Drugs / CINRYZE
CINRYZE
also known as
C1-esterase inhibitor · Berinert · C1 Esterase Inhibitor [Human] · C1 INH-nf · C1-INH · C1 inhibitor · C1 inhibitor (human) · HAEGARDA · +5 more
Protein / enzyme biologic targets C1R, C1S via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cinryze | — | 2011-06-15 | europa.eu ↗ |
Trials 38 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01694381 | Sep → Oct 2012 | ischemic stroke | TSI, LLC | Terminated | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT02435732 | Dec 2020 → May 2021 | kidney failure | University of Wisconsin, Madison | Unknown | No outcome recorded |
| Phase 1 | NCT01759602 | Jan → Nov 2013 | neuromyelitis optica | Michael Levy | Completed | No outcome recorded |
| Phase 1 | NCT01760343 | Jan → Mar 2013 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT00432510 | Oct 2006 → Feb 2007 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04696146 | Mar 2021 → Jul 2022 | end stage renal failure | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02134314 | Sep 2014 → Mar 2017 | end stage renal failure, ischemic disease, kidney failure | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01576523 | Apr → Dec 2012 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 1/2 | NCT01134510 | Aug 2011 → Nov 2013 | — | Stanley Jordan, MD | Completed | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT06919003 | Sep 2025 → May 2031 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06359782 | Nov 2024 → Mar 2027 expected | acquired aneurysmal subarachnoid hemorrhage | Haaglanden Medical Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT04489160 | Feb 2021 → Jul 2023 | traumatic brain injury | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT05010876 | Feb → Jun 2021 | COVID-19 | Ramsay Santé | Completed | No outcome recorded |
| Phase 2 | NCT02936479 | Oct 2016 → Oct 2018 | transplant rejection | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT01756157 | Feb → Sep 2013 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01426763 | Sep → Nov 2011 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01147302 | Aug 2011 → Apr 2013 | transplant rejection | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01095497 | Jun → Dec 2010 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01095510 | Jun 2010 → Apr 2012 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04898309 | Dec 2021 → May 2023 | hereditary angioedema | AO GENERIUM | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT00168103 | Jun 2005 → Oct 2007 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT03221842 | Nov 2017 → Jan 2021 | transplant rejection | CSL Behring | Terminated | No outcome recorded |
| Phase 3 | NCT02865720 | Sep 2016 → Jun 2017 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02547220 | May 2016 → May 2019 | acute transplant rejection | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT02584959 | Nov 2015 → Jul 2017 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT02316353 | Dec 2014 → Sep 2017 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT02052141 | Mar 2014 → May 2017 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01912456 | Jan 2014 → Oct 2015 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT01843530 | Nov 2013 → Oct 2018 | renin-angiotensin-aldosterone system-blocker-induced angioedema | Technical University of Munich | Completed | No outcome recorded |
| Phase 3 | NCT00438815 | Sep 2006 → Mar 2009 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00462709 | Jun 2006 → Mar 2009 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 3 | NCT00292981 | Aug 2005 → Feb 2010 | hereditary angioedema | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT00289211 | Mar 2005 → Apr 2007 | hereditary angioedema with C1Inh deficiency | Shire | Completed | No outcome recorded |
| Phase 3 | NCT01005888 | Mar 2005 → Aug 2007 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03576469 | Jun 2018 → Dec 2019 | common variable immunodeficiency | IMMUNOe Research Centers | Completed | No outcome recorded |
| Phase 4 | NCT03051698 | Nov 2016 → Oct 2019 | asthma | T. van der Poll | Terminated | No outcome recorded |
| Phase 4 | NCT01467947 | Nov 2011 → Oct 2014 | hereditary angioedema with C1Inh deficiency | CSL Behring | Completed | No outcome recorded |
| Phase 4 | NCT00914966 | Aug 2009 → May 2012 | hereditary angioedema | Shire | Completed | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02251041 Comparator | Sep 2014 → Feb 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01766414 Comparator | Sep → Oct 2013 | infectious disease with sepsis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01275976 Comparator | Apr 2012 → Feb 2015 | infectious disease with sepsis, multiple organ dysfunction syndrome | UMC Utrecht | Terminated | No outcome recorded |
| Phase 3 | NCT00748202 Comparator | Sep 2008 → Dec 2010 | hereditary angioedema | Johann Wolfgang Goethe University Hospital | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00785018 Comparator | Nov → Dec 2008 | multiple organ dysfunction syndrome | Radboud University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 25 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-09-26 | CSL Behring | CSL Receives Manufacturing and Marketing Authorization in Japan for “Berinert® S.C. Injection 2000,” as a Medicine for prevention of Acute Hereditary Angioedema (HAE) attacks csl.com ↗ |
| 2021-08-03 | CSL Behring | FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience csl.com ↗ |
| 2020-11-19 | CSL Behring | New Survey Finds Vast Majority of People Living with Hereditary Angioedema (HAE) Value Efficacy and Specific Correction of C1 INH Deficiency When Choosing an HAE Therapy csl.com ↗ |
| 2020-09-28 | CSL Behring | U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients csl.com ↗ |
| 2018-06-21 | Takeda | Shire Announces FDA Approval for Label Expansion of CINRYZE® (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients takeda.com ↗ |
| 2018-02-15 | Takeda | Shire Announces FDA Acceptance of sBLA for CINRYZE® (C1 esterase inhibitor [human]) for Pediatric Hereditary Angioedema Use takeda.com ↗ |
| 2018-01-24 | Takeda | FDA Grants Approval to Shire for Technology Transfer of CINRYZE® (C1 esterase inhibitor [human]) Drug Product Manufacturing Process to Vienna, Austria Manufacturing Site takeda.com ↗ |
| 2017-10-29 | CSL Behring | Data on the Preventive Effects of HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) in Subjects with Very Frequent HAE Attacks Presented by CSL Behring at the 2017 ACAAI Annual Scientific Meeting csl.com ↗ |
| 2017-10-24 | CSL Behring | New Data for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) to be presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting csl.com ↗ |
| 2017-09-11 | Takeda | Shire’s Investigational Subcutaneous C1 esterase inhibitor (C1 INH [Human]) Liquid for Injection (SHP616) Significantly Reduces Hereditary Angioedema Monthly Attack Rate Versus Placebo in a Phase 3 Pivotal Trial takeda.com ↗ |
| 2017-07-25 | CSL Behring | HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) Now Available in the United States for Patients with Hereditary Angioedema csl.com ↗ |
| 2017-07-21 | CSL Behring | CSL Behring Receives Orphan-Drug Exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) csl.com ↗ |
| 2017-06-23 | CSL Behring | FDA Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), First and Only Subcutaneous Preventive Treatment for Hereditary Angioedema csl.com ↗ |
| 2017-03-16 | Takeda | Shire Receives European Approval for Label Extension of CINRYZE®▼to Prevent and Treat Hereditary Angioedema (HAE) Attacks in Paediatric Patients with HAE takeda.com ↗ |
| 2016-07-18 | CSL Behring | U.S. FDA Approves CSL Behring’s Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE) csl.com ↗ |
| 2015-10-13 | Takeda | Shire’s CINRYZE® (C1 esterase inhibitor [human]) Receives FDA Fast Track Designation for Investigation in the Treatment of Antibody Mediated Rejection (AMR) in Patients Receiving Kidney Transplants takeda.com ↗ |
| 2015-08-25 | Takeda | Shire to Attain Enhanced CINRYZE® Manufacturing Flexibility and Capacity takeda.com ↗ |
| 2013-04-16 | CSL Behring | CSL Behring Receives European Health Authorities’ Approval of Berinert® for Short-Term Prophylaxis in Adults and Children csl.com ↗ |
| 2013-02-23 | CSL Behring | CSL Behring Analysis Shows Berinert® Provides Significant Relief from Cutaneous Attacks of Hereditary Angioedema csl.com ↗ |
| 2012-03-06 | CSL Behring | CSL Behring Study Confirms Early Treatment with Berinert Provides Faster Resolution of Acute Hereditary Angioedema Symptoms csl.com ↗ |
| 2012-01-03 | CSL Behring | CSL Behring Receives FDA Approval of Expanded Label on Berinert®; for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema csl.com ↗ |
| 2011-08-25 | CSL Behring | CSL Behring Receives European Health Authorities’ Approval for Self-Administration of Berinert csl.com ↗ |
| 2010-06-02 | CSL Behring | CSL Behring Receives Canadian Notice of Compliance for Berinert® csl.com ↗ |
| 2010-01-27 | CSL Behring | CSL Behring Launches Berinert® Expert Network (B.E.N.™), Support System for Hereditary Angioedema Healthcare Providers, Patients and Caregivers csl.com ↗ |
| 2009-10-12 | CSL Behring | CSL Behring Announces FDA Approval of Berinert®, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S. csl.com ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CINRYZE | “OBJECTIVES: To evaluate the use of Cinryze (nanofiltered C1-esterase inhibitor [C1 INH-nf]) for the acute management and prevention of hereditary angioedema attacks in the...” PMID 23312695 ↗ Jan 201310“CINRYZE® (C1 Esterase Inhibitor [Human])” NCT01147302 ↗ |
| Known as | Berinert | “The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH)...” PMID 21884533 ↗ Sep 20118“A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of...” NCT01576523 ↗ “are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury.” NCT02936479 ↗ |
| Known as | C1 Esterase Inhibitor [Human] | “A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated...” NCT02547220 ↗7“Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema” NCT02052141 ↗ |
| Known as | C1 INH-nf | “OBJECTIVES: To evaluate the use of Cinryze (nanofiltered C1-esterase inhibitor [C1 INH-nf]) for the acute management and prevention of hereditary angioedema attacks in the...” PMID 23312695 ↗ Jan 20137“A retrospective analysis of clinical trial and compassionate-use data was conducted to identify subjects who received nanofiltered C1 esterase inhibitor (C1 INH-nf; human)...” PMID 23484892 ↗ Mar 2013 “The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.” NCT00438815 ↗ “Biological: C1 esterase inhibitor [human] (C1INH-nf)” NCT01005888 ↗ “nanofiltered C1 inhibitor (C1 INH-nf; human)” PMID 25295804 ↗ Sep 2014 “C1 esterase inhibitor [human] (C1INH-nf)” NCT00432510 ↗ “C1 esterase inhibitor [human] (C1INH-nf)” NCT00462709 ↗ “C1 esterase inhibitor [human] (C1INH-nf)” NCT00289211 ↗ |
| Known as | C1 inhibitor | “Long-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE)” PMID 33588897 ↗ Feb 20216“OBJECTIVE: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI.” PMID 34863258 ↗ Dec 2021 “C1 inhibitor (C1-INH, Berinert) inhibits the classical and lectin pathways of C activation.” PMID 25606785 ↗ Feb 2015 “C1-inhibitor (C1INH) a relatively abundant plasma inhibitor” NCT01694381 ↗ |
| Known as | C1 inhibitor (human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00914966 ↗ |
| Known as | C1-esterase inhibitor | “Biological: C1 esterase inhibitor [human] (C1INH-nf)” NCT01005888 ↗ |
| Known as | C1-INH | “The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks” NCT02316353 ↗7“Cinryze® (Shire ViroPharma Inc., Lexington, MA, USA), a nanofiltered C1 inhibitor (C1-INH), is approved in Europe for the treatment” PMID 28662509 ↗ Jun 2017 “OBJECTIVE: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI.” PMID 34863258 ↗ Dec 2021 “C1 inhibitor (C1-INH, Berinert) inhibits the classical and lectin pathways of C activation.” PMID 25606785 ↗ Feb 2015 “human plasma-derived C1 esterase inhibitor (C1 INH) as add-on therapy to SOC for AMR” PMID 27184779 ↗ Jun 2016 “C1-inhibitor (C1INH) a relatively abundant plasma inhibitor” NCT01694381 ↗ “C1 inhibitor (human) [C1 INH]” NCT00914966 ↗ |
| Known as | C1-INH concentrate | “The placebo-controlled study International Multicentre Prospective Angioedema C1-INH Trial 1 (I.M.P.A.C.T.1) demonstrated that 20 U/kg C1 esterase inhibitor (C1-INH)...” PMID 21884533 ↗ Sep 2011 |
| Known as | C1-INH-R | “C1-esterase inhibitor [recombinant] (C1-INH-R)” NCT03576469 ↗ |
| Known as | CSL830 | “In a phase 2 trial, the use of CSL830, a nanofiltered C1 inhibitor preparation that is suitable for subcutaneous injection, resulted in functional levels of C1 inhibitor...” PMID 28328347 ↗ Mar 2017 |
| Known as | HAEGARDA | “Long-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE)” PMID 33588897 ↗ Feb 20211“a subcutaneous C1 inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) twice weekly significantly reduced the frequency of acute edema attacks.” PMID 31485239 ↗ Aug 2019 |
| Known as | pdC1-INH | “Long-term prophylaxis with twice-weekly intravenous injections of plasma-derived C1-inhibitor (pdC1-INH) has been established as an effective treatment.” PMID 26016741 ↗ Aug 2015 |
| Known as | pnfC1-INH | “OBJECTIVE: To assess the incidence of antibody formation during treatment with pasteurized, nanofiltered plasma-derived C1-INH (pnfC1-INH) in patients with hereditary...” PMID 27788880 ↗ Oct 2016 |
| Action | Restore | “Placebo-controlled studies established the efficacy of replacement therapy with C1 esterase inhibitor (C1-INH) concentrate for treating single acute hereditary angioedema (HAE) attacks” PMID 22856636 ↗ Jul 2012 |
| Modality | Protein / enzyme biologic | “Biological: C1 esterase inhibitor [human] (C1INH-nf)” NCT00289211 ↗ |
| Route | Intravenous | “C1-INH administered intravenously by slow injection or infusion” NCT00168103 ↗ |
| Target | C1R | “although C1r and C1s are targets of C1-inh” PMID 25191939 ↗ Sep 2014 |
| Target | C1S | “although C1r and C1s are targets of C1-inh” PMID 25191939 ↗ Sep 2014 |