Inavolisib clinical trials
Inavolisib is named as an intervention in 24 current clinical trials in our USA, Spain, South Korea, UK, Canada, Germany, Italy, Australia, France, Poland, Brazil, China, Mexico, Taiwan, Belgium, Turkey, Israel, Japan, Switzerland, Denmark, Singapore, Portugal, Egypt, Netherlands, Norway, Czechia and India registers. 15 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Hoffmann-La Roche (17). The most-studied condition is Breast Cancer.
Where Inavolisib is approved
All regulators →Of the three regulators tracked here, the first to approve Inavolisib was the US, on 10 Oct 2024. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Inavolisib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Inavolisib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 7 listed patents; the last listed expires 14 Jun 2038 (US 12410189).
- Latest patent on the drug substance itself: 26 Apr 2038 (US 11028100).
- Exclusivity NCE: New chemical entity, until 10 Oct 2029.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Inavolisib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Inavolisib works
All drug targets →- PI3-kinase p110-alpha subunit inhibitor InhibitorTarget: PIK3CA phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 3
- Central nervous system cancerPhase 2
- Central nervous system neoplasmPhase 2
- Colorectal cancerPhase 2
- Endometrial cancerPhase 2
- Endometrial carcinomaPhase 2
- Fallopian tube neoplasmPhase 2
- Ovarian epithelial tumorPhase 2
- Prostate cancerPhase 2
- HER2 positive breast carcinomaPhase 1/2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4650215, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9636, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Inavolisib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: ItovebiEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Inavolisib
24 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Inavolisib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Inavolisib on the HPRA medicines list.
- Itovebi 3 mg film-coated tabletsRoche Registration GmbH · EU/1/25/1942/001
- Itovebi 9 mg film-coated tabletsRoche Registration GmbH · EU/1/25/1942/002
Supply shortages
No entry for Inavolisib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Inavolisib
19 conditionsAll 19 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 9 |
| Metastatic Breast Cancer | 3 |
| Cancer | 1 |
| Metastatic Castration-Resistant Prostate Cancer | 1 |
| Metastatic Colorectal Cancer | 1 |
| Solid Tumor | 1 |
| Solid Tumors | 1 |
| Non-Small Cell Lung Cancer | 1 |
| Colorectal Cancer | 1 |
| Advanced Solid Tumors | 1 |
| Ovarian Cancer | 1 |
| Diabetes Type II | 1 |
| PIK3CA-Mutated Cancers | 1 |
| Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer | 1 |
| Pancreatic Ductal Adenocarcinoma (PDAC) | 1 |
| Locally Advanced Breast Cancer | 1 |
| Early-stage Breast Cancer | 1 |
| HER2-positive Breast Cancer | 1 |
| Endometrial Cancer | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Hoffmann-La Roche | 17 |
| Genentech, Inc | 2 |
| Fudan University | 1 |
| German Cancer Research Center | 1 |
| GBG Forschungs GmbH | 1 |
| MedSIR | 1 |
| National Cancer Institute, Naples | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Inavolisib trials
How many clinical trials are testing Inavolisib?
24 current trials in our USA, Spain, South Korea, UK, Canada, Germany, Italy, Australia, France, Poland, Brazil, China, Mexico, Taiwan, Belgium, Turkey, Israel, Japan, Switzerland, Denmark, Singapore, Portugal, Egypt, Netherlands, Norway, Czechia and India registers name Inavolisib (also registered as RO7113755) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Inavolisib trials recruiting patients?
Yes. 15 of the 24 trials are recruiting: 11 with sites in USA, 11 with sites in Spain, 10 with sites in South Korea, 9 with sites in UK, 8 with sites in Canada, 10 with sites in Germany, 7 with sites in Italy, 8 with sites in Australia, 7 with sites in France, 7 with sites in Poland, 6 with sites in Brazil, 5 with sites in China, 7 with sites in Mexico, 6 with sites in Taiwan, 4 with sites in Belgium, 5 with sites in Turkey, 2 with sites in Israel, 3 with sites in Japan, 1 with sites in Switzerland, 1 with sites in Denmark, 1 with sites in Singapore, 1 with sites in Egypt and 1 with sites in India. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Inavolisib clinical trials?
Hoffmann-La Roche (17), Genentech, Inc (2), Fudan University (1) and German Cancer Research Center (1), among 7 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Inavolisib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Inavolisib, for example Itovebi 3 mg film-coated tablets (Roche Registration GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Inavolisib shortage?
Not in the lists we track: Inavolisib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Inavolisib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Inavolisib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Inavolisib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.