Olutasidenib, Cyp1a2, Cyp2b6, Cyp2c8, Cyp2c9, Cyp2c19, Cyp3a4, And Oatp1b1 Probe Substrates
Glioma, Solid Tumor Malignancies, Cholangiocarcinoma, Aml (Acute Myeloid Leukemia)
Phase IV
Recruiting
Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
Mar 12, 2026
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Olutasidenib + Tmz
High Grade Glioma, Astrocytoma, Astrocytoma, Grade Iii, Astrocytoma, Grade Iv, Diffuse Intrinsic Pontine Glioma, Who Grade Iii Glioma, Who Grade Iv Glioma, Metastatic Brain Tumor, Diffuse Midline Glioma, H3 K27m-Mutant, Thalamus Tumor, Spinal Tumor, Idh1 Mutation, Idh1 R132, Idh1 R132c, Idh1 R132h, Idh1 R132s, Idh1 R132g, Idh1 R132l, Oligodendroglioma
Phase II
Recruiting
Study of Olutasidenib and Temozolomide in HGG
Nov 22, 2023
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R906289 Monosodium
Low Risk Myelodysplastic Syndromes
Phase I/II
Recruiting
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Mar 02, 2022
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Fostamatinib
COVID19, Pneumonia, Pneumonia, Viral, Sars (Severe Acute Respiratory Syndrome), Sars Pneumonia, Sars-Associated Coronavirus As Cause Of Disease Classified Elsewhere
Phase III
Completed
Double-Blind, Randomized, Placebo-Controlled, Multi-Center Phase 3 Study to Evaluate the Efficacy and Safety of Fostamatinib in COVID-19 Subjects
Nov 13, 2020
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Fostamatinib Disodium
Warm Antibody Autoimmune Hemolytic Anemia
Phase III
Enrolling By Invitation
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Oct 23, 2019
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Fostamatinib Disodium
Warm Antibody Autoimmune Hemolytic Anemia
Phase III
Completed
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
Dec 03, 2018
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Fostamatinib 150 Mg Bid
Warm Antibody Autoimmune Hemolytic Anemia
Phase II
Completed
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
Nov 19, 2015
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Fostamatinib Disodium Tablet 100 Mg, Fostamatinib Disodium Tablet 150 Mg
Iga Nephropathy
Phase II
Withdrawn
Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy
Apr 29, 2015
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Fostamatinib 150 Mg, Fostamatinib 100 Mg
Iga Nephropathy
Phase II
Completed
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
Apr 10, 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 Rigel (RIGL) have in its pipeline
RIGL is currently developing the following drugs: Olutasidenib, Cyp1a2, Cyp2b6, Cyp2c8, Cyp2c9, Cyp2c19, Cyp3a4, And Oatp1b1 Probe Substrates, Olutasidenib + Tmz, Ly3871801. These drug candidates are in various stages of clinical development as the company works toward FDA approval.