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Swedish Orphan Biovitrum AB (SE:SOBI)
:SOBI
Efanesoctocog Alfa
Hemophilia A
Phase IV
Recruiting
Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
Apr 16, 2025
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Pacritinib
Vexas, Vexas Syndrome
Phase II
Recruiting
A Study to Assess the Effectiveness and Safety of Pacritinib in Patients With VEXAS Syndrome (PAXIS)
Jan 07, 2025
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Efanesoctocog Alfa
Hemophilia, Haemophilia A (Moderate Or Severe), Hemophilia, Classic, Haemophilia, Classic Hemophilia, Synovial Hypertrophy
Phase IV
Recruiting
A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis
Dec 18, 2024
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Anakinra
Familial Mediterranean Fever (Fmf )
Phase IV
Not Yet Recruiting
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
Oct 08, 2024
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Efanesoctocog Alfa
Severe Haemophilia A
Phase III
Recruiting
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
Oct 02, 2024
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Efanesoctocog Alfa
Hemophilia A
Phase I
Recruiting
Pharmacokinetic Comparison of Efanesoctocog Alfa vs Other EHL-rFVIII Products in Participants With Severe Haemophilia A
Aug 28, 2024
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Haemophilia Early Arthropathy Detection With Ultrasound (Head-Us), Haemophilia Joint Health Score (Hjhs)
Hemophilia B, Hemophilia A
Phase IV
Terminated
An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa
Apr 24, 2023
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Efanesoctocog Alfa
Hemophilia A, Severe
Phase III
Active Not Recruiting
A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
Mar 21, 2023
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Emapalumab-Lzsg 5 Mg/Ml [Gamifant]
Primary Hemophagocytic Lymphohistiocytosis
Phase IV
Completed
A Post-authorization Study to Describe the Safety and Efficacy of Emapalumab for the Treatment of pHLH in Treatment Experienced Chinese Patients
Feb 13, 2023
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Anakinra
Still's Disease, Juvenile Onset, Still's Disease, Adult-Onset
Phase III
Active Not Recruiting
A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)
Nov 22, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Swedish Orphan Biovitrum AB (SOBI) have in its pipeline
SOBI is currently developing the following drugs: Efanesoctocog Alfa, Pacritinib, Efanesoctocog Alfa. These drug candidates are in various stages of clinical development as the company works toward FDA approval.