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Sapanisertib/Serabelisib - Faeth Therapeutics, Inc.

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Drug Profile

Sapanisertib/Serabelisib - Faeth Therapeutics, Inc.

Alternative Names: FTH-001 + FTH-003; FTH-001/003; FTH-001/FTH-003; FTH-003/FTH-001; PIKTOR; Serabelisib/Sapanisertib

Latest Information Update: 19 Aug 2026

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At a glance

  • Originator Faeth Therapeutics
  • Developer Faeth Therapeutics, Inc.
  • Class 2 ring heterocyclic compounds; Alkanes; Amines; Antineoplastics; Benzoxazoles; Imidazoles; Ketones; Morpholines; Pyrazoles; Pyrazolones; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; MTORC1 protein inhibitors; MTORC2 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Endometrial cancer
  • Phase I/II HER2 negative breast cancer

Most Recent Events

  • 17 Aug 2026 Sapanisertib/Serabelisib - Faeth Therapeutics, Inc. receives Fast Track designation for Endometrial cancer [PO] (Combination therapy, Late-stage disease, Recurrent, Second-line therapy or greater) in USA
  • 30 Apr 2026 Phase-I/II clinical trials in HER2-negative-breast-cancer (Second-line therapy or greater, Combination therapy, Metastatic disease, Late-stage disease, Recurrent) in USA (PO) (NCT07558733)
  • 09 Mar 2026 Chemical structure information added.

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