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Drug

Capivasertib

Approved · FDA / EMA
ClassSerine/threonine-protein kinase AKT inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Truqap, Capivasertibum.

5
Research papers
28
Active clinical trials
3
Protein targets
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Molecular Analysis for Therapy Choice (MATCH)

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer.

Research2023-06-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Capivasertib
Aliases & brands
TruqapCapivasertibum
RxNorm CUI
2669967
ChEMBL ID
CHEMBL2325741
ATC codes
L01EX27
UNII
WFR23M21IE
Primary mechanism
Serine/threonine-protein kinase AKT inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORSerine/threonine-protein kinase AKT inhibitor
INHIBITORSerine/threonine-protein kinase AKT inhibitor
INHIBITORSerine/threonine-protein kinase AKT inhibitor

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-11-162024-06-17)
Earliest approval
2023-11-16
Latest approval
2026-06-12
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-06-12Indication expansion
Indication expansion: CAPIVASERTIB (NDA218197)
Evidence ↗
2026-05-27Label change
Label change: CAPIVASERTIB (NDA218197)
Evidence ↗
2025-11-14Label change
Label change: CAPIVASERTIB (NDA218197)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-06-17ApprovalMulti-authority
Approval: Truqap (EMA)
Indication: Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breastShow full indication

Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

37 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
37
registered trials across all phases
LATEST COMPLETION 2026
28
Active studies
15
Recruiting
9
Late-stage (III+)
7
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 37
Phase 111Phase 1 / 26Phase 211Phase 39

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20202024
Most influential
Recent papers
Major research themes6
Breast Neoplasms3Antineoplastic Combined Chemotherapy Protocols1Aromatase Inhibitors1Erb-b2 Receptor Tyrosine Kinases1Molecular Targeted Therapy1Proto-Oncogene Proteins c-akt1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology2
  • The Annals of pharmacotherapy1
  • The Lancet. Oncology1
  • The New England journal of medicine1
Leading researchers
  • Turner NC3
  • Abraham J2
  • Baird RD2
  • Cortes J2
  • de Bruin EC2
  • Foxley A2
  • Park YH2
  • Bliss JM1
Leading institutions
free-text, unnormalised
  • Cancer Research UK Cambridge Centre2
  • American Society of Clinical Oncology1
  • Barts Cancer Institute1
  • Barts Hospital NHS Trust1
  • Breast Cancer Now Toby Robins Research Centre1
  • Cancer Research UK Edinburgh Centre1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Studied across 4 of the same disease areas as Capivasertib in the shared literature.

4 shared diseases3 shared papers

Studied across 4 of the same disease areas as Capivasertib in the shared literature.

4 shared diseases1 shared paper

Studied across the same disease area as Capivasertib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.