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  1. pharmadog
  2. ›drugs
  3. ›IDELALISIB
drug · small molecule
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IDELALISIB

Marketedupdated 3mo ago
by $GILD GILEAD SCIENCES, INC.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 2
  • tagApproval2 co-mentions · 1 sources
  • tagSmall Molecule1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 10 investigational indications.

targets

Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform

all catalysts(1)

approval · 1
Feb 17, 2026
approval
6mo ago
IDELALISIB — FDA approval
IDELALISIB
→

Trials studying IDELALISIB

  • phase4A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphomarecruitingn=150
  • phase3A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLLactive not recruitingn=310
  • phase3A 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) Inhibitorsrecruitingn=250
  • phase1ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLLactive not recruitingn=3
  • phase3Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)active not recruitingn=238
  • phase3A Study of DZD8586 Versus Investigator's Choice in r/r CLL/SLL (TAI-SHAN6)recruitingn=250
  • phase2A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLLcompletedn=27
  • phase1Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignanciesterminatedn=203
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 11, 2030
~3.6 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

  • Sep 2, 2033compositionUS 9469643
  • Sep 2, 2033compositionUS 9469643
  • Mar 5, 2033compositionUS 10730879
  • Mar 5, 2033compositionUS 10730879
  • Mar 5, 2033compositionUS 8865730
  • Mar 5, 2033compositionUS 8865730
  • Mar 11, 2030method-of-use (U-1914)US 94924493.6y
  • Mar 11, 2030method-of-use (U-1914)US 94924493.6y

News(1)

  • CLL-321 Trial Efficacy and Safety Results Analysis
    Phase 3 results: pirtobrutinib boosts PFS, delays next treatment after prior BTK therapy, and shows low cardiac toxicity.
    onclive · 3mo ago
brand
IDELALISIB
trade names
Zydelig
generic
IDELALISIB
MOA
PI3-kinase p110-delta subunit inhibitor
indication
Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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