Drugs / Fibrinogen Concentrate Human
Fibrinogen Concentrate Human
also known as
Human Fibrinogen · FCH · Haemocomplettan P · Fibrinogen human · EVARREST · EVARREST Fibrin Sealant Patch · FGTW · Raplixa · +3 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | TachoSil | — | 2004-06-08 | europa.eu ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03780894 | Nov 2018 → Jan 2021 | — | Blood and Tissue Bank of Catalonia | Completed | No outcome recorded |
| Phase 26 trials · 3 met primary | ||||||
| Phase 2 | NCT05091684 | Feb 2022 → May 2023 | blood platelet disease, hemorrhagic disease | University Hospital of Saint-Etienne | Terminated | No outcome recorded |
| Phase 2 | NCT04434001 | Feb 2020 → May 2021 | acquired coagulation factor deficiency, acute lung injury, congenital heart disease, hemorrhagic disease | IRCCS Policlinico S. Donato | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02117349 | Dec 2014 → Nov 2017 | — | Mallinckrodt | Terminated | Met primary |
| Phase 2 | NCT01575756 | Jun 2013 → Jan 2015 | congenital afibrinogenemia | Octapharma | Completed | No outcome recorded |
| Phase 2 | NCT00658723 | Mar 2008 → Apr 2009 | vascular hemostatic disease | Ethicon, Inc. | Completed | Met primary |
| Phase 2 | NCT00496262 | Jul 2007 → May 2008 | congenital fibrinogen deficiency | CSL Behring | Completed | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT01124981 | Feb 2011 → Dec 2014 | coagulation protein disease | Isala | Completed | Missed primary |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT01475669 | Jan 2012 → Jul 2014 | — | CSL Behring | Completed | Missed primary |
| Phase 3 | NCT00916656 | Oct 2009 → Mar 2014 | congenital afibrinogenemia | CSL Behring | Withdrawn | No outcome recorded |
| Phase 3 | NCT00365248 | Oct 2005 → May 2008 | liver disorder | Nycomed | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT03183479 | Jun 2017 → Aug 2019 | adolescent idiopathic scoliosis, hemorrhagic disease | Peking Union Medical College Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01955811 | Dec 2012 → Aug 2014 | — | Medical University Innsbruck | Completed | No outcome recorded |
| Phase 4 | NCT00290836 | May 2004 → Aug 2007 | — | Nycomed | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT03784794 | Nov 2018 → Nov 2020 | acquired coagulation factor deficiency, hemorrhagic disease | Angel Augusto Perez Calatayud | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT01681030 Comparator | Aug 2012 → Aug 2013 | cardiovascular disorder | Ethicon, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00701142 Comparator | Jun 2008 → Mar 2010 | aortic aneurysm | CSL Behring | Completed | No outcome recorded |
| Phase 3 | NCT02040428 Comparator | Jan 2014 → Jul 2015 | cardiovascular disorder | Ethicon, Inc. | Completed | Met primary |
| Phase 4 | NCT00440401 Comparator | Feb → Aug 2007 | vascular hemostatic disease | Nycomed | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Octapharma | Results Fewer Blood Components Transfused with fibryga® Than Cryoprecipitate, Secondary Analysis of Prespecified FIBRES Subgroups Reports octapharma.com ↗ |
| 2025-12-19 | Grifols Therapeutics LLC | Regulatory Grifols receives US FDA approval for new fibrinogen concentrate, FESILTYTM (fibrinogen, human-chmt) grifols.com ↗ |
| 2025-12-19 | Biotest | Regulatory Biotest gibt US-FDA-Zulassung für Grifols Fesilty bekannt biotest.com ↗ |
| 2025-11-13 | Biotest | Regulatory Biotest erhält Zulassung für neues Human Fibrinogen Prufibry in Deutschland biotest.com ↗ |
| 2025-06-23 | Biotest | Results Biotest´s positive Ergebnisse der Phase III-Studie zu Fibrinogen wurden in der Fachzeitschrift „The Lancet’s eClinicalMedicine” veröffentlicht biotest.com ↗ |
| 2025-01-09 | Grifols Therapeutics LLC | Regulatory Grifols submits Biologics License Application for its new fibrinogen solution to U.S. FDA grifols.com ↗
Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading manufacturer of plasma-derived medicines, today announced it has submitted a Biologics License Application (BLA) for its new potential fibrinogen treatment to the United States Food and Drug Administration (FDA). |
| 2025-01-09 | Biotest | Regulatory Wichtiger Meilenstein für Biotest - Zulassungsantrag für Fibrinogen in den USA bei der US Food and Drug Administration (FDA) eingereicht biotest.com ↗
Die Biologics License Application (BLA) für Fibrinogen von Biotest wurde bei der US Food and Drug Administration eingereicht. |
| 2024-08-09 | Octapharma | Regulatory FDA approves fibryga® for acquired fibrinogen deficiency, potentially ushering in a new standard of care octapharma.com ↗
Octapharma USA, Inc. has announced the expanded approval of fibryga ® , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA). |
| 2024-02-14 | Grifols Therapeutics LLC | Results Grifols announces positive topline phase 3 fibrinogen clinical trial results grifols.com ↗
The FC from Biotest, a Grifols Group company, met the primary endpoint. |
| 2021-03-30 | Octapharma | Regulatory FDA approvals strengthen Octapharma USA pediatric critical care product portfolio octapharma.com ↗
The supplement approvals resulted in new product labeling for Octaplas ™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga® , Fibrinogen (Human) Lyophilized Powder for Reconstitution. |
| 2020-08-14 | Octapharma | Regulatory Octapharma’s Fibryga® receives Health Canada approval to treat acquired fibrinogen deficiency (AFD) in surgical settings octapharma.com ↗
Octapharma Canada announces that Fibryga® (Human Fibrinogen Concentrate, HFC) has received Health Canada approval for use in treatment of acquired fibrinogen deficiency (AFD), in the course of surgical interventions. |
| 2019-10-31 | Octapharma | Results Octapharma announces publication of data on fibryga® for the treatment of acquired fibrinogen deficiency in patients undergoing cardiac surgery octapharma.com ↗
The data met the study’s prespecified noninferiority criterion and led to early termination of the trial. |
| 2012-12-19 | CSL Behring | Results Phase II Study Indicates that Fibrinogen Concentrate Given as a First-Line Therapy Safely Reduces Need for Transfusion after Aortic Surgery csl.com ↗
Clinical study results published today in the journal Anesthesiology showed that human fibrinogen concentrate can significantly reduce the need for blood transfusion when given as an intra-operative, targeted first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. |
All press releases naming this drug 16 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fibrinogen Concentrate Human | “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 ↗ Oct 2009 |
| Known as | EVARREST | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01681030 ↗ |
| Known as | EVARREST Fibrin Sealant Patch | “EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components...” NCT01681030 ↗ |
| Known as | FCH | “OBJECTIVES: To assess the pharmacokinetic (PK) profile, clot integrity and safety of fibrinogen concentrate (human) (FCH) in patients with afibrinogenemia.” PMID 19804533 ↗ Oct 20092“Single-dose human fibrinogen concentrate (FCH) was associated with the transfusion of increased allogeneic blood products (ABPs) versus placebo.” PMID 30462259 ↗ Apr 2019 “Fibrinogen Concentrate, Human (FCH)” NCT00916656 ↗ |
| Known as | FGTW | “Fibrinogen (FGTW)” NCT01955811 ↗ |
| Known as | Fibrinogen human | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00365248 ↗ |
| Known as | Haemocomplettan P | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01124981 ↗ |
| Known as | Human Fibrinogen | “Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen...” NCT00658723 ↗4“These samples will be spiked with Human Fibrinogen and clotting tests will be performed.” NCT01955811 ↗ “Equine collagen with Human Fibrinogen and Human Thrombin” NCT02040428 ↗ “Equine collagen with Human Fibrinogen and Human Thrombin” NCT01681030 ↗ |
| Known as | Raplixa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02117349 ↗ |
| Known as | RiaSTAP | “Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]” NCT03780894 ↗ |
| Known as | RiaSTAPTM | “Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.” NCT01575756 ↗ |
| Known as | TachoSil | “Fibrinogen human (TachoSil)” NCT00365248 ↗ |
| Action | Restore | “Together with the clot integrity and safety data and published data on efficacy, the results support the idea that FCH substitution can restore hemostasis with a good safety profile.” PMID 19804533 ↗ Oct 2009 |
| Modality | Protein / enzyme biologic | “Human fibrinogen/thrombin and bovine aprotinin” NCT00290836 ↗ |
| Route | Intravenous | “Single intravenous infusion of 70 mg/kg body weight” NCT00496262 ↗ |