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AboutPricing
Drug ReportsIdelalisib
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 beta isoform, phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit gamma isoform, and phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform.
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Events Timeline
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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
ZYDELIGGilead SciencesN-205858 RX2014-07-23
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zydeligNew Drug Application2025-02-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-hodgkin lymphoma—D008228C85.9
lymphoid leukemia—D007945C91
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Idelalisib, Zydelig, Gilead Sciences Inc
94696432033-09-02DP
88657302033-03-05DS, DPU-1615
107308792033-03-05DS, DP
94924492030-03-11U-1914
RE446382025-08-05DS, DP
RE445992025-07-21U-1558, U-1615
89809012025-05-12U-1678
91494772025-05-12U-1757
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EM: Phosphatidylinositol-3-kinase (pi3k) inhibitors
— L01EM01: Idelalisib
HCPCS
No data
Clinical
Clinical Trials
73 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9121451232
NeoplasmsD009369—C803——126
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell chronic lymphocytic leukemiaD015451—C91.1131710—643
LeukemiaD007938—C95111210—637
Lymphoid leukemiaD007945—C91111310—637
Non-hodgkin lymphomaD008228—C85.9772—216
Follicular lymphomaD008224—C82581—114
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——75——213
RecurrenceD012008——34——17
Waldenstrom macroglobulinemiaD008258—C88.026———7
Mantle-cell lymphomaD020522—C83.152———6
B-cell lymphoma marginal zoneD018442—C88.435———6
Hematologic neoplasmsD019337——31——15
Myeloid leukemia acuteD015470—C92.031———4
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.032———4
Large b-cell lymphoma diffuseD016403—C83.322———4
Myeloid leukemiaD007951—C9221———3
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C252————2
Primary myelofibrosisD055728—D47.42————2
Multiple myelomaD009101—C90.02————2
AnemiaD000740EFO_0004272D64.91———12
Plasma cell neoplasmsD054219——2————2
AdenocarcinomaD000230——2————2
ThrombocytosisD013922—D75.832————2
Prostatic neoplasmsD011471—C611————1
Castration-resistant prostatic neoplasmsD064129——1————1
CarcinomaD002277—C80.01————1
Show 18 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ThrombocytopeniaD013921HP_0001873D69.6————11
LeukopeniaD007970EFO_0004233D72.819————11
CytopeniaD000095542——————11
Digestive signs and symptomsD012817——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIdelalisib
INNidelalisib
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 classphosphatidylinositol 3-kinase (PI3K) inhibitors
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Structure (InChI/SMILES or Protein Sequence)
CC[C@H](Nc1ncnc2[nH]cnc12)c1nc2cccc(F)c2c(=O)n1-c1ccccc1
Identifiers
PDB—
CAS-ID870281-82-6
RxCUI—
ChEMBL IDCHEMBL2216870
ChEBI ID82701
PubChem CID11625818
DrugBankDB09054
UNII IDYG57I8T5M0 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zydelig – Gilead Sciences
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,137 documents
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Safety
Black-box Warning
Black-box warning for: Zydelig
Adverse Events
Top Adverse Reactions
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6,820 adverse events reported
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