Iptacopan (Fabhalta) Report issue

Small molecule Orphan Drug FDA Approved FDA Breakthrough Therapy FDA Priority Review FDA

Active Ingredient History

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Chemistry

  • SMILES: CCO[C@H]1CCN(Cc2c(OC)cc(C)c3[nH]ccc23)[C@H](c2ccc(C(=O)O)cc2)C1
  • InChIKey: RENRQMCACQEWFC-UGKGYDQZSA-N
  • Mol. Mass: 422.53
  • ALogP: 4.93
  • ChEMBL Molecules:
    iptacopan  
    iptacopan hydrochloride  
More Chemistry

Pharmacology

Organizations (1)

Research & Development (1)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (1)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (13)

Approved Indications (1)


 

Hemoglobinuria, Paroxysmal (approved 2023)

Experimental Indications - Clinical Trial Phases 1-4 (13)


 

Agglutination (Phase 2)

Atypical Hemolytic Uremic Syndrome (Phase 3)

Drugs, Investigational (Phase 3)

Glomerulonephritis (Phase 2)

Glomerulonephritis, IGA (Phase 3)

Glomerulonephritis, Membranoproliferative (Phase 3)

Glomerulonephritis, Membranous (Phase 2)

Hemoglobinuria, Paroxysmal (Phase 3)

Kidney Diseases (Phase 3)

Liver Diseases (Phase 1)

Lupus Nephritis (Phase 2)

Macular Degeneration (Phase 2)

Thrombocytopenia (Phase 2)

Overview

  • Highest Phase: Phase 3
  • # of Trials: 22
  • # of Trial Organizations: 1

Trials by Phase

Trial Phase Start Date Organizations Indications

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