ITOVEBI (inavolisib)
Itovebi is a kinase inhibitor used for adults with advanced or metastatic breast cancer that has a specific PIK3CA mutation. It helps patients whose cancer is hormone receptor-positive and HER2-negative, particularly when the disease has returned after previous endocrine therapy. This medication is used alongside palbociclib and fulvestrant to manage cases that have become resistant to standard endocrine treatments.
How ITOVEBI Works
This drug works by targeting and inhibiting PI3K, specifically the alpha subunit. It triggers the breakdown of the mutated PI3K protein and blocks downstream signaling that usually promotes cell growth. This process reduces the proliferation of cancer cells and helps induce cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-10-10
- Patent Cliff
- 2038
- Revenue
- $133M (FY-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
ITOVEBI Approval History
What ITOVEBI Treats
1 indicationsITOVEBI is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
ITOVEBI Target & Pathway
ProTarget
A family of enzymes involved in cell growth, proliferation, and survival signaling. PI3K pathway activation is common in cancer. Inhibiting specific PI3K isoforms is effective in certain blood cancers and solid tumors.
ITOVEBI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ITOVEBI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ITOVEBI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ITOVEBI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05862285 UmbrellaMAX | BX44273 2022-003414-36, 2023-504263-16-00 | Ph 3 | recruiting | A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study |
| NCT06496568 | CO43909 2021-006618-36 | Ph 1 | active not recruiting | A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers |
| NCT04802759 | CO42867 2020-004889-19, 2023-507495-48-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer |
| NCT07368998 optINAVO | WO46063 2025-522805-39-00 | Ph 2 | recruiting | To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer |
| NCT07144111 | GP45942 | Ph 1 | recruiting | A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib |
| NCT04589845 | BO41932 2020-001847-16, 2023-507418-28-00 | Ph 2 | active not recruiting | Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study |
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT07287150 InavoPC | CO45813 2025-521327-67-00 | Ph 2 | recruiting | A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer |
| NCT06790693 INAVO123 | WO45654 2024-516162-11-00 | Ph 3 | recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer |
| NCT05894239 INAVO122 | WO44263 2022-502046-28-00 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer |
| NCT07054190 | BO45853 2024-518811-20-00 | Ph 2 | recruiting | A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer |
| NCT04929223 | WO42758 2021-001207-33, 2023-505163-37-00 | Ph 1 | recruiting | A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) |
| NCT07405801 | CO46274 2025-523013-28-00 | Ph 2 | recruiting | A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer |
| NCT07522697 MITO END-4 | MITO END-4 2025-522981-61-00 2025-522981-61-00 | Ph 2 | not yet recruiting | Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4 |
| NCT04486352 EndoMAP | AFT-50 | Ph 1, Ph 2 | recruiting | A Study of Targeted Agents for Patients With Recurrent or Persistent Endometrial Cancer |
| NCT04191499 INAVO120 results posted | WO41554 2019-002455-42, 2023-505812-39-00 | Ph 2, Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer |
| NCT03424005 Morpheus-panBC | CO40115 2017-002038-21, 2023-503629-20-00 | Ph 1, Ph 2 | recruiting | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer |
| NCT03006172 | GO39374 2016-003022-17, 2023-508124-36-00 | Ph 1 | active not recruiting | To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer |
| NCT04931342 BOUQUET | WO42178 GOG-3051, ENGOT-GYN2 | Ph 2 | active not recruiting | A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors |
| NCT05708235 MiRaDoR | MedOPP485 2023-505661-89-00 | Ph 2 | recruiting | A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population |
| NCT04449874 | GO42144 2020-000084-22, 2023-506311-18-00 | Ph 1 | active not recruiting | A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation |
| NCT07323576 INAVO-CRC | WO46300 2025-523014-84-00 | Ph 2 | withdrawn | A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal Cancer |
| NCT04849364 PERSEVERE results posted | HCRN BRE18-334 | Ph 2 | terminated | Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer |
| NCT05332561 | DKFZ-2019-008 2020-002606-22, 01EK2202A | Ph 2 | recruiting | Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) |
| NCT05306041 GeparPiPPa | GBG105 | Ph 2 | recruiting | Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer |
| NCT04632992 MyTACTIC results posted | ML42439 | Ph 2 | completed | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response |
| NCT04551521 | NCT-PMO-1602 | Ph 2 | completed | CRAFT: The NCT-PMO-1602 Phase II Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ITOVEBI FDA Label Details
Indications & Usage
FDA Label (PDF)ITOVEBI is indicated for the treatment of Breast Cancer.
ITOVEBI Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for ITOVEBI
Revenue Insights
- • FY-2025: $133M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 28 active patents
Trial Analysis
- • 28 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment