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fluorothymidine F 18
fluorothymidine F 18 is a Small molecule drug developed by John M. Buatti. It is currently in Phase 2 development. Also known as: [F-18] Fluorothymidine.
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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 | fluorothymidine F 18 |
|---|---|
| Also known as | [F-18] Fluorothymidine |
| Sponsor | John M. Buatti |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia (PHASE2)
- Transformation of Plexiform Neurofibromas to Malignant Peripheral Nerve Sheath Tumors in Neurofibromatosis Type 1 (PHASE1)
- Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy (EARLY_PHASE1)
- Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement (PHASE2)
- Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma (PHASE1)
- SARC037: A Phase I/II Study to Evaluate the Safety of Trabectedin in Combination With Irinotecan in Ewing Sarcoma Patients (PHASE1, PHASE2)
- Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer (PHASE1)
- [18F]FLT PET/CT in Rb+ Metastatic Breast Cancer (PHASE1)
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:
- fluorothymidine F 18 CI brief — competitive landscape report
- fluorothymidine F 18 updates RSS · CI watch RSS
- John M. Buatti portfolio CI
Frequently asked questions about fluorothymidine F 18
What is fluorothymidine F 18?
Who makes fluorothymidine F 18?
Is fluorothymidine F 18 also known as anything else?
What development phase is fluorothymidine F 18 in?
Related
- Manufacturer: John M. Buatti — full pipeline
- Also known as: [F-18] Fluorothymidine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing