Drugs / Capivasertib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | US (FDA) | — | progesterone-receptor positive breast cancer | 2023-06-12 | “AstraZeneca’s New Drug Application (NDA) for capivasertib in combination with Faslodex (fulvestrant) has been accepted and granted Priority Review in the US” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | TRUQAP | — | 2026-06-12 | fda.gov ↗ |
| Approved | EU (EMA) | Truqap | — | 2024-06-17 | europa.eu ↗ |
| Approved | US (FDA) | TRUQAP | — | 2023-11-16 | fda.gov ↗ |
Trials 60
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 120 trials | ||||||
| Phase 1 | NCT07241065 | Mar → Jun 2026 overdue | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1 | NCT07343960 | Jan → Nov 2026 expected | — | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1 | NCT07088913 | Jul 2025 → Feb 2026 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05419401 | Apr → Jul 2022 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04958226 | Oct 2021 → Feb 2023 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05039801 | Sep 2021 → Mar 2028 expected | chondrosarcoma, cutaneous melanoma, endometrial carcinoma, head and neck squamous cell carcinoma +3 | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04944771 | Jul 2021 → May 2022 | hematopoietic and lymphoid cell neoplasm | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04742036 | Feb 2021 → Jul 2022 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04712396 | Feb → Mar 2021 | breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04556773 | Dec 2020 → Aug 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04087174 | Aug 2019 → Jun 2021 | prostate cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03772561 | Dec 2018 → Dec 2026 expected | cancer | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 1 | NCT03616587 | Oct 2018 → Sep 2024 overdue | estrogen-receptor positive breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03310541 | Oct 2017 → May 2023 | breast cancer, prostate cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02208375 | Nov 2014 → Jun 2028 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, endometrium adenocarcinoma, fallopian tube carcinoma +4 | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02338622 | Mar 2014 → Mar 2016 | cancer of unknown primary site | Royal Marsden NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1 | NCT01895946 | Dec 2013 → Feb 2015 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01692262 | Nov 2012 → Jun 2014 | castration-resistant prostate carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01353781 | Jun 2011 → Jul 2014 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01226316 | Dec 2010 → Apr 2019 | HER2 positive breast carcinoma, cervical cancer, endometrial cancer, estrogen-receptor positive breast cancer +1 | AstraZeneca | Completed | No outcome recorded |
| Phase 1/210 trials · 1 met primary · 3 missed | ||||||
| Phase 1/2 | NCT07793578 | Jan 2027 → Sep 2029 expected | urothelial carcinoma | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07175415 | Oct 2026 → Oct 2031 expected | T lymphoblastic leukemia/lymphoma, acute lymphoblastic leukemia | Princess Maxima Center for Pediatric Oncology | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07486648 | May 2026 → Oct 2028 expected | non-small cell lung carcinoma | Shanxi Province Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07294677 | Mar 2026 → Mar 2032 expected | leukemia, lymphoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03742102 | Dec 2018 → Nov 2024 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | Missed primary |
| Phase 1/2 | NCT02813135 | Aug 2016 → Feb 2031 expected | childhood malignant neoplasm | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01992952 | May 2014 → Mar 2019 overdue | estrogen-receptor positive breast cancer | Velindre NHS Trust | Active not recruiting | Met primary |
| Phase 1/2 | NCT02121639 | Jan 2014 → Oct 2020 | prostate cancer | University Hospital Southampton NHS Foundation Trust | Completed | Missed primary |
| Phase 1/2 | NCT01625286 | Oct 2012 → Jan 2017 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | Missed primary |
| Phase 220 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06613516 | Feb → Sep 2025 | estrogen-receptor positive breast cancer | Imperial College London | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06607757 | Dec 2024 → Jun 2026 overdue | — | GBG Forschungs GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT05593497 | May 2024 → May 2027 expected | prostate cancer | VA Office of Research and Development | Recruiting | No outcome recorded |
| Phase 2 | NCT06837792 | Oct 2023 → Oct 2026 expected | Her2-receptor negative breast cancer | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT05720260 | Jan 2023 → Dec 2024 overdue | estrogen-receptor positive breast cancer | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05008055 | Nov 2021 → Aug 2023 | B-cell non-Hodgkin lymphoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT03801369 | Dec 2018 → Oct 2024 | female breast carcinoma, triple-negative breast carcinoma | Gordon Mills, MD, PhD | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03660826 | Sep 2018 → Dec 2024 overdue | endometrial mixed adenocarcinoma, endometrial serous adenocarcinoma, endometrial undifferentiated carcinoma, endometrioid adenocarcinoma | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 2 | NCT03182634 | Dec 2016 → Nov 2022 | female breast carcinoma | Institute of Cancer Research, United Kingdom | Unknown | Mixed |
| Phase 2 | NCT04439123 | May 2016 → Nov 2019 overdue | adult lymphoma, plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02576444 | Nov 2015 → Nov 2019 | cancer | Joseph Paul Eder | Terminated | No outcome recorded |
| Phase 2 | NCT02523014 | Sep 2015 → Jan 2027 expected | NF2-related schwannomatosis, intracranial meningioma | Alliance for Clinical Trials in Oncology | Recruiting | Met primary |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02664935 | May 2015 → Nov 2023 | adenocarcinoma, non-small cell lung carcinoma, squamous cell carcinoma | University of Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT02449655 | Feb 2015 → Jul 2018 | gastric adenocarcinoma | Samsung Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02451956 | Jan 2015 → May 2019 | gastric cancer | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02525068 | Dec 2014 → Dec 2019 | prostate adenocarcinoma | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
| Phase 2 | NCT02117167 | Apr 2014 → Dec 2018 | non-small cell lung carcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT02299999 | Apr 2014 → Dec 2022 overdue | breast cancer | UNICANCER | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02077569 | Jan 2014 → Feb 2017 | invasive breast carcinoma | University of Nottingham | Completed | No outcome recorded |
| Phase 310 trials · 3 met primary | ||||||
| Phase 3 | NCT07802626 | Oct 2026 → Oct 2034 expected | hormone receptor-positive breast cancer | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07281833 | Nov 2025 → Mar 2030 expected | hormone receptor-positive breast cancer | West German Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06764186 | Jan 2025 → Dec 2027 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06635447 | Sep 2024 → Oct 2026 expected | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05348577 | Mar 2022 → Mar 2026 overdue | prostate cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04862663 | May 2021 → Nov 2027 expected | Her2-receptor negative breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT04493853 | Jul 2020 → Oct 2024 overdue | — | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT04305496 | Apr 2020 → May 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT03997123 | Jun 2019 → Mar 2026 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03903835 | Feb 2019 → Dec 2026 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Karolinska Institutet | Recruiting | Met primary |
| Comparator or background therapy4 trials | ||||||
| Phase 1/2 | NCT07287917 Background | Jan 2026 → Feb 2028 expected | cutaneous melanoma, hormone receptor-positive breast cancer | Aminex Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07426822 Background | Apr 2026 → Apr 2027 expected | hormone receptor-positive breast cancer | Maryam Lustberg | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02423603 Comparator | May 2014 → Jun 2017 | breast cancer | Queen Mary University of London | Completed | No outcome recorded |
| Phase 3 | NCT06982521 Comparator | Aug 2025 → Apr 2028 expected | hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | AstraZeneca | Regulatory Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗ |
| 2026-05-28 | Menarini Group | Results Menarini Group Presents New Data from the Phase 1b/2 ELEVATE Study of Elacestrant in Combination with Capivasertib in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting menarini.com ↗
ELEVATE results reported at ASCO 2026 (abstract 1098)¹ include safety and preliminary efficacy data from the phase 1b elacestrant (258-345 mg) plus capivasertib (320-400 mg) cohorts (n=31), which demonstrate preliminary median progression-free survival (mPFS) benefit in the recommended phase 2 dose (RP2D) cohort. |
| 2026-04-30 | AstraZeneca | Regulatory Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗
The Committee voted 7 to 1, with 1 abstaining. |
| 2025-04-29 | AstraZeneca | Results Update on CAPItello-280 Phase III trial of Truqap in metastatic castration-resistant prostate cancer astrazeneca.com ↗
AstraZeneca is discontinuing the CAPItello-280 Phase III trial evaluating the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC). |
| 2024-11-25 | AstraZeneca | Results Truqap combination in PTEN-deficient metastatic hormone-sensitive prostate cancer demonstrated statistically significant and clinically meaningful improvement in radiographic progression-free survival in CAPItello-281 Phase III trial astrazeneca.com ↗
Overall survival (OS) data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. |
| 2024-06-20 | AstraZeneca | Regulatory Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. |
| 2024-06-18 | AstraZeneca | Results Update on the CAPItello-290 Phase III trial for Truqap plus chemotherapy in advanced or metastatic triple-negative breast cancer astrazeneca.com ↗
While the CAPItello-290 trial results have not shown what we hoped, they provide important information to further understand this aggressive form of breast cancer where patients are in urgent need of new treatments. |
| 2024-04-29 | AstraZeneca | Regulatory Truqap plus Faslodex recommended for approval in the EU by CHMP for patients with advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2024-03-27 | AstraZeneca | Regulatory Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in Japan for the treatment of adult patients with unresectable or recurrent PIK3CA, AKT1, or PTEN-altered hormone receptor (HR)-positive, HER2-negative breast cancer following progression after treatment with endocrine therapy. |
| 2023-11-17 | AstraZeneca | Regulatory Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer astrazeneca.com ↗
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). |
| 2023-06-12 | AstraZeneca | Regulatory Capivasertib in combination with Faslodex granted Priority Review in the US for patients with advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2022-12-08 | AstraZeneca | Results Capivasertib plus Faslodex reduced the risk of disease progression or death by 40% versus Faslodex in advanced HR-positive breast cancer astrazeneca.com ↗
In the AKT pathway biomarker-altered population, capivasertib plus Faslodex reduced the risk of disease progression or death by 50% versus placebo plus Faslodex (HR of 0.50, 95% CI 0.38-0.65; p=<0.001; median 7.3 versus 3.1 months). |
| 2022-10-26 | AstraZeneca | Results Capivasertib plus Faslodex significantly improved progression-free survival vs. Faslodex in CAPItello-291 Phase III trial in advanced HR-positive breast cancer astrazeneca.com ↗
The trial met both primary endpoints, improving PFS in the overall patient population and in a prespecified biomarker subgroup of patients whose tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN genes. |
| 2022-10-26 | AstraZeneca | Results Camizestrant significantly improved progression-free survival vs. Faslodex in SERENA-2 Phase II trial in advanced ER-positive breast cancer astrazeneca.com ↗
In addition to these results, the Company has also announced today positive results from the CAPitello-291 Phase III trial of capivasertib in HR-positive advanced breast cancer. |
| 2021-11-05 | AstraZeneca | Results AstraZeneca advances ambition to redefine care for blood cancer at ASH 2021 astrazeneca.com ↗
Preclinical data will be presented showing that capivasertib (AZD5363), an AKT inhibitor being evaluated in a number of solid and haematological tumours, showed significant activity in murine DLBCL models when combined with venetoclax. |
| 2018-05-24 | AstraZeneca | Results AstraZeneca heads to 2018 ASCO Annual Meeting with its diversified oncology portfolio and next-generation pipeline astrazeneca.com ↗ |
All press releases naming this drug 19 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | capivasertib | “BEECH investigated the efficacy of capivasertib (AZD5363), an oral inhibitor of AKT isoforms 1-3, in combination with the first-line weekly paclitaxel for advanced or...” PMID 30860570 ↗ May 201947“Assessing these mutations clinically, we conducted a phase II clinical trial testing the AKT inhibitor capivasertib (AZD5363) in patients with solid tumors harboring AKT...” PMID 35440569 ↗ Apr 2022 “6. Fulvestrant (administered same as above) + Capivasertib 400mg oral administration twice a day(dosed on Days 1 to 4 in each week of a 28-day treatment cycle)” NCT06837792 ↗ “Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.” NCT04305496 ↗ “Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT.” PMID 32035020 ↗ Feb 2020 “inhibitor AZD5363 (capivasertib)” PMID 32205016 ↗ Feb 2020 |
| Known as | AZC5363 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2325741 ↗ |
| Known as | AZD5363 | “A Phase I Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib) in Healthy Male Subjects” NCT05419401 ↗20“Capivasertib (AZD5363) is a potent selective oral inhibitor of all three isoforms of the serine/threonine kinase AKT.” PMID 32035020 ↗ Feb 2020 |
| Known as | CAPIVASERTIB (AZD5363) | ChEMBL registry synonym — accepted as the source's own label CHEMBL2325741 ↗ |
| Known as | TRUQAP | ChEMBL registry synonym — accepted as the source's own label CHEMBL2325741 ↗ |
| Action | Inhibit | “a selective pan-AKT inhibitor” PMID 29066505 ↗ Oct 2017 |
| Modality | Small molecule | — CHEMBL2325741 ↗ |
| Route | Oral | “the first-in-human evaluation of oral AZD5363” PMID 29066505 ↗ Oct 2017 |
| Target | AKT1 | “capivasertib - a potent, selective inhibitor of AKT1/2/3” PMID 36572571 ↗ Nov 2022 |