# Gedatolisib

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

## TL;DR

An intravenous drug that blocks the whole PI3K/mTOR pathway, approved in July 2026 for hormone-positive breast cancer.

## Summary

Gedatolisib is an intravenous pan-class I PI3K and mTORC1/2 inhibitor, given at 180 mg weekly for 3 weeks of every 4 alongside palbociclib and fulvestrant, so it shuts down the whole PI3K/AKT/mTOR axis rather than one isoform. Celcuity's VIKTORIA-1 trial tested it after progression on a CDK4/6 inhibitor in PIK3CA-wild-type HR-positive, HER2-negative advanced breast cancer and supported FDA approval in July 2026, listed among that month's oncology approvals. Its notable feature is activity in PIK3CA-wild-type disease, a group without a targeted PI3K-pathway option until now. Stomatitis, neutropenia, hyperglycaemia and rash are the main adverse events. Results in the PIK3CA-mutant cohort, and whether weekly infusions are acceptable against oral alternatives, are open. For a newcomer: a pathway-wide PI3K/mTOR blocker for hormone-driven breast cancer after CDK4/6 therapy stops working.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Revtorpyk
- Modality: Small-molecule pan-PI3K/mTOR inhibitor
- Mechanism: Pan-class I PI3K and mTORC1/2 inhibitor, intravenous weekly.
- Approvals: US 2026: HR+/HER2- advanced breast cancer after CDK4/6 inhibitor (July 2026)
- Dosing: IV infusion; 180 mg weekly, 3 weeks on 1 week off, with palbociclib and fulvestrant

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gedatolisib

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [AKT](https://onco.cc/targets/akt/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- companies: [Celcuity](https://onco.cc/companies/celcuity/)
- trials: [Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/trials/nct06190899/), [Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)](https://onco.cc/trials/nct05501886/), [Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)](https://onco.cc/trials/nct06757634/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

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