Registered South Africa · SAHPRA

ITOVEBI 3 mg

INAVOLISIB

60/26/0051 INN generic

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Registration & product details

Registration no.
60/26/0051
Registration date
2026/08/18
Expiry date
-
Status
Registered
Active ingredient
INAVOLISIB
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Roche Products (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-09-02 04:02:16 · updated 2026-10-28 04:13:08

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

Molecular reference: inavolisib

PubChem CID 124173720

Molecular formula: C18H19F2N5O4

Mechanism of action

Inavolisib is a mutant-selective PI3Kα inhibitor that targets the p110α catalytic subunit of PI3Kα, specifically in its mutated form. PI3Kα is a critical component of the PI3K pathway, which is activated by receptor tyrosine kinases (RTKs) at the plasma membrane. This pathway regulates cell growth, survival, and metabolism. In non-mutant settings, inhibition of PI3Kα by standard PI3K inhibitors leads to initial suppression of the pathway. However, feedback mechanisms often upregulate RTK expression, leading to sustained PI3K signaling despite the inhibition. In contrast, inavolisib selectively binds to the mutant p110α/p85β complex, triggering proteasome-mediated degradation of the mutant p110α subunit. This degradation disrupts downstream signaling and prevents feedback reactivation of the PI3K pathway. By degrading mutant p110α, inavolisib achieves sustained inhibition of PI3K signaling, particularly in tumors driven by activating mutations in PI3Kα.

Pharmacodynamics

The exposure-response relationship in regards to inavolisib efficacy has not been characterized. Higher systemic exposure of inavolisib was associated with higher incidence of Grade ≥2 anemia, Grade ≥2 hyperglycemia, and inavolisib dosage modifications due to adverse reactions.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.