Drugs / CINRYZE
CINRYZE
also known as
C1 Esterase Inhibitor [Human] · C1 INH-nf · Berinert · C1-INH · C1-inhibitor · C1 Inhibitor, Human · C1-esterase inhibitor · pnfC1-INH
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed angioedema, hereditary, 4 1 milestone | |||||
| Filed | US (FDA) | CINRYZE | angioedema, hereditary, 4 | 2018-02-15 | “FDA accepted the CINRYZE® (C1 esterase inhibitor [human]) supplemental Biologics License Application (sBLA)” takeda.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Cinryze | — | 2011-06-15 | europa.eu ↗ |
Trials 26
| 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 13 trials | ||||||
| Phase 1 | NCT02435732 | Dec 2020 → May 2021 | kidney failure | University of Wisconsin, Madison | Unknown | 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 1/21 trial | ||||||
| Phase 1/2 | NCT04696146 | Mar 2021 → Jul 2022 | end stage renal failure | Cedars-Sinai Medical Center | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 2 missed | ||||||
| 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 | NCT01756157 | Feb → Sep 2013 | hereditary angioedema | Shire | Completed | Missed primary |
| Phase 2 | NCT01426763 | Sep → Nov 2011 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01147302 | Aug 2011 → Apr 2013 | transplant rejection | Shire | Completed | Missed primary |
| Phase 2 | NCT01095497 | Jun → Dec 2010 | hereditary angioedema | Shire | Completed | No outcome recorded |
| Phase 2 | NCT01095510 | Jun 2010 → Apr 2012 | hereditary angioedema | Shire | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04898309 | Dec 2021 → May 2023 | hereditary angioedema | AO GENERIUM | Withdrawn | No outcome recorded |
| Phase 38 trials · 4 met primary · 1 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT02052141 | Mar 2014 → May 2017 | hereditary angioedema | Shire | Completed | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00289211 | Mar 2005 → Apr 2007 | hereditary angioedema with C1Inh deficiency | Shire | Completed | Met primary |
| Phase 3 | NCT01005888 | Mar 2005 → Aug 2007 | hereditary angioedema | Shire | Completed | Met primary |
| Phase 43 trials | ||||||
| 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 |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT02251041 Comparator | Sep 2014 → Feb 2019 | — | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 31
| Date | Issuer | Release |
|---|---|---|
| 2022-09-26 | CSL Behring | Regulatory 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 | Regulatory FDA Approves New BERINERT® (C1 Esterase Inhibitor, Human (Intravenous)) Administration Kit for Increased Patient Convenience csl.com ↗ |
| 2020-06-06 | BioCryst Pharmaceuticals | Results Hereditary Angioedema Patients Report Breakthrough Attacks on Current Injectable/Infused Prophylaxis Medication biocryst.com ↗
Patient-reported attack history shows patients treated with current injectable or infused prophylactic medications (Takhzyro ® , Haegarda ® , Cinryze ® ) continue to experience breakthrough attacks with a mean ranging from 0.9 to 1.8 attacks over the three months prior to survey. |
| 2018-06-21 | Takeda | Regulatory Shire Announces FDA Approval for Label Expansion of CINRYZE® (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients takeda.com ↗
With the FDA label expansion of CINRYZE, children as young as 6 years old living with HAE now have the first FDA approved treatment option available to help prevent attacks. |
| 2018-02-15 | Takeda | Regulatory Shire Announces FDA Acceptance of sBLA for CINRYZE® (C1 esterase inhibitor [human]) for Pediatric Hereditary Angioedema Use takeda.com ↗
The filing has received Priority Review designation from the FDA, which means CINRYZE has an accelerated review target of eight months, instead of the standard of 12 months. |
| 2018-01-24 | Takeda | Regulatory 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 ↗
“With the FDA’s approval of the tech transfer, we are pleased to strengthen our supply reliability for adult and adolescent HAE patients who count on Cinryze to help prevent attacks,” said Matt Walker, Head of Technical Operations. |
| 2017-09-11 | Takeda | Results 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 ↗
This study met its primary endpoint and all key secondary endpoints. |
| 2017-03-22 | CSL Behring | Results NEJM Publishes Pivotal Data on Preventing HAE Attacks csl.com ↗
The study met its primary efficacy endpoint, significantly reducing the time-normalized number of HAE attacks. |
| 2017-03-16 | Takeda | Regulatory Shire Receives European Approval for Label Extension of CINRYZE®▼to Prevent and Treat Hereditary Angioedema (HAE) Attacks in Paediatric Patients with HAE takeda.com ↗
CINRYZE is now the first and only Hereditary angioedema treatment approved for routine prevention in paediatrics |
| 2016-07-18 | CSL Behring | Regulatory U.S. FDA Approves CSL Behring’s Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE) csl.com ↗
18 Jul 2016 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients. |
| 2015-10-13 | Takeda | Regulatory 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 ↗
today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CINRYZE ® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients. |
| 2014-07-03 | CSL Behring | Results Study Suggests C1-INH May Aid in Prevention of Antibody-Mediated Rejection Following Kidney Transplant csl.com ↗
The study shows that post-transplant treatment with C1-INH results in significant increases in the levels of complement components 3 and 4, suggesting that C1-INH inhibits activation of the complement system following transplantation. |
| 2014-03-01 | CSL Behring | Results Patient Satisfaction and Convenience Increased with Current Hereditary Angioedema Treatment Options, According to Study Findings csl.com ↗
As our results have shown, current treatment practices now align more closely with current HAE treatment guidelines, with patients demonstrating an increase in satisfaction and physicians noticing improved patient outcomes. |
| 2013-08-01 | Halozyme Therapeutics | Results Halozyme Provides Update on ViroPharma Phase 2 Trial of Subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) Formulation with rHuPH20 halozyme.com ↗
The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. |
| 2013-04-16 | CSL Behring | Regulatory CSL Behring Receives European Health Authorities’ Approval of Berinert® for Short-Term Prophylaxis in Adults and Children csl.com ↗ |
| 2013-02-23 | CSL Behring | Results CSL Behring Analysis Shows Berinert® Provides Significant Relief from Cutaneous Attacks of Hereditary Angioedema csl.com ↗
New data from a CSL Behring analysis show that treatment with Berinert® , C1 Esterase Inhibitor (Human), provides significant resolution of cutaneous attacks of hereditary angioedema (HAE). |
| 2012-09-21 | Halozyme Therapeutics | Regulatory ViroPharma And Halozyme Provide Update On Clinical Development Of Subcutaneous Cinryze® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) halozyme.com ↗
ViroPharma Incorporated (Nasdaq: VPHM) and Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced today that the U.S. Food & Drug Administration (FDA) has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. |
| 2012-08-11 | CSL Behring | Results Analysis Finds Improvements in Health-Related Quality of Life for Hereditary Angioedema Patients Treated with C1-Inhibitor csl.com ↗
More than half of the HAE patients participating in the assessment reported feeling somewhat or much better with the availability of C1-INH concentrate, and more than 80 percent of participants indicated a more optimistic outlook on the future. |
| 2012-03-06 | CSL Behring | Results CSL Behring Study Confirms Early Treatment with Berinert Provides Faster Resolution of Acute Hereditary Angioedema Symptoms csl.com ↗
While HAE patients treated within six hours of attack onset and those treated six hours or more after attack onset experienced a similar median time to onset of symptom relief, symptoms resolved considerably faster in patients who were treated earlier. |
| 2012-03-06 | Halozyme Therapeutics | Results ViroPharma and Halozyme Announce Positive Data of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Recombinant Human Hyaluronidase (rHuPH20) halozyme.com ↗
According to the presenters, these data demonstrate that subcutaneous co-administration of Cinryze with rHuPH20 was easy to administer, well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations. |
| 2012-01-03 | CSL Behring | Regulatory CSL Behring Receives FDA Approval of Expanded Label on Berinert®; for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema csl.com ↗
As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks. |
| 2011-12-06 | Halozyme Therapeutics | Results ViroPharma and Halozyme Therapeutics Announce Positive Data From Initial Phase 2 Assessment of Subcutaneous Cinryze® (C1 esterase inhibitor [human]) with Hyaluronidase (rHuPH20) halozyme.com ↗
In this study, the addition of rHuPH20 led to higher maximum levels and greater systemic exposure of functional and antigenic C1 inhibitor (C1 INH) for both Cinryze doses evaluated (1000 and 2000 units) as compared to subcutaneous administration of Cinryze alone. |
| 2011-11-05 | CSL Behring | Results Study Shows Efficacy of C1-Esterase Inhibitor Concentrate in Treating Acute Attacks of Hereditary Angioedema in Children and Adolescents csl.com ↗
New findings demonstrate that treatment with C1-esterase inhibitor (C1-INH) concentrate is effective in treating acute swelling attacks in children and adolescents with type I or type II hereditary angioedema (HAE), a rare and serious genetic disorder. |
| 2011-11-05 | CSL Behring | Results Study Shows C1-Esterase Inhibitor Concentrate Is Safe and Consistently Effective for Long-Term Treatment of Hereditary Angioedema Attacks at Any Body Location csl.com ↗
Additional data presented at the meeting confirms that C1-INH concentrate provided consistent and reliable treatment response in patients treated for multiple successive HAE attacks at any body location. |
| 2011-08-25 | CSL Behring | Regulatory CSL Behring Receives European Health Authorities’ Approval for Self-Administration of Berinert csl.com ↗
The expanded European label allows patients to self-administer Berinert by intravenous infusion, after consultation with a physician and after receiving the appropriate training. |
| 2010-06-02 | CSL Behring | Regulatory CSL Behring Receives Canadian Notice of Compliance for Berinert® csl.com ↗
02 Jun 2010 CSL Behring Canada announced today that it has received Notice of Compliance for Berinert® (Human C1 Esterase Inhibitor). |
| 2010-05-27 | CSL Behring | Regulatory First and Only Human C1-Esterase Inhibitor Approved for Treatment of Acute Attacks of Hereditary Angioedema throughout Europe, US and other countries csl.com ↗
27 May 2010 CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. |
| 2010-02-26 | CSL Behring | Results Surveys Reveal High Frequency of Prodromal Symptoms Prior to Acute Hereditary Angioedema Attacks csl.com ↗
According to survey findings, patients experienced prodromal symptoms before 70.5 percent of the 305 reported HAE attacks. |
| 2010-02-26 | CSL Behring | Results Study Shows C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute, Successive Attacks of Hereditary Angioedema at All Body Sites csl.com ↗
C1-esterase inhibitor (C1-INH) concentrate is an effective, well-tolerated therapy that rapidly relieves acute swelling attacks and successive attacks at any body location in patients with hereditary angioedema (HAE), a rare and serious genetic disorder, according to data presented today at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. |
| 2009-10-12 | CSL Behring | Regulatory 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 ↗
12 Oct 2009 CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert® C1-Esterase Inhibitor, Human for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE), a rare and serious genetic disorder, in adult and adolescent patients. |
| 2009-03-15 | CSL Behring | Results C1-Esterase Inhibitor Concentrate Rapidly Relieves Acute Swelling Attacks Across All Body Sites in Patients with Hereditary Angioedema, According to Study csl.com ↗ |
All press releases naming this drug 37 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 34 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 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01467947 ↗ |
| 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)” NCT00289211 ↗ “C1 esterase inhibitor [human] (C1INH-nf)” NCT00432510 ↗ “C1 esterase inhibitor [human] (C1INH-nf)” NCT00462709 ↗ |
| Known as | C1 Inhibitor, Human | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04489160 ↗ |
| Known as | C1-esterase inhibitor | “Biological: C1 esterase inhibitor [human] (C1INH-nf)” NCT01005888 ↗ |
| Known as | C1-INH | “Cinryze® (Shire ViroPharma Inc., Lexington, MA, USA), a nanofiltered C1 inhibitor (C1-INH), is approved in Europe for the treatment” PMID 28662509 ↗ Jun 20174“OBJECTIVE: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI.” PMID 34863258 ↗ Dec 2021 “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-inhibitor | “OBJECTIVE: To study the safety and efficacy of C1-inhibitor (C1-INH) compared to placebo in patients with TBI.” PMID 34863258 ↗ Dec 20214“C1-inhibitor (C1INH) a relatively abundant plasma inhibitor” NCT01694381 ↗ |
| 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 | Inhibit | “C1 esterase inhibitor (human)” NCT01095497 ↗ |
| Modality | Protein / enzyme biologic | “Biological: C1 esterase inhibitor [human] (C1INH-nf)” NCT00289211 ↗ |
| Route | Intravenous | “1,000 Units (U) of C1INH-nf administered intravenously (IV).” NCT00289211 ↗ |