comparator | Mar 2022 → Jan 2026 | acute kidney injury, ischemic stroke | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 2 | NCT04912141 Comparator | Apr 2021 → Apr 2023 | myocardial infarction | Pharming Technologies B.V. | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04705831 Comparator | Jan 2021 → Mar 2024 | COVID-19, post-viral disorder | IMMUNOe Research Centers | Completed | No outcome recorded |
| Phase 2 | NCT04414631 Comparator | Aug 2020 → Sep 2021 | COVID-19 | University Hospital, Basel, Switzerland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02869347 Comparator | Jan 2017 → May 2018 | acute kidney injury | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 3 | NCT06679426 Comparator | Dec 2024 → Dec 2025 overdue | renin-angiotensin-aldosterone system-blocker-induced angioedema | University of Cincinnati | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06690047 Comparator | Aug 2018 → Apr 2022 | hereditary angioedema | Bernstein Clinical Research Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2020-08-17 | Pharming Technologies B.V. | Results Pharming announces the publication of data from a compassionate use program of RUCONEST® in COVID-19 patients in a peer-reviewed journal pharming.com ↗ |
| 2020-04-30 | Pharming Technologies B.V. | Regulatory Pharming receives European Commission approval for treatment of acute hereditary angioedema attacks in children with RUCONEST® pharming.com ↗
The extension of the indication means that RUCONEST® is now approved for the treatment of acute angioedema attacks in adults, adolescents, and children (aged two years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency in Europe |
| 2020-04-21 | Pharming Technologies B.V. | Results Pharming reports encouraging results from use of RUCONEST® in COVID-19 patients pharming.com ↗
Following treatment with RUCONEST®, fever resolved in four of the five patients within 48 hours, and laboratory markers of inflammation decreased significantly (CRP, IL-6). |
| 2020-03-27 | Pharming Technologies B.V. | Regulatory CHMP adopts positive opinion for treatment of acute angioedema attacks in children with hereditary angioedema with RUCONEST® pharming.com ↗ |
| 2020-03-09 | Pharming Technologies B.V. | Regulatory Pharming receives FDA approval of new facility for expansion of RUCONEST® production pharming.com ↗ |
| 2020-01-21 | Pharming Technologies B.V. | Regulatory Pharming receives EMA approval of new facility for expansion of RUCONEST® production (2020) pharming.com ↗
Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®. |
| 2019-02-25 | Pharming Technologies B.V. | Results Pharming announces abstract presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting and sponsorship of the AAAAI Foundation Michael M. Frank, MD, FAAAI Lectureship pharming.com ↗
The authors concluded that short-term prophylaxis with RUCONEST®, administered within approximately 60 minutes before the procedure, was efficacious and safe in adults and reduced the risk of an attack post-procedure. |
| 2019-01-21 | Pharming Technologies B.V. | Regulatory Pharming receives EMA approval of new facility for expansion of RUCONEST® production (2019) pharming.com ↗ |
| 2018-10-17 | Pharming Technologies B.V. | Results Pharming reports positive data from first investigator-initiated study of rhC1-Inhibitor (RUCONEST®) in Contrast-induced Nephropathy pharming.com ↗
The overall assessment of the study also showed trends that patients undergoing more invasive interventions and procedures requiring higher volumes of contrast medium experienced a stronger benefit from the RUCONEST® treatment. |
| 2017-11-27 | Pharming Technologies B.V. | Regulatory Pharming Submits Supplemental Biologics License Application to FDA for RUCONEST® for Prophylaxis of Hereditary Angioedema Attacks pharming.com ↗ |
| 2017-10-02 | Pharming Technologies B.V. | Results Pharming announces positive data from paediatric clinical trial with RUCONEST® pharming.com ↗
RUCONEST® provided clinically meaningful relief of symptoms in children with hereditary angioedema. |
| 2017-09-11 | Pharming Technologies B.V. | Results Pharming announces conclusion of FDA End of Phase 2 interactions on RUCONEST® for Prophylaxis of HAE pharming.com ↗
The two studies enrolled a total of 56 patients and showed consistent efficacy and safety results. |
All press releases naming this drug 23 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Recombinant Human C1 Inhibitor | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00225147 ↗ |
| Known as | C1 Esterase Inhibitor | “RUCONEST (C1 Esterase Inhibitor [Recombinant])” NCT04705831 ↗ |
| Known as | ConA | “Conestat alfa (ConA), a recombinant human C1 inhibitor, may prevent thromboinflammation.” PMID 37965347 ↗ Oct 2023 |
| Known as | conestat alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04912141 ↗ |
| Known as | Recombinant Human C1 Esterase Inhibitor | “Recombinant Human C1 Esterase Inhibitor (Ruconest®) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group,...” NCT04530136 ↗ |
| Known as | Ruconest | “Conestat alfa (Ruconest®) intervention group” NCT05145283 ↗ |
| Action | Inhibit | “recombinant human C1 inhibitor” NCT00262288 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human C1-inhibitor (rhC1INH)” NCT00225147 ↗ |
| Route | Intravenous | “Patients with an eligible attack were randomized to a single intravenous dose of rhC1INH or saline.” PMID 20920772 ↗ Oct 2010 |