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UGN-103
UGN-103 is a Small molecule Small molecule drug developed by UroGen Pharma Ltd.. It is currently in Phase 3 development for Non-muscle invasive bladder cancer. Also known as: UGN-103 (mitomycin) for intravesical solution.
UGN-103 is a synthetic, small molecule that targets the urothelial cancer cells.
UGN-103 is a small molecule being studied in a Phase 3 clinical trial for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. The study, NCT06331299, is evaluating the efficacy and safety of UGN-103 in patients with this condition.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | UGN-103 |
|---|---|
| Also known as | UGN-103 (mitomycin) for intravesical solution |
| Sponsor | UroGen Pharma Ltd. |
| Drug class | Small molecule |
| Target | Not publicly disclosed |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
UGN-103 works by selectively targeting and killing cancer cells in the bladder, while sparing healthy cells. This is achieved through a unique mechanism that involves the disruption of the cancer cells' ability to repair DNA damage. As a result, the cancer cells undergo programmed cell death, or apoptosis.
Approved indications
- Non-muscle invasive bladder cancer
Common side effects
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
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:
- UGN-103 CI brief — competitive landscape report
- UGN-103 updates RSS · CI watch RSS
- UroGen Pharma Ltd. portfolio CI
Frequently asked questions about UGN-103
What is UGN-103?
How does UGN-103 work?
What is UGN-103 used for?
Who makes UGN-103?
Is UGN-103 also known as anything else?
What drug class is UGN-103 in?
What development phase is UGN-103 in?
What are the side effects of UGN-103?
What does UGN-103 target?
Related
- Drug class: All Small molecule drugs
- Target: All drugs targeting Not publicly disclosed
- Manufacturer: UroGen Pharma Ltd. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Non-muscle invasive bladder cancer
- Also known as: UGN-103 (mitomycin) for intravesical solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing