Drug Profile

Ipatasertib - Genentech

Alternative Names: GCD 0068; GDC-0068; RG-7440; RO 5532961

Latest Information Update: 12 Feb 2025

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At a glance

Originator Array BioPharma
Developer Big Ten Cancer Research Consortium; Chugai Pharmaceutical; Dana-Farber Cancer Institute; Genentech; National Cancer Institute (USA); Roche; Roche Farma; SOLTI Breast Cancer Research Group
Class Amines; Antineoplastics; Chlorinated hydrocarbons; Heterocyclic bicyclo compounds; Ketones; Piperazines; Pyrimidines; Small molecules
Mechanism of Action Proto-oncogene protein c-akt inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Phase III Breast cancer; HER2 negative breast cancer; Triple negative breast cancer
Phase II Gastrointestinal cancer; Haematological malignancies; Ovarian cancer; Solid tumours
Phase I/II Endometrial cancer; Prostate cancer
Phase I Head and neck cancer
No development reported HER2 positive breast cancer

07 Nov 2024 Hoffmann-La Roche completes the phase II CUPISCO trial for Cancer (Second-line therapy or greater, Combination therapyAustralia, Austria, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, South Korea, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Spain, Switzerland, Thailand, Turkey, United Kingdom (NCT03498521)
26 Sep 2024 Hoffmann-La Roche completes the phase-I/II MORPHEUS HR+BC trial in HER2-negative-breast-cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in South Korea, USA, Israel (PO) (NCT03280563)
13 Sep 2024 Interim efficacy data from a phase II CUPISCO trial in Cancer presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)

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