Delving into the Latest Updates on Turoctocog alfa with Synapse

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

Novoeight I.V., Recombinant Human Coagulation Factor VIII(Novo Nordisk), Recombinant factor VIII(Novo Nordisk)

+ [10]

Target

F10

Action

stimulants

Mechanism

F10 stimulants(Coagulation factor X stimulants)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

HemorrhageHemophilia A

Inactive Indication-

Originator Organization

Novo Nordisk A/S

Active Organization

Novo Nordisk A/SNovo Nordisk Pharmaceuticals Pty Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (15 Oct 2013),

Hemophilia A

Regulation-

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Structure/Sequence

Sequence Code 453129443

Source: *****

Sequence Code 139887

Source: *****

The study has descriptive purposes, with aim of assessing how turoctocog alfa is used in the everyday practice and to provide a baseline for the management of haemophilia A and does not involve any change in the clinical management of participants. Data will be extrapolated from the existing paper based medical records and uploaded to an electronic database specifically created for the study. Baseline information/history will be recorded at time of switching from previous FVIII replacement therapy to turoctocog alfa from the enrolled participants and outcomes will be collected according to participants visit format.

Start Date10 Nov 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT04584892

/ CompletedNot Applicable

Turoctocog Alfa in Haemophilic Italian Patients: Protection and Engagement in Recreational Activities (THIRd). An Observational, Prospective, Multicentre, Cohort Study on Italian Patients With Haemophilia A in Prophylaxis Treatment With Turoctocog Alfa Under Current Clinical Conditions

This is a study on Italian patients with haemophilia A in prophylaxis treatment with Turoctocog alfa under routine clinical conditions. The purpose of the study is to investigate the therapeutic scheme in a population of patients treated with Turoctocog alfa and to investigate the participation in recreational activities, the level of physical activity, and quality of life. Participants will get NovoEight® (Turoctocog alfa) as prescribed to them by the study doctor. The study will last for about 12 months. Participants will be requested to fill in the Questionnaires investigating the participation in recreational activities, the level of physical activity, and quality of life.

Start Date12 Apr 2021

Sponsor / Collaborator

Novo Nordisk A/S

NCT03179748

/ CompletedNot Applicable

Non-interventional, Multi-Centre, Post-Authorisation Safety Study With Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

The trial is conducted in North America. The aim of the trial is to assess the safety of turoctocog alfa under conditions of routine clinical care in patients with haemophilia A in Mexico

Start Date20 Jun 2018

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Turoctocog alfa

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100 Translational Medicine associated with Turoctocog alfa

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100 Patents (Medical) associated with Turoctocog alfa

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456

Literatures (Medical) associated with Turoctocog alfa

10 Jan 2025·Current Pharmaceutical Design

A Comparative Review on the Production of Factor VIII in Human and Non-human Hosts

Article

Author: Sarrafzadeh, Mohammad-Hossein ; Moghimi, Hamid ; Ghaemi, Amirhossein

Hemophilia A (HA) is an inherited condition that is characterized by a lack of coagulation factor VIII (FVIII), which is needed for blood clotting. To produce recombinant factor VIII (rFVIII) for treatment, innovative methods are required. This study presents a thorough examination of the genetic engineering and biotechnological methods that are essential for the production of this complex process. Multiple host cells, such as animal, microbial, and human cell lines, are examined. Cultivating genetically modified cells enables the production of rFVIII, with further changes after protein synthesis, such as glycosylation, taking place in eukaryotic cells to guarantee correct folding. The extraction and purification of rFVIII require advanced methods, including affinity chromatography, to improve the purity of the protein. The purified protein undergoes rigorous quality control, which includes Sodium dodecyl-sulfate polyacrylamide gel electrophoresis (SDSPAGE) analysis, to assess its identity, purity, and functioning. The scalability of this approach allows for the synthesis of significant amounts of rFVIII for therapeutic purposes. Optimization strategies include modifying B-domain-deleted (BDD) FVIII, including introns in FVIII complementary DNA (cDNA) sequences to boost synthesis and storage, and making changes to chaperone-binding areas to optimize protein release. Furthermore, the search for a modified form of FVIII that has a longer duration of action in the body shows potential for enhancing the effectiveness of synthetic FVIII and progressing the treatment of hemophilia A. Future research should focus on improving the treatment of hemophilia A by developing a variant of FVIII that has increased stability and reduced immunogenicity.

01 Jan 2025·Research and Practice in Thrombosis and Haemostasis

Intermediate-dose immune tolerance induction outperforms with faster success, less bleeding, and no added cost in comparison with low dose: a multicenter randomized clinical trial

Article

Author: Xu, Qian ; Li, Zhengping ; Zhang, Heng ; Yao, Wanru ; Cheng, Xiaoling ; Zhen, Yingzi ; Fang, Yongjun ; Liu, Guoqing ; Huang, Jie ; Wu, Runhui ; Li, Zekun ; Xie, Liangzhi ; Poon, Man-Chiu ; Li, Gang ; Chen, Zhenping ; Zhou, Min ; Yang, Can ; Jin, Jiao

BackgroundLow-dose (LD) or intermediate-dose (MD) immune tolerance induction (ITI) is effective in children with severe hemophilia A (SHA) with high-titer inhibitors (HTIs) and is attractive in countries with economic constraints. However, high-quality evidence of their use is lacking.ObjectivesThis was a multicenter randomized clinical trial comparing the efficacy, safety, and medication cost between LD-ITI and MD-ITI for SHA-HTI children.MethodsChildren with SHA aged <8 years with historical/pre-ITI inhibitor titer 5 to 200 Bethesda Units/mL in 3 centers were randomized 1:1 to receive LD-ITI (recombinant factor VIII [rFVIII] 50 IU/kg every other day) or MD-ITI (rFVIII 100 IU/kg/d) from January 2022 to June 2024 (ChiCTR2200056603, https://www.chictr.org.cn).ResultsThirty-one patients (16 in MD-ITI and 15 in LD-ITI) were enrolled and followed for >24 months (median, 26.9; range, 24.0-29.5 months). The 2 groups had similar baseline clinical characteristics and similar success rates (93.8% [MD-ITI] vs 86.7% [LD-ITI]). Compared with LD-ITI, MD-ITI patients took a shorter median time to success (4.2 months vs 10.1 months) and partial success (2.7 months vs 6.6 months) and had lower mean rates for all bleeding (0.38/mo vs 1.40/mo) and joint bleeding (0.11/mo vs 0.83/mo). Between the 2 groups, although the MD-ITI group had higher rFVIII consumption (12,775 vs 7680 IU/kg), their total medication costs to success were similar (3626.49 vs 3240.38 US$/kg).ConclusionFor SHA-HTI children, the success rate and cost for MD-ITI and LD-ITI regimens were similar. MD-ITI regimen would be a priority for regions with economic constraints, considering the shorter time to success, better bleeding control, and no increase in medication cost.

31 Dec 2024·Hematology

Real-world long-term safety and effectiveness of turoctocog alfa in the treatment of haemophilia A in Japan: results from a multicentre, non-interventional, post-marketing study

Article

Author: Deguchi, Ayumi ; Nagao, Azusa ; Nogami, Keiji

OBJECTIVESTo assess the safety and effectiveness of turoctocog alfa in previously treated patients (PTPs) and previously untreated patients (PUPs) with haemophilia A in a real-world setting in Japan.METHODSThis multicentre, non-interventional, post-marketing study recruited patients with haemophilia A who initiated treatment with turoctocog alfa from 18 sites (08/2014-12/2018). The primary endpoint was adverse events (AEs) during the 2-year study period.RESULTSThe safety and effectiveness analysis set included 39 patients. In total, 13 (33.3%) patients reported ≥1 AE; incidence rate was 60.4 events/100 patient-years of exposure (PYE). Treatment was withdrawn in two cases: pruritus in a PTP and factor VIII inhibitor development in a PUP. Inhibitor development occurred in 2.6% of all patients, with an incidence rate of 3.8 events/100 PYE. The rate of inhibitor development was 0%, 25% and 20% in PTPs, PUPs and PUPs with severe type, respectively. The haemostatic success rate was 91.4% for 383 bleeding episodes and 85.7% for 14 surgeries. The negative binomial annualised bleeding rate for the prophylaxis regimen was 6.19 episodes/year (95% CI, 3.69-10.38). The mean (SD) total consumption of turoctocog alfa (n = 34; excluding FVIII inhibitors) was 5,382.6 (7,180.1) IU/kg/year/patient; consumption was 4,133.1 (1,452.4) IU/kg/year/patient for prophylaxis.DISCUSSIONThe effectiveness and safety profiles were comparable to those observed in other turoctocog alfa trials; effectiveness analysis and consumption were not affected by treatment regimens.CONCLUSIONLong-term use of turoctocog alfa therapy in clinical practice posed no newly identified safety issues and was effective for prophylaxis and treatment of bleeds in patients with haemophilia A in Japan.

100 Deals associated with Turoctocog alfa

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Turoctocog alfa	B02BD02	DB09109

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	European Union	Novo Nordisk A/S	13 Nov 2013
Hemorrhage	Norway	Novo Nordisk A/S	13 Nov 2013
Hemorrhage	Liechtenstein	Novo Nordisk A/S	13 Nov 2013
Hemorrhage	Iceland	Novo Nordisk A/S	13 Nov 2013
Hemophilia A	Canada	Novo Nordisk A/S	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hemophilia A	Phase 3	Turkey	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Phase 3	Serbia	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Phase 3	Russia	Novo Nordisk A/S	01 Apr 2009
Hemorrhage	Phase 3	Turkey	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Brazil	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Montenegro	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Taiwan Province	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Switzerland	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Israel	Novo Nordisk A/S	01 Apr 2009
Hemophilia A	Discovery	Malaysia	Novo Nordisk A/S	01 Apr 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISTH2020	Not Applicable	-	130	Turoctocog alfa	zshrdexqlo(uvdwwbgjzo) = two allergy events deiuyugmqr (dkrtutcmwo ) View more	-	12 Jul 2020
NCT03588741 (CTgov)	Phase 3	Hemophilia A	1	Turoctocog alfa	iopktmsbtw(oxeolszjjb) = veeodxfsyg qazyyqsnbs (oxgwtrlvxr, focccgofvf - rqejadhznn) View more	-	07 Jul 2020
NCT02938585 (Guardian 7, Pubmed) Manual	Phase 3	Hemorrhage \| Hemophilia A	62	recombinant factor VIII (prophylaxis)	(nfbxsixzbd) = fdqjwknfil qhjugrjprm (hgeuushhel )	Positive	23 Jun 2020
NCT02938585 (Guardian 7, Pubmed) Manual	Phase 3	Hemorrhage \| Hemophilia A	62	recombinant factor VIII	xvoiflohob(rnrwhahnxd) = jtuothxcjr pimsivdzwv (hbwlhzcmsw )	Positive	23 Jun 2020
NCT03449342 (guardian 10, CTgov)	Phase 4	Hemorrhage \| Hemophilia A	60	turoctocog alfa (Adolescents (12 - <18 Years))	gasqvwojkh(zwylcfulum) = grwrvgaspy iokdhncijy (zoglcyvrbc, hvcvtacqof - uaexauonwm) View more	-	18 Mar 2020
NCT03449342 (guardian 10, CTgov)	Phase 4	Hemorrhage \| Hemophilia A	60	turoctocog alfa (Adults (≥18 Years))	gasqvwojkh(zwylcfulum) = qrgavpoljj iokdhncijy (zoglcyvrbc, rgqmeqpcaf - nhnfxplquj) View more	-	18 Mar 2020
NCT01493778 (guardia 4, Pubmed \| Haemophilia) Manual	Phase 3	Hemophilia A First line	21	turoctocog alfa	(sukydvetxw) = xfypjoyshx fcofybkdoe (azzmodsedx, 3.34 - 5.44)	Positive	01 Jan 2020
NCT02938585 (Guardian 7 \| guardian TM 7, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	68	turoctocog alfa (Small Children (0 to <6 Years))	xsjvuzajhp(vxtcmyzmdc) = erdkbpsqjy iwiwhqcjsc (nvlrtsluog, pzbkodabba - nzccekvwji) View more	-	26 Aug 2019
NCT02938585 (Guardian 7 \| guardian TM 7, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	68	turoctocog alfa (Older Children (6 to <12 Years))	xsjvuzajhp(vxtcmyzmdc) = kittckqjfm iwiwhqcjsc (nvlrtsluog, hvtljbdqbb - mgdhzoyauu) View more	-	26 Aug 2019
NCT02938585 (Guardian 7, ISTH2019)	Phase 3	Hemophilia A	68	Turoctocog alfa	gnlrrhnhol(fzstaoghua) = rhorrxccpz cbocplbgan (hspnltsdyx ) View more	Positive	10 Jun 2019
NCT01493778 (guardian™4 \| guardia 4, CTgov)	Phase 3	Hemophilia A	60	turoctocog alfa	veexwqxgqc(uxgchmbjqh) = yriochyegq pgolmklfsq (bjdjbjsvae, vammliyidq - blwdsfucfw) View more	-	30 Oct 2018
NCT00840086 (guardian™1 \| guardian®1, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	150	Turoctocog Alfa (All Subjects Treated With Turoctocog Alfa)	nwhdwmgwad(hogxnyvzbb) = pbprvlghwl ulkvksaejr (ddetygcjmj, bdgwgxqsea - lxrshgwqmv) View more	-	04 Sep 2014
NCT00840086 (guardian™1 \| guardian®1, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	150	turoctocog alpha (Total (Part A + Part B))	xtndcfqqhy(psdbmjxehu) = ggfksjdclj dhcaercabj (ddadupkzvl, ethkzaguko - fbeickuicy) View more	-	04 Sep 2014
NCT01138501 (guardian®3 \| guardian™ 3, CTgov)	Phase 3	Hemophilia A	65	Turoctocog Alfa	uiyaeqdhai(lhqzevqscp) = nsmckfrufm drrhvllgpj (ldbzvaypoz, twadfqypvq - fyxkpdcwow) View more	-	11 Jun 2014

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Turoctocog alfa

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation