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Fitostimoline
Fitostimoline is a Small molecule drug developed by Universidad Autónoma de Bucaramanga. It is currently in Phase 1 development. Also known as: Triticum vulgare.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Fitostimoline |
|---|---|
| Also known as | Triticum vulgare |
| Sponsor | Universidad Autónoma de Bucaramanga |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers (PHASE4)
- Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze (NA)
- Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft
- Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
- The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure (NA)
- Mesenchymal Stromal Cell Derivatives in the Treatment of Chronic Diabetic Foot Ulcers Type 1 and 2 (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:
- Fitostimoline CI brief — competitive landscape report
- Fitostimoline updates RSS · CI watch RSS
- Universidad Autónoma de Bucaramanga portfolio CI
Frequently asked questions about Fitostimoline
What is Fitostimoline?
Who makes Fitostimoline?
Is Fitostimoline also known as anything else?
What development phase is Fitostimoline in?
Related
- Manufacturer: Universidad Autónoma de Bucaramanga — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Triticum vulgare
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing