Capivasertib clinical trials
Capivasertib is named as an intervention in 25 current clinical trials in our USA, France, Canada, Spain, Belgium, South Korea, Taiwan, UK, Poland, Brazil, Australia, Israel, China, Mexico, Germany, Turkey, Italy, Japan, Netherlands, Czechia, India, Denmark, Portugal, Sweden, Switzerland, Austria, Singapore, Norway, Egypt and Ireland registers. 11 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is AstraZeneca (10). The most-studied condition is Metastatic Breast Cancer. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Capivasertib is approved
All regulators →Of the three regulators tracked here, the first to approve Capivasertib was the US, on 16 Nov 2023. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Capivasertib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Capivasertib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 9 listed patents; the last listed expires 16 Apr 2033 (US 10039766).
- Latest patent on the drug substance itself: 16 Apr 2033 (US 9487525).
- Exclusivity I-991: New indication: in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulat…, until 12 Jun 2029.
- Exclusivity NCE: New chemical entity, until 16 Nov 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Capivasertib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Capivasertib works
All drug targets →- Serine/threonine-protein kinase AKT inhibitor InhibitorTarget: Serine/threonine-protein kinase AKT✓ In ChEMBL and the Guide to Pharmacology
- Prostate cancerPhase 3
- Triple-negative breast carcinomaPhase 3
- Familial gastric cancerPhase 2
- CancerPhase 2
- Endometrial cancerPhase 2
- Follicular lymphomaPhase 2
- Gastric adenocarcinomaPhase 2
- LymphomaPhase 2
- Mantle cell lymphomaPhase 2
- Marginal zone lymphomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2325741, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7709, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Capivasertib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Capivasertib. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Capivasertib with fulvestrant for treating hormone receptor-positive HER2-negative advanced breast cancer after endocrine treatment NICE TA1063 | Optimised | 15 May 2025 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Capivasertib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TruqapEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Capivasertib
- ChEMBL
- CHEMBL2325741
- DrugBank
- DB12218
- PubChem CID
- 25227436
- CAS number
- 1143532-39-1
- FDA UNII
- WFR23M21IE
- Wikidata
- Q27074756
- Wikipedia
- Capivasertib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Capivasertib
25 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Capivasertib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Capivasertib. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.
2025-523460-21-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Centro Di Riferimento Oncologico Di Aviano | Italy |
Capivasertib across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Capivasertib on the HPRA medicines list.
- TRUQAP 160 mg film-coated tabletsAstraZeneca AB · EU/1/24/1820/001
- TRUQAP 200 mg film-coated tabletsAstraZeneca AB · EU/1/24/1820/002
Supply shortages
No entry for Capivasertib in the EMA, FDA or German BfArM shortage lists we track.
Recent approvals
- TruqapFDA · 16 Nov 2023 · New Drug (NDA) · Astrazeneca
Conditions studied with Capivasertib
36 conditionsAll 36 conditions
| Condition (as registered) | Trials |
|---|---|
| Metastatic Breast Cancer | 5 |
| Breast Cancer | 4 |
| Triple Negative Breast Neoplasms | 2 |
| Locally Advanced (Inoperable) or Metastatic Breast Cancer | 2 |
| Prostate Cancer | 2 |
| PIK3CA Mutation | 1 |
| HER2- Negative Breast Cancer | 1 |
| Hormone Receptor Positive Tumor | 1 |
| Hormone-Sensitive Prostate Cancer | 1 |
| Moderate Hepatic Impairment | 1 |
| Melanoma (Skin Cancer) | 1 |
| HER2-low Hormone Receptor Positive Breast Cancer | 1 |
| Lung Cancer (NSCLC) | 1 |
| Lung Cancer (Non-Small Cell) | 1 |
| Advanced Non-small-cell Lung Cancer | 1 |
| CCCA Assessed by Ki67 Drop Below <2.7% From Baseline | 1 |
| HR-positive Breast Cancer | 1 |
| Advanced Breast Cancer | 1 |
| Pediatric Cancer | 1 |
| Locally Advanced or Metastatic Breast Cancer | 1 |
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | 1 |
| Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) | 1 |
| Advanced Lymphoma | 1 |
| Advanced Malignant Solid Neoplasm | 1 |
| Bladder Carcinoma | 1 |
| Breast Carcinoma | 1 |
| Endometrial Adenocarcinoma | 1 |
| Endometrial Mixed Cell Adenocarcinoma | 1 |
| Endometrial Serous Adenocarcinoma | 1 |
| Endometrial Undifferentiated Carcinoma | 1 |
| Intracranial Meningioma | 1 |
| Recurrent Meningioma | 1 |
| NF2 Gene Mutation | 1 |
| Premenopausal Breast Cancer | 1 |
| ER Positive Breast Cancer | 1 |
| Solid Tumor, Adult | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Capivasertib trials
How many clinical trials are testing Capivasertib?
25 current trials in our USA, France, Canada, Spain, Belgium, South Korea, Taiwan, UK, Poland, Brazil, Australia, Israel, China, Mexico, Germany, Turkey, Italy, Japan, Netherlands, Czechia, India, Denmark, Portugal, Sweden, Switzerland, Austria, Singapore, Norway, Egypt and Ireland registers name Capivasertib (also registered as AZD5363) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Capivasertib trials recruiting patients?
Yes. 11 of the 25 trials are recruiting: 3 with sites in USA, 2 with sites in France, 2 with sites in Canada, 2 with sites in Spain, 3 with sites in Belgium, 1 with sites in South Korea, 2 with sites in Taiwan, 1 with sites in UK, 1 with sites in Poland, 1 with sites in Brazil, 1 with sites in Australia, 1 with sites in Israel, 1 with sites in Mexico, 3 with sites in Germany, 1 with sites in Turkey, 2 with sites in Italy, 2 with sites in Netherlands, 1 with sites in Czechia, 2 with sites in Denmark, 2 with sites in Portugal, 1 with sites in Sweden, 2 with sites in Switzerland, 1 with sites in Austria, 2 with sites in Singapore, 1 with sites in Norway and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Capivasertib clinical trials?
AstraZeneca (10), National Cancer Institute (NCI) (2), Relay Therapeutics, Inc (1) and Stemline Therapeutics, Inc (1), among 15 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Capivasertib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Capivasertib licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Capivasertib, for example TRUQAP 160 mg film-coated tablets (AstraZeneca AB). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Capivasertib shortage?
Not in the lists we track: Capivasertib has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Capivasertib works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Capivasertib works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Capivasertib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.