A Phase 3 interventional study of UGN-103 in Bladder Cancer, Urothelial Carcinoma and Urothelial Carcinoma Bladder, sponsored by UroGen Pharma Ltd.. Completed at 48 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by UroGen Pharma Ltd. · Phase 3, Interventional, and Treatment
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Among 11 studies in Non-Muscle Invasive Bladder Neoplasms by UroGen Pharma Ltd. — none open to participants now, 1 under way, 1 of them phase 3. Non-Muscle Invasive Bladder Neoplasms · UroGen Pharma Ltd..
Among the 11 studies in Non-Muscle Invasive Bladder Neoplasms by UroGen Pharma Ltd., this one is the 3rd largest by enrollment, is the only one that started in 2024, is one of 4 in phase 3, and was the 11th registered.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
Browse Non-Muscle Invasive Bladder Neoplasms studies →None of the 11 studies in Non-Muscle Invasive Bladder Neoplasms by UroGen Pharma Ltd. is open now. The open studies under Non-Muscle Invasive Bladder Neoplasms, anywhere →
Of the 92 Non-Muscle Invasive Bladder Neoplasms studies recruiting now, 77 (84%) set no upper age limit and 5 (5%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 99 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Median enrollment 51 across the 11 interventional studies. Of the 9 that completed or were terminated, 4 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
UroGen Pharma Ltd. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Non-Muscle Invasive Bladder Neoplasms by UroGen Pharma Ltd., from their registry updates:
This tab as a report to print or save as PDF → With an account.
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Eligible patients were treated with UGN-103 once weekly for 6 weeks (a total of 6 doses).
Efficacy was assessed by the complete response rate (CRR) at the 3-month Visit (approximately 3 months after the first instillation). Response was determined based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab.
Patients who had a complete response (CR) at the 3-month Visit, defined as having no detectable disease (NDD) in the bladder, entered the Follow-up Period of the study. During the Follow-up Period, patients return to the clinic every 3 months for evaluation of response. Patients remain on study until disease recurrence, disease progression, death, or the last patient completes 12 months of follow-up (ie,12 months after the 3-month Visit), whichever occurs first.
Patients who had a non-complete response (NCR) at the 3-month Visit underwent investigator-designated standard of care (SOC) and had a separate End of Study (EOS) Visit performed.
Study conduct is ongoing and data are summarized through a cutoff date of 18 Mar 2026. As of the data cutoff date, ongoing patients were followed through at least Study Month 9, with the earliest enrolled patients followed through Study Month 15.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's enrollment of 99 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →UroGen Pharma Ltd. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Has intermediate-risk disease, defined as having 1 or 2 of the following:
Has adequate organ and bone marrow function as determined by routine laboratory tests:
Exclusion Criteria:
History of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received UGN-103 (75 mg mitomycin) once weekly for 6 weeks (a total of 6 doses).
Drug: UGN-103
UGN-103 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-103 allow for local administration of mitomycin as a liquid under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
Also known as: UGN-103 (mitomycin) for intravesical solution
Complete Response Rate (CRR)
CRR is defined as the proportion of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.
Time frame: 3 months
Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit
DOR is defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Time frame: Up to 15 months
Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit
DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment.
Time frame: Up to 15 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-103 or pre-treatment AEs that worsened during the study.
Time frame: Up to 15 months
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
The number of patients with each type of event is summarized.
Time frame: 6 months
Number of Participants With Post-baseline PCS Chemistry Values
The number of patients with each type of event is summarized.
Time frame: 6 months
Mitomycin Plasma Concentrations
Mitomycin plasma concentrations were assessed in a subset of patients treated with UGN-103.
Time frame: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-103.
Mitomycin Maximum Plasma Concentration (Cmax)
Mitomycin Cmax was assessed in a subset of patients treated with UGN-103.
Time frame: 0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-103.
| Milestone | UGN-103 |
|---|---|
| Started | 99 |
| Completed | 27 |
| Not completed | 72 |
| Withdrew: Ongoing in the study | 61 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Lost to follow-up | 1 |
CRR is defined as the proportion of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.
| percentage of participants | UGN-103 |
|---|---|
| Complete Response Rate (CRR) | 77.8 (68.3 to 85.5) |
DOR is defined as the time from the date of evidence of CR at the 3-month Visit to the earliest date of recurrence or progression or death due to any cause, whichever occurred first.
Results for this outcome have not been posted.
DCR rate at scheduled disease assessment time points, defined as the proportion of patients who achieved CR at the 3-month Visit and maintained CR (ie, no detectable disease) up to that particular follow-up disease assessment.
Results for this outcome have not been posted.
The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-103 or pre-treatment AEs that worsened during the study.
| Participants | UGN-103 |
|---|---|
| Any TEAEs | 59 |
| Any serious TEAEs | 2 |
| Any TEAEs of special interest | 37 |
The number of patients with each type of event is summarized.
| Participants | UGN-103 |
|---|---|
| Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline | 0 |
| Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline | 0 |
| Leukocytes ≤ 2.8 × 10^9/L | 2 |
| Leukocytes ≥ 16.0 × 10^9/L | 2 |
| Lymphocytes < 0.5 × 10^9/L | 1 |
| Lymphocytes > 20 × 10^9/L | 0 |
| Neutrophils < 1.0 × 10^9/L | 1 |
| Platelets < 75 × 10^9/L | 0 |
| Platelets ≥ 700 × 10^9/L | 0 |
The number of patients with each type of event is summarized.
| Participants | UGN-103 |
|---|---|
| Alanine aminotransferase > 3 × ULN | 0 |
| Aspartate aminotransferase > 3 × ULN | 0 |
| Bilirubin > 1.5 × ULN | 1 |
| Creatinine > 194 μmol/L | 0 |
| Gamma glutamyl transferase > 2.5 × ULN | 0 |
| Potassium < 3.0 mmol/L | 1 |
| Potassium > 5.5 mmol/L | 9 |
| Sodium ≤ 130 mmol/L | 2 |
| Sodium > 150 mmol/L | 0 |
Mitomycin plasma concentrations were assessed in a subset of patients treated with UGN-103.
| ng/mL | UGN-103 |
|---|---|
| Pre-instillation | 0.00 ± 0.00 |
| 30 minutes post-instillation | 1.05 ± 0.90 |
| 1 hour post-instillation | 0.76 ± 0.46 |
| 2 hours post-instillation | 0.63 ± 0.66 |
| 3 hours post-instillation | 0.50 ± 0.53 |
| 4 hours post-instillation | 0.35 ± 0.36 |
| 5 hours post-instillation | 0.36 ± 0.39 |
| 6 hours post-instillation | 0.32 ± 0.50 |
Mitomycin Cmax was assessed in a subset of patients treated with UGN-103.
| ng/mL | UGN-103 |
|---|---|
| Mitomycin Maximum Plasma Concentration (Cmax) | 1.09 ± 0.85 |
Collected over Up to 15 months. Study conduct is ongoing and data are summarized through a cutoff date of 18 Mar 2026. As of the data cutoff date, ongoing patients were followed through at least Study Month 9, with the earliest enrolled patients followed through Study Month 15.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UGN-103 | 0/99 (0%) | 2/99 (2%) | 59/99 (59.6%) |
| Event | UGN-103 |
|---|---|
| Atrial fibrillationCardiac disorders | 1/99 |
| OsteomyelitisInfections and infestations | 1/99 |
| Staphylococcal sepsisInfections and infestations | 1/99 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 1/99 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/99 |
| Event | UGN-103 |
|---|---|
| DysuriaRenal and urinary disorders | 19/99 |
| FatigueGeneral disorders | 8/99 |
| Urinary tract infectionInfections and infestations | 8/99 |
| PollakiuriaRenal and urinary disorders | 8/99 |
| HaematuriaRenal and urinary disorders | 6/99 |
| NauseaGastrointestinal disorders | 4/99 |
| HeadacheNervous system disorders | 4/99 |
| Urethral stenosisRenal and urinary disorders | 4/99 |
| Vulvovaginal candidiasisInfections and infestations | 1/28 |
| Vulvovaginal pruritusReproductive system and breast disorders | 1/28 |
All patients who received any dose of UGN-103 (intent-to-treat \[ITT\] analysis set).
| Age, Categorical(Participants) | UGN-103 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 77 |
| Age, Continuous(years) | UGN-103 |
|---|---|
| Median | 71 (46 to 93) |
| Sex: Female, Male(Participants) | UGN-103 |
|---|---|
| Female | 28 |
| Male | 71 |
| Ethnicity (NIH/OMB)(Participants) | UGN-103 |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 95 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | UGN-103 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 98 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | UGN-103 |
|---|---|
| United States | 26 |
| Georgia | 17 |
| Latvia | 16 |
| Romania | 12 |
| Bulgaria | 11 |
| Estonia | 10 |
| Spain | 7 |
| Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)(Participants) | UGN-103 |
|---|---|
| Yes | 98 |
| No | 1 |
| Previous LG-NMIBC Episode(s) Within 1 Year(Participants) | UGN-103 |
|---|---|
| Yes | 57 |
| No | 42 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2024 to primary completion in Sep 2025, 12 months.
Results were first posted in Sep 2026, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →
UroGen Pharma Ltd.