NDAORALTABLETPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
28
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRUQAP (capivasertib) is an oral small-molecule AKT inhibitor approved by the FDA in November 2023. It is indicated for hormone receptor-positive, HER2-negative breast cancer in combination with hormone therapy. The drug works by inhibiting AKT serine/threonine kinase, a key regulator of cell survival and proliferation in certain cancer cells.
$0.002BPart D
Growth6.8 years to LOEEarly-stage commercial trajectory with minimal market penetration in 2023; commercial team expansion likely as awareness and adoption accelerate.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.