OLUTASIDENIB
Rezlidhia (olutasidenib) is a small molecule pharmaceutical. Olutasidenib was first approved as Rezlidhia on 2022-12-01. It is used to treat myeloid leukemia acute in the USA. It is known to target 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
Rezlidhia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olutasidenib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REZLIDHIA | Rigel Pharmaceuticals | N-215814 RX | 2022-12-01 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rezlidhia | New Drug Application | 2023-03-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myeloid leukemia acute | — | D015470 | C92.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OLUTASIDENIB, REZLIDHIA, RIGEL PHARMS INC | |||
| 2029-12-01 | ODE-413 | ||
| 2027-12-01 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Olutasidenib, Rezlidhia, Rigel Pharms Inc | |||
| 11723905 | 2039-11-12 | DP | |
| 11738018 | 2039-07-17 | U-3684 | |
| 10532047 | 2039-05-16 | DP | |
| 10959994 | 2039-05-16 | DP | |
| 11013733 | 2039-05-16 | U-3496 | |
| 11013734 | 2039-05-16 | U-3495 | |
| 11376246 | 2039-05-16 | U-3495 | |
| 11497743 | 2039-05-16 | U-3495 | |
| 9834539 | 2035-09-18 | DS, DP | U-3497 |
| 10414752 | 2035-09-18 | DP | |
| 10550098 | 2035-09-18 | DP | |
| 11498913 | 2035-09-18 | DP | |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
10 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 4 | 4 | — | — | — | 6 |
| Myelodysplastic syndromes | D009190 | — | D46 | 4 | 4 | — | — | — | 6 |
| Neoplasms | D009369 | — | C80 | 3 | 3 | — | — | — | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 2 | — | — | — | 4 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 3 | — | — | — | 4 |
| Preleukemia | D011289 | — | — | 3 | 3 | — | — | — | 4 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 2 | 2 | — | — | — | 4 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | 2 | — | — | — | 4 |
| Syndrome | D013577 | — | — | 1 | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | OLUTASIDENIB |
| INN | olutasidenib |
| Description | Olutasidenib, sold under the brand name Rezlidhia, is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation. Olutasidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | mutated isocitrate dehydrogenase (IDH) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@H](Nc1ccc(C#N)n(C)c1=O)c1cc2cc(Cl)ccc2[nH]c1=O |
Identifiers
| PDB | — |
| CAS-ID | 1887014-12-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297610 |
| ChEBI ID | — |
| PubChem CID | 118955396 |
| DrugBank | DB16267 |
| UNII ID | 0T4IMT8S5Z (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
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)
Variants
No data
Financial
Revenue by drug
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Rezlidhia – Rigel Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 198 documents
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Safety
Black-box Warning
Black-box warning for: Rezlidhia
Adverse Events
Top Adverse Reactions
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72 adverse events reported
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