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
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 202616 patients
Phase 3Active Not Recruiting
Pediatric Patients Aged 4 to 11 Years With APDS
Start: Feb 2023Est. completion: Dec 202515 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.