Last reviewed 2026-04-23 · How we verify

CAL-101

CAL-101 is a selective, irreversible inhibitor of phosphatidylinositol 3-kinase (PI3K).

CAL-101 is a selective, irreversible inhibitor of phosphatidylinositol 3-kinase (PI3K). Used for Chronic lymphocytic leukemia (CLL).

At a glance

Mechanism of action

By inhibiting PI3K, CAL-101 disrupts the PI3K/AKT signaling pathway, which is involved in cell proliferation and survival. This leads to the induction of apoptosis in cancer cells.

Approved indications

• Chronic lymphocytic leukemia (CLL)

Common side effects

• Diarrhea
• Nausea
• Fatigue

Key clinical trials

• A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6) (PHASE3)
• A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (PHASE4)
• A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (PHASE3)
• A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL (PHASE2)
• A Phase 2 Study of CAL101 in Patients With Idiopathic Pulmonary Fibrosis (PHASE2)
• A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL (PHASE3)
• A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL (PHASE1, PHASE2)
• ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL (PHASE1)

Primary sources

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