drug · small molecule
ivosidenib
Marketedupdated 3mo agoby Les Laboratoires Servier SAS🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 5Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 5 investigational indications.
targets
Isocitrate dehydrogenase [NADP] cytoplasmic
all catalysts(0)
nothing on the calendar yet
Trials studying ivosidenib
- phase2Ivosidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH1
- phase2Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 Cholangiocarcinoma
- phase1A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
- phase2Ivosidenib as Post-HSCT Maintenance for AML
- phase2Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 Mutant Cholangiocarcinoma
- phase3Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
- phase1A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
- phase2Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
Patent cliff
source: FDA Orange Bookfirst barrier falls
Oct 24, 2026
70 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Jun 7, 2039method-of-use (U-3113)US 10980788
- Oct 18, 2036method-of-use (U-3387)US 10653710
- Mar 13, 2035formulationUS 10449184
- Mar 13, 2035formulationUS 10799490
- Mar 13, 2035formulationUS 9968595
- Aug 19, 2033compositionUS 9474779
- Jan 18, 2033method-of-use (U-3215)US 10717764
- Jan 18, 2033method-of-use (U-3742)US 11667673
- Jan 18, 2033compositionUS 9850277
- Jun 21, 2030method-of-use (U-3385)US 106101253.9y
FDA exclusivities (4)
- Oct 24, 2030ODE-447Orphan Drug (7y)4.2y
- Aug 25, 2028ODE-368Orphan Drug (7y)2.0y
- Oct 24, 2026I-924Indication (3y)70d
- May 2, 2026ODE-242Orphan Drug (7y)
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