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Biocryst Pharmaceuticals (BCRX)
NASDAQ:BCRX
Bcx17725
Netherton Syndrome
Phase I
Recruiting
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Jul 30, 2024
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Bcx10013
Paroxysmal Nocturnal Hemoglobinuria
Phase I
Completed
Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)
Oct 20, 2023
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Bcx9930
Paroxysmal Nocturnal Hemoglobinuria
Phase II
Terminated
Long-term Safety of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria
Feb 14, 2023
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Berotralstat
Hereditary Angioedema, Pediatric
Phase III
Active Not Recruiting
Berotralstat Treatment in Children With Hereditary Angioedema
Jun 30, 2022
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Bcx9930
Complement 3 Glomerulopathy, Immunoglobulin A Nephropathy, Membranous Nephropathy
Phase II
Terminated
Study to Evaluate the Safety, Tolerability of BCX9930 in Participants With Either Complement 3 Glomerulopathy (C3G), Immunoglobulin A Nephropathy (IgAN), or Primary Membranous Nephropathy (PMN)
Nov 26, 2021
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Bcx9930 Monotherapy
Paroxysmal Nocturnal Hemoglobinuria (Pnh)
Phase II
Terminated
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants Not Receiving Other Complement Inhibitor Therapy
Nov 02, 2021
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Ravulizumab, Eculizumab, Bcx9930
Paroxysmal Nocturnal Hemoglobinuria (Pnh)
Phase II
Terminated
BCX9930 for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in Participants With Inadequate Response to C5 Inhibitor Therapy
Nov 02, 2021
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Berotralstat
Hereditary Angioedema, Hae
Phase III
Active Not Recruiting
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
Jun 14, 2021
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Ravulizumab, Eculizumab, Bcx9930
Paroxysmal Nocturnal Hemoglobinuria, Pnh
Phase II
Terminated
A Long-Term Safety Study of BCX9930 in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Jan 07, 2021
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Bcx9930
Paroxysmal Nocturnal Hemoglobinuria
Phase I/II
Completed
First-in-Human Study of BCX9930 in Healthy Volunteers and Patients With PNH
Mar 23, 2020
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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 Biocryst Pharmaceuticals (BCRX) have in its pipeline
BCRX is currently developing the following drugs: Bcx17725, Bcx10013, Bcx9930. These drug candidates are in various stages of clinical development as the company works toward FDA approval.