inavolisib
Trade name: Itovebi
Small moleculeapprovedBreakthrough Therapy FDA
Approved
Oct 10, 2024
Clinical trial activity
19 trials · 14 clinical orgs · 2 marketing orgs
Phase 1
5
Phase 2
14
Phase 3
5
Phase 4
0
Earliest trial started Nov 1, 2016 (NCT03006172)
Timeline
Indications
Approved for
Mechanism of action
PIK3C2B inhibitor
- PI3-kinase p110-alpha subunitINHIBITOR
PI3-kinase p110-alpha subunit inhibitor
Approval history
- approvedPriority reviewBreakthroughOct 10, 2024
Chemistry & pharmacology
Loading structure…
SMILES
C[C@H](Nc1ccc2c(c1)OCCn1cc(N3C(=O)OC[C@H]3C(F)F)nc1-2)C(N)=O- Mol. weight
- 407.38 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4650215 ↗
Also known as
- gdc-0077
- gdc-0077
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07287150 | Phase 2 | Mar 31, 2026 | Roche |
| NCT07245797 | Phase 2 | Dec 15, 2025 | Fudan University |
| NCT07054190 | Phase 2 | Sep 9, 2025 | Roche |
| NCT07146386 | Phase 3 | Aug 31, 2025 | Government of China |
| NCT07144111 | Phase 1 | Aug 21, 2025 | Genentech |
| NCT06790693 | Phase 3 | Apr 9, 2025 | Roche |
| NCT06496568 | Phase 1 | Dec 11, 2023 | Roche |
| NCT05708235 | Phase 2 | Sep 30, 2023 | MedSIR, University of Valencia |
| NCT05894239 | Phase 3 | Jul 28, 2023 | Roche |
| NCT05646862 | Phase 3 | Jan 31, 2023 | Roche |
| NCT05332561 | Phase 2 | Dec 31, 2022 | German Cancer Research Center, Technical University of Munich |
| NCT05306041 | Phase 2 | Jun 30, 2022 | German Breast Group Forschungs GmbH, Roche, University of Duisburg-Essen |
| NCT04929223 | Phase 1 | Oct 22, 2021 | Roche |
| NCT04849364 | Phase 2 | Aug 24, 2021 | Foundation Medicine, Genentech, Hoosier Cancer Research Network, Indiana University, Pfizer |
| NCT04802759 | Phase 1/Phase 2 (Phase 2) | Jun 20, 2021 | Roche |
| NCT04632992 | Phase 2 | Dec 31, 2020 | Genentech |
| NCT04589845 | Phase 2 | Nov 30, 2020 | Roche |
| NCT04191499 | Phase 2/Phase 3 (Phase 3) | Dec 13, 2019 | Roche |
| NCT03006172 | Phase 1 | Nov 1, 2016 | Genentech, Roche |
Showing 19 of 19 trials
Page 1 / 1
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 12 | 10 | 3 | 2016 |
| Genentech | For profit | 4 | 3 | 2 | 2016 |
| Foundation Medicine | For profit | 1 | 0 | 1 | 2021 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| German Breast Group Forschungs GmbH | For profit | 1 | 1 | 1 | 2022 |
| German Cancer Research Center | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Government of China | Government | 1 | 1 | 1 | 2025 |
| Hoosier Cancer Research Network | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Indiana University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| MedSIR | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Pfizer | For profit | 1 | 0 | 1 | 2021 |
| Technical University of Munich | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of Duisburg-Essen | Academic/Hospital | 1 | 0 | 1 | 2022 |
| University of Valencia | Academic/Hospital | 1 | 0 | 1 | 2023 |
14 organizations
Page 1 / 1