Last reviewed 2026-04-23 · How we verify

AZD9833 with palbociclib

AstraZeneca · Phase 1 active Small molecule

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

CDK4/6 inhibitor

CDK4/6 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 name	AZD9833 with palbociclib
Sponsor	AstraZeneca
Drug class	SERD + CDK4/6 inhibitor
Target	CDK4/6
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 1

Mechanism of action

AZD9833 is a selective estrogen receptor degrader (SERD) combined with palbociclib, a CDK4/6 inhibitor, which targets the cell cycle progression.

Approved indications

Breast cancer

Common side effects

Fatigue
Nausea
Diarrhea

Competitive intelligence

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

AZD9833 with palbociclib CI brief — competitive landscape report
AZD9833 with palbociclib updates RSS · CI watch RSS
AstraZeneca portfolio CI

Frequently asked questions about AZD9833 with palbociclib

What is AZD9833 with palbociclib?

AZD9833 with palbociclib is a SERD + CDK4/6 inhibitor drug developed by AstraZeneca, indicated for Breast cancer.

How does AZD9833 with palbociclib work?

CDK4/6 inhibitor

What is AZD9833 with palbociclib used for?

AZD9833 with palbociclib is indicated for Breast cancer.

Who makes AZD9833 with palbociclib?

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

What drug class is AZD9833 with palbociclib in?

AZD9833 with palbociclib belongs to the SERD + CDK4/6 inhibitor class. See all SERD + CDK4/6 inhibitor drugs at /class/serd-cdk4-6-inhibitor.

What development phase is AZD9833 with palbociclib in?

AZD9833 with palbociclib is in Phase 1.

What are the side effects of AZD9833 with palbociclib?

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

What does AZD9833 with palbociclib target?

AZD9833 with palbociclib targets CDK4/6 and is a SERD + CDK4/6 inhibitor.

Drug class: All SERD + CDK4/6 inhibitor drugs
Target: All drugs targeting CDK4/6
Manufacturer: AstraZeneca — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Breast cancer

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