Gedatolisib For Injection 180 mg Suppliers & Bulk Manufacturers

Available Forms: Powder vial (IV infusion)

Available Strengths: 180 mg

Reference Brands: Revtorpyk (Celcuity)

Category: Oncology Cancer Care

Gedatolisib (Revtorpyk, Celcuity) is an intravenous PI3K/mTOR inhibitor for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, used with fulvestrant with or without palbociclib. The US FDA approved it in July 2026. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Gedatolisib blocks all four forms of PI3K and both mTOR complexes, shutting down the PI3K/AKT/mTOR pathway that HR-positive breast cancers use to escape hormone therapy. Unlike the oral drugs alpelisib, inavolisib and capivasertib, which are used mainly when the tumour carries a PIK3CA or related mutation, gedatolisib is approved for tumours without a PIK3CA mutation. It is given intravenously rather than as a daily tablet.

The US FDA approved gedatolisib as Revtorpyk in July 2026 for adults with HR-positive, HER2-negative, PIK3CA wild-type advanced or metastatic breast cancer after progression on a CDK4/6 inhibitor, in combination with fulvestrant with or without palbociclib. It is given by weekly infusion from 180 mg powder vials.

Sourcing and licensing notes. Gedatolisib is patented and made only by Celcuity; there is no generic. Capivasertib, also listed on PharmaTradz, is an oral option in the same pathway. We confirm registration status for each destination before quoting.