Glpg Car T-Cell Therapy
Hematological Malignancies
Phase III
Recruiting
Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
Oct 21, 2024
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Filgotinib
Bioavailability
Phase I
Completed
Relative Bioavailability and Effect of Food Study With an Oral Mini-tablet Formulation of Filgotinib in Healthy Subjects
Sep 11, 2023
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Glpg3667
Systemic Lupus Erythematosus
Phase II
Active Not Recruiting
A Study Evaluating the Effects of GLPG3667 Administered As Oral Treatment in Adult Participants with Active Systemic Lupus Erythematosus
May 03, 2023
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Glpg3667
Dermatomyositis
Phase II
Active Not Recruiting
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
Jan 13, 2023
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Filgotinib
Ulcerative Colitis
Phase III
Terminated
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Jul 26, 2022
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Glpg3667 Capsule, [14C]-Glpg3667 Solution For Infusion, [14C]-Glpg3667 Capsule
Healthy
Phase I
Completed
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667
Apr 13, 2022
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Itraconazole, Glpg3667
Healthy
Phase I
Completed
Drug-drug Interaction Study with GLPG3667 and Itraconazole in Healthy Subjects
Feb 28, 2022
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Midazolam, Glpg4716
Healthy
Phase I
Completed
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
Aug 30, 2021
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Glpg4716, Nintedanib, Pirfenidone
Healthy
Phase I
Completed
Drug-drug Interaction Study with GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects
Jul 20, 2021
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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 Lakefront Biotherapeutics (GXEA) have in its pipeline
GXEA is currently developing the following drugs: Glpg Car T-Cell Therapy, Glpg5101, Filgotinib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.