Positives

• APDS patients on leniolisib showed significant shrinkage of swollen lymph nodes and a rise in naive B cells, normalizing immune dysregulation that overlaps with patterns seen in some Long COVID phenotypes PubMed.
  
  
• Patients in the open-label extension reported sustained tolerability of long-term daily dosing without serious adverse events Drugs.com.
  
  

Negatives

• More than 10% of patients reported headache, sinusitis, and atopic dermatitis as ongoing side effects during treatment Medscape.
  
  
• A Long COVID patient seeking leniolisib would find no published efficacy data in PASC, with current trials limited to APDS and CVID populations through 2026 GlobeNewswire.
  
  

Hurdles & Side Effects

• Patients without a confirmed APDS genetic diagnosis cannot access the FDA-approved indication, and the drug's ultra-rare-disease pricing makes off-label Long COVID use prohibitive Immune Deficiency Foundation.
  
  
• A patient interested in leniolisib for immune-dysregulated Long COVID would have to wait for the CVID Phase 2 readout expected in late 2026 before any expanded-use pathway could open Pharming.