capivasertib
Trade name: Truqap
Small moleculeapprovedFast Track FDA
Approved
Nov 16, 2023
Clinical trial activity
30 trials · 26 clinical orgs · 1 marketing orgs
Phase 1
15
Phase 2
19
Phase 3
9
Phase 4
0
Earliest trial started May 31, 2016 (NCT04439123)
Timeline
2010s
- Jan 1, 2016
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2019
AstraZeneca — Earliest Phase 3 Sponsor(trial)
2020s
- Nov 16, 2023
AstraZeneca — Earliest FDA Approval
- Nov 16, 2023
AstraZeneca — Marketing Organization
- Nov 16, 2023
AstraZeneca — NDA Organization
Indications
Approved for
Studied for
- Breast Neoplasms · Phase 3
- Cell Cycle Checkpoints · Phase 2
- Healthy Volunteers · Phase 1
- Lymphoma · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Multiple Myeloma · Phase 2
- Mutation · Phase 3
- Neoplasms · Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Prostatic Neoplasms · Phase 3
- Triple Negative Breast Neoplasms · Phase 3
Mechanism of action
- AKT/p21CIP1INHIBITOR
AKT/p21CIP1 inhibitor
- Serine/threonine-protein kinase AKTINHIBITOR
Serine/threonine-protein kinase AKT inhibitor
Part of Astra Zeneca's Open Innovation program
Approval history
- approvedPriority reviewFast trackNov 16, 2023
Chemistry & pharmacology
Loading structure…
SMILES
NC1(C(=O)N[C@@H](CCO)c2ccc(Cl)cc2)CCN(c2nc[nH]c3nccc2-3)CC1- Mol. weight
- 428.92 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
First in class
Sources
- ChEMBLCHEMBL2325741 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07175415 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2026 | AbbVie, AstraZeneca, Humboldt University, Princess Maxima Center for Pediatric Oncology |
| NCT07294677 | Phase 1/Phase 2 (Phase 2) | Mar 17, 2026 | University of Chicago |
| NCT07241065 | Phase 1 | Jan 28, 2026 | AstraZeneca, Parexel |
| NCT07281833 | Phase 3 | Dec 31, 2025 | AstraZeneca, West German Study Group |
| NCT07287917 | Phase 1/Phase 2 (Phase 2) | Dec 18, 2025 | Aminex Therapeutics, Inc. |
| NCT06982521 | Phase 3 | Aug 26, 2025 | Relay Therapeutics, Inc. |
| NCT07088913 | Phase 1 | Jul 28, 2025 | AstraZeneca, Parexel |
| NCT06764186 | Phase 3 | Jan 7, 2025 | Apices Soluciones S.L., AstraZeneca, SOLTI Breast Cancer Research Group |
| NCT06613516 | Phase 2 | Nov 1, 2024 | AstraZeneca, Imperial College London, Natera, Inc., Sharp Clinical Services |
| NCT06635447 | Phase 3 | Sep 26, 2024 | AstraZeneca |
| NCT06607757 | Phase 2 | Sep 15, 2024 | AstraZeneca, German Breast Group Forschungs GmbH |
| NCT05720260 | Phase 2 | Jan 17, 2023 | National Taiwan University |
| NCT05593497 | Phase 2 | Jan 1, 2023 | Department of Veteran Affairs |
| NCT05419401 | Phase 1 | Apr 11, 2022 | AstraZeneca, Quotient |
| NCT05348577 | Phase 3 | Mar 25, 2022 | AstraZeneca |
| NCT05008055 | Phase 2 | Nov 3, 2021 | AstraZeneca, Parexel |
| NCT04958226 | Phase 1 | Oct 15, 2021 | AstraZeneca |
| NCT04944771 | Phase 1 | Jul 26, 2021 | AstraZeneca, Parexel |
| NCT04862663 | Phase 3 | May 10, 2021 | AstraZeneca |
| NCT04742036 | Phase 1 | Feb 22, 2021 | AstraZeneca, Fudan University |
Showing 20 of 30 trials
Page 1 / 2
Organizations
Research & Development (26)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 22 | 18 | 3 | 2018 |
| Parexel | For profit | 6 | 0 | 2 | 2019 |
| AbbVie | For profit | 1 | 0 | 1 | 2026 |
| Aminex Therapeutics, Inc. | For profit | 1 | 1 | 1 | 2025 |
| Apices Soluciones S.L. | For profit | 1 | 0 | 1 | 2025 |
| Barts & The London NHS Trust | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Daiichi Sankyo | For profit | 1 | 0 | 1 | 2020 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2023 |
| ECOG-ACRIN Cancer Research Group | Academic/Hospital | 1 | 0 | 1 | 2016 |
| Fudan University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| German Breast Group Forschungs GmbH | For profit | 1 | 1 | 1 | 2024 |
| Humboldt University | Academic/Hospital | 1 | 0 | 1 | 2026 |
| Imperial College London | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Natera, Inc. | For profit | 1 | 0 | 1 | 2024 |
| National Cancer Institute (NCI) | Government | 1 | 1 | 1 | 2016 |
| National Taiwan University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| National University of Singapore | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Princess Maxima Center for Pediatric Oncology | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Quotient | For profit | 1 | 0 | 1 | 2022 |
26 organizations
Page 1 / 2
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | Nov 16, 2023 |
| AstraZeneca | For profit | NDA | Nov 16, 2023 |