Zydelig(idelalisib)
Zydelig (idelalisib) is a small molecule pharmaceutical. Idelalisib was first approved as Zydelig on 2014-07-23. It is used to treat lymphoid leukemia and non-hodgkin lymphoma in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia and non-hodgkin lymphoma. The pharmaceutical is active against phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform. In addition, it is known to target phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform, phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform, and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit beta isoform.
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Commercial
Trade Name
FDA
EMA
Zydelig
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Idelalisib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYDELIG | Gilead Sciences | N-205858 RX | 2014-07-23 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| zydelig | New Drug Application | 2020-10-30 |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | C85.9 | 5 | 6 | — | — | 2 | 11 | |
| Waldenstrom macroglobulinemia | D008258 | C88.0 | 1 | 5 | — | — | — | 6 | |
| Myeloid leukemia acute | D015470 | C92.0 | 3 | 1 | — | — | — | 4 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 3 | 2 | — | — | — | 4 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 2 | 1 | — | — | — | 3 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 1 | 2 | — | — | — | 3 | |
| Myelodysplastic syndromes | D009190 | D46 | 1 | 1 | — | — | — | 2 | |
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | 1 | — | — | — | 2 | |
| Hodgkin disease | D006689 | C81 | 1 | 1 | — | — | — | 2 | |
| Recurrence | D012008 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | — | — | — | — | 2 |
| Primary myelofibrosis | D055728 | D47.4 | 2 | — | — | — | — | 2 | |
| Multiple myeloma | D009101 | C90.0 | 2 | — | — | — | — | 2 | |
| Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | IDELALISIB |
| INN | idelalisib |
| Description | Idelalisib is a member of the class of quinazolines that is 5-fluoro-3-phenylquinazolin-4-one in which the hydrogen at position 2 is replaced by a (1S)-1-(3H-purin-6-ylamino)propyl group. used for for the treatment of refractory indolent non-Hodgkin's lymphoma and relapsed chronic lymphocytic leukemia. It has a role as an antineoplastic agent, an apoptosis inducer and an EC 2.7.1.137 (phosphatidylinositol 3-kinase) inhibitor. It is a member of purines, an organofluorine compound, a member of quinazolines, an aromatic amine and a secondary amino compound. |
| Classification | Small molecule |
| Drug class | phosphatidylinositol 3-kinase (PI3K) inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@H](Nc1ncnc2[nH]cnc12)c1nc2cccc(F)c2c(=O)n1-c1ccccc1 |
Identifiers
| PDB | 4XE0 |
| CAS-ID | 870281-82-6 |
| RxCUI | 1544460 |
| ChEMBL ID | CHEMBL2216870 |
| ChEBI ID | 82701 |
| PubChem CID | 11625818 |
| DrugBank | DB09054 |
| UNII ID | YG57I8T5M0 (ChemIDplus, GSRS) |
Target
Agency Approved
PIK3CD
PIK3CD
Organism
Homo sapiens
Gene name
PIK3CD
Gene synonyms
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform
Protein synonyms
p110delta, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit delta, phosphatidylinositol-4,5-bisphosphate 3-kinase 110 kDa catalytic subunit delta, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta short variant 8/20, phosphoinositide-3-kinase C, phosphoinositide-3-kinase, catalytic, delta polypeptide variant p37delta, PI3-kinase p110 subunit delta, PI3Kdelta, PtdIns-3-kinase subunit p110-delta
Uniprot ID
Mouse ortholog
Pik3cd (18707)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform (Q8CJ28)
Alternate
PIK3CA
PIK3CA
PIK3CG
PIK3CG
PIK3CB
PIK3CB
Organism
Homo sapiens
Gene name
PIK3CA
Gene synonyms
NCBI Gene ID
Protein name
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
Protein synonyms
mutant phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha, p110alpha, phosphatidylinositol 3-kinase, catalytic, 110-KD, alpha, phosphatidylinositol 3-kinase, catalytic, alpha polypeptide, Phosphatidylinositol 4,5-bisphosphate 3-kinase 110 kDa catalytic subunit alpha, phosphatidylinositol-4,5-bisphosphate 3-kinase 110 kDa catalytic subunit alpha, Phosphoinositide 3-kinase alpha, Phosphoinositide-3-kinase catalytic alpha polypeptide, phosphoinositide-3-kinase, catalytic, alpha polypeptide, PI3-kinase p110 subunit alpha, PtdIns-3-kinase subunit p110-alpha, Serine/threonine protein kinase PIK3CA
Uniprot ID
Mouse ortholog
Pik3ca (18706)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (Q0VGQ5)
Variants
Clinical Variant
No data
Financial
Zydelig - Gilead Sciences
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Trends
PubMed Central
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Additional graphs summarizing 3,325 documents
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Safety
Black-box Warning
Black-box warning for: Zydelig
Adverse Events
Top Adverse Reactions
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44 adverse events reported
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