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Last update 24 Dec 2025

Rurioctocog alfa pegol

Last update 24 Dec 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Recombinant coagulation factor

Synonyms

Adynovi, Antihemophilic Factor (Recombinant), PEGylated, EHL rFVIII PEG

+ [15]

Target

F10

Action

stimulants

Mechanism

F10 stimulants(Coagulation factor X stimulants)

Therapeutic Areas

Congenital DisordersHemic and Lymphatic DiseasesOther Diseases

Active Indication

Coagulation Protein DisordersHemophilia AHemorrhage

Inactive Indication-

Originator Organization

Baxalta, Inc.

Active Organization

Baxalta, Inc.

Takeda Pharmaceutical Co., Ltd.Takeda Development Center Americas, Inc.

+ [3]

Inactive Organization

Baxter Innovations GmbH

Takeda (China) International Trading Co. Ltd.Baxalta Canada Corp.

License Organization

Nektar Therapeutics

Baxter International, Inc.

Healthcare Partners

Drug Highest PhaseApproved

First Approval Date

United States (13 Nov 2015),

Hemophilia A

Regulation-

Structure/Sequence

Sequence Code 26728

Source: *****

Clinical Trials associated with Rurioctocog alfa pegol

NCT05707351

/ CompletedPhase 3

A Phase 3, Prospective, Multicenter, Open-label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (ADYNOVATE) Administered for Prophylaxis and Treatment of Bleeding in Chinese Previously Treated Patients With Severe Hemophilia A (FVIII <1%)

The main aim of the study is to determine how well Adynovate works to decrease bleeding in previously treated Chinese men and boys with severe hemophilia A when given prophylactically.
Participants will be treated with Adynovate twice a week for 26 weeks or until participants have received 50 days of treatment with Adynovate (whichever takes longer). Participants will need to visit their study clinic several times during their participation.

Start Date27 Mar 2023

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT05042440

/ CompletedPhase 1

A Phase 1, Single-Site, Open-Label Study to Assess Pharmacokinetics of Efanesoctocog Alfa (BIVV001), Standard Half-Life and Extended Half-Life FVIII After Each Single Intravenous Injection in a Fixed Sequence, in Previously Treated Adults With Severe Hemophilia A

Primary objective
• To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection
Secondary objectives
* To characterize additional pharmacokinetic (PK) parameters of BIVV001, SHL rFVIII and EHL rFVIII after a single IV injection
* To evaluate the safety and tolerability of a single IV injection of BIVV001

Start Date11 Aug 2021

Sponsor / Collaborator

Sanofi

NCT04941898

/ CompletedNot Applicable

Adynovate Special Drug Use Result Survey (Perioperative Administration)

This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII.
The aims of this study are as follows:
* To check for side effects from TAK-660.
* To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.

Start Date30 Jun 2021

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

100 Clinical Results associated with Rurioctocog alfa pegol

100 Translational Medicine associated with Rurioctocog alfa pegol

100 Patents (Medical) associated with Rurioctocog alfa pegol

Literatures (Medical) associated with Rurioctocog alfa pegol

01 May 2025·ADVANCES IN THERAPY

Efficacy and Safety of Recombinant Factor VIII in Previously Untreated and Previously Treated Children with Hemophilia A: A Systematic Review

Review

Author: Sun, Jing ; Wang, Zhenguo ; Zhou, Xuan ; Feng, Xiaoqin

INTRODUCTION:

Inhibitor development is a primary concern for pediatric patients with hemophilia A (HA) undergoing recombinant factor VIII (rFVIII) therapy, yet relevant research is lacking. We aimed to compare the efficacy and safety of standard (SHL) and extended half-life (EHL) rFVIII products in previously treated (PTPs) and untreated (PUPs) pediatric patients with HA.

METHODS:

Following PRISMA guidelines, we searched clinical studies from PubMed, Embase, and Cochrane Library. Data were extracted and a single-arm meta-analysis was performed.

RESULTS:

This systematic review included 16 studies involving 1145 patients. Three studies reported changes in annual bleeding rate (ABR); their results displayed no statistically significant difference in ABR changes in pediatric patients with HA after rFVIII treatment. Ten studies reported inhibitor development, nine focused on PUPs. Here, EHL rFVIII showed a proportion of inhibitors at 27.5% (95% confidence interval [CI] 22.6%; 32.6%), and third-generation SHL rFVIII showed a proportion of inhibitors at 36.4% (27.2%; 46.2%), with a high-titer proportion of 20.9% (12.9%; 30.3%) for the latter. Both SHL rFVIII (octocog alfa) and EHL rFVIII (rurioctocog alfa pegol) presented low proportions of inhibitor development. Octocog alfa exhibited the lowest high-titer inhibitor incidence, marked at 12.7% (5.3%; 24.5%). Eleven studies addressed adverse events (AEs), with octocog alfa showing low reported treatment-related AEs at a proportion of 14.5% (6.5%; 26.7%).

CONCLUSION:

Our analysis revealed that both octocog alfa and rurioctocog alfa pegol showed low inhibitor development, with octocog alfa having few treatment-related AEs. Regular monitoring for inhibitors during rFVIII therapy is important.

01 Jan 2025·ADVANCES IN THERAPY

Efanesoctocog Alfa versus Standard and Extended Half-Life Factor VIII Prophylaxis in Adolescent and Adult Patients with Haemophilia A without Inhibitors

Review

Author: Klamroth, Robert ; Kragh, Nana ; Wojciechowski, Piotr ; Margas, Wojciech ; Bystrická, Linda ; Arnaud, Alix ; Wdowiak, Marlena ; Guyot, Patricia ; Wilson, Amanda ; Tosetto, Alberto

INTRODUCTION:

In the Phase 3 XTEND-1 trial, (NCT04161495) efanesoctocog alfa prophylaxis provided superior bleed protection versus pre-study factor VIII (FVIII) replacement therapy in patients with severe haemophilia A. The aim of this study was to indirectly compare bleed outcomes between efanesoctocog alfa and standard/extended half-life (SHL and EHL) FVIII replacement therapies in adolescent and adult patients with severe haemophilia A without inhibitors.

METHODS:

A systematic literature review was conducted to identify Phase 3 trials of EHL and SHL FVIII replacement therapies for comparison with efanesoctocog alfa data from XTEND-1. Matching-adjusted indirect comparisons were used to compare annualised bleeding rates (ABRs) for any, treated, joint, and spontaneous bleeds between efanesoctocog alfa and comparators. The estimates from respective comparisons were pooled using random-effect meta-analyses to evaluate the overall difference between efanesoctocog alfa and comparator therapies.

RESULTS:

Four EHL therapies (rurioctocog alfa pegol, efmoroctocog alfa, turoctocog alfa pegol, damoctocog alfa pegol) and two octocog alfa SHL therapies were included. In meta-analyses, efanesoctocog alfa was associated with significantly lower ABRs for any [mean difference (95% CI) - 2.24 ( - 3.24; - 1.25)], spontaneous [ - 1.52 ( - 2.33; - 0.72)], and joint bleeds [ - 1.60 ( - 2.32; - 0.88)] versus EHL therapies, and with significantly lower ABRs for any [ - 3.61 ( - 4.43; - 2.79)], treated [ - 1.55 ( - 1.89; - 1.20)], spontaneous [ - 2.52 ( - 3.31; - 1.72)], and joint bleeds [ - 3.42 ( - 4.77; - 2.08)] versus SHL therapies.

CONCLUSION:

Efanesoctocog alfa was associated with significantly lower ABRs (any, spontaneous and joint) compared with EHL or SHL prophylaxis therapies. Patients had, on average, 2.2 and 3.6 fewer bleeds per year versus EHL and SHL therapies, respectively.

01 Dec 2024·Blood Research

Real-world insights into the management of hemophilia A in Italy: treatment patterns and healthcare resource utilization

Article

Author: Cappuccilli, Maria ; Leogrande, Melania ; Perrone, Valentina ; Esposti, Luca Degli

Abstract:

Purpose:

This real-world analysis described the Hemophilia A (HA) population in Italy, evaluating drug utilization and consumption of factor VIII (FVIII) products of patients under prophylaxis and on-demand therapy.

Methods:

From Jan-2017 to Jun-2022, male patients with HA were identified through prescriptions of FVIII products [extended half-life FVIII, standard half-life recombinant FVIII, and plasma-derived FVIII (EHL FVIII, SHL rFVIII, and pdFVIII, respectively)], or emicizumab or FVIII plus von Willebrand factor or HA-related hospitalization using administrative flows of Italian healthcare entities. Patients on treatment with FVIII products during 2021–2022 were stratified by treatment regimen (prophylaxis/on-demand). The mean annual consumption expressed in International Units (IU) of EHL FVIII and SHL FVIII in patients treated during 2021–2022 having at least 12-month follow-up were assessed.

Results:

Among included HA patients, 145 (39.5%) received EHL FVIII and 222 (60.5%) SHL FVIII. Of 165 patients on prophylaxis, 105 (64%) received an EHL FVIII and 60 (36%) an SHL FVIII. The mean annual consumption of FVIII was 336,700 IU (median 319,000 IU) for EHL FVIII and 440,267 IU (median 360,500 IU) for SHL FVIII. Specifically, for patients on EHL FVIII, the most common drugs were efmoroctocog alfa (N = 51) and damoctocog alfa pegol (N = 50), followed by turoctocog alfa pegol (N = 25) and rurioctocog alfa pegol (N = 19). Of 702 HA patients initially treated with FVIII products, 74 (10.5%) switched to emicizumab during follow-up.

Conclusion:

These findings revealed an extensive use of EHL FVIII products, suggesting growing efforts from clinicians to optimize prophylactic strategies and achieve better bleeding protection.

News (Medical) associated with Rurioctocog alfa pegol

03 Sep 2025

·pharma.economictimes.indiatimes.com

GST waiver for 36 drugs; formulations under 5% slab

New Delhi: Executing the much-awaited overhaul of the Goods and Services Tax (GST) regime, the GST Council has brought a major relief for patients by reducing the indirect tax on medicines to 5 per cent, along with exempting as many as 36 life-saving medicines and other critical drugs. The GST council—a statutory body highest decision making body on indirect taxes led by the Union Finance Ministry at its 56th meeting in the national capital has recommended to reduce the GST on all drugs and medicines (finished formulations) from 12 per cent to 5 per cent under the new two-tier tax structure of 5 and 18 per cent slabs to be effective from September 22. Additionally the body has also recommended to exempt GST on 33 lifesaving drugs and on 3 other medicines used for treatment of cancer, rare diseases and other severe chronic diseases. Speaking at a press briefing after the council 10.5-hour long marathon meet, Finance Minister Nirmala Sitharaman said, “all recommendations have been cleared with zero reservations and have corrected various inverted duty structure problems, classification related issues and that this rationalization exercise will bring predictability and stability of GST.” “These reforms have been carried out with a focus on the common man, and after a rigorous evaluation process in most sectors including healthcare, the rates have come down drastically, she added. Previously, medicines in India were taxed at 5 per cent for life-saving and essential drugs, and at 12 per cent for others but following the announcement all medicines will attract a standard duty of 5 per cent with extensions for several medicines specified at the end of this article. Welcoming the move, Sudarshan Jain, Secretary General, IPA said, “the decision to exempt life-saving and cancer medicines from GST, is a step that will bring direct relief to patients and their families. and, the reduction in GST on a wide range of medicines from 12 per cent to 5 per cent will further help to ease the overall treatment burden and make essential therapies more affordable.” Meanwhile, for companies, the clarity on a 5 per cent slab and exemptions removes long-standing ambiguity, enabling transparent pricing and better market planning. The move will expand access in semi-urban and rural markets, ease litigation, and free up resources for innovation, said Manoj Mishra, Partner and Tax Controversy Management Leader, Grant Thornton Bharat LLP. Notably, on the issue of inverted duty involving APIs and key starting materials—which are currently taxed at 18 per cent against 12 or 5 per cent for finished formulations—further clarity is awaited from the industry. ETPharma earlier reported that, in a letter to the Finance Minister, the national chemist body, the All India Organisation of Chemists and Druggists (AIOCD) had urged, “to bring all medicines including vitamins, probiotics, nutritional, food supplements under the 5 per cent GST slab. The rate rationalization comes days after Prime Minister Narendra Modi had pitched for introducing next-gen reforms across sectors to “increase ease of living for the common man and strengthen the economy.” However, this rationalization brings a revenue shortfall challenge for governments with states likely to bear a greater share of the burden, as they receive over 40 percent of the inter-state inflows in addition to their own SGST collections. Responding to a media query at the media briefing Arvind Shrivastava, Revenue Secretary said that, based on the consumption of FY23-24 the ministry has estimated that the net revenue implication of this proposal will be around Rs 48,000 crore. “However the exercise will trigger buoyancy effects and will have a positive impact on consumer and compliance. And therefore we believe this proposal will be fiscally sustainable both for centers and the states,” Shrivastava noted. ' S.no. Drug Indication Brand name and (Company) 1 Onasemnogene abeparvovec SMA (One-time gene therapy) Zolgensma (Novartis) 2 Asciminib Blood Cancer Scemblix (Novartis) 3 Mepolizumab Asthma Nucala (GSK) 4 Pegylated Liposomal Irinotecan Pancreatic Cancer Onivyde (Ipsen) 5 Daratumumab Cancer Darzalex (J&J subsidiary) 6 Daratumumab subcutaneous Cancer Darzalex Faspro (J&J subsidiary) 7 Teclistamab Blood Cancer Tecvayli (J&J subsidiary) 8 Amivantamab Lung Cancer Rybrevant (J&J subsidiary) 9 Alectinib Lung Cancer Alecensa (Roche) 10 Risdiplam SMA Evrysdi (Roche) 11 Obinutuzumab Blood Cancer Gazyva (Roche) 12 Polatuzumab vedotin Blood Cancer Polivy (Roche) 13 Entrectinib Cancer Rozlytrek (Roche) 14 Atezolizumab Cancer (PD-L1 immunotherapy) Tecentriq (Roche) 15 Spesolimab GPP flares Spevigo (Boehringer Ingelheim) 16 Velaglucerase Alpha Gaucher Vpriv (Takeda) 17 Agalsidase Alfa Fabry disease Replagal (Takeda) 18 Rurioctocog Alpha Pegol Hemophilia Adynovate (Takeda) 19 Idursulphatase Type II Mucopolysaccharidosis Elaprase (Takeda) 20 Alglucosidase Alfa Pompe Myozyme (Sanofi) 21 Laronidase Type I Mucopolysaccharidosis Aldurazyme (Sanofi) 22 Olipudase Alfa ASMD Xenpozyme (Sanofi) 23 Tepotinib Lung Cancer Tepmetko (Maerck KGaA) 24 Avelumab Cancer (PDL-1 immunotherapy) Bavencio (Pfizer) 25 Emicizumab Hemophilia Hemlibra (Roche subsidiary) 26 Belumosudil cGVHD - 27 Miglustat Gaucher Zavesca (J&J subsidiary) 28 Velmanase Alfa Alpha-mannosidosis - 29 Alirocumab Cholesterol lowering drug (LDL-C) Praluent (Sanofi) 30 Evolocumab Cholesterol lowering drug (LDL-C) Repatha (Amgen) 31 Cystamine Bitartrate Cystagon - 32 CI-Inhibitor injection Hereditary Angioedema - 33 Inclisiran Cholesterol lowering drug (LDL-C) Leqvio (Novartis) 34 Agalsidase Beta Fabry disease Fabrazyme (Sanofi) 35 Imiglucerase Gaucher Cerezyme (Sanofi) 36 Eptacog alfa activated recombinant coagulation factor VIIa Hemophilia NovoSeven Note: Above is the list of medicines exempted from GST tax recommended by the 56th GST Council Meet/ Source: PIB By Abhijeet Singh ,

Gene Therapy

06 Sep 2024

·synapse.patsnap.com

Grünenthal acquires Valinor for $250 million to obtain an opioid antagonist product

Recently, the German company Grünenthal, specializing in the development of pain relief medications, announced the acquisition of the American pharmaceutical manufacturer Valinor Pharma for $250 million in order to obtain the rights to Movantik (naloxegol), a treatment for opioid-induced constipation developed by Valinor. It is reported that in 2023, sales of this product reached $200 million in the United States. Since Grünenthal already holds the rights to Movantik in the European Union, the acquisition of Valinor will allow Grünenthal to have complete control over the Movantik brand in all markets outside of Canada. The United States is considered the company's most important growth market, and the acquisition of Valinor will strengthen Grünenthal's position in the pain management sector in the U.S. About NaloxegolNaloxegol is a selective peripherally-acting μ-opioid receptor antagonist (PAMORA) and a pegylated form of naloxone. This product was originally developed by Nektar Therapeutics and further developed by AstraZeneca. It was approved by the U.S. FDA in September 2014 for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Notably, Nektar holds a patent for its drug pegylation technology, and naloxegol's advantage over the opioid receptor antagonist naloxone stems from its pegylated structure, which confers high selectivity for peripheral opioid receptors while not crossing the blood-brain barrier. According to a pharmacological study published in 2017, naloxegol is a potent antagonist at human μ-opioid receptors in vitro, with a Ki value of 7.42 nM, demonstrating an action similar to that of non-PEGylated naloxone. AstraZeneca published the clinical study results of Naloxegol in the New England Journal of Medicine in 2014. Compared to placebo, the use of Naloxegol significantly improved treatment response rates without reducing the analgesic effects mediated by opioids. In addition to Naloxegol, Nektar developed ADYNOVATE in collaboration with Baxter and Baxalta. ADYNOVATE is an extended half-life recombinant Factor VIII (rFVIII) product for the treatment of hemophilia. In January 2019, Takeda Pharmaceutical acquired Shire, gaining ownership of Baxalta and ADYNOVATE as a result. About PEGylated PharmaceuticalsPEGylated pharmaceuticals are composed of various reagents, including linkers, crosslinkers, and labels. Different types of reagents include amine, carboxyl, and carboxyl PEGylation. Currently, PEGylated drugs are primarily used to treat conditions such as cancer, chronic kidney disease, hepatitis, multiple sclerosis, hemophilia, and gastrointestinal diseases. In March 1990, ADAGEN produced by Enzon Pharmaceuticals was the first PEGylated protein approved by the U.S. Food and Drug Administration (FDA) for market entry. Since the launch of ADAGEN, a large number of PEGylated proteins and peptide drugs have followed suit, and many more are in clinical trials or development stages. Among the FDA-approved drugs, Pegasys and Neulasta generated sales exceeding $5 billion in 2011. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

31 Oct 2023

·www.prnewswire.com

Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products

The well-established matching-adjusted indirect comparison (MAIC) methodology was used to compare the efficacy of personalised prophylaxis with Nuwiq® against other recombinant FVIII products Personalised prophylaxis with Nuwiq® can lead to higher rates of patients with zero bleeds compared with other recombinant FVIII products, albeit with higher weekly doses The data were published recently in the European Journal of Haematology LACHEN, Switzerland, Oct. 31, 2023 /PRNewswire/ -- Data from a matching-adjusted indirect comparison (MAIC) of Nuwiq® (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis were published in the European Journal of Haematology1. Preliminary data from the MAIC were presented by Dr Craig Kessler, Lombardi Comprehensive Cancer Center and Georgetown University Medical Center, at the 65th ASH Annual Meeting & Exposition in December 20222. Continue Reading Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products The analysis used MAIC – a well-established statistical approach – to compare the efficacy of pharmacokinetic (PK)-guided, personalised prophylaxis with Nuwiq® (simoctocog alfa) versus Eloctate® (efmoroctocog alfa), Jivi® (damoctocog alfa pegol), and Adynovate® (rurioctocog alfa pegol). The analysis used data from prospective clinical trials of personalised prophylaxis in adults with severe haemophilia A. Dr Kessler commented, "This MAIC exercise provides important comparative data on the efficacy and consumption of various recombinant FVIII products in adults with haemophilia A on personalised prophylaxis. The results can be considered by clinicians and patients when treatment decisions are being made." MAICs are a way of comparing the efficacy of different medical interventions or products in the absence of head-to-head randomised trials3. By matching patient populations based on clinically relevant baseline characteristics, it reduces inherent differences between the studies and can provide comparative evidence of relative treatment effects. Individual patient data from patients treated with Nuwiq® in the NuPreviq study were compared with aggregated data from 117 patients treated with Eloctate® in the personalised prophylaxis arm of the A-LONG study, 110 patients treated with Jivi® in the PROTECT VIII study, and patients treated with Adynovate® in the PROPEL study (which had two arms targeting different FVIII trough levels: 1–3% (57 patients) and 8–12% (58 patients)). A significantly higher percentage of patients with zero bleeds was reported with Nuwiq® compared with Eloctate® (75% vs 45%), Jivi® (77% vs 38%) or Adynovate® (target trough level 1–3%; 78% vs 42%). The efficacy of Nuwiq® was similar to that of Adynovate® in the 8–12% arm (77% vs 62%). The mean annualised bleeding rate was significantly lower with Nuwiq® than with Jivi® (1.5 vs 4.9). Consistent with the approved dosing, the mean FVIII weekly dose was significantly higher for Nuwiq® than Eloctate®, Jivi® or Adynovate® 1–3%, but lower than for Adynovate® 8–12%. Further details of the study can be found in the European Journal of Haematology publication. In addition, a short video summarising the results is available in the online version of the article. About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein4. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor4. Nuwiq® treatment has been assessed in nine4-6 completed clinical trials which included 201 previously treated patients (190 individuals)4 and 108 previously untreated patients5 with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations7. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups7. References Kessler CM et al. Eur J Haematol 2023; 111:757–67. Kessler CM and Tiede A. Blood 2022; 140(Suppl. 1): 2755–6. Signorovitch JE et al. Value Health 2012; 15:940–7. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. Liesner RJ et al. Thromb Haemost 2021; 121:1400–8. Octapharma AG, data on file. Nuwiq® Summary of Product Characteristics. Logo - Video - SOURCE Octapharma AG

Clinical ResultDrug ApprovalClinical Study

100 Deals associated with Rurioctocog alfa pegol

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rurioctocog alfa pegol	B02BD02	DB16007

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Coagulation Protein Disorders	Japan	Takeda Pharmaceutical Co., Ltd.	05 Dec 2017
Hemophilia A	United States	Takeda Pharmaceuticals U.S.A., Inc.	13 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	United States	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Phase 3	United States	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	Japan	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	Japan	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Phase 3	Australia	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	Australia	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Phase 3	Austria	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Phase 3	Austria	Baxalta, Inc.	15 Oct 2013
Hemorrhage	Phase 3	Bulgaria	Baxalta Innovations GmbH	15 Oct 2013
Hemorrhage	Phase 3	Bulgaria	Baxalta, Inc.	15 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02615691 (CTgov)	Phase 3	Hemophilia A	120	ITI+PEGylated Recombinant Factor VIII	jckdulpxmd = grivstztds kqohpiypeu (udltphbhol, tywwpigjag - qtalpmhvnh) View more	-	28 Jul 2025
NCT05707351 (CTgov)	Phase 3	Hemorrhage \| Hemophilia A	37	Adynovate	hjyfojldee(uysxhuypby) = pxhnarmfcr tjxvsgclwj (zpodtksjks, 13.61) View more	-	01 May 2025
NCT05042440 (Phase 1 sequential pharmacokinetic study, EHA2024) Manual	Phase 1	Hemophilia A FVIII	13	Octocog alfa	udstxpemkq(ahirjwagji) = zomthgaqvf jdsbqlhyqj (uzytzudiey ) View more	Positive	14 May 2024
	Phase 1	Hemophilia A FVIII	13	Rurioctocog alfa pegol	udstxpemkq(ahirjwagji) = gidnltjspz jdsbqlhyqj (uzytzudiey ) View more	Positive	14 May 2024
NCT02615691 (Pubmed)	Phase 3	Hemophilia A	80	Rurioctocog alfa pegol prophylaxis	prcvfygcil(huuksalarr) = Thirteen patients experienced 14 treatment-related adverse events, including 10 cases of FVIII inhibitor development wxpudozqek (zpishkcelo )	-	03 Oct 2023
NCT05042440 (Pubmed \| Res Pract Thromb Haemost)	Phase 1	Hemophilia A	-	Octocog alfa	zuwjatcleo(kpbbeltthg) = xoudamlyzr nsouvynock (seyhzkbdhg )	Positive	01 May 2023
NCT05042440 (Pubmed \| Res Pract Thromb Haemost)	Phase 1	Hemophilia A	-	Rurioctocog alfa pegol	zuwjatcleo(kpbbeltthg) = xerwfjzysr nsouvynock (seyhzkbdhg )	Positive	01 May 2023
NCT01736475 (PROLONG-ATE, Pubmed) Manual	Phase 2/3	Hemophilia A	10	rurioctocog alfa pegol	xtquaaequs(csyynudvbl) = vfqrcenuke kyxaxwhdfn (bsiefqehyq )	Positive	01 Sep 2019
NCT02585960 (PROPEL, CTgov)	Phase 3	Hemophilia A	135	BAX 855 (BAX 855-Low Level)	qiivauxvve = ekphzvtqjg yokmflqjbs (xocnhafylo, kafztdfggv - yeffzfjwsf) View more	-	26 Aug 2019
NCT02585960 (PROPEL, CTgov)	Phase 3	Hemophilia A	135	BAX 855 (BAX 855-High Level)	qiivauxvve = dkdpbzprth yokmflqjbs (xocnhafylo, hhegfptaqr - uqpexrctjd) View more	-	26 Aug 2019
NCT01945593 (ISTH2019)	Phase 3	Hemophilia A	216	SHP660 prophylaxis	qshrbgcouk(kzjienoknd) = znsmhawfdg uavmtonnbd (lhikuumxwe ) View more	-	10 Jun 2019
NCT01945593 (CONTINUATION, ISTH2019)	Phase 3	Hemophilia A	216	Rurioctocog alfa pegol	xzigjphylk(qdwksidfqn) = a non-serious mild AE that resolved ~3-4 weeks after study end ielkxoissz (fgrcvgmvwq )	-	10 Jun 2019
NCT01945593 (CONTINUATION, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	218	BAX 855 (BAX 855: Age < 2 Years)	sitvxcucya = itoqacigao expbanaghl (mpxmxvwfio, ptpvqnkxxv - ojgixrtjtn) View more	-	01 May 2019
NCT01945593 (CONTINUATION, CTgov)	Phase 3	Hemorrhage \| Hemophilia A	218	BAX 855 (BAX 855: Age >= 2 to <12 Years)	sitvxcucya = zksutyvzsj expbanaghl (mpxmxvwfio, cwtogqibbh - otnfrrczra) View more	-	01 May 2019

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis