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Drug

Leniolisib phosphate

Approved · EMA

Also known as leniolisib (as phosphate).

RxNorm2633006
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Joenja (EMA)

Regulatory2026-05-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Leniolisib phosphate
Aliases & brands
leniolisib (as phosphate)
RxNorm CUI
2633006
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2026-05-21
Latest approval
2026-05-21
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-05-21Approval
Approval: Joenja (EMA)

Indication: Joenja is indicated for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.