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Drug ReportsUmbralisib
Umbralisib
Ukoniq (umbralisib) is a small molecule pharmaceutical. Umbralisib was first approved as Ukoniq on 2021-02-05. It is used to treat b-cell lymphoma marginal zone and follicular lymphoma in the USA. The pharmaceutical is active against phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform. In addition, it is known to target casein kinase I isoform epsilon.
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FDA Novel Drug Approvals 2021
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Umbralisib tosylate
Tradename
Company
Number
Date
Products
UKONIQTG TherapeuticsN-213176 DISCN2021-02-05
1 products, RLD
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
b-cell lymphoma marginal zone—D018442C88.4
follicular lymphoma—D008224C82
Agency Specific
FDA
EMA
Expiration
Code
UMBRALISIB TOSYLATE, UKONIQ, TG THERAPS
2026-02-05NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Umbralisib Tosylate, Ukoniq, Tg Theraps
99697402035-05-26DS, DPU-3063, U-3064
104147732035-05-26DS, DPU-3063, U-3064
109472442035-05-26U-3063, U-3064
91505792033-07-02DS, DP
96690332033-07-02U-3063, U-3064
100720132033-07-02U-3063, U-3064
105701422033-07-02DS, DPU-3063, U-3064
109819192033-07-02U-3063, U-3064
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX25: Umbralisib
HCPCS
No data
Clinical
Clinical Trials
35 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
B-cell chronic lymphocytic leukemiaD015451—C91.18123——19
Follicular lymphomaD008224—C82271——8
Mantle-cell lymphomaD020522—C83.1441——6
Large b-cell lymphoma diffuseD016403—C83.3—21——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228—C85.963———7
Hodgkin diseaseD006689—C8142———5
Waldenstrom macroglobulinemiaD008258HP_0005508C88.022———3
B-cell lymphoma marginal zoneD018442—C88.411———2
B-cell lymphomaD016393——11———1
LymphomaD008223—C85.9—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——1————1
Pancreatic neoplasmsD010190EFO_0003860C251————1
Stomach neoplasmsD013274EFO_0003897C161————1
Esophageal neoplasmsD004938—C151————1
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A1————1
Rectal neoplasmsD012004——1————1
Polycythemia veraD011087—D451————1
Primary myelofibrosisD055728—D47.41————1
Reactive arthritisD016918EFO_0007460M02.31————1
T-cell lymphoma peripheralD016411——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUmbralisib
INNumbralisib
Description
Umbralisib, sold under the brand name Ukoniq, is an anti-cancer medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.
Classification
Small molecule
Drug classphosphatidylinositol 3-kinase (PI3K) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)Oc1ccc(-c2nn([C@@H](C)c3oc4ccc(F)cc4c(=O)c3-c3cccc(F)c3)c3ncnc(N)c23)cc1F
Identifiers
PDB—
CAS-ID1532533-67-7
RxCUI—
ChEMBL IDCHEMBL3948730
ChEBI ID—
PubChem CID72950888
DrugBankDB14989
UNII ID38073MQB2A (ChemIDplus, GSRS)
Target
Agency Approved
PIK3CD
PIK3CD
Organism
Homo sapiens
Gene name
PIK3CD
Gene synonyms
NCBI Gene ID
5293
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
Q5SR49
Mouse ortholog
Pik3cd (18707)
phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform (Q8CJ28)
Alternate
TPTEP2-CSNK1E
TPTEP2-CSNK1E
Organism
Homo sapiens
Gene name
TPTEP2-CSNK1E
Gene synonyms
NCBI Gene ID
102800317
Protein name
casein kinase I isoform epsilon
Protein synonyms
CKI-epsilon, LOC400927-CSNK1E readthrough
Uniprot ID
P49674
Mouse ortholog
—
—
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 587 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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93 adverse events reported
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