# Serabelisib

Source: https://onco.cc/drugs/serabelisib/  
OnCo record `serabelisib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Serabelisib is an experimental small-molecule drug from Faeth Therapeutics in phase 2 trials for HR-positive / HER2-negative breast cancer and endometrial cancer, aimed at PIK3CA / PI3K-alpha.

## Summary

Serabelisib (FTH-001, MLN1117) is a small-molecule drug developed by Faeth Therapeutics. Its target is PIK3CA / PI3K-alpha. ClinicalTrials.gov describes the intervention as: Serabelisib is a selective, small molecule inhibitor of PI3Kα. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, in HR-positive / HER2-negative breast cancer and endometrial cancer. The largest, NCT06463028, plans to enrol 40 participants with primary completion expected 2028-09. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Code: FTH-001, MLN1117
- Modality: small molecule
- Mechanism: Small-molecule drug directed at PIK3CA / PI3K-alpha, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.

## Sources

- ClinicalTrials.gov: trials of Serabelisib: https://clinicaltrials.gov/search?intr=FTH-001
- Sponsor page: https://www.faeththerapeutics.com

## Connected records

- cancers: [Endometrial cancer](https://onco.cc/cancers/endometrial/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- targets: [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- companies: [Celcuity](https://onco.cc/companies/celcuity/), [Takeda](https://onco.cc/companies/takeda/)
- trials: [Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer](https://onco.cc/trials/nct07558733/), [Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial ](https://onco.cc/trials/nct06463028/)

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