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 CEO: Severin Schwan
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 |
|---|---|---|---|---|---|---|---|---|
NCT05862285 |
UmbrellaMAX | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
36% |
2025-12-24 |
Patient Enrollment|Primary Endpoints|Treatments |
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 |
Adenocarcinoma|Endometrial Cancer|Endometrioid Carcinoma |
2027-01-31 |
2025-07-04 |
||
NCT03673787 |
IceCAP | P2 |
Active, not recruiting |
Glioblastoma|Prostate Cancer |
2026-03-01 |
12% |
2025-05-15 |
|
2023-508826-92-00 |
SOLTI-1507 | P1 |
Recruiting |
Breast Cancer |
2025-12-16 |
2025-05-02 |
Treatments |
|
NCT03337698 |
Morpheus Lung | P2 |
Completed |
Non-Small-Cell Lung Cancer |
2025-10-14 |
12% |
2025-12-13 |
Primary Endpoints |
2019-000810-12 |
2019-000810-12 | P3 |
Completed |
Triple Negative Breast Cancer |
2025-10-09 |
51% |
2025-07-09 |
Treatments |
NCT05276973 |
NCI-2022-01930 | P1 |
Active, not recruiting |
Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer|Endometrioid Carcinoma|Serous Cystadenocarcinoma |
2025-01-30 |
2025-03-01 |
Primary Endpoints|Study Completion Date |
|
2018-002190-21 |
ROME | P2 |
Completed |
Non-Small-Cell Lung Cancer|Intestinal Cancer|Breast Cancer |
2024-09-06 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2022-003414-36 |
2022-003414-36 | P3 |
Active, not recruiting |
Unknown |
2033-09-11 |
36% |
||
2023-504263-16-00 |
BX44273 | P3 |
Recruiting |
Oncology Unspecified |
2033-03-01 |
36% |
2025-05-02 |
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 |
|
jRCT2031230279 |
jRCT2031230279 | P3 |
Recruiting |
Oncology Unspecified |
2027-02-28 |
|||
NCT04920708 |
FAIM | P2 |
Recruiting |
Breast Cancer |
2026-09-01 |
53% |
2023-10-28 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
2019-001072-11 |
2019-001072-11 | P3 |
Completed |
Breast Cancer |
2024-12-21 |
34% |
2025-07-07 |
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 |
NCT04650581 |
FINER | P3 |
Active, not recruiting |
Breast Cancer |
2025-05-23 |
15% |
2025-08-13 |
Primary Endpoints |
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 |
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 |