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ethynyluracil
ethynyluracil is a Small molecule drug developed by SWOG Cancer Research Network. It is currently in Phase 2 development. Also known as: 776C85.
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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 | ethynyluracil |
|---|---|
| Also known as | 776C85 |
| Sponsor | SWOG Cancer Research Network |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors (PHASE1)
- Eniluracil Hand Foot Syndrome (PHASE1)
- Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer (PHASE2)
- Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Mouth Cancer (PHASE1, PHASE2)
- Fluorouracil With or Without Eniluracil in Treating Patients With Advanced Colorectal Cancer (PHASE3)
- Study of Eniluracil + 5-Fluorouracil (5-FU) + Leucovorin Versus Capecitabine in Metastatic Breast Cancer (PHASE2)
- SWOG-S9635 Fluorouracil Plus Ethynyluracil in Advanced Colorectal Cancer Not Responded to Fluorouracil (PHASE2)
- Eniluracil, Fluorouracil, and Oxaliplatin in Treating Patients With Advanced Colorectal Cancer (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:
- ethynyluracil CI brief — competitive landscape report
- ethynyluracil updates RSS · CI watch RSS
- SWOG Cancer Research Network portfolio CI
Frequently asked questions about ethynyluracil
What is ethynyluracil?
Who makes ethynyluracil?
Is ethynyluracil also known as anything else?
What development phase is ethynyluracil in?
Related
- Manufacturer: SWOG Cancer Research Network — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 776C85
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing