Joenja
(Leniolisib)Phase 3Small molecule
Joenja is one of 10 small molecule programs targeting PIDs Linked to PI3K. It is currently in Phase 3.
3
Indications
6
Total Trials
4
Active Trials
9
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
1
Patents
Pipeline
Status by Indication[3][1]
Indication
Competition
Competitive Landscape
10 competitors in Pediatric Patients
#DrugCompanyPhaseTrials
1Ibsrela
AArdelyx
Phase 3
Blood Withdrawn
Emergent BioSolutionsPhase 3
Nsaids
RochePhase 3
Lexiscan
AstellasPhase 2
Bupivacaine Liposome
Pacira Pharmaceuticals, IncPhase 3
Joenja
PPharming Technologies B.V.
Phase 3
FCN-159
SShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Phase 2
Local Anaesthetic
CCali Pharmaceuticals LLC
Preclinical
Glycolic Acid
UUniversity of Pennsylvania
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Pediatric Patients2 trials
Efficacy1 trial
Common Variable Immunodeficiency (CVID)1 trial
Regulatory
FDA Approval Timeline[4]
Mar 24, 2023
JOENJA
NDA NDA217759
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Leniolisib. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]FDA Orange Book — Patent and exclusivity data for Joenja. U.S. Food & Drug Administration.
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[2]
- Highest Phase
- Phase 3[1]
- Company
- PPharming Technologies B.V.
Patent Landscape[5]
Patent Cliff
Feb 19, 2032
Earliest patent expiration — generic entry possible after this date
Patent #Expires
8653092Feb 19, 2032