drug
olutasidenib
Marketedupdated 3mo agoby $RIGL RIGEL PHARMACEUTICALS INC
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all catalysts(0)
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Trials studying olutasidenib
- phase2A Phase 2 Study Evaluating Olutasidenib in Combination With Hypomethylating Agents in Patients With IDH1-mutated Higher-risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Advanced Myeloproliferative Neoplasm
- phase2Study of Olutasidenib and Temozolomide in HGG
- phase2Olutasidenib, Venetoclax, and Azacitidine in IDH1 Mutated Newly Diagnosed Acute Myeloid Leukemia Patients Eligible for Intensive Induction Chemotherapy
- phase2Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations
- phase4Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies
- phase2Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
- phase2A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
- phase1Olutasidenib Single Plus Combo Therapy in IDH1mut AML After Induction and Consolidation
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 1, 2027
~1.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (14)
- Nov 12, 2039formulationUS 11723905
- Jul 17, 2039method-of-use (U-3684)US 11738018
- May 16, 2039compositionUS 10532047
- May 16, 2039formulationUS 10959994
- May 16, 2039method-of-use (U-3496)US 11013733
- May 16, 2039method-of-use (U-3495)US 11013734
- May 16, 2039method-of-use (U-3495)US 11376246
- May 16, 2039method-of-use (U-3495)US 11497743
- May 16, 2039compositionUS 12053463
- Sep 18, 2035formulationUS 10414752
- Sep 18, 2035formulationUS 10550098
- Sep 18, 2035formulationUS 11498913
- Sep 18, 2035compositionUS 12275715
- Sep 18, 2035compositionUS 9834539
FDA exclusivities (2)
- Dec 1, 2029ODE-413Orphan Drug (7y)3.3y
- Dec 1, 2027NCENew Chemical Entity (5y)1.3y
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