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AZD9833 with abemaciclib
AZD9833 with abemaciclib is a CDK4/6 inhibitor Small molecule drug developed by AstraZeneca. It is currently in Phase 1 development for Breast cancer.
AZD9833 is a CDK4/6 inhibitor, and abemaciclib is a CDK4/6 inhibitor.
AZD9833 is a CDK4/6 inhibitor, and abemaciclib is a CDK4/6 inhibitor. Used for Breast cancer.
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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.
| 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 abemaciclib |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | CDK4/6 inhibitor |
| Target | CDK4/6 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 1 |
Mechanism of action
AZD9833 and abemaciclib work by inhibiting cyclin-dependent kinases 4 and 6, which are involved in cell cycle progression. This inhibition can lead to cell cycle arrest and apoptosis in cancer cells.
Approved indications
- Breast cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer (PHASE3)
- A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (PHASE1, PHASE2)
- Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (PHASE1)
- Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (PHASE3)
- An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AZD9833 with abemaciclib CI brief — competitive landscape report
- AZD9833 with abemaciclib updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about AZD9833 with abemaciclib
What is AZD9833 with abemaciclib?
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What does AZD9833 with abemaciclib target?
Related
- Drug class: All 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