Drug Profile

Sapanisertib - Takeda Oncology

Alternative Names: CB-228; FTH-003; HY-13328; INK-128; MLN-0128; TAK-228

Latest Information Update: 13 Feb 2025

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At a glance

Originator Intellikine
Developer Calithera Biosciences; Dana-Farber Cancer Institute; European Network for Translational Research in Ovarian Cancer (EUTROC); M. D. Anderson Cancer Center; National Cancer Institute (USA); Stanford University School of Medicine; Takeda; Takeda Oncology
Class Antineoplastics; Benzoxazoles; Pyrazolones; Pyrimidines; Small molecules
Mechanism of Action 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

Phase II Bladder cancer; Cancer; Endometrial cancer; Fallopian tube cancer; Glioblastoma; Neuroendocrine tumours; Ovarian cancer; Peritoneal cancer; Precursor cell lymphoblastic leukaemia-lymphoma; Soft tissue sarcoma; Thyroid cancer; Urogenital cancer
Phase I/II Liver cancer; Merkel cell carcinoma; Sarcoma
Preclinical Leukaemia
No development reported Non-small cell lung cancer; Solid tumours
Discontinued HER2 negative breast cancer; Multiple myeloma; Prostate cancer; Renal cell carcinoma; Triple negative breast cancer; Waldenstrom's macroglobulinaemia

06 Feb 2025 National Cancer Institute plans a phase I/II trial for Liver cancer (Combination therapy, Metastatic disease, Second-line therapy or greater, Late-stage disease) in May 2025 (PO) (NCT06811116)
12 Dec 2024 Phase-II clinical trials in Endometrial cancer (Combination therapy, Recurrent, Second-line therapy or greater, Late-stage disease, Inoperable/Unresectable) in USA (PO) (NCT06463028)
09 May 2024 Phase-II clinical trials in Cancer (Late-stage disease, Metastatic disease) in USA (PO) (NCT06385496)

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