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AZD9833 with capivasertib

AstraZeneca · Phase 1 active Small molecule

AZD9833 with capivasertib is a CDK4/6 inhibitor and PI3K inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development for Breast cancer.

AZD9833 is a CDK4/6 inhibitor, and capivasertib is a pan-PI3K inhibitor.

AZD9833 is a CDK4/6 inhibitor, and capivasertib is a pan-PI3K inhibitor. Used for Breast cancer.

Likelihood of approval
12.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Big-pharma sponsor +3.0pp
    AstraZeneca is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2033–2036 —
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic nameAZD9833 with capivasertib
SponsorAstraZeneca
Drug classCDK4/6 inhibitor and PI3K inhibitor
TargetCDK4/6 and PI3K
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 1

Mechanism of action

AZD9833 works by inhibiting the CDK4/6 pathway, while capivasertib targets the PI3K pathway. This combination may help treat certain types of cancer.

Approved indications

Common side effects

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Frequently asked questions about AZD9833 with capivasertib

What is AZD9833 with capivasertib?

AZD9833 with capivasertib is a CDK4/6 inhibitor and PI3K inhibitor drug developed by AstraZeneca, indicated for Breast cancer.

How does AZD9833 with capivasertib work?

AZD9833 is a CDK4/6 inhibitor, and capivasertib is a pan-PI3K inhibitor.

What is AZD9833 with capivasertib used for?

AZD9833 with capivasertib is indicated for Breast cancer.

Who makes AZD9833 with capivasertib?

AZD9833 with capivasertib is developed by AstraZeneca (see full AstraZeneca pipeline at /company/astrazeneca).

What drug class is AZD9833 with capivasertib in?

AZD9833 with capivasertib belongs to the CDK4/6 inhibitor and PI3K inhibitor class. See all CDK4/6 inhibitor and PI3K inhibitor drugs at /class/cdk4-6-inhibitor-and-pi3k-inhibitor.

What development phase is AZD9833 with capivasertib in?

AZD9833 with capivasertib is in Phase 1.

What are the side effects of AZD9833 with capivasertib?

Common side effects of AZD9833 with capivasertib include Fatigue, Nausea, Diarrhea.

What does AZD9833 with capivasertib target?

AZD9833 with capivasertib targets CDK4/6 and PI3K and is a CDK4/6 inhibitor and PI3K inhibitor.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing