Capivasertib
Capivasertib (Truqap) is the first AKT inhibitor, for breast cancer with PI3K-pathway mutations and, since 2026, for prostate cancer with PTEN loss.
CAPItello-291 (with fulvestrant in HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alterations, 2023). CAPItello-281 (with abiraterone in PTEN-deficient mHSPC) approved Q2 2026. AstraZeneca.
1.Oral drug is absorbed and reaches the tumour
- Route
- Oral
- Schedule
- 400 mg twice daily for 4 days on, 3 days off, with fulvestrant (breast) or abiraterone plus prednisone (prostate)
- Dose modifications
- Reduce to 320 then 240 mg for grade 3 diarrhoea, rash, or hyperglycaemia; hold for fasting glucose >250 mg/dL
- Monitoring
- Fasting glucose and HbA1c at baseline and periodically; skin; loperamide guidance
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
- Commercial insurance
- covered with prior authorisation
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. PIK3CA, AKT1 or PTEN alteration by an approved test required.
- Assistance programmes
- AstraZeneca Access 360
- AZ&Me Prescription Savings
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Notes
- UK-discovered (ICR/AstraZeneca) AKT inhibitor licensed 2024; NICE initially issued negative draft guidance in 2024 then recommended it with fulvestrant in 2025 after a revised deal. TA number not verified.
Sources: NICE search: capivasertib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 16 Nov 2023ApprovalUS
HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant (CAPItello-291): first AKT inhibitor source
- Q2 2026ApprovalUS
PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant |
| US | 2026 | PTEN-deficient metastatic prostate cancer with abiraterone |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea CAPItello-291 | 77% | 12% |
| Cutaneous adverse reactions CAPItello-291 | 56% | 15% |
| Fatigue CAPItello-291 | 38% | 1.9% |
| Nausea CAPItello-291 | 35% | 1.3% |
| Stomatitis CAPItello-291 | 25% | 1.9% |
| Vomiting CAPItello-291 | 21% | 1.9% |
| Hyperglycaemia Warning: DKA reported | — | — |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part D (oral); commercial plans per formulary, often with prior authorisation | not disclosed | astrazeneca-us.com/medicines/access-360 |
| United Kingdom | NICE: recommended with fulvestrant for PIK3CA/AKT1/PTEN-altered HR+ breast cancer (TA998) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery for this drug: (TITLE:"Capivasertib" OR ABSTRACT:"Capivasertib" OR TITLE:"Truqap" OR ABSTRACT:"Truqap") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Capivasertib, not a curated reading list.