Last reviewed 2026-06-01 · How we verify

dalpiciclib + capecitabine + endocrine therapy

Fujian Cancer Hospital · Phase 3 active Small molecule Under review

dalpiciclib + capecitabine + endocrine therapy is a CDK4/6 inhibitor + chemotherapy + endocrine therapy Small molecule drug developed by Fujian Cancer Hospital. It is currently in Phase 3 development for HR-positive, HER2-negative advanced or metastatic breast cancer.

Dalpiciclib is a CDK4/6 inhibitor that blocks the cell cycle, while capecitabine is a chemotherapy medication that interferes with DNA synthesis, and endocrine therapy targets hormone receptors to slow cancer growth.

Dalpiciclib, a CDK4/6 inhibitor, is used in combination with capecitabine, a thymidylate synthase inhibitor, and endocrine therapy for the treatment of advanced breast cancer, particularly in patients with hormone receptor-low/HER2-negative status. This combination is being studied in clinical trials, such as NCT07005557, for its efficacy in treating node-positive, ER+/HER2- breast cancer in older patients.

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	dalpiciclib + capecitabine + endocrine therapy
Sponsor	Fujian Cancer Hospital
Drug class	CDK4/6 inhibitor + chemotherapy + endocrine therapy
Target	CDK4/6, estrogen receptors
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

Dalpiciclib works by inhibiting the CDK4/6 enzymes, which are involved in cell cycle progression. Capecitabine is a prodrug that is converted into 5-fluorouracil, a chemotherapy agent that interferes with DNA synthesis. Endocrine therapy, in this case, likely involves targeting hormone receptors such as estrogen receptors to slow cancer growth.

Approved indications

HR-positive, HER2-negative advanced or metastatic breast cancer

Common side effects

Diarrhea
Nausea
Fatigue
Vomiting
Hand-foot syndrome

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.

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:

dalpiciclib + capecitabine + endocrine therapy CI brief — competitive landscape report
dalpiciclib + capecitabine + endocrine therapy updates RSS · CI watch RSS
Fujian Cancer Hospital portfolio CI

Frequently asked questions about dalpiciclib + capecitabine + endocrine therapy

What is dalpiciclib + capecitabine + endocrine therapy?

dalpiciclib + capecitabine + endocrine therapy is a CDK4/6 inhibitor + chemotherapy + endocrine therapy drug developed by Fujian Cancer Hospital, indicated for HR-positive, HER2-negative advanced or metastatic breast cancer.

How does dalpiciclib + capecitabine + endocrine therapy work?

What is dalpiciclib + capecitabine + endocrine therapy used for?

dalpiciclib + capecitabine + endocrine therapy is indicated for HR-positive, HER2-negative advanced or metastatic breast cancer.

Who makes dalpiciclib + capecitabine + endocrine therapy?

dalpiciclib + capecitabine + endocrine therapy is developed by Fujian Cancer Hospital (see full Fujian Cancer Hospital pipeline at /company/fujian-cancer-hospital).

What drug class is dalpiciclib + capecitabine + endocrine therapy in?

dalpiciclib + capecitabine + endocrine therapy belongs to the CDK4/6 inhibitor + chemotherapy + endocrine therapy class. See all CDK4/6 inhibitor + chemotherapy + endocrine therapy drugs at /class/cdk4-6-inhibitor-chemotherapy-endocrine-therapy.

What development phase is dalpiciclib + capecitabine + endocrine therapy in?

dalpiciclib + capecitabine + endocrine therapy is in Phase 3.

What are the side effects of dalpiciclib + capecitabine + endocrine therapy?

Common side effects of dalpiciclib + capecitabine + endocrine therapy include Diarrhea, Nausea, Fatigue, Vomiting, Hand-foot syndrome.

What does dalpiciclib + capecitabine + endocrine therapy target?

dalpiciclib + capecitabine + endocrine therapy targets CDK4/6, estrogen receptors and is a CDK4/6 inhibitor + chemotherapy + endocrine therapy.

Drug class: All CDK4/6 inhibitor + chemotherapy + endocrine therapy drugs
Target: All drugs targeting CDK4/6, estrogen receptors
Manufacturer: Fujian Cancer Hospital — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for HR-positive, HER2-negative advanced or metastatic breast cancer

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