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favorable outcome
favorable outcome is a Small molecule drug developed by Centre d'Investigation Clinique et Technologique 805. It is currently in Phase 2 development.
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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 | favorable outcome |
|---|---|
| Sponsor | Centre d'Investigation Clinique et Technologique 805 |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Molecular Insights Into Post-Cardiac Arrest Brain Injury Via CSF Multi-Omics
- A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) (PHASE3)
- Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis
- Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)
- Prophylaxis Regimen for Hemophilia A Patients (PHASE4)
- White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA (PHASE2)
- Clinical Utility of a PCR Compared to Culture and Sensitivity Testing for the Management of cUTI in Adults. (NA)
- Prognostic Factors for ACDF With BAK/C in Cervical Disc Disease
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:
- favorable outcome CI brief — competitive landscape report
- favorable outcome updates RSS · CI watch RSS
- Centre d'Investigation Clinique et Technologique 805 portfolio CI
Frequently asked questions about favorable outcome
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Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing