Capivasertib
Also known as Truqap
ASTRAZENECA PLC AZN · Locally Advanced (Inoperable) or Metastatic Breast Cancer; Breast Cancer; Hormone-Sensitive Prostate Cancer; Locally Advanced or Metastatic Breast Cancer; Prostate Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
7
From ClinicalTrials.gov
Latest FDA action
Approved
NDA218197,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Locally Advanced (Inoperable) or Metastatic Breast Cancer; Breast Cancer; Hormone-Sensitive Prostate Cancer; Locally Advanced or Metastatic Breast Cancer; Prostate Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 218197 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218197 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 25 Jun 20197 linked trials
- Filed Completed
- Approved Current stageFirst approval 16 Nov 2023
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Capivasertib. Editors add each one with its source.
Filed application
No filed application is on record for Capivasertib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Capivasertib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06764186ClinicalTrials.gov record for NCT06764186 (opens in a new tab)CAPItana | 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 | Phase 3 | Active, not recruiting | 101 (actual) | 30 Nov 2027 (estimated) | No |
| NCT06635447ClinicalTrials.gov record for NCT06635447 (opens in a new tab)CAPItrue | Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients | Phase 3 | Active, not recruiting | 293 (actual) | 31 Oct 2026 (estimated) | No |
| NCT05348577ClinicalTrials.gov record for NCT05348577 (opens in a new tab)CAPItello280 | Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC) | Phase 3 | Active, not recruiting | 1,035 (actual) | 4 Mar 2026 (estimated) | No |
| NCT04862663ClinicalTrials.gov record for NCT04862663 (opens in a new tab)CAPItello-292 | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) | Phase 3 | Active, not recruiting | 893 (actual) | 1 Nov 2027 (estimated) | No |
| NCT04493853ClinicalTrials.gov record for NCT04493853 (opens in a new tab)CAPItello-281 | Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency | Phase 3 | Active, not recruiting | 1,012 (actual) | 7 Oct 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04493853 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CAPItello-281
Serious adverse events (Adverse events, including SAEs, will be collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug, up to data cut-off for the Primary analysis (approximately 49 months). In Screening Part 1, only SAEs related to study procedures must be reported; AEs occurring during this period do not require reporting.): Capivasertib + Abiraterone 214 of 503; Placebo + Abiraterone 131 of 503 Source: ClinicalTrials.gov results for NCT04493853 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing CAPItello-281 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04305496ClinicalTrials.gov record for NCT04305496 (opens in a new tab)CAPItello-291 | Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer | Phase 3 | Active, not recruiting | 818 (actual) | 9 May 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04305496 (opens in a new tab) |
Posted results on ClinicalTrials.gov for CAPItello-291
Serious adverse events (Adverse events (AEs) and serious adverse events (SAEs) were collected from time of signature of the informed consent form, throughout the treatment period and including the 30-day follow-up period after discontinuation of study drug. Only treatment emergent AEs are presented.): Capi (Global Cohort) 57 of 355; Placebo (Global Cohort) 28 of 350; Capi (China Cohort) 20 of 71; Placebo (China Cohort) 3 of 62 More posted outcomes or analyses are on the study page. All posted results for NCT04305496 Source: ClinicalTrials.gov results for NCT04305496 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing CAPItello-291 (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT03997123ClinicalTrials.gov record for NCT03997123 (opens in a new tab)CAPItello-290 | Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC | Phase 3 | Active, not recruiting | 923 (actual) | 16 Mar 2026 (estimated) | No |
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA218197Action letter for NDA218197 (opens in a new tab) | Supplement 6 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA218197Action letter for NDA218197 (opens in a new tab) | Supplement 4 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA218197Action letter for NDA218197 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Truqap (EMEA/H/C/006017)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- AstraZeneca AB
- Active substance (INN)
- capivasertib
- ATC code
- L01EX27
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Truqap (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 218197 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06764186 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT06635447 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05348577 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04862663 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04493853 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04305496 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03997123 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA218197 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.