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Last update 24 Mar 2025
Moroctocog alfa
Last update 24 Mar 2025
Overview
Basic Info
Drug Type Recombinant coagulation factor |
Synonyms Antihemophilic Factor (Recombinant)(Genetics Institute), BDDrFVIII, FuseNGO + [14] |
Target |
Action stimulants |
Mechanism F10 stimulants(Coagulation factor X stimulants), Blood coagulation pathway activation, Coagulation factor VIII replacements |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (13 Apr 1999), |
RegulationPriority Review (China) |
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Structure/Sequence
Sequence Code 139887
Source: *****
Sequence Code 9955158
Source: *****
Related
23
Clinical Trials associated with Moroctocog alfaChiCTR2200056603
The outcome comparison of low- and medium-dose immune tolerance induction therapy using domestic recombinant coagulation factor VIII in severe hemophilia A children with high titer inhibitor: a randomized controlled clinical trial
CTRI/2020/01/022930
A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH MOROCTOCOG ALFA (AF-CC) PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATE AND SEVERE HEMOPHILIA A FOR A DURATION OF8 WEEKS
NCT02718677
NON-INTERVENTIONAL STUDY TO ASSESS THE HEALTH-RELATED QUALITY OF LIFE IN SEVERE OR MODERATELY SEVERE HEMOPHILIA A SUBJECTS TREATED WITH REFACTO AF ROUTINE PROPHYLAXIS
100 Clinical Results associated with Moroctocog alfa
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100 Translational Medicine associated with Moroctocog alfa
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100 Patents (Medical) associated with Moroctocog alfa
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128
Literatures (Medical) associated with Moroctocog alfa01 Dec 2024iScience
Advances in biopharmaceutical products for hemophilia
Review
Author: Yang, Huichuan ; Yu, Ding ; Wu, Junzheng ; He, Yanlin ; Liu, Xiaoling
Hemophilia is caused by the deficiency of clotting factors due to a single genetic abnormality. Replacement therapies have evolved from plasma-derived to recombinant coagulation factor concentrates but continue to have certain limitations. Monoclonal antibodies are clinical prophylactic treatment options unaffected by inhibitors and have better compliance than coagulation factor concentrates for patients with hemophilia. Gene therapy is a breakthrough in hemophilia treatment, as it drives the hepatic expression of factor VIII or factor IX and requires only a single administration to enable long-term replacement treatment in adult patients. Furthermore, biopharmaceutical products that target new pathways unaffected by inhibitors, including tissue factor pathway inhibitors, activated protein C, and antithrombin, as well as pharmaceutical technology advances to reduce dosing frequency, have demonstrated promising clinical results. This review provides a comprehensive overview of these biopharmaceutical products and explores the future of hemophilia treatment.
01 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 ; Zhou, Xinyue ; Wu, Xia ; 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
Moroctocog Alfa (AF-CC) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients with Hemophilia A 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 A is an X-linked congenital disorder, characterized by factor VIII (FVIII) deficiency. Globally, India has the highest population of patients with hemophilia, and there is a clear unmet need for appropriate and effective treatment for this patient population. This multicenter, open-label, post-approval study evaluated the safety and efficacy of moroctocog alfa in patients with moderate or severe congenital hemophilia A in India.
Methods:
Intravenous moroctocog alfa was administered 30 ± 5 IU/kg 3 times weekly for bleeding prophylaxis, according to the local product document. Participants were treated for up to 8 weeks, with an up to 4-week screening period and a subsequent post-treatment, 28-day safety observation period. Patients continued in the study until at least 24 exposure days or a period of up to 8 weeks on moroctocog alfa.
Results:
A total of 50 participants were enrolled, and 48 (85.7%) completed the study. No participants developed FVIII inhibitors during the study. The mean (SD) annualized bleeding rate during moroctocog alfa prophylaxis was 0.79 (2.0) with a median (range) of 0.00 (0.0, 6.8). The mean (SD) annualized total factor consumption (TFC) per participant was 287,432 (93,866) IU; the mean (SD) annualized TFC by weight per participant was 4176 (858) IU/kg. Moroctocog alfa was well tolerated with no reported treatment-emergent adverse event-related dose reductions, discontinuations, or serious adverse events.
Conclusion:
Moroctocog alfa was safe, effective, and well tolerated in Indian participants with congenital moderate to severe hemophilia A. No participant developed FVIII inhibitors during the study.
100 Deals associated with Moroctocog alfa
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08232 | Moroctocog alfa |
R&D Status
Approved
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Von Willebrand Diseases | Australia | 26 Jun 2009 | |
| Hemophilia A | European Union | 13 Apr 1999 | |
| Hemophilia A | Iceland | 13 Apr 1999 | |
| Hemophilia A | Liechtenstein | 13 Apr 1999 | |
| Hemophilia A | Norway | 13 Apr 1999 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Atrial Fibrillation | Phase 3 | - | 20 May 2002 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Not Applicable | - | ffyplojats(lqtgpozefo) = sqermzjhmo jzgcwyojqw (ackhfeqxnz ) | - | 09 Jun 2021 | |||
ffyplojats(lqtgpozefo) = ccljyglspo jzgcwyojqw (ackhfeqxnz ) | |||||||
Not Applicable | 27 | eyfgjfuovy(rqbpkroytw) = kphgstabyg pqelvyjbfe (lfdyqenvjp ) View more | Positive | 10 Jun 2019 | |||
Phase 3 | 66 | (Moroctocog Alfa (AF-CC), On Demand Cohort: On Demand Therapy) | uwciccyxct(dmqfbnbkwd) = pvyzopxqzr tiyzjcaqdc (clacfernrd, 32.2) | - | 11 Jan 2019 | ||
(Moroctocog Alfa (AF-CC), On Demand Cohort: RP Therapy 25 IU/kg) | uwciccyxct(dmqfbnbkwd) = wuwjncmctr tiyzjcaqdc (clacfernrd, 2.2) View more | ||||||
Phase 1 | 13 | hncdokdtto(jvwepuiunk) = kcxgzlvckn uashwyrcoj (cnggzuruzj ) View more | Positive | 01 Jul 2017 | |||
Phase 1 | 13 | owcbqxdjod(gdhakjqapk) = sowagqauoz tomswfpnwf (pukcgjevcc, 44) View more | - | 15 Jun 2016 | |||
Phase 3 | 53 | ltqnlshlpu(icckibjxsb) = ikqofqqvxi gfdrgcrerm (bskkqzaino, 0.65) View more | - | 08 Feb 2011 | |||
Phase 3 | 1 | ttbsvpcpsi = pfplqfgxxb vozbzdntqv (dujdttexol, qpeindplcr - rybauxvjtm) View more | - | 04 Jan 2011 | |||
Phase 3 | 30 | (Bolus Injection) | pemjjmhxzk = fiydykuibp bvyoedqben (ixdhycfgjl, kytlrwmujs - qedygfklce) View more | - | 20 Jul 2009 | ||
(Continuous Infusion) | pemjjmhxzk = xiegvajkcs bvyoedqben (ixdhycfgjl, ythcilkmlt - pppopfbdbg) View more |
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