Contact Us
Drug Search Results
More Filters [+]

Simoctocog alfa

Alternative Names: simoctocog alfa, Nuwiq, OCTA-101, OCTA101, OCTA 101
Latest Update: 2024-11-16
Latest Update Note: Clinical Trial Update

Product Description

Simoctocog alfa (human-cl rhFVIII, Nuwiq) is a 4th generation recombinant FVIII (rFVIII), without chemical modification or fusion with any other protein/fragment. Nuwiq is produced in a human embryonic kidney cell line (HEK293F), which ensures human-specific post-translational protein processing. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6595650/)

Mechanisms of Action: FVIII Replacer

Novel Mechanism: Yes

Modality: Coagulation Factor

Route of Administration: Intravenous

FDA Designation: None *

Approval Status: Not Approved

Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Chile | Colombia | Croatia | Cyprus | Denmark | Dominican Republic | Estonia | France | Germany | Hungary | Ireland | Italy | Japan | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Portugal | South Africa | Spain | Taiwan | Ukraine | United Arab Emirates | United Kingdom | United States | Venezuela

Approved Indications: None

Known Adverse Events: None

Company: Octapharma
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Simoctocog alfa

Countries in Clinic:

Active Clinical Trial Count: 1

Highest Development Phases

Phase 2: Hemophilia A

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
2018-002776-40

P2

Completed

Hemophilia A

2022-02-18

Recent News Events

Date

Type

Title

06/10/2024

News Article

 Octapharma's continuing dedication to improving the lives of people with rare bleeding disorders to be showcased at ISTH 2024

06/10/2024

News Article

 Octapharma's continuing dedication to improving the lives of people with rare bleeding disorders to be showcased at ISTH 2024

05/09/2024

PubMed

 Simoctocog alfa (Nuwiq()) in children: early steps in life's journey for people with severe hemophilia A.

03/01/2024

PubMed

 Clinical efficacy of simoctocog alfa versus extended half-life recombinant FVIII concentrates in hemophilia A patients undergoing personalized prophylaxis using a matching-adjusted indirect comparison method.

01/01/2024

PubMed

 Safety, pharmacokinetics and efficacy of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A.

11/27/2023

News Article

 Octapharma to present new clinical and scientific data at ASH 2023 from ongoing research initiatives aimed at advancing care for people living with bleeding disorders

06/06/2023

News Article

 Octapharma presents new data at ISTH 2023 in an ongoing commitment to improve the lives of people with bleeding disorders

Did PRYZM just deliver the data you were looking for?
Did you try our Excel download too?

Now that you’ve used PRYZM, we hope you’re able to see for yourself that it was designed and developed by people who actually use this data for a living. By applying next-generation technology for aggregating and curating this info across multiple key sources PRYZM delivering the latest information at your fingertips just the way you need it and with industry leading speed and cost effectiveness.

Our subscribers enjoy unlimited searches and receive this data on their own secure instance so they can overlay any additional internal/proprietary data on top of the search results and blend that data with real-time industry intel from PRYZM. Discover how you can continue to uncover the competitive landscape and drive strategy.

Suggestions