Drug profile · INN
inavolisib
ITOVEBI
inavolisib (ITOVEBI) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.
Drug details — inavolisib
- US status
- approved
- Class
- —
- Route
- ORAL
- Patents
- 0
- Programs
- 12
- Data quality
- 0.84
Quick answer
inavolisib (ITOVEBI) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
PI3-kinase p110-alpha subunit inhibitor
Primary target: Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
Recent coverage
FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer
The FDA has approved FoundationOne CDx as a companion diagnostic for inavolisib (Itovebi) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. This approval expands the targeted therapy landscape and underscores the importance of genomic testing in patient selection.
Celcuity's Gedatolisib Trial Misses Expectations, Highlighting PIK3CA Inhibitor Challenges
Celcuity's Phase 3 VIKTORIA-1 trial for gedatolisib in PIK3CA-mutated breast cancer did not meet 'lofty' expectations, prompting a re-evaluation of PIK3CA inhibitor development. This analysis examines the trial outcomes, competitive landscape, and strategic implications for pharmaceutical teams.
Pipeline programs
Related & competitor drugs
Frequently asked questions
What is inavolisib?
inavolisib (ITOVEBI) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for inavolisib?
ITOVEBI is a marketed brand name for inavolisib. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of inavolisib?
inavolisib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.