Last reviewed 2026-05-23 · How we verify

UGN-102

UroGen Pharma Ltd. · Phase 3 active Small molecule ✓ Verified May 2026

UGN-102 is a Intravesical chemotherapy agent Small molecule drug developed by UroGen Pharma Ltd.. It is currently in Phase 3 development for Upper tract urothelial carcinoma, Non-muscle invasive bladder cancer. Also known as: UGN-102 (mitomycin) for intravesical solution.

UGN-102 is a mitomycin C-based intravesical therapy that delivers chemotherapy directly to the bladder urothelium to treat non-muscle invasive bladder cancer.

UGN-102 is a small molecule being studied as a treatment for low-grade intermediate-risk non-muscle invasive bladder cancer. It is being evaluated in a Phase 3 clinical trial (NCT05243550) as a primary chemopreventive treatment for this condition.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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-102
Also known as	UGN-102 (mitomycin) for intravesical solution
Sponsor	UroGen Pharma Ltd.
Drug class	Intravesical chemotherapy agent
Target	DNA (mitomycin C mechanism)
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 3

Mechanism of action

UGN-102 combines mitomycin C, a DNA-crosslinking chemotherapy agent, with a reverse thermal gel carrier that allows prolonged dwell time in the bladder. The formulation enables sustained drug contact with bladder cancer cells while minimizing systemic absorption, enhancing local efficacy for upper tract urothelial carcinoma and other bladder malignancies.

Approved indications

Upper tract urothelial carcinoma
Non-muscle invasive bladder cancer

Common side effects

Dysuria
Urinary frequency
Hematuria
Bladder irritation

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-102 CI brief — competitive landscape report
UGN-102 updates RSS · CI watch RSS
UroGen Pharma Ltd. portfolio CI

Frequently asked questions about UGN-102

What is UGN-102?

UGN-102 is a Intravesical chemotherapy agent drug developed by UroGen Pharma Ltd., indicated for Upper tract urothelial carcinoma, Non-muscle invasive bladder cancer.

How does UGN-102 work?

UGN-102 is a mitomycin C-based intravesical therapy that delivers chemotherapy directly to the bladder urothelium to treat non-muscle invasive bladder cancer.

What is UGN-102 used for?

UGN-102 is indicated for Upper tract urothelial carcinoma, Non-muscle invasive bladder cancer.

Who makes UGN-102?

UGN-102 is developed by UroGen Pharma Ltd. (see full UroGen Pharma Ltd. pipeline at /company/urogen-pharma-ltd).

Is UGN-102 also known as anything else?

UGN-102 is also known as UGN-102 (mitomycin) for intravesical solution.

What drug class is UGN-102 in?

UGN-102 belongs to the Intravesical chemotherapy agent class. See all Intravesical chemotherapy agent drugs at /class/intravesical-chemotherapy-agent.

What development phase is UGN-102 in?

UGN-102 is in Phase 3.

What are the side effects of UGN-102?

Common side effects of UGN-102 include Dysuria, Urinary frequency, Hematuria, Bladder irritation.

What does UGN-102 target?

UGN-102 targets DNA (mitomycin C mechanism) and is a Intravesical chemotherapy agent.

Drug class: All Intravesical chemotherapy agent drugs
Target: All drugs targeting DNA (mitomycin C mechanism)
Manufacturer: UroGen Pharma Ltd. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Upper tract urothelial carcinoma
Indication: Drugs for Non-muscle invasive bladder cancer
Also known as: UGN-102 (mitomycin) for intravesical solution

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing