Last reviewed · How we verify
Ribociclib; abemaciclib; palbociclib; Dalpiciclib
Ribociclib; abemaciclib; palbociclib; Dalpiciclib is a Small molecule drug developed by Hongmei Zheng, PhD. It is currently in Phase 1 development. Also known as: Letrozole, Anastrozole, Esomeprazole.
Ribociclib, abemaciclib, palbociclib, and dalpiciclib are small molecule inhibitors of cyclin-dependent kinase 4 (CDK4). They are used in the treatment of breast cancer, particularly in combination with endocrine therapy, to inhibit the progression of the disease in various stages, including advanced and stage II and III breast cancer.
-
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).
| 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 | Ribociclib; abemaciclib; palbociclib; Dalpiciclib |
|---|---|
| Also known as | Letrozole, Anastrozole, Esomeprazole |
| Sponsor | Hongmei Zheng, PhD |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer (PHASE2)
- Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer (PHASE2)
- Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer (PHASE3)
- The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment (NA)
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:
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib CI brief — competitive landscape report
- Ribociclib; abemaciclib; palbociclib; Dalpiciclib updates RSS · CI watch RSS
- Hongmei Zheng, PhD portfolio CI
Frequently asked questions about Ribociclib; abemaciclib; palbociclib; Dalpiciclib
What is Ribociclib; abemaciclib; palbociclib; Dalpiciclib?
Who makes Ribociclib; abemaciclib; palbociclib; Dalpiciclib?
Is Ribociclib; abemaciclib; palbociclib; Dalpiciclib also known as anything else?
What development phase is Ribociclib; abemaciclib; palbociclib; Dalpiciclib in?
Related
- Manufacturer: Hongmei Zheng, PhD — full pipeline
- Also known as: Letrozole, Anastrozole, Esomeprazole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing