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APDS

3
Pipeline Programs
3
Companies
2
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
2
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
6100%

On Market (1)

Approved therapies currently available

Pharming Group
JOENJAApproved
leniolisib
Pharming Group
oral2023
2M Part D

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Pharming Group
Pharming GroupLEIDEN, Netherlands
2 programs
1
LeniolisibPHASE_3Small Molecule
LeniolisibPHASE_3Small Molecule
Fortrea
FortreaDURHAM, NC
2 programs
2
LeniolisibPhase 3Small Molecule
LeniolisibPhase 3Small Molecule
Labcorp
LabcorpBURLINGTON, NC
2 programs
LeniolisibPHASE_3Small Molecule1 trial
LeniolisibPHASE_3Small Molecule1 trial
Active Trials
NCT05693129Active Not Recruiting16Est. Oct 2028
NCT05438407Active Not Recruiting15Est. Dec 2026

Trial Timeline

Clinical trial activity over time

2023
2024
2025
2026
2027
2028
LabcorpLeniolisib
LabcorpLeniolisib

Clinical Trials (2)

Total enrollment: 31 patients across 2 trials

Pediatric Patients Aged 1 to 6 Years With APDS

Start: Aug 2023Est. completion: Oct 202816 patients
Phase 3Active Not Recruiting

Pediatric Patients Aged 4 to 11 Years With APDS

Start: Feb 2023Est. completion: Dec 202615 patients
Phase 3Active Not Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
3 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.