NDAORALTABLETPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
28
Data completeness
5/8 — Partial
Priority Review
TRUQAP (capivasertib) by AstraZeneca. Approved for breast cancer, prostate cancer. First approved in 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRUQAP (capivasertib) is an oral AKT inhibitor approved by the FDA in November 2023 for treating multiple cancer types including triple-negative breast cancer, prostate cancer, and B-cell non-Hodgkin lymphoma. The drug works by inhibiting protein kinase B (AKT), a key signaling enzyme involved in tumor cell survival and proliferation. It is administered as an oral tablet and represents AstraZeneca's precision oncology strategy across solid and hematologic malignancies.
$2MPart D
GrowthGrowing
6.9 years to LOEEarly commercial phase with significant growth potential; AstraZeneca is building the franchise across multiple cancer types, indicating expanding teams in oncology commercial and medical affairs.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (2)
Clinical Trials (28)
HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
Started Oct 2026
42 enrolled
Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) RecurrentLymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory+2 more
Rash & Diarrhea Prophylaxis With Capivasertib
Started Apr 2026
108 enrolled
Metastatic HR+/HER2- Breast Cancer
A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
Started Mar 2026
42 enrolled
Healthy Participants
A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
Started Jan 2026
20 enrolled
Moderate Hepatic Impairment
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
Started Nov 2025
250 enrolled
Breast CancerHR-positive Breast CancerAdvanced Breast Cancer+2 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.