AstraZeneca Tests Capivasertib in Liver-Impaired Patients: What Investors Should Watch

AstraZeneca (AZN) announced an update on their ongoing clinical study.

Study Overview: AstraZeneca is running a Phase I study called “A Phase I, Single-dose, Non-randomized, Open-label, Parallel Group Study to Assess the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment.” The goal is to see how the body handles capivasertib and how safe it is in people with moderate liver problems compared with people with normal liver function. This work matters because many cancer patients have some level of liver impairment, and clear safety and dosing guidance can expand real-world use of the drug.

Intervention/Treatment: The study tests a single oral dose of capivasertib (also known as AZD5363), an AKT inhibitor used in oncology. One group has moderate liver impairment and the other has normal liver function. The aim is to understand if liver function changes how the drug is absorbed, processed, and cleared, and whether dose adjustments may be needed.

Study Design: This is an interventional Phase I trial with no random assignment; patients are placed into groups based on their liver function. Both groups receive capivasertib, so there is no placebo. The study is open-label, meaning both doctors and participants know what is being given. The main purpose is basic science: to understand drug levels and safety, not to test how well the drug works against cancer.

Study Timeline: The study was first submitted on 7 January 2026, marking the formal start of the current development step. It is listed as recruiting, showing that patient enrollment is active and data are still being gathered. The latest update to the record was submitted on 21 January 2026, which signals that the trial information is current. Primary and final completion dates have not yet been posted, underscoring that results are still several quarters away.

Market Implications: For investors, this update reinforces AstraZeneca’s push to build a wider label and stronger safety package for capivasertib. Clean liver-impairment data can support broader prescribing and reduce uncertainty for oncologists, which is important for long-term revenue durability if capivasertib gains or expands approvals. The trial also shows continued investment in fine-tuning dosing, a positive sign for risk management and regulatory dialogue. While near-term stock impact is likely modest given the early-stage and narrow focus, progress here supports the drug’s lifecycle value and may help AstraZeneca compete more effectively against other targeted therapy players in the oncology space. The study is ongoing and updated, with further details available on the ClinicalTrials.gov portal.

To learn more about AZN’s potential, visit the AstraZeneca drug pipeline page.