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
Competitive Landscape
3 companies ranked by most advanced pipeline stage
Pharming GroupLEIDEN, Netherlands
2 programs1
LeniolisibPHASE_3Small Molecule
LeniolisibPHASE_3Small Molecule
FortreaDURHAM, NC
2 programs2
LeniolisibPhase 3Small Molecule1 trial
LeniolisibPhase 3Small Molecule1 trial
Active Trials
Trial Timeline
Clinical trial activity over time
2023
2024
2025
2026
2027
2028
FortreaLeniolisib
FortreaLeniolisib
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.