Joenja

(Leniolisib)

Small molecule

PPharming Technologies B.V.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Immune Dysregulation

NCT06897358

Phase 3Active, not recruiting

Pediatric Patients

NCT05693129

Phase 2Active, not recruiting

Immune Dysregulation

NCT06549114

Q2 2029

Phase 2Recruiting

Immune Dysregulation

NCT06990529

Clinical

Trials by Indication[1]

Immune Dysregulation3 trials

Long-term Safety and Efficacy of Leniolisib in PIDs With Immune Dysregulation

Recruiting·PPharming Technologies B.V.·Phase 2·NCT06990529·12 enrolled

Leniolisib for Immune Dysregulation in PIDs

Active, not recruiting·PPharming Technologies B.V.·Phase 2·NCT06549114·12 enrolled

Leniolisib for Immune Dysregulation in CVID

Active, not recruiting·PPharming Technologies B.V.·Phase 2·NCT06897358·20 enrolled

Pediatric Patients2 trials

Pediatric Patients Aged 1 to 6 Years With APDS

Active, not recruiting·PPharming Technologies B.V.·Phase 3·NCT05693129·16 enrolled

Pediatric Patients Aged 4 to 11 Years With APDS

Active, not recruiting·PPharming Technologies B.V.·Phase 3·NCT05438407·15 enrolled

Efficacy1 trial

An Open-Label Study to Assess the Safety & Efficacy of Leniolisib in Japanese Patients With APDS

Unknown status·PPharming Technologies B.V.·Phase 3·NCT06249997·3 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 24, 2023

JOENJA

NDA NDA217759

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Leniolisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Leniolisib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA217759). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Joenja. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pharming Technologies B.V. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PPharming Technologies B.V.

Patent Landscape[4]

Patent Cliff

Feb 19, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8653092Feb 19, 2032

Joenja

Expected Milestones

Q4 2026

Q2 2029

Trials by Indication[1]

Immune Dysregulation3 trials

Pediatric Patients2 trials

Efficacy1 trial

FDA Approval Timeline[3]

References

Drug Info

Quick Facts

Patent Landscape[4]

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