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futibatinib, fulvestrant
futibatinib, fulvestrant is a Small molecule drug developed by Taiho Oncology, Inc.. It is currently in Phase 2 development. Also known as: TAS-120 + fulvestrant.
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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).
| 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 | futibatinib, fulvestrant |
|---|---|
| Also known as | TAS-120 + fulvestrant |
| Sponsor | Taiho Oncology, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. (PHASE2, PHASE3)
- A Study of TAS-120 in Patients With Metastatic Breast Cancer (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:
- futibatinib, fulvestrant CI brief — competitive landscape report
- futibatinib, fulvestrant updates RSS · CI watch RSS
- Taiho Oncology, Inc. portfolio CI
Frequently asked questions about futibatinib, fulvestrant
What is futibatinib, fulvestrant?
Who makes futibatinib, fulvestrant?
Is futibatinib, fulvestrant also known as anything else?
What development phase is futibatinib, fulvestrant in?
Related
- Manufacturer: Taiho Oncology, Inc. — full pipeline
- Also known as: TAS-120 + fulvestrant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing