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(CDK)4/6 inhibitor

Tianjin Medical University Cancer Institute and Hospital · Phase 3 active Small molecule

(CDK)4/6 inhibitor is a CDK4/6 inhibitor Small molecule drug developed by Tianjin Medical University Cancer Institute and Hospital. It is currently in Phase 3 development for Hormone receptor-positive, HER2-negative breast cancer (likely indication based on CDK4/6 inhibitor class). Also known as: ET, Palbociclib；, Abemaciclib / Ribociclib / Palbociclib.

CDK4/6 inhibitors block cyclin-dependent kinases 4 and 6, which prevents phosphorylation of the retinoblastoma protein and halts cell cycle progression at the G1/S checkpoint.

CDK4/6 inhibitors block cyclin-dependent kinases 4 and 6, which prevents phosphorylation of the retinoblastoma protein and halts cell cycle progression at the G1/S checkpoint. Used for Hormone receptor-positive, HER2-negative breast cancer (likely indication based on CDK4/6 inhibitor class).

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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(CDK)4/6 inhibitor
Also known asET, Palbociclib；, Abemaciclib / Ribociclib / Palbociclib
SponsorTianjin Medical University Cancer Institute and Hospital
Drug classCDK4/6 inhibitor
TargetCDK4, CDK6
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Mechanism of action

CDK4/6 inhibitors are small molecules that bind to and inhibit cyclin-dependent kinases 4 and 6, enzymes critical for driving cells from G1 phase into S phase of the cell cycle. By preventing retinoblastoma protein phosphorylation, these inhibitors cause cell cycle arrest in cancer cells, particularly in hormone receptor-positive breast cancer. This mechanism is often used in combination with endocrine therapy to enhance anti-tumor activity.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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Frequently asked questions about (CDK)4/6 inhibitor

What is (CDK)4/6 inhibitor?

(CDK)4/6 inhibitor is a CDK4/6 inhibitor drug developed by Tianjin Medical University Cancer Institute and Hospital, indicated for Hormone receptor-positive, HER2-negative breast cancer (likely indication based on CDK4/6 inhibitor class).

How does (CDK)4/6 inhibitor work?

CDK4/6 inhibitors block cyclin-dependent kinases 4 and 6, which prevents phosphorylation of the retinoblastoma protein and halts cell cycle progression at the G1/S checkpoint.

What is (CDK)4/6 inhibitor used for?

(CDK)4/6 inhibitor is indicated for Hormone receptor-positive, HER2-negative breast cancer (likely indication based on CDK4/6 inhibitor class).

Who makes (CDK)4/6 inhibitor?

(CDK)4/6 inhibitor is developed by Tianjin Medical University Cancer Institute and Hospital (see full Tianjin Medical University Cancer Institute and Hospital pipeline at /company/tianjin-medical-university-cancer-institute-and-hospital).

Is (CDK)4/6 inhibitor also known as anything else?

(CDK)4/6 inhibitor is also known as ET, Palbociclib；, Abemaciclib / Ribociclib / Palbociclib.

What drug class is (CDK)4/6 inhibitor in?

(CDK)4/6 inhibitor belongs to the CDK4/6 inhibitor class. See all CDK4/6 inhibitor drugs at /class/cdk4-6-inhibitor.

What development phase is (CDK)4/6 inhibitor in?

(CDK)4/6 inhibitor is in Phase 3.

What are the side effects of (CDK)4/6 inhibitor?

Common side effects of (CDK)4/6 inhibitor include Neutropenia, Leukopenia, Anemia, Diarrhea, Nausea, Fatigue.

What does (CDK)4/6 inhibitor target?

(CDK)4/6 inhibitor targets CDK4, CDK6 and is a CDK4/6 inhibitor.

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