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 |
Trade Name
FDA
EMA
Tibsovo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ivosidenib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TIBSOVO | Servier | N-211192 RX | 2018-07-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tibsovo | New Drug Application | 2022-06-09 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
IVOSIDENIB, TIBSOVO, SERVIER | |||
| 2028-08-25 | ODE-368 | ||
| 2026-05-02 | ODE-242 | ||
| 2025-07-20 | ODE-203 | ||
| 2025-05-25 | I-893 | ||
| 2024-08-25 | I-875 | ||
| 2023-07-20 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ivosidenib, Tibsovo, Servier | |||
| 10980788 | 2039-06-07 | U-3112, U-3113, U-3214, U-3383 | |
| 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 |
| 9850277 | 2033-01-18 | DS, DP | U-2350, U-2533, U-2534, U-3213, U-3386 |
| 10717764 | 2033-01-18 | U-3215 | |
| 10610125 | 2030-06-21 | U-2784, U-2785, U-3385 | |
HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 1 | — | — | 3 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 1 | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Tobacco use disorder | D014029 | F17 | 1 | — | — | — | — | 1 | |
| Cigarette smoking | D000073865 | 1 | — | — | — | — | 1 | ||
| Smoking | D012907 | EFO_0003768 | F17 | 1 | — | — | — | — | 1 |
| Smoking cessation | D016540 | EFO_0004319 | 1 | — | — | — | — | 1 | |
| Craving | D066249 | 1 | — | — | — | — | 1 | ||
| Smoking reduction | D000074264 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 1 | 1 |
| Psychotic disorders | D011618 | F20.81 | — | — | — | — | 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,631 documents
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Safety
Black-box Warning
Black-box warning for: Tibsovo
Adverse Events
Top Adverse Reactions
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293 adverse events reported
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