Prescription medicine
Capivasertib Brand names: Truqap
Capivasertib (Truqap) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the capivasertib FDA label on DailyMed (effective June 12, 2026, AstraZeneca Pharmaceuticals LP); the NDA 218197 record on Drugs@FDA; every capivasertib label on DailyMed.
Highlights of the record
FDA label of June 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following pro
Forms and strengths
- 160 mg
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 16, 2023 Truqap, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 16, 2033 Truqap tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is capivasertib used for?
From the label: indications and usageTRUQAP is a kinase inhibitor indicated: HR positive, HER2 negative locally advanced or metastatic breast cancer
in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN -alterations as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. […]
Conditions named in the indications of capivasertib's FDA labels, with every medicine labeled for each:
From other capivasertib labelsProstate cancer: in combination with abiraterone and prednisone for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.
Source: FDA drug label (TRUQAP), AstraZeneca Pharmaceuticals LP, effective June 12, 2026 (SPL set d698c106-2322-401e-b738-cbd83c843ecf), via openFDA; the full label on DailyMed
Is there a generic for capivasertib (Truqap)?
No generic capivasertib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Truqap tablets: the compound patent runs to April 16, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the capivasertib label say about other medicines?
The capivasertib label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abiraterone | warnings and precautions | TRUQAP is used in combination with fulvestrant or abiraterone. |
| Fulvestrant | warnings and precautions | Refer to the Full Prescribing Information of fulvestrant for pregnancy and contraception information. |
| Loperamide | warnings and precautions | In the 257 patients with diarrhea, 59% required anti-diarrheal medications to manage symptoms. |
Source: FDA drug label (TRUQAP), AstraZeneca Pharmaceuticals LP, effective June 12, 2026 (SPL set d698c106-2322-401e-b738-cbd83c843ecf), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as capivasertib?
17 other medicines are given the same way (oral) and in the same FDA class as capivasertib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Talazoparib | Breast cancer, Prostate cancer | none listed | n/a | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Olaparib | Breast cancer, Prostate cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as capivasertib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to capivasertib
- 17 medicines for the same use
- Check an interaction
- what two or more labels say about each other