Product Description
An orally bioavailable inhibitor of the serine/threonine protein kinase Akt (protein kinase B) with potential antineoplastic activity. Ipatasertib binds to and inhibits the activity of Akt in a non-ATP-competitive manner, which may result in the inhibition of the PI3K/Akt signaling pathway and tumor cell proliferation and the induction of tumor cell apoptosis. Activation of the PI3K/Akt signaling pathway is frequently associated with tumorigenesis and dysregulated PI3K/Akt signaling may contribute to tumor resistance to a variety of antineoplastic agents. (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ipatasertib)
Mechanisms of Action: Akt Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Mexico, Netherlands, New Zealand, North Macedonia, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Breast Cancer|Oncology Unspecified|Prostate Cancer|Triple Negative Breast Cancer
Phase 2: Adenocarcinoma|Endometrial Cancer|Endometrioid Carcinoma|Glioblastoma|Intestinal Cancer|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Ovarian Cancer
Phase 1: Fallopian Tube Cancer|Peritoneal Cancer|Serous Cystadenocarcinoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03337698 |
Morpheus Lung | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2025-10-14 |
12% |
2025-12-13 |
Primary Endpoints |
NCT05862285 |
UmbrellaMAX | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
39% |
2025-12-24 |
Patient Enrollment|Primary Endpoints|Treatments |
2019-000810-12 |
2019-000810-12 | P3 |
Completed |
Triple Negative Breast Cancer |
2025-10-09 |
51% |
2025-07-09 |
Treatments |
2018-002190-21 |
ROME | P2 |
Completed |
Breast Cancer|Non-Small-Cell Lung Cancer|Intestinal Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT04589845 |
BO41932 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2032-09-25 |
12% |
2025-04-09 |
|
NCT04931342 |
BOUQUET | P2 |
Active, not recruiting |
Ovarian Cancer |
2028-02-28 |
12% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05538897 |
NCI-2022-07505 | P2 |
Active, not recruiting |
Endometrioid Carcinoma|Adenocarcinoma|Endometrial Cancer |
2027-01-31 |
2025-07-04 |
||
NCT04920708 |
FAIM | P2 |
Recruiting |
Breast Cancer |
2026-09-01 |
53% |
2023-10-28 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT03673787 |
IceCAP | P2 |
Active, not recruiting |
Glioblastoma|Prostate Cancer |
2026-03-01 |
12% |
2025-05-15 |
|
NCT05276973 |
NCI-2022-01930 | P1 |
Active, not recruiting |
Serous Cystadenocarcinoma|Fallopian Tube Cancer|Ovarian Cancer|Endometrioid Carcinoma|Peritoneal Cancer |
2025-01-30 |
2025-03-01 |
Primary Endpoints|Study Completion Date |
|
2023-504263-16-00 |
BX44273 | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
39% |
2025-05-02 |
Treatments |
jRCT2031230279 |
jRCT2031230279 | P3 |
Recruiting |
Oncology Unspecified |
2027-02-28 |
|||
NCT04650581 |
FINER | P3 |
Active, not recruiting |
Breast Cancer |
2025-05-23 |
17% |
2025-08-13 |
Primary Endpoints |
2019-001072-11 |
2019-001072-11 | P3 |
Completed |
Breast Cancer |
2024-12-21 |
34% |
2025-07-07 |
Treatments |
jRCT2080223518 |
jRCT2080223518 | P3 |
Completed |
Prostate Cancer |
2024-05-16 |
|||
2016-004429-17 |
2016-004429-17 | P3 |
Completed |
Prostate Cancer |
2024-04-24 |
43% |
2025-05-06 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
2023-508826-92-00 |
SOLTI-1507 | P1 |
Recruiting |
Breast Cancer |
2025-12-16 |
2025-05-02 |
Treatments |
|
NCT04253561 |
IPATHER | P1 |
Recruiting |
Breast Cancer |
2025-06-25 |
12% |
2023-04-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-507418-28-00 |
BO41932 | P2 |
Recruiting |
Oncology Solid Tumor Unspecified |
2032-09-25 |
12% |
2025-05-02 |
Treatments |
NCT03424005 |
Morpheus-panBC | P2 |
Recruiting |
Breast Cancer |
2030-09-30 |
12% |
2025-11-29 |
|
2023-508194-89-00 |
WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
2025-05-02 |
Treatments |
|
2019-003192-18 |
CRAFT | P2 |
Completed |
Oncology Solid Tumor Unspecified |
2024-12-30 |
2025-06-01 |
Treatments |
|
NCT03280563 |
MORPHEUS HR+BC | P2 |
Completed |
Breast Cancer |
2024-09-26 |
66% |
2025-11-11 |
|
2023-507495-48-00 |
CO42867 | P2 |
Recruiting |
Breast Cancer |
2024-05-23 |
12% |
2025-05-02 |
Treatments |
2022-003414-36 |
2022-003414-36 | P3 |
Active, not recruiting |
Unknown |
2033-09-11 |
39% |