Tibsovo(ivosidenib)
Tibsovo (ivosidenib) is a small molecule pharmaceutical. Ivosidenib was first approved as Tibsovo on 2018-07-20. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat cholangiocarcinoma and myeloid leukemia acute. The pharmaceutical is active against isocitrate dehydrogenase [NADP] cytoplasmic.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Tibsovo
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tibsovo | New Drug Application | 2024-09-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IVOSIDENIB, TIBSOVO, SERVIER | |||
| 2030-10-24 | ODE-447 | ||
| 2028-08-25 | ODE-368 | ||
| 2026-10-24 | I-924 | ||
| 2026-05-02 | ODE-242 | ||
| 2025-07-20 | ODE-203 | ||
| 2025-05-25 | I-893 | ||
| 2024-08-25 | I-875 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ivosidenib, Tibsovo, Servier | |||
| 10980788 | 2039-06-07 | U-3112, U-3113, U-3214, U-3383, U-3743 | |
| 10653710 | 2036-10-18 | U-3387 | |
| 9968595 | 2035-03-13 | DP | U-2351, U-2533, U-2534, U-3384 |
| 10449184 | 2035-03-13 | DP | |
| 10799490 | 2035-03-13 | DP | U-2981, U-2982, U-3384 |
| 9474779 | 2033-08-19 | DS, DP | U-2350, U-2533, U-2534, U-3213, U-3386, U-3742 |
| 9850277 | 2033-01-18 | DS, DP | U-2350, U-2533, U-2534, U-3213, U-3386, U-3742 |
| 10717764 | 2033-01-18 | U-3215 | |
| 11667673 | 2033-01-18 | U-3742 | |
| 10610125 | 2030-06-21 | U-2784, U-2785, U-3385 | |
HCPCS
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Clinical
Clinical Trials
54 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 12 | 8 | 4 | — | 4 | 24 |
| Leukemia | D007938 | — | C95 | 11 | 5 | 4 | — | 2 | 18 |
| Myeloid leukemia | D007951 | — | C92 | 12 | 5 | 4 | — | 1 | 18 |
| Myelodysplastic syndromes | D009190 | — | D46 | 5 | 4 | 3 | — | — | 11 |
| Preleukemia | D011289 | — | — | 4 | 2 | 3 | — | — | 9 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 4 | 3 | 2 | — | 1 | 8 |
| Syndrome | D013577 | — | — | 1 | 2 | 2 | — | — | 5 |
| Chondrosarcoma | D002813 | — | — | 1 | 1 | 1 | — | — | 3 |
| Bone marrow transplantation | D016026 | — | — | — | — | 1 | — | — | 1 |
| Acute disease | D000208 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 7 | 5 | — | — | — | 11 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 5 | 2 | — | — | — | 6 |
| Hematologic neoplasms | D019337 | — | — | 4 | 1 | — | — | 1 | 5 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 2 | — | — | 1 | 5 |
| Recurrence | D012008 | — | — | 1 | 1 | — | — | — | 2 |
| Unknown primary neoplasms | D009382 | — | — | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Sarcoma | D012509 | — | — | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| Neuroblastoma | D009447 | EFO_0000621 | — | — | 1 | — | — | — | 1 |
Show 22 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ivosidenib |
| INN | ivosidenib |
| Description | Ivosidenib is a tertiary carboxamide resulting from the formal condensation of the carboxy group of (2S)-1-(4-cyanopyridin-2-yl)-5-oxopyrrolidine-2-carboxylic acid with the secondary amino group of (2S)-2-(2-chlorophenyl)-N-(3,3-difluorocyclobutyl)-2-[(5-fluoropyridin-3-yl)amino]acetamide. It is approved by the FDA for the treatment of acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation. It has a role as an antineoplastic agent and an EC 1.1.1.42 (isocitrate dehydrogenase) inhibitor. It is a member of monochlorobenzenes, a cyanopyridine, a member of pyrrolidin-2-ones, an organofluorine compound, a tertiary carboxamide and a secondary carboxamide. |
| Classification | Small molecule |
| Drug class | mutated isocitrate dehydrogenase (IDH) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | N#Cc1ccnc(N2C(=O)CC[C@H]2C(=O)N(c2cncc(F)c2)[C@H](C(=O)NC2CC(F)(F)C2)c2ccccc2Cl)c1 |
Identifiers
| PDB | — |
| CAS-ID | 1448347-49-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989958 |
| ChEBI ID | — |
| PubChem CID | 71657455 |
| DrugBank | DB14568 |
| UNII ID | Q2PCN8MAM6 (ChemIDplus, GSRS) |
Target
Agency Approved
IDH1
IDH1
Organism
Homo sapiens
Gene name
IDH1
Gene synonyms
PICD
NCBI Gene ID
Protein name
isocitrate dehydrogenase [NADP] cytoplasmic
Protein synonyms
Cytosolic NADP-isocitrate dehydrogenase, epididymis luminal protein 216, epididymis secretory protein Li 26, epididymis secretory sperm binding protein, IDPc, isocitrate dehydrogenase (NADP(+)) 1, cytosolic, isocitrate dehydrogenase 1 (NADP+), soluble, NADP(+)-specific ICDH, NADP-dependent isocitrate dehydrogenase, cytosolic, NADP-dependent isocitrate dehydrogenase, peroxisomal, Oxalosuccinate decarboxylase
Uniprot ID
Mouse ortholog
Idh1 (15926)
isocitrate dehydrogenase [NADP] cytoplasmic (Q3UAV7)
Alternate
No data
Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Tibsovo
Adverse Events
Top Adverse Reactions
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1,406 adverse events reported
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