Ozmosi | Sapanisertib Drug Profile
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Sapanisertib

Pronounced as: sah-pah-NIS-er-tib

Alternative Names: sapanisertib, mln0128, tak-228, tak 228, tak228, cb-228, cb228, cb 228
Clinical Status: Active
Latest Update: 2025-11-25
Latest Update Note: Clinical Trial Update

Product Description

Sapanisertib is a dual TORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells. These mutations are found in a considerable sub-population of patients across multiple solid tumor types. (Sourced from: https://www.calithera.com/mtorc1-2-inhibitor-sapanisertib-cb-228/)

Mechanisms of Action: mTOR Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Lung Cancer *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Calithera Biosciences
Company Location: Western America
Company Founding Year: 2010
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Sapanisertib

Countries in Clinic: Germany, United Kingdom, United States

Active Clinical Trial Count: 2

Recent & Upcoming Milestones

Highest Development Phases

Phase 2: Carcinosarcoma|Clear Cell Adenocarcinoma|Clear Cell Sarcoma|Endometrial Cancer|Endometrioid Carcinoma|Fallopian Tube Cancer|Mixed Tumor, Mullerian|Ovarian Cancer|Peritoneal Cancer|Serous Cystadenocarcinoma

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT06463028

FTH-PIK-201

P2

Recruiting

Endometrial Cancer

2028-09-01

12%

2025-06-05

Primary Endpoints

NCT03648489

DICE

P2

Completed

Ovarian Cancer|Endometrioid Carcinoma|Fallopian Tube Cancer|Peritoneal Cancer|Clear Cell Adenocarcinoma|Serous Cystadenocarcinoma|Carcinosarcoma|Mixed Tumor, Mullerian|Clear Cell Sarcoma

2023-11-30

49%

2024-09-21

Primary Endpoints