Inavolisib bulk supplier for pharma manufacturers

Inavolisib 3mg, 9mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 3mg, 9mg

Reference Brands: Itovebi (USA/EU)

Inavolisib is a targeted oral PI3K-alpha inhibitor used in combination with palbociclib and fulvestrant for treating PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer. It not only inhibits the mutated PI3Kα enzyme but also promotes its degradation, selectively acting on cancer cells with PIK3CA mutations. The drug has shown strong efficacy in prolonging progression-free survival in clinical trials.

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Product Description:

Inavolisib is an oral inhibitor of PI3K-alpha that is selective for the mutated form of the enzyme and, unusually, also promotes degradation of mutant HER2-phosphorylated p110-alpha protein. PIK3CA mutations occur in roughly forty percent of hormone receptor-positive, HER2-negative advanced breast cancers, where they drive growth and contribute to resistance to endocrine therapy.

It is used with palbociclib and fulvestrant in adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer that has progressed during or shortly after endocrine therapy. In its pivotal trial the triple combination roughly doubled progression-free survival compared with palbociclib and fulvestrant alone. The toxicity follows from the target: hyperglycaemia is expected, because PI3K-alpha mediates insulin signalling, and it is managed with glucose monitoring and sometimes metformin. Stomatitis, diarrhoea, rash and neutropenia from the combination are common. It is selective enough to be better tolerated than older pan-PI3K inhibitors.

Sourcing notes. Originator product, on patent, no generic. FDA approval came in late 2024 and European approval in mid-2025, with other markets following. Use requires PIK3CA mutation testing, so a destination market without that testing cannot use the product. Supply is through authorised distribution.

Inavolisib — third party manufacturing & bulk supply

Inavolisib 3mg, 9mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Inavolisib is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Inavolisib listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Inavolisib is used in combination with palbociclib and fulvestrant to treat adults with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer that carries a PIK3CA mutation. It is specifically indicated for patients whose disease has become resistant to endocrine therapy.

Inavolisib is made from the active substance inavolisib, a selective PI3K-alpha inhibitor. It works by blocking and degrading the mutant PI3K-alpha enzyme, which helps stop cancer cell growth in tumors driven by PIK3CA mutations.

The trade name of inavolisib is Itovebi.

Inavolisib (Itovebi) is developed and manufactured by Roche/Genentech.

The generic name is inavolisib.

The brand name is Itovebi.

Inavolisib is manufactured by Roche/Genentech at their approved global pharmaceutical production facilities, depending on regional supply requirements.