TRUQAP (capivasertib)
Truqap is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. Eligible patients must have one or more PIK3CA, AKT1, or PTEN alterations as detected by an FDA-approved test. This regimen is prescribed following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
How TRUQAP Works
Capivasertib is an inhibitor of all three isoforms of the serine/threonine kinase AKT (AKT1, AKT2, and AKT3). It works by inhibiting the phosphorylation of downstream AKT substrates that drive tumor growth and survival. AKT overactivation in these tumors is typically driven by PIK3CA or AKT1 mutations or the loss of PTEN (a tumor suppressor) function. By blocking this signaling pathway, capivasertib reduces the proliferation of cancer cells, particularly in tumors harboring these specific genetic alterations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-11-16
- Patent Cliff
- 2033
- Revenue
- $233M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
TRUQAP Approval History
What TRUQAP Treats
1 indicationsTRUQAP is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
TRUQAP Target & Pathway
ProTarget
TRUQAP Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRUQAP's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRUQAP treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRUQAP
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT07287917 | AMXT1501-103 | Ph 1, Ph 2 | recruiting | Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors |
| NCT02523014 | A071401 NCI-2015-00546 | Ph 2 | recruiting | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas |
| NCT06982521 ReDiscover-2 | RLY-2608-102 | Ph 3 | recruiting | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer |
| NCT04439123 results posted | NCI-2020-02980 NCI-2020-02980, EAY131-Y | Ph 2 | active not recruiting | Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) |
| NCT04493853 CAPItello-281 | D361BC00001 2023-504998-20-00, 2020-000346-33 | Ph 3 | active not recruiting | Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency |
| NCT03660826 results posted | NCI-2017-01672 NCI-2017-01672, NRG-GY012 | Ph 2 | active not recruiting | Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone |
| NCT04305496 CAPItello-291 results posted | D3615C00001 2023-505042-25-00, 2019-003629-78 | Ph 3 | active not recruiting | Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer |
| NCT03742102 BEGONIA results posted | D933LC00001 2018-000764-29 | Ph 1, Ph 2 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer |
| NCT04862663 CAPItello-292 | D361DC00001 2020-004637-20 | Ph 3 | recruiting | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) |
| NCT05039801 | 2021-0265 NCI-2021-09063, 2021-0265 | Ph 1 | recruiting | IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors |
| NCT07241065 | D3615C00005 | Ph 1 | recruiting | A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants |
| NCT07343960 | D3615C00004 | Ph 1 | recruiting | A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment |
| NCT06764186 CAPItana | D3612L00005 | Ph 3 | active not recruiting | A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain |
| NCT06635447 CAPItrue | D3612R00016 | Ph 3 | active not recruiting | Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients |
| NCT05593497 SNARE | SPLP-001-21F | Ph 2 | recruiting | A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss |
| NCT07294677 CAVALRY | IRB25-1773 | Ph 1, Ph 2 | recruiting | CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL |
| NCT07088913 | D3615C00006 | Ph 1 | completed | A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants |
| NCT07281833 CAPIcorn | WSG-AM14 (CAPIcorn) | Ph 3 | recruiting | 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 |
| NCT03801369 results posted | STUDY00018504 NCI-2019-00388, STUDY00018504 | Ph 2 | terminated | AMTEC IIT: Phase 2 Multiarm Study in TNBC |
| NCT07426822 SAFE-CAP | 2000037614 | Ph 2 | not yet recruiting | Rash & Diarrhea Prophylaxis With Capivasertib |
| NCT02813135 ESMART | 2016-000133-40 2016/2396, 2024-514791-40-00 | Ph 1, Ph 2 | recruiting | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors |
| NCT05563220 ELEVATE | STML-ELA-0222 | Ph 1, Ph 2 | recruiting | Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer |
| NCT02208375 | 2013-0784 NCI-2014-01973, 2013-0784 | Ph 1 | active not recruiting | mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian |
| NCT06613516 CaptAin | 22CX7530 2022-000802-82 | Ph 2 | withdrawn | Effect of Capivasertib on ctDNA in ER Positive Breast Cancer |
| NCT03997123 CAPItello-290 | D3614C00001 2018-004687-64 | Ph 3 | active not recruiting | Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC |
| NCT04556773 DB-08 | D967JC00002 2023-505690-33-00, 2020-002797-27 | Ph 1 | active not recruiting | A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer |
| NCT07175415 HEM-iSMART E | 2025-523132-39-00 | Ph 1, Ph 2 | not yet recruiting | HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies |
| NCT06607757 | GBG118 - LOBSTER 2023-509292-17-00 | Ph 2 | recruiting | Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer |
| NCT05348577 CAPItello280 | D361EC00001 2023-504996-26-00, 2021-005201-27 | Ph 3 | active not recruiting | Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) |
| NCT05008055 CAPITAL results posted | D361FC00001 2021-000870-27 | Ph 2 | completed | Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
| NCT05720260 | 202109031MIPD | Ph 2 | recruiting | Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC |
| NCT04958226 | D3614C00003 | Ph 1 | completed | A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours |
| NCT04742036 | D3614C00002 | Ph 1 | completed | Capivasertib China PK Study |
| NCT04087174 | D3618C00002 | Ph 1 | completed | A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer |
| NCT04944771 | D3614C00005 2021-000836-74 | Ph 1 | completed | Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants |
| NCT04712396 | D3614C00004 | Ph 1 | completed | A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRUQAP FDA Label Details
Indications & Usage
FDA Label (PDF)TRUQAP is indicated for the treatment of Breast Cancer.
TRUQAP Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TRUQAP
Revenue Insights
- • Q4-2025: $233M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 28 active patents
Trial Analysis
- • 37 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment