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Omeros Corp (OMER)
NASDAQ:OMER
Oms906 Study Drug
Paroxysmal Nocturnal Hemoglobinuria
Phase II
Recruiting
Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
Feb 17, 2024
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Oms906 Study Drug
C3 Glomerulopathy, Idiopathic Immune Complex-Mediated Glomerulonephritis
Phase II
Recruiting
Safety and Efficacy Study of OMS906 in Patients With C3G and ICGN
Jan 04, 2024
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Ravulizumab, Oms906 Study Drug - 3 Mg/Kg, Oms906 Study Drug - 5 Mg/Kg
Paroxysmal Nocturnal Hemoglobinuria
Phase II
Active Not Recruiting
Safety and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria Patients With a Sub-optimal Response to Ravulizumab
Jul 11, 2023
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Oms906 Study Drug
Paroxysmal Nocturnal Hemoglobinuria
Phase I
Unknown
Study of the Safety and Efficacy of OMS906 in Patients With Paroxysmal Nocturnal Hemoglobinuria
May 04, 2023
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Biological: Narsoplimab
Thrombotic Microangiopathies, Hematopoietic Stem Cell Transplantation
Phase II
Recruiting
Efficacy and Safety Study of Narsoplimab in Pediatric Patients With High-Risk Hematopoietic Stem Cell Transplant TMA
Apr 06, 2023
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Oms721, Vehicle (D5w Or Saline)
Iga Nephropathy
Phase III
Terminated
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
Jun 21, 2018
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Oms721
Atypical Hemolytic Uremic Syndrome, Thrombotic Microangiopathies
Phase III
Recruiting
Safety and Efficacy Study of OMS721 in Patients With Atypical Hemolytic Uremic Syndrome
Apr 17, 2017
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Oms721 (Narsoplimab)
Lupus Nephritis, Igan, Mn, C3 Glomerulopathy
Phase II
Unknown
Safety Study of IgAN, LN, MN, & C3 Glomerulopathy Including Dense Deposit Disease Treated With OMS721
Feb 10, 2016
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Oms721
Thrombotic Microangiopathies
Phase II
Completed
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies
Aug 18, 2014
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Phenylephrine Hcl, Oms302
Unilateral Cataract Extraction, Congenital Cataract
Phase III
Completed
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
May 01, 2014
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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 Omeros Corp (OMER) have in its pipeline
OMER is currently developing the following drugs: Oms906 Study Drug, Oms906 Study Drug, Ravulizumab, Oms906 Study Drug - 3 Mg/Kg, Oms906 Study Drug - 5 Mg/Kg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.