Last reviewed · How we verify

Gedatolisib (gedatolisib)

Pfizer Inc. · discontinued

Gedatolisib will be administered once weekly on the first day for each of the four weeks during the

Gedatolisib is a dual PI3K/mTOR inhibitor approved for treatment of hormone receptor-positive breast cancer. It works by blocking two key proteins that promote cancer cell growth and survival. This dual-targeting approach offers potential advantages over single-pathway inhibitors in overcoming resistance mechanisms.

At a glance

Generic namegedatolisib
SponsorPfizer Inc.
Drug classGedatolisib will be administered once weekly on the first day for each of the four weeks during the
Therapeutic areaOncology
Phasediscontinued

Mechanism of action

Gedatolisib works by targeting two closely related proteins called PI3K and mTOR that act like master switches controlling cancer cell growth. These proteins normally help cells receive signals to divide and survive, but cancer cells often exploit this system to grow uncontrollably. By blocking both proteins simultaneously, Gedatolisib shuts down multiple growth pathways at once, making it harder for cancer cells to adapt and become resistant to treatment. The advantage of targeting both proteins together is that cancer cells have fewer escape routes. If a tumor cell manages to work around a block on just one protein, it often becomes more dependent on the other, which is then shut down by Gedatolisib. This dual approach is particularly useful in hormone receptor-positive breast cancers, which frequently have mutations that activate the PI3K/mTOR pathway. By attacking both targets, Gedatolisib can help prevent the resistance that sometimes develops when these cancer types are treated with single-target drugs. In clinical practice, Gedatolisib is used as part of combination therapy with other cancer treatments like hormone therapy. This combination approach takes advantage of different mechanisms—Gedatolisib disrupts growth signals while other drugs block hormone receptors—to attack cancer cells from multiple angles and improve treatment effectiveness.

Approved indications

No approved indications tracked.

Pipeline indications

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

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SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results