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Samuraciclib (samuraciclib)
Samuraciclib (generic name: samuraciclib) is a drug developed by Pfizer Inc.. It is currently in Phase 2 development.
Samuraciclib is a small molecule used in clinical trials for various breast cancer conditions, including metastatic and locally advanced breast cancer, as well as advanced solid malignancies. It is being studied in combination with other treatments, such as Elacestrant Dihydrochloride, in clinical trials like NCT05963997.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | samuraciclib |
|---|---|
| Sponsor | Pfizer Inc. |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (PHASE1, PHASE2)
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (PHASE1, PHASE2)
- A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants (PHASE2)
- Modular Study to Evaluate CT7001 Alone in Cancer Patients With Advanced Malignancies (PHASE1, PHASE2)
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer. (Sub-Study C) (PHASE1, PHASE2)
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:
- Samuraciclib CI brief — competitive landscape report
- Samuraciclib updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Samuraciclib
What is Samuraciclib?
Who makes Samuraciclib?
What is the generic name of Samuraciclib?
What development phase is Samuraciclib in?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing