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Last Updated: July 14, 2025

Investigational Drug Information for Ipatasertib


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What is the drug development status for Ipatasertib?

Ipatasertib is an investigational drug.

There have been 56 clinical trials for Ipatasertib. The most recent clinical trial was a Phase 2 trial, which was initiated on June 1st 2023.

The most common disease conditions in clinical trials are Breast Neoplasms, Triple Negative Breast Neoplasms, and Prostatic Neoplasms. The leading clinical trial sponsors are Hoffmann-La Roche, Genentech, Inc., and National Cancer Institute (NCI).

There are eighty US patents protecting this investigational drug and zero international patents.

Recent Clinical Trials for Ipatasertib
TitleSponsorPhase
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored StudyHoffmann-La RochePhase 4
Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recurrent or Metastatic Endometrial CancersNational Cancer Institute (NCI)Phase 1/Phase 2
Study of Chemotherapy Plus Ipatasertib in Participants With Solid Tumors With AKT Mutations, A ComboMATCH Treatment TrialNational Cancer Institute (NCI)Phase 2

See all Ipatasertib clinical trials

Clinical Trial Summary for Ipatasertib

Top disease conditions for Ipatasertib
Top clinical trial sponsors for Ipatasertib

See all Ipatasertib clinical trials

US Patents for Ipatasertib

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
Ipatasertib ⤷  Try for Free Polymeric nanoparticles and methods of making and using same Merck Sharp & Dohme Corp. (Rahway, NJ) Pfizer Inc. (New York, NY) ⤷  Try for Free
Ipatasertib ⤷  Try for Free Combinations of AKT inhibitor compounds and chemotherapeutic agents, and methods of use GENENTECH, INC. (South San Francisco, CA) ⤷  Try for Free
Ipatasertib ⤷  Try for Free Spiro[3H-indole-3,2'-pyrrolidin]-2(1H)-one compounds and derivatives as MDM2-P53 inhibitors Boehringer Ingelheim International GmbH (Ingelheim am Rhein, DE) ⤷  Try for Free
Ipatasertib ⤷  Try for Free 7-Benzyl-4-(2-methylbenzyl)-2,4,6,7,8,9-hexahydroimidazo [1,2-A]pyrido[3,4-E]pyrimidin-5(1H)-one, analogs thereof, and salts thereof and methods for their use in therapy Oncoceutics, Inc. (Philadelphia, PA) ⤷  Try for Free
Ipatasertib ⤷  Try for Free Tank-binding kinase inhibitor compounds Gilead Sciences, Inc. (Foster City, CA) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for Ipatasertib

Drugname Country Document Number Estimated Expiration Related US Patent
Ipatasertib European Patent Office EP3119395 2034-03-17 ⤷  Try for Free
Ipatasertib Spain ES2872552 2034-03-17 ⤷  Try for Free
Ipatasertib World Intellectual Property Organization (WIPO) WO2015142605 2034-03-17 ⤷  Try for Free
Ipatasertib Australia AU2012236135 2031-04-01 ⤷  Try for Free
Ipatasertib Australia AU2012236138 2031-04-01 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Development Update and Market Projection for Ipatasertib

Last updated: January 3, 2025

Introduction to Ipatasertib

Ipatasertib, developed by Genentech, a subsidiary of Roche, is an orally administered small molecule inhibitor of the AKT protein, a key component in the PI3K/AKT signaling pathway. This pathway is crucial for cell growth, proliferation, and survival, making it a target for cancer therapy.

Clinical Development History

Early Promise and Phase II Success

In early clinical trials, ipatasertib showed promise, particularly in combination with other therapies. A Phase II study evaluating AKT blockade with ipatasertib in metastatic castration-resistant prostate cancer (mCRPC) demonstrated superior antitumor activity when combined with abiraterone, especially in patients with PTEN-loss tumors. This combination prolonged radiographic progression-free survival (rPFS) and showed trends in overall survival and time-to-PSA progression[3].

Phase III Setbacks

Despite the initial promise, ipatasertib faced significant setbacks in Phase III trials. In the IPATential150 trial for metastatic CRPC, the drug hit only one of two co-primary endpoints in June 2020. Further disappointment came in February 2021 when the IPATunity130 study in hormone receptor-positive, HER2-negative advanced breast cancer was terminated due to the drug failing both efficacy endpoints[1][5].

Recent Developments and Discontinuation

Roche announced in its 2022 full-year financial report that it would be discontinuing the development of ipatasertib for castration-resistant prostate cancer, along with several other candidates. This decision followed multiple clinical failures and the lack of significant improvement in overall survival in subsequent analyses[1][5].

Current Clinical Status

Ongoing and New Indications

Although the Phase III trials for prostate and breast cancer have been discontinued, ipatasertib is still under clinical development for other indications. It is currently in Phase I for paranasal sinus and nasal cavity cancer, among other solid tumors. The drug is being investigated for its potential in treating various types of cancers, including advanced or metastatic HER2-positive breast cancer, epithelial ovarian cancer, and several types of head and neck cancers[4].

Market Projection

Market Growth Potential

Despite the setbacks, the market for AKT inhibitors like ipatasertib is projected to grow. The overall market for such drugs is expected to see robust growth, with a compound annual growth rate (CAGR) of approximately 15%[2].

Challenges and Opportunities

The discontinuation of ipatasertib for certain indications does not necessarily reflect the overall potential of AKT inhibitors in cancer therapy. The failure of ipatasertib in specific trials highlights the complexity and challenges of targeting the AKT pathway but also underscores the ongoing interest and research in this area. Other companies and research institutions continue to explore AKT inhibitors, indicating a persistent market opportunity[2].

Regulatory and Clinical Milestones

Upcoming Trials and Approvals

While ipatasertib itself is no longer a focus for Roche in certain indications, the company is anticipating several late-stage and regulatory milestones for other drugs in its pipeline. This includes approvals for Vabysmo, Tecentriq, and Polivy, as well as pivotal readouts for Tecentriq, Venclexta, Susvimo, Xolair, and Alecensa. These developments suggest that Roche remains active and optimistic about its oncology portfolio, even if ipatasertib is no longer part of it[1].

Conclusion

Ipatasertib's development journey highlights the challenges and complexities of cancer drug development. Despite its promising early results, the drug faced significant hurdles in later-stage trials. While it is no longer being pursued for certain indications, the ongoing research and development in the AKT inhibitor space suggest that the market for these drugs will continue to grow.

Key Takeaways

  • Ipatasertib is an AKT inhibitor that showed initial promise in Phase II trials but faced setbacks in Phase III.
  • The drug has been discontinued for castration-resistant prostate cancer and other indications.
  • It is still under development for other types of cancers, including paranasal sinus and nasal cavity cancer.
  • The market for AKT inhibitors is projected to grow despite the challenges faced by ipatasertib.
  • Roche continues to have a robust pipeline with several upcoming regulatory and clinical milestones.

FAQs

What is ipatasertib and how does it work?

Ipatasertib is a small molecule inhibitor of the AKT protein, targeting the PI3K/AKT signaling pathway crucial for cell growth and proliferation.

Why was ipatasertib discontinued for prostate cancer?

Ipatasertib was discontinued for castration-resistant prostate cancer due to its failure to meet efficacy endpoints in Phase III trials and the lack of significant improvement in overall survival.

What other indications is ipatasertib being investigated for?

Ipatasertib is currently under clinical development for various solid tumors, including paranasal sinus and nasal cavity cancer, HER2-positive breast cancer, and several types of head and neck cancers.

What is the market outlook for AKT inhibitors like ipatasertib?

The market for AKT inhibitors is projected to grow with a CAGR of approximately 15%, despite the challenges faced by ipatasertib.

What are the next steps for Roche after discontinuing ipatasertib?

Roche is focusing on other drugs in its pipeline, anticipating several late-stage and regulatory milestones for drugs like Vabysmo, Tecentriq, and Polivy.

Sources

  1. Roche Abandons AKT Prostate Cancer Asset - BioSpace
  2. Ipatasertib Market Size And Projection - Market Research Intellect
  3. Randomized Phase II Study Evaluating Akt Blockade with Ipatasertib - AACR Journals
  4. Ipatasertib by Genentech USA for Paranasal Sinus And Nasal Cavity Cancer - Pharmaceutical Technology
  5. The AKT is over: Roche dumps phase 3 prostate cancer prospect - Fierce Biotech

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