eptacog alfa (activated)
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn brain injury 2 milestones | |||||
| Withdrawn | EU (EMA) | NovoSeven® | brain injury | 2005-08-11 | “The continued consultations with the European regulatory authorities (EMEA) have led Novo Nordisk to withdraw the phase 2-based registration file for NovoSeven® in trauma.” novonordisk.com ↗ “har Novo Nordisk nu trukket sin fase 2-baserede ansøgning om brug af NovoSeven® ved traumebehandling tilbage.” novonordisk.com ↗ |
| Filed | EU (EMA) | NovoSeven® | brain injury | — | “I januar 2005 indsendte Novo Nordisk ansøgning om tilladelse til at markedsføre NovoSeven® i Europa til behandling af ikke-penetrerende traumer, baseret på kliniske fase 2-data.” novonordisk.com ↗ “Novo Nordisk filed an application for European marketing approval for the use of NovoSeven® in blunt trauma based on clinical phase 2 data.” novonordisk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | NovoSeven | — | 1996-02-23 | europa.eu ↗ |
Trials 22
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT04768699 | Dec 2020 → Dec 2021 | hemophilia A, hemophilia B | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02470871 | Jul 2015 → Jul 2016 | congenital factor VII deficiency | CSL Behring | Completed | No outcome recorded |
| Phase 1 | NCT01561950 | May 2008 → Jan 2009 | vascular hemostatic disease | Novo Nordisk A/S | Terminated | No outcome recorded |
| Phase 1 | NCT00770718 | Apr 2008 → Apr 2010 | intracerebral hemorrhage | University of Utah | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT01561937 | Jan 2007 → Jul 2008 | vascular hemostatic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01561924 | Nov 2005 → May 2006 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT00486278 | Jun 2007 → Jun 2010 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00266006 | Jan 2006 → Apr 2007 | acquired coagulation factor deficiency, intracerebral hemorrhage | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00102037 | Jul 2004 → Feb 2006 | acquired coagulation factor deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00154492 | Apr 2004 → Aug 2006 | cirrhosis of liver, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT00426803 | Aug 2002 → Jun 2004 | acquired coagulation factor deficiency, intracerebral hemorrhage | Novo Nordisk A/S | Completed | Met primary |
| Phase 2 | NCT01601613 | Jul 2001 → Nov 2002 | Dengue hemorrhagic fever, hemorrhagic disease | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 37 trials · 2 missed | ||||||
| Phase 3 | NCT05695391 | Jun 2024 → Jun 2025 | hemophilia | LFB | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT02548143 | Aug 2016 → Aug 2017 | hemophilia | LFB | Completed | No outcome recorded |
| Phase 3 | NCT01392547 | Jul 2011 → Aug 2012 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT00184548 | Oct 2005 → Sep 2008 | hemorrhagic disease | Novo Nordisk A/S | Terminated | Missed primary |
| Phase 3 | NCT00214656 | Jun 2005 → Jun 2008 | blood coagulation disease, coronary artery disorder, heart valve disorder, myocardial ischemia | Austin Health | Unknown | No outcome recorded |
| Phase 3 | NCT00127283 | May 2005 → Jan 2007 | hemorrhagic disease, intracerebral hemorrhage | Novo Nordisk A/S | Completed | Missed primary |
| Phase 3 | NCT00375323 | — | hemophilia A | Medical University of Vienna | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07157423 | Aug 2025 → Aug 2027 expected | — | Novo Nordisk A/S | Recruiting | No outcome recorded |
| Phase 4 | NCT00108797 | Sep 2001 → Feb 2006 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT00166309 | Jul 2000 → Jun 2005 | severe hemophilia A | Skane University Hospital | Completed | Missed primary |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT01949792 Comparator | Sep → Nov 2013 | congenital hematological disorder, hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT03196284 Background | Aug 2017 → Sep 2018 | hemophilia A, hemophilia B | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 2 | NCT01105546 Comparator | Dec 2010 → Feb 2014 | hemophilia A | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 2 | NCT00810888 Comparator | Nov 2010 → Apr 2016 | intracerebral hemorrhage | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00128050 Comparator | Jan 2005 → Dec 2008 | intracerebral hemorrhage | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
| Phase 2/3 | NCT02484638 Comparator | Jul 2015 → Mar 2018 | hemophilia A, hemophilia B | CSL Behring | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT01625390 Comparator | Jun 2012 → Mar 2014 | hemophilia A, hemophilia B | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT03496883 Comparator | Dec 2021 → Jan 2028 expected | intracerebral hemorrhage | Joseph Broderick, MD | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03935334 Comparator | Jul 2018 → Jan 2021 | hemophilia | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 3 | NCT03079063 Comparator | Mar 2017 → Nov 2020 | congenital factor VII deficiency | AryoGen Pharmed Co. | Completed | No outcome recorded |
| Phase 4 | NCT01800435 Comparator | Oct 2011 → Oct 2012 | hemophilia A | Oslo University Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-09-19 | Beijing Tiantan Biological Products Co., Ltd. | Results 国药天坛蓉生rFⅦa瞬效止血，极速守护生命防线 ——止血更迅速、更有效、更安全 tiantanbio.com ↗
临床止血疗效显著，较同类产品，在止血成功率、每次出血平均给药次数、成功止血时间等指标上具有明显优势。 |
| 2017-02-01 | Takeda | Results New data from Shire aim to help close the diagnosis and treatment gap for people with Hemophilia takeda.com ↗
Results found a multi-fold increase in thrombin generation, indicating a potential thrombotic risk, for patients who receive the investigational agent combined with FEIBA or rFVIIa. |
| 2014-10-20 | AO GENERIUM | Results Научно-практическая конференция «Нерешенные вопросы акушерства и гинекологии» generium.ru ↗ |
| 2013-12-03 | AO GENERIUM | Results Cеминар "Современные медицинские технологии в лечении кровотечений" generium.ru ↗ |
| 2013-11-11 | AO GENERIUM | Results Семинар "Современные медицинские технологии в лечении акушерских кровотечений" generium.ru ↗ |
| 2013-10-04 | AO GENERIUM | Results Конференция «Современные стандарты в кардиоанестезиологии" generium.ru ↗
Согласно итогам клинического исследования в НЦССХ, посвященного исследованию эффективности и безопасности препарата Коагил-VII (rFVIIa) у взрослых пациентов и детей, данное лекарство является эффективным гемостатическим препаратом у больных кардиохирургического профиля любого возраста. |
| 2013-10-02 | AO GENERIUM | Results Тольяттинская осень-2013 generium.ru ↗
Собственный клинический опыт применения rVIIa в гематологическом научном центре МЗ РФ позволил докладчику сделать вывод, согласно которому rFVIIa может быть использован как «средство спасения» при геморрагическом синдроме. |
| 2008-06-11 | Novo Nordisk A/S | Results Novo Nordisk discontinues phase 3 clinical trial with NovoSeven® in trauma novonordisk.com ↗
Novo Nordisk today announced the decision to discontinue the phase 3 clinical trial with NovoSeven® for the treatment of bleeding in patients with severe trauma. |
| 2008-06-11 | Novo Nordisk A/S | Results Novo Nordisk indstiller klinisk fase 3-forsøg med NovoSeven® til traumebehandling novonordisk.com ↗
Novo Nordisk meddelte i dag, at virksomheden har besluttet at indstille det kliniske fase 3-forsøg med NovoSeven® til behandling af blødninger hos patienter med svære traumer. |
| 2007-02-26 | Novo Nordisk A/S | Results Phase 3 stroke trial shows that NovoSeven® reduces bleeding in the brain, but does not improve long-term clinical outcomes novonordisk.com ↗
The trial showed that treatment with NovoSeven® significantly reduced intracerebral bleeding compared to placebo treatment. |
| 2007-02-26 | Novo Nordisk A/S | Results Fase 3-forsøg inden for hjerneblødning viser, at NovoSeven® reducerer blødning, men forbedrer ikke det langsigtede behandlingsresultat novonordisk.com ↗
Forsøget viste, at behandling med NovoSeven® medførte en signifikant reduktion af blødningen i forhold til placebobehandling. |
| 2005-08-11 | Novo Nordisk A/S | Regulatory Regnskabsmeddelelse for perioden 1. januar til 30. juni 2005 novonordisk.com ↗
På baggrund af de fortsatte drøftelser med de europæiske registreringsmyndigheder (EMEA) har Novo Nordisk nu trukket sin fase 2-baserede ansøgning om brug af NovoSeven® ved traumebehandling tilbage. |
All press releases naming this drug 21 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eptacog alfa (activated) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02470871 ↗ |
| Known as | activated recombinant factor VII | “Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗1“A multicentred randomised, double blind, placebo-controlled trial evaluating the efficacy and safety of activated recombinant factor VII (rVIIa) in complex cardiac surgery.” NCT00214656 ↗ |
| Known as | activated recombinant human factor VII | “activated recombinant human factor VII (rFVIIa)” NCT01601613 ↗1“activated recombinant human factor VII” NCT00102037 ↗ |
| Known as | AryoSeven | “A single dose of eptacog alfa biosimilar (AryoSeven) 90 μg/kg or 270 μg/kg.” NCT03935334 ↗ |
| Known as | Coagulation Factor VIIa (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02548143 ↗ |
| Known as | Eptacog alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00128050 ↗ |
| Known as | Factor VIIa | “The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH.” NCT00128050 ↗ |
| Known as | Niastase | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗1“Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗ |
| Known as | NovoSeven | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗12“Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 2007 “Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in...” NCT00127283 ↗ “the study will compare the effects of a drug called recombinant activated factor VII (NovoSeven®) or rFVIIa with a placebo to determine which is better for reducing ICH growth.” NCT00810888 ↗ “The primary endpoint is the evaluation of efficacy of Factor VIIa (Eptacog alfa, NovoSeven, Novo Nordisk) on rebleeding after surgery for primary supratentorial ICH.” NCT00128050 ↗ “NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg” NCT01800435 ↗ “A single dose of eptacog alfa (Novoseven) 90 μg/kg or 270 μg/kg.” NCT03935334 ↗ “Use of NovoSeven® in Active Variceal Bleeding” NCT00154492 ↗ “Eptacog alfa (NovoSeven)” NCT07157423 ↗ |
| Known as | recombinant activated coagulation factor VII | “OBJECTIVE: To investigate whether recombinant activated coagulation factor VII (rFVIIa) reduces hemorrhage expansion among patients with spot sign-positive ICH.” PMID 31424491 ↗ Dec 2019 |
| Known as | recombinant activated factor VII | “Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 20078“We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and...” PMID 18480205 ↗ May 2008 “Control of bleeding in children with Dengue hemorrhagic fever using recombinant activated factor VII: a randomized, double-blind, placebo-controlled study.” PMID 16269927 ↗ Nov 2005 “We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.” PMID 15728810 ↗ Feb 2005 |
| Known as | Recombinant Factor VIIa | “FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic...” PMID 16990605 ↗ Sep 20063“The purpose of this study is to evaluate the treatment of Recombinant Factor VIIa (eptacog alfa (activated)) in patients with acute intracerebral bleeding.” NCT00127283 ↗ “"Salvage Use" of Recombinant Factor VIIa After Inadequate Haemostasis in Complex Cardiac Surgery” NCT00214656 ↗ “Recombinant Factor VIIa (NovoSeven)” NCT00375323 ↗ |
| Known as | recombinant FVIIa | “with one to three doses of recombinant FVIIa (rFVIIa) at 90 lg kg(-1) in the treatment of acute joint bleeds in hemophilia patients with inhibitors.” PMID 22470921 ↗ Jan 2012 |
| Known as | rFVIIa | “A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Activated Recombinant Factor VII...” NCT00184548 ↗8“Evidence suggests greater doses of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) than currently administered may result in enhanced...” PMID 18081834 ↗ Dec 2007 “FEIBA (factor VIII inhibitor-bypassing activity), an activated prothrombin complex concentrate (aPCC), and NovoSeven, recombinant factor VIIa (rFVIIa), are used as hemostatic...” PMID 16990605 ↗ Sep 2006 “We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII (rFVIIa) reduced growth of the hematoma and improved survival and...” PMID 18480205 ↗ May 2008 “the study will compare the effects of a drug called recombinant activated factor VII (NovoSeven®) or rFVIIa with a placebo to determine which is better for reducing ICH growth.” NCT00810888 ↗ “with one to three doses of recombinant FVIIa (rFVIIa) at 90 lg kg(-1) in the treatment of acute joint bleeds in hemophilia patients with inhibitors.” PMID 22470921 ↗ Jan 2012 “We sought to determine whether recombinant activated factor VII (rFVIIa) can reduce hematoma growth after intracerebral hemorrhage.” PMID 15728810 ↗ Feb 2005 “activated recombinant human factor VII (rFVIIa)” NCT01601613 ↗ “Recombinant Activated Factor VII (rFVIIa)” NCT00770718 ↗ |
| Known as | rVIIa | “This randomised placebo controlled study will test the hypothesis that Recombinant Activated Factor VII (rVIIa) will improve haemostasis after an inadequate response to...” NCT00214656 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant activated factor VII” PMID 17906567 ↗ Oct 2007 |
| Route | Intravenous | “to be administered bolus i.v. (intravenous) over approx. three hours.” NCT00184548 ↗ |