Treats hormone receptor (HR)-positive, human epidermal growth factor receptor 2…. Sold as Truqap. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Capivasertib (sold as Truqap), first approved Nov 16, 2023, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Truqap | Part D | $378M | +105% | 4,013 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA TestingHR Positive/HER-2 Negative Breast Cancer · SWOG Cancer Research Network | Phase 3 | Not yet recruiting | Sep 3, 2026 |
| Immunotherapy Plus Capivasertib for Metastatic Bladder CancerAdvanced Urothelial Carcinoma · VA Office of Research and Development | Phase 1 / Phase 2 | Not yet recruiting | Aug 28, 2026 |
| Fast-Her: Fasting Effects on Breast Cancer TreatmentMetastatic Breast Cancer · University of Minnesota | Not applicable | Recruiting | Jun 3, 2026 |
| Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L OsimertinibLung Cancer (NSCLC), Lung Cancer (Non-Small Cell) · Shanxi Province Cancer Hospital | Phase 1 / Phase 2 | Not yet recruiting | Mar 20, 2026 |
| Rash & Diarrhea Prophylaxis With CapivasertibMetastatic HR+/HER2- Breast Cancer · Maryam Lustberg | Phase 2 | Recruiting | Feb 23, 2026 |
| A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic ImpairmentModerate Hepatic Impairment · AstraZeneca | Phase 1 | Recruiting | Jan 15, 2026 |
| CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBLLeukemia, Lymphoma · University of Chicago | Phase 1 / Phase 2 | Recruiting | Dec 19, 2025 |
| Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid TumorsMelanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer · Aminex Therapeutics, Inc. | Phase 1 / Phase 2 | Recruiting | Dec 17, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 16, 2023 | TruqapNDA 218197 · New molecular entity | Astrazeneca | 6 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA