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Ipatasertib

Pronounced as: eye-PAT-uh-SER-tib

Alternative Names: ipatasertib, gdc-0068
Clinical Status: Active
Latest Update: 2025-12-23
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Ipatasertib

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%