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Last update 24 Mar 2025
Nonacog alfa
Last update 24 Mar 2025
Overview
Basic Info
Drug Type Recombinant coagulation factor |
Synonyms Benefix, Benefix Rts, Blood-coagulation-factor-IX-synthetic-human, Factor-IX-Genetics-Institute + [9] |
Target |
Action stimulants |
Mechanism F8 stimulants(Coagulation factor VIII stimulants), Blood coagulation pathway activation |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (11 Feb 1997), |
RegulationSpecial Review Project (China), Orphan Drug (Japan) |
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Structure/Sequence
Sequence Code 23878
Related
18
Clinical Trials associated with Nonacog alfaCTRI/2020/01/022929
A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF8 WEEKS - BeneFIX
NCT04286412
A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO SEVERE HEMOPHILIA B FOR A DURATION OF 8 WEEKS.
NCT03186677
A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients
100 Clinical Results associated with Nonacog alfa
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100 Translational Medicine associated with Nonacog alfa
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100 Patents (Medical) associated with Nonacog alfa
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80
Literatures (Medical) associated with Nonacog alfa01 Nov 2024GENE THERAPY
Activated factor X delivered by adeno-associated virus significantly inhibited bleeding and alleviated hemophilic synovitis in hemophilic mice
Article
Author: He, Xinyi ; Zhang, Feixu ; Xiao, Xiao ; Wu, Xia ; Zhou, Xinyue ; Li, Zhanao ; Hua, Baolai
In hemophilia, deficiency of factor VIII or IX prevents the activation of the common coagulation pathway, and inhibits the conversion of FX to activated FXa, which is required for thrombin generation. We hypothesized that the direct expressed FXa has the potential to activate the common pathway and restore coagulation in hemophilia patients. In this study, the cassettes that expressed FXa, FXaop and FXa-FVII were packaged into an engineered AAV capsid, AAV843, and were delivered into hemophilia A and B mice by intravenous injection. AAV-FXaop could be stably expressed in vivo and showed the best immediate and prolonged hemostatic effects, similar to those of commercial drugs (Xyntha and Benefix). AAV-FXaop also significantly inhibited bleeding in hemophilia A mice with inhibitors. In addition, FXa expression in joints significantly alleviated the occurrence of hemophilic synovitis. AAV-delivered FXa may be a novel target for treating hemophilic and hemophilic synovitis.
01 Oct 2023Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion
Nonacog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Moderately Severe or Severe Hemophilia B in India
Article
Author: Choraria, Nirmalkumar ; Simoneau, Damien ; Pai, Seema ; Ramakanth, G S H ; Chhabra, Amit ; Gupta, Pritam ; John, M Joseph ; Apte, Shashikant ; Rupon, Jeremy ; Parvatini, Shyam ; Chand, Rohit ; Rangarajan, Savita ; Muley, Hitesh Bhaskarrao
Abstract:
Purpose:
Hemophilia B is an X-linked congenital bleeding disorder caused by a deficiency of coagulation factor IX (FIX) clotting activity. This study evaluated safety and efficacy of nonacog alfa, a recombinant human blood coagulation FIX replacement product, in males aged 12–65 years with hemophilia B (FIX activity ≤ 2%) with or without inhibitors in India.
Methods:
In this multicenter, open-label, post-approval phase 4 study, participants were treated for up to 8 weeks, with up to a 4-week screening period and a subsequent post-treatment 28-day safety observation period. Intravenous nonacog alfa 40 IU/kg (range 13–78 IU/kg) was administered at intervals of 3–4 days, in accordance with the approved local product document.
Results:
A total of 25 participants were enrolled and completed the study. No participants developed FIX inhibitors during the study, experienced treatment-related adverse events (AEs) or serious AEs, or developed a thrombotic event and/or hypersensitivity reaction. No participants experienced bleeding events requiring on-demand treatment with nonacog alfa. Seventeen bleeding episodes (16 spontaneous and 1 traumatic) were reported in 10 participants; all occurred post treatment, with the exception of a minor gum-bleeding event, and were managed without treatment. The mean (SD) annualized total factor consumption (TFC) per patient was 224,582 (75,527) IU; the mean (SD) annualized TFC by weight per patient was 3639 (573) IU/kg.
Conclusion:
Nonacog alfa was safe and effective for the prevention of hemorrhagic episodes in Indian males with congenital, severe hemophilia B. No participants developed FIX inhibitors, and no new safety signals were reported.
01 Mar 2023Research and practice in thrombosis and haemostasis
Treatment switch to nonacog beta pegol factor IX in hemophilia B: A Canadian cost-consequence analysis based on real-world factor IX consumption and clinical outcomes.
Article
Author: Bentley, Anthony ; Matino, Davide ; Christoffersen, Pia ; Germini, Federico ; Iorio, Alfonso ; Poon, Man-Chiu ; Luckevich, Maria D ; Caillaud, Alexandre ; MacDonald, Vance ; Iserman, Emma ; Keepanasseril, Arun
Background:
The Canadian Bleeding Disorders Registry (CBDR) is a source of real-world data for Canadian patients with hemophilia B. Nonacog beta pegol (N9-GP), an extended half-life (EHL) recombinant factor IX (FIX) concentrate, was awarded a Canadian Blood Services contract in 2018 and subsequently made available across Canada (except Québec) to adult patients. For most patients already on another EHL FIX treatment, a switch to N9-GP occurred.
Objectives:
This study estimates the impact on treatment costs of a switch from a prior FIX to N9-GP based on annualized bleed rates and FIX consumption volumes before and after N9-GP switch from the CBDR.
Methods:
Real-world data from the CBDR for total FIX consumption and annualized bleed rates were used to inform a deterministic 1-year cost-consequence model. The model considered that the EHL to N9-GP switches were from eftrenonacog alfa and the standard half-life switches were from nonacog alfa. Because FIX prices are confidential in Canada, the model assumed cost parity for annual prophylaxis with each FIX based on the product monograph recommended dosing regimen to calculate an estimated price per international unit for each product.
Results:
The switch to N9-GP resulted in improvements in real-world annualized bleed rates and therefore reductions in annual breakthrough bleed treatment costs. Switching to N9-GP also resulted in reduced real-world annual FIX consumption for prophylaxis. Overall, annual treatment costs were 9.4% and 10.5% lower after the switch to N9-GP from nonacog alfa and eftrenonacog alfa, respectively.
Conclusion:
N9-GP improves clinical outcomes and may be cost-saving vs nonacog alfa and eftrenonacog alfa.
100 Deals associated with Nonacog alfa
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R&D Status
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hemophilia B | United States | 11 Feb 1997 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 4 | 25 | gzvfkcvbup = kapblkjjvf pynadktyly (ebfivgenga, aattegzcoq - wmyzrlpjaq) View more | - | 30 Jul 2021 | |||
Phase 4 | 70 | vvzryyvynd(gxsaelhzth) = lrchofhkht oidjcuixcp (himfqkmkeh, 0 - 7.7) View more | Positive | 28 May 2021 | |||
Phase 2 | 13 | fkvcsfeivw(nacqznqzhg) = ykkzyayigx hfwqsjpfcy (hdjftugwzm, 563.081) View more | - | 25 Jul 2017 | |||
Phase 4 | 70 | innpkyusms(mizzbitmbb) = mwdybsmvqr uhofsqlnfi (udlegekpnr, hfqnaqjsbs - pzbimoihfm) View more | - | 04 May 2017 | |||
Phase 1 | 12 | (BeneFIX 50 IU/kg; >=6 and <12 Years) | ebddujwlkt(okkpbiiowz) = wwepsishfw xotrbrosvo (stdoupkeet, 26) View more | - | 25 Jul 2016 | ||
(BeneFIX 50 IU/kg; Age Group:>=12 Years) | ebddujwlkt(okkpbiiowz) = svpotenpjx xotrbrosvo (stdoupkeet, 16) View more | ||||||
Phase 3 | 50 | (BeneFIX OD1) | hvnvtroumv(auguutoiju) = vkxmjirxkg pofwiyhcku (lxrlgrnlwt, xockdbrpwp - awutcqfdln) View more | - | 23 Aug 2011 | ||
(BeneFIX 100 IU/kg) | hvnvtroumv(auguutoiju) = ktoezbxheq pofwiyhcku (lxrlgrnlwt, fgknyfwhib - lzaqwcxguy) View more | ||||||
Phase 3 | 35 | wgbfxriwum(nonnptfhpj) = cbkzmfctcd zpetzlhopd (lcjalqqblv, 0.72) View more | - | 04 Jan 2011 | |||
Phase 4 | 1 | mqoleakctq(lzdlumasxx) = opbeyscdjd qeedzepyht (wrdzdbnvqu, yvfjkaylkw - scsufxagqu) View more | - | 29 Jun 2010 |
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