Leniolisib
Joenja (leniolisib) is a small molecule pharmaceutical. Leniolisib was first approved as Joenja on 2023-03-24. It is used to treat primary immunodeficiency diseases 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 phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform.
Download report
Favorite
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
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Joenja
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| joenja | New Drug Application | 2023-03-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| primary immunodeficiency diseases | — | D000081207 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LENIOLISIB PHOSPHATE, JOENJA, PHARMING | |||
| 2030-03-24 | ODE-430 | ||
| 2028-03-24 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Leniolisib Phosphate, Joenja, Pharming | |||
| 8653092 | 2032-02-19 | DS, DP | |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
7 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 2 | 1 | — | — | 2 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | 2 | 1 | — | — | 2 |
| Lymphadenopathy | D000072281 | HP_0002716 | R59.1 | — | 1 | 1 | — | — | 1 |
| Common variable immunodeficiency | D017074 | EFO_0000367 | D83 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | — | — | — | 1 |
| Primary immunodeficiency diseases | D000081207 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Leniolisib |
| INN | leniolisib |
| Description | Leniolisib (INN), sold under the brand name Joenja, is a medication used for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS). It is a kinase inhibitor that is taken by mouth.
|
| Classification | Small molecule |
| Drug class | phosphatidylinositol 3-kinase (PI3K) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(=O)N1CC[C@H](Nc2ncnc3c2CN(c2cnc(OC)c(C(F)(F)F)c2)CC3)C1 |
Identifiers
| PDB | — |
| CAS-ID | 1354690-24-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3643413 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16217 |
| UNII ID | L22772Z9CP (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
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
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 191 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
195 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use