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.
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FDA approval date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Joenja
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| joenja | New Drug Application | 2025-06-05 |
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
10 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 |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 2 | 1 | — | 1 | 3 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | 3 | 1 | — | — | 3 |
| Common variable immunodeficiency | D017074 | EFO_0000367 | D83 | — | 2 | 1 | — | — | 2 |
| Lymphadenopathy | D000072281 | — | R59.1 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary immunodeficiency diseases | D000081207 | — | — | — | 2 | — | — | — | 2 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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
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Trends
PubMed Central
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Additional graphs summarizing 241 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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534 adverse events reported
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