18 and older, any sex, with Bladder Cancer or Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Complete Response (CR) Rate for UGN-102 TreatmentPrimary· 3 months after the first instillation of UGN-102
To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology.
Group
Value
95% CI
UGN-102
65.1
52.0 – 76.7
Durable Complete Response (DCR) RateSecondary· 6, 9, and 12 months after the first instillation of UGN-102
To evaluate the durability of response in patients with LG NMIBC who achieve CR. DCR rate was defined as the percentage of patients who maintained CR at the respective time point.
6 months (3 months after CR at the 3-month Visit)
Group
Value
95% CI
UGN-102
95.1
83.5 – 99.4
9 months (6 months after CR at the 3-month Visit)
Group
Value
95% CI
UGN-102
73.2
57.1 – 85.8
12 months (9 months after CR at the 3-month Visit)
Group
Value
95% CI
UGN-102
61.0
44.5 – 75.8
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.Secondary· Up to 12 months
The number of patients with each type of event will be summarized. Adverse event severity was graded according to Common Terminology Criteria for Adverse Events version 5.0 as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant), Grade 4 (life-threatening), Grade 5 (fatal).
Any TEAEs
Group
Value
95% CI
UGN-102
57
Any study drug or procedure related TEAEs
Group
Value
95% CI
UGN-102
40
Maximum severity Grade 1
Group
Value
95% CI
UGN-102
26
Maximum severity Grade 2
Group
Value
95% CI
UGN-102
24
Maximum severity Grade 3
Group
Value
95% CI
UGN-102
5
Maximum severity Grade 4
Group
Value
95% CI
UGN-102
1
Maximum severity Grade 5
Group
Value
95% CI
UGN-102
1
Any TEAEs leading to treatment discontinuation
Group
Value
95% CI
UGN-102
6
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory ValuesSecondary· Up to 12 months
The number of patients who met PCS criteria for chemistry or hematology parameters post-baseline will be summarized
Any PCS chemistry value
Group
Value
95% CI
UGN-102
8
Any PCS hematology value
Group
Value
95% CI
UGN-102
4
Number of Participants With Post-baseline PCS Vital Signs ValuesSecondary· Up to 12 months
The number of patients who met PCS criteria for vital signs parameters post-baseline will be summarized
Group
Value
95% CI
UGN-102
8
Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination FindingsSecondary· Up to 12 months
The number of patients with abnormal, CS physical examination findings post-baseline will be summarized
Group
Value
95% CI
UGN-102
0
Number of Participants With Post-baseline CS Urology-oriented Physical Examination FindingsSecondary· Up to 12 months
The number of patients with abnormal, CS urology-oriented physical examination findings post-baseline will be summarized
Group
Value
95% CI
UGN-102
2
Mitomycin Plasma ConcentrationsSecondary· 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102
Mitomycin plasma concentrations were assessed in a subset of 6 patients treated with UGN-102
Pre-instillation
Group
Value
95% CI
UGN-102
0
± 0
0.5 hours post-instillation
Group
Value
95% CI
UGN-102
0.75
± 0.57
1 hour post-instillation
Group
Value
95% CI
UGN-102
0.60
± 0.42
2 hours post-instillation
Group
Value
95% CI
UGN-102
0.34
± 0.17
3 hours post-instillation
Group
Value
95% CI
UGN-102
1.88
± 3.13
4 hours post-instillation
Group
Value
95% CI
UGN-102
1.93
± 3.49
5 hours post-instillation
Group
Value
95% CI
UGN-102
0.57
± 0.61
6 hours post-instillation
Group
Value
95% CI
UGN-102
0.32
± 0.32
Mitomycin Area Under the Plasma Concentration-time Curve (AUC)Secondary· 0 (pre-instillation) to 6 hours after the first instillation of UGN-102
Mitomycin AUC was assessed in a subset of 6 patients treated with UGN-102
Group
Value
95% CI
UGN-102
5.69
± 7.30
Mitomycin Maximum Plasma Concentration (Cmax)Secondary· 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102
Mitomycin Cmax was assessed in a subset of 6 patients treated with UGN-102
Group
Value
95% CI
UGN-102
2.27
± 3.33
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
UGN-102
Serious: 5/63 (8%)
Deaths: 1/63
Serious adverse events (9 terms)
Reaction
System
UGN-102
Acute myeloid leukemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05136898 — Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
· Phase 3
· completed
NCT04688931 — A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
· Phase 3
· terminated
Other recruiting trials for Bladder Cancer
Currently open trials in the same condition.
NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
· Phase 3
· recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer
· Phase 2
· recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer
· Phase 2
· recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
· Phase 1
· recruiting
Other UroGen Pharma Ltd. trials
Trials by the same sponsor.
NCT05375903 — A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
· Phase 1
· completed
NCT05136898 — Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC)
· Phase 3
· completed
NCT04688931 — A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
· Phase 3
· terminated
NCT04006691 — Efficacy and Safety of UGN-101 in Recurrent Patients
· Phase 3
· withdrawn
NCT02793128 — The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UroGen Pharma Ltd.
Last refreshed: 16 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03558503.