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Capivasertib (Truqap) is the first AKT inhibitor, for breast cancer with PI3K-pathway mutations and, since 2026, for prostate cancer with PTEN loss.
Capivasertib is an ATP-competitive pan-AKT inhibitor given intermittently at 400 mg twice daily for 4 days on and 3 days off, a schedule chosen to limit hyperglycaemia and rash. It was approved in 2023 with fulvestrant for HR-positive, HER2-negative advanced breast cancer carrying PIK3CA, AKT1 or PTEN alterations after CAPItello-291, and in Q2 2026 with abiraterone for PTEN-deficient metastatic hormone-sensitive prostate cancer after CAPItello-281, the first AKT inhibitor in either disease. AstraZeneca markets it. Diarrhoea (77%, 12% grade 3 or higher) and cutaneous reactions (56%, 15%) are the main toxicities. The breast label is limited to tumours with a pathway alteration, and sequencing against PI3K-alpha inhibitors such as inavolisib is unresolved. For a newcomer: a pill that blocks the AKT node of the PI3K pathway in tumours that have switched it on.
ATP-competitive pan-AKT inhibitor, intermittent 4-days-on/3-off dosing. Connects to AKT and PIK3CA / PI3K-alpha.
1.Oral drug is absorbed and reaches the tumour
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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).
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.
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.
Sources: NICE TA1063. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
HR+/HER2- breast cancer with PIK3CA/AKT1/PTEN alteration, with fulvestrant (CAPItello-291): first AKT inhibitor source
PTEN-deficient metastatic prostate cancer with abiraterone (CAPItello-281) source
| 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 |
| EU | 2024 | ER+/HER2- mBC with PIK3CA/AKT1/PTEN alteration; 17 Jun 2024 |
| 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.
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The latest in a line of negative targeted-therapy trials in triple-negative disease (EGFR, VEGF, iniparib, now AKT): a modest delay in progression that did not translate into survival, in the same year that an antibody-drug conjugate did. It is why the roadmap treats pathway-targeted small molecules as the road not taken.
Capivasertib-fulvestrant is a standard option for tumours with PIK3CA, AKT1 or PTEN alterations after a CDK4/6 inhibitor, adding a second targeted pathway to endocrine therapy.
PAKT gives the trial-based prevalence of PI3K-pathway alteration in first-line metastatic TNBC (one in five) and the strongest signal for AKT inhibition in that subgroup; the phase 3 CAPItello-290 did not confirm it.
Query 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.
Shares Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, Hyperglycaemia (PI3K/AKT inhibitor class effect), PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), Choline metabolism in cancer.
Shares Hyperglycaemia (PI3K/AKT inhibitor class effect), PI3K/AKT-pathway inhibitor + endocrine therapy (± CDK4/6), Molecular-progression switching beyond ESR1, PIK3CA mutation.
Shares PAKT, Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC, PTEN, AKT.
Shares PAKT, Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC, PTEN, AKT.
Shares Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors, 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, Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients, Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292).
Shares AKT1 E17K mutation, PIK3CA mutation, PTEN, AKT.
Shares PTEN alteration (sequencing) and PTEN loss (IHC), PTEN, AKT, Androgen receptor signalling.
Shares Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer, Hyperglycaemia (PI3K/AKT inhibitor class effect), Choline metabolism in cancer, PTEN loss.