Drugs / Capivasertib
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 58 · a red edge is where a trial was stopped
| 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 1/29 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 1/2 | NCT02121639 | Jan 2014 → Oct 2020 | prostate cancer | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 1/2 | NCT01625286 | Oct 2012 → Jan 2017 | estrogen-receptor positive breast cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 220 trials | ||||||
| Phase 2 | NCT06613516 | Feb → Sep 2025 | estrogen-receptor positive breast cancer | Imperial College London | Withdrawn | No outcome recorded |
| 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 |
| Phase 2 | NCT03660826 | Sep 2018 → Dec 2024 overdue | endometrial endometrioid adenocarcinoma, endometrial mixed adenocarcinoma, endometrial serous adenocarcinoma, endometrial undifferentiated carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03182634 | Dec 2016 → Nov 2022 | female breast carcinoma | Institute of Cancer Research, United Kingdom | Unknown | No outcome recorded |
| 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 | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 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 39 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04305496 | Apr 2020 → May 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| 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 | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| 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 22 trials | ||||||
| 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 31 trial | ||||||
| Phase 3 | NCT06982521 Comparator | Aug 2025 → Apr 2028 expected | hormone receptor-positive breast cancer | Relay Therapeutics, Inc. | Recruiting | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-12 | AstraZeneca | Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗ |
| 2026-04-30 | AstraZeneca | Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer astrazeneca.com ↗ |
| 2025-04-29 | AstraZeneca | Update on CAPItello-280 Phase III trial of Truqap in metastatic castration-resistant prostate cancer astrazeneca.com ↗ |
| 2024-11-25 | AstraZeneca | 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 ↗ |
| 2024-06-20 | AstraZeneca | Truqap plus Faslodex approved in the EU for patients with advanced ER-positive breast cancer astrazeneca.com ↗ |
| 2024-06-18 | AstraZeneca | Update on the CAPItello-290 Phase III trial for Truqap plus chemotherapy in advanced or metastatic triple-negative breast cancer astrazeneca.com ↗ |
| 2024-04-29 | AstraZeneca | 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 | Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer astrazeneca.com ↗ |
| 2023-11-17 | AstraZeneca | Truqap (capivasertib) plus Faslodex approved in the US for patients with advanced HR-positive breast cancer astrazeneca.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 68 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 201945“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 |