Drugs / Mitomycin C
Mitomycin C
also known as
MMC · mitomycin · Jelmyto · MITO · Mitolem · Mitomycin C (Mutamycin) · Mytomycin C · NSC-26980
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer | 2026-08-17 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin)” urogen.com ↗ |
Trials 116 · started per year
today
1
1
1
1
2
3
5
4
1
6
2
3
3
4
6
2
1
6
3
3
8
1
7
7
2
6
3
2
2
2
3
2
5
2
4
199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
News releases announcing trial results or a regulatory action · 68
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | UroGen Pharma Ltd. | Regulatory UroGen Submits NDA for UGN-103, an Investigational Treatment of Recurrent LG-IR-NMIBC urogen.com ↗
today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. |
| 2026-05-15 | UroGen Pharma Ltd. | Results UroGen Reports 94.5% Six-Month Duration of Response in Phase 3 UTOPIA Trial, Advancing UGN-103 Toward Potential Approval in Recurrent Low-Grade Intermediate-Risk NMIBC urogen.com ↗
The six-month results from UTOPIA are generally consistent with the 91.9% (95% CI: 86.9, 95.0) six-month DOR observed with ZUSDURI™ (mitomycin) for intravesical therapy in its pivotal ENVISION trial. |
| 2026-05-13 | UroGen Pharma Ltd. | Results ZUSDURI Median Duration of Response Still Not Reached with 64.5% 36-month Duration of Response in the Pivotal ENVISION Trial urogen.com ↗
At a median follow-up of 35.5 months, the median DOR had not been reached. |
| 2026-03-30 | UroGen Pharma Ltd. | Results Journal of Urology Publishes ENVISION Trial Results Showing 72.2% 24-Month Duration of Response with ZUSDURI urogen.com ↗
The publication reports a 72.2% probability of remaining event-free at 24 months after complete response (CR) (95% CI: 64%, 79%) as determined by Kaplan-Meier analysis. |
| 2026-02-27 | UroGen Pharma Ltd. | Results ZUSDURI™ Achieves Durable Complete Responses Across EORTC Risk Groups in Patients with Recurrent LG-IR-NMIBC urogen.com ↗
CR rates at three months were 83.9%, 81.2%, and 60.0% in patients with low (1-4), intermediate (5-9), and high (10-17) EORTC recurrence scores, respectively, with the majority of responders across all groups remaining recurrence-free at 24 months. |
| 2025-11-06 | UroGen Pharma Ltd. | Results UroGen Reports Third Quarter 2025 Financial Results as ZUSDURI™ Launch Gains Momentum urogen.com ↗
Reported three-month complete response rate of 77.8% from the Phase 3 UTOPIA trial of UGN-103, consistent with ENVISION results; |
| 2025-11-06 | UroGen Pharma Ltd. | Results UroGen Reports 77.8% Three-Month Complete Response Rate from Phase 3 UTOPIA Trial of UGN-103 and Receives FDA Agreement on NDA Submission Strategy in Recurrent LG-IR-NMIBC Based on UTOPIA Trial urogen.com ↗ |
| 2025-10-02 | UroGen Pharma Ltd. | Results ZUSDURI™ Clinical Review Published in Reviews in Urology™ Highlights Durable Efficacy and Manageable Safety Profile in Recurrent Low-Grade, Intermediate-Risk Non–Muscle Invasive Bladder Cancer urogen.com ↗
Across late-stage clinical trials (OPTIMA II, ATLAS, and ENVISION), UGN-102 demonstrated complete response (CR) rates between 64.8% and 79.6% at three months. |
| 2025-08-05 | UroGen Pharma Ltd. | Results UroGen Announces 24-Month Duration of Response of 72.2% from the Pivotal Phase 3 ENVISION Trial of ZUSDURI, the First and Only FDA-Approved Medicine for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
24-month Duration of Response (DOR) of 72.2% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) |
| 2025-07-28 | UroGen Pharma Ltd. | Results UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology urogen.com ↗
A 75% complete response (CR) rate was observed at three months (95% CI: 34.9, 96.8), and no new safety concerns were identified. |
| 2025-07-21 | UroGen Pharma Ltd. | Results UroGen Announces Five-Year Long-Term Extension Study of the OPTIMA II Trial Demonstrates Long-Term Durability of Response to ZUSDURI™ in Patients with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
Findings published in the journal of Clinical Genitourinary Cancer show patients remained event-free for a median of two years after achieving complete response with ZUSDURI (mitomycin) intravesical solution. |
| 2025-06-12 | UroGen Pharma Ltd. | Regulatory U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the U.S. Food and Drug Administration (FDA) approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC. |
| 2025-06-02 | UroGen Pharma Ltd. | Results UroGen Announces Data at ASCO 2025 Annual Meeting on UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from the ENVISION and ATLAS clinical studies exploring investigational therapy UGN-102 (mitomycin) for intravesical solution for the treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. |
| 2025-05-21 | UroGen Pharma Ltd. | Regulatory UroGen Announces Outcome of Oncologic Drugs Advisory Committee for UGN-102 for the Treatment of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
By a narrow margin, the ODAC voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent LG-IR-NMIBC. |
| 2025-05-07 | UroGen Pharma Ltd. | Regulatory UroGen Announces FDA Advisory Committee for UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
The ODAC meeting will provide an opportunity for independent clinicians and other experts to evaluate the UGN-102 data and make a recommendation to the FDA as to whether the NDA should be approved and under what conditions. |
| 2025-04-27 | UroGen Pharma Ltd. | Results OLYMPUS Long-Term Follow-Up Study Reports Nearly Four-Year Duration of Response in Subset of Patients with Low-Grade Upper Tract Urothelial Cancer Who Achieved a Complete Response to Initial JELMYTO Treatment urogen.com ↗
Of these patients, 21 had new-onset UTUC, and 20 had recurrent UTUC at baseline; there were no significant differences in durability between groups, with 8 patients in each group experiencing recurrence or death not due to treatment. |
| 2025-04-27 | UroGen Pharma Ltd. | Results New Patient-Reported Outcomes from UGN-102 Clinical Trials Show the Investigational Treatment Did Not Adversely Affect Functionality, Symptom Burden, and Quality of Life in Patients with LG-IR-NMIBC urogen.com ↗
Aggregated quality of life data across three robust clinical trials suggests that UGN-102 is quite tolerable without negatively impacting symptom burden, patient function or quality of life compared to baseline. |
| 2025-04-27 | UroGen Pharma Ltd. | Results New Long-Term Follow-Up Data from OPTIMA II Study of UGN-102 Demonstrates Median Duration of Response of Two Years in Patients with LG-IR-NMIBC urogen.com ↗
The median Kaplan–Meier estimate of duration of response for the 41 patients that achieved CR was 24.2 months (95% CI 9.72, 47.18), with a median follow-up time of 33.6 months (95% CI 10.78, 42.94). |
| 2025-04-26 | UroGen Pharma Ltd. | Results UroGen Announces Updated 18-Month Duration of Response (DOR) of 80.6% from the Phase 3 ENVISION Trial of UGN-102, an Investigational Treatment for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG-IR-NMIBC) urogen.com ↗
18-month DOR of 80.6% by Kaplan-Meier estimate was attained in patients who achieved a complete response (CR) at three months (79.6%) |
| 2025-02-14 | UroGen Pharma Ltd. | Results UroGen Announces Results from Subgroup Analyses of the Pivotal ENVISION Trial Evaluating Impact of Baseline Tumor Burden and Focality on Response to UGN-102 urogen.com ↗
Analyses of pre-specified subgroups showed comparable CR rates and DOR patterns across different levels of tumor burden (defined as the sum of the diameters of all visible tumors) and number of tumors at baseline in patients treated with UGN-102. |
| 2025-02-12 | UroGen Pharma Ltd. | Results Data from a Long-Term Follow-up Study to the OLYMPUS Trial that Shows a Median Duration of Response of Nearly Four Years in Patients Achieving Complete Response with JELMYTO Published in The Journal of Urology urogen.com ↗
The median duration of response of nearly four years in patients who achieved a complete response underscores the potential of JELMYTO to offer sustained control of the disease. |
| 2025-01-15 | UroGen Pharma Ltd. | Results ENVISION Trial Results Published in the February Issue of The Journal of Urology Highlight UGN-102 Achievement of 82.3% Duration of Response at 12 Months Paving the Way for the Potential First FDA-Approved Treatment for LG-IR-NMIBC in June 2025 urogen.com ↗
The ENVISION trial also met its primary endpoint, showing a 79.6% (95% CI, 73.9%, 84.5%) CR rate at three months in patients treated with UGN-102. |
| 2024-12-05 | UroGen Pharma Ltd. | Results UGN-102 Showed Promising Long-Term Results in the Phase 3 ENVISION Trial, Potentially Paving the Way for First FDA-Approved Treatment for LG-IR-NMIBC urogen.com ↗
UGN-102 demonstrated 82.3% duration of response (DOR) at 12 months in patients who achieved complete response at 3 months |
| 2024-12-05 | UroGen Pharma Ltd. | Results Long-Term Follow-up Study to the OLYMPUS Trial Presented at SUO 2024 Reports Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO® urogen.com ↗
The study results were presented at the Society for Urologic Oncology (SUO) annual meeting in Dallas, Texas , and were recently published online in the Journal of Urology . |
| 2024-11-26 | UroGen Pharma Ltd. | Results New Data from a Long-Term Follow-up Study to the OLYMPUS Trial Show Median Duration of Response of Four Years in Patients Who Achieved a Complete Response with JELMYTO® urogen.com ↗ |
| 2024-10-28 | UroGen Pharma Ltd. | Results ENVISION Trial Results Published in the Journal of Urology Report 82.3% Duration of Response 12 Months after Achieving Complete Response for UGN-102, Potentially First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC urogen.com ↗
The Kaplan-Meier Estimate of Duration of Response at 12 Months in Patients Who Achieved a Complete Response at Three Months was 82.3% |
| 2024-08-14 | UroGen Pharma Ltd. | Regulatory UroGen Submits Completed UGN-102 NDA Seeking Approval as the First FDA-Approved Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗ |
| 2024-06-13 | UroGen Pharma Ltd. | Results UroGen Announces Unprecedented 82.3% Duration of Response at 12 Months in the ENVISION Trial Investigating UGN-102 as Potentially the First FDA-Approved Non-Surgical Treatment for LG-IR-NMIBC urogen.com ↗
In addition to the 12-month data, the DOR Kaplan Meier estimates at 15 (n=43) and 18 (n=9) months were both 80.9% (95%CI, 73.9%, 86.2%). |
| 2024-05-13 | UroGen Pharma Ltd. | Results UroGen Pharma Announces Date for ENVISION Data, New Long-Term Jelmyto Durability Data, and Reports 2024 First Quarter Financial Results and Business Highlights urogen.com ↗
Post-hoc analysis of OLYMPUS study for JELMYTO shows disease-free periods more than 47.8 months in LG-UTUC |
| 2024-05-05 | UroGen Pharma Ltd. | Results New Real-World Retrospective Analysis Presented at AUA 2024 Reports 86% Recurrence-Free Survival (RFS) at 24 Months with JELMYTO® Across All Studied Patient and Disease Characteristics in Cohort of Responders to Induction Therapy urogen.com ↗
Among the 30% of the complete responders who received maintenance therapy, RFS at 24 months was 100%, vs. 61% for those who did not receive maintenance therapy. |
| 2024-05-04 | UroGen Pharma Ltd. | Results UroGen Announces Results from ATLAS Showing Robust UGN-102 Durability of Response in New and Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer at AUA 2024 urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced results from a new analysis of the ATLAS trial, which estimates using Kaplan Meier methods the probabilities of remaining in complete response for both new and recurrent low-grade intermediate-risk non- muscle invasive bladder cancer (LG-IR-NMIBC) patients following treatment with investigational drug UGN-102 as primary therapy, with or without subsequent transurethral resection of the bladder tumor (TURBT) at 3 months. |
| 2024-05-04 | UroGen Pharma Ltd. | Results New Real-World Study on Retrograde Instillation of JELMYTO® for Treatment of Low-Grade Upper Tract Urothelial Cancer Reports Similar Complete Response Rate and Lower Stricture Rate Compared to OLYMPUS Pivotal Trial urogen.com ↗ |
| 2024-04-15 | UroGen Pharma Ltd. | Regulatory UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗ |
| 2024-01-24 | UroGen Pharma Ltd. | Regulatory UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102 urogen.com ↗
The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen |
| 2023-10-03 | UroGen Pharma Ltd. | Regulatory Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024 urogen.com ↗ |
| 2023-08-08 | UroGen Pharma Ltd. | Results The Journal of Urology Publishes Peer-Reviewed Article Highlighting UGN-102 Data in Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
Tumor-free complete response rate at three months was 65% for patients who only received UGN-102, compared to a 64% complete response rate at three months for patients who underwent TURBT. |
| 2023-07-27 | UroGen Pharma Ltd. | Results UGN-102, in Development as the Potential First Non-Surgical Therapy for LG-IR-NMIBC, Met Primary Endpoints in Both Phase 3 ATLAS and ENVISION Clinical Trials urogen.com ↗
Both ATLAS and ENVISION trials met their primary endpoints. |
| 2023-07-10 | UroGen Pharma Ltd. | Results Retrospective Study Finds JELMYTO® Use Effective Following Partial Ablation or Biopsy in Larger Volume Low-Grade Upper Tract Urothelial Tumors that Impede Kidney Preservation urogen.com ↗ |
| 2023-06-20 | UroGen Pharma Ltd. | Results Retrospective Study Reveals Lower Stricture Rate and Comparable Oncological Outcomes with Antegrade Administration of JELMYTO® Versus Retrograde Administration urogen.com ↗
Investigators reported that the overall rate of stricture occurrence was lower with the antegrade approach (12%) compared to retrograde group (32%). |
| 2023-05-01 | UroGen Pharma Ltd. | Results First Study to Evaluate JELMYTO® Use Post-Complete Endoscopic Ablation Reports 69% of Patients were Disease Free at the Time of First Endoscopic Evaluation urogen.com ↗ |
| 2023-04-30 | UroGen Pharma Ltd. | Results New Retrospective Study Presented at AUA 2023 Provides Evidence of Similar Outcomes Utilizing JELMYTO® in the Treatment of UTUC of the Ureter and Renal Pelvis urogen.com ↗
The investigators reported no difference in outcomes at first endoscopic evaluation based on UTUC tumor location (ureter vs. renal pelvis) (p=0.644). |
| 2023-01-11 | UroGen Pharma Ltd. | Results Results of the First Post-Commercial Utilization Review of JELMYTO® Provide New Evidence that Reinforces its Efficacy and Safety in Patients with Low-Grade Upper Tract Urothelial Cancer urogen.com ↗
Primary chemoablation resulted in a 70% complete response (CR) rate for patients with tumors less than 1cm (CR rates following primary therapy were lower for larger tumors consistent with previous reporting) while 69% achieved CR when JELMYTO was combined with laser ablation. |
| 2022-12-02 | UroGen Pharma Ltd. | Results UroGen Announces New Data from the OPTIMA II Study that Show Median Durability of Response of 24.4 Months for UGN-102, an Investigational Non-Surgical Chemoablative Treatment for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
The median DOR among the 15 patients was 24.4 months (10.1 to 30.7 months). |
| 2022-12-01 | UroGen Pharma Ltd. | Results UroGen Announces New Data from the OLYMPUS Trial that Shows Median Durability of Response of 28.9 Months for JELMYTO®, the Only Non-Surgical, Chemoablative Treatment for Adults with Low-Grade Upper Tract Urothelial Cancer urogen.com ↗
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced new data from the OLYMPUS registration trial designed to obtain long-term follow-up data on JELMYTO ® (mitomycin) for pyelocalyceal solution that shows median durability of response (DOR) of 28.9 months. |
| 2022-11-14 | UroGen Pharma Ltd. | Results UroGen Highlights New Real-World Safety Data Published in The British Journal of Urology International That Showed a Low Rate of Ureteral Stenosis When Antegrade Administration of JELMYTO® was Used in Patients with Upper Tract Urothelial Carcinoma urogen.com ↗ |
| 2022-09-28 | UroGen Pharma Ltd. | Regulatory FDA Authorizes an Extension of the In-Use Period for UroGen Pharma’s JELMYTO® Admixture to 96 Hours Following Reconstitution urogen.com ↗
the U.S. Food and Drug Administration (FDA) has authorized an extension of the in-use period for JELMYTO ® (mitomycin) for pyelocalyceal solution admixture from 8 hours to 96 hours (four days) following reconstitution of the product. |
| 2022-05-16 | UroGen Pharma Ltd. | Results UroGen Highlights New Data Presented at AUA that Adds to the Evidence Supporting In-Office Nephrostomy Tube Administration of JELMYTO®, the only Non-Surgical, Kidney-Sparing Treatment for Adults with Low Grade Upper Tract Urothelial Cancer urogen.com ↗
These data provide additional evidence that instillation via a nephrostomy tube is an effective instillation method with a safety profile that offers an encouraging option to appropriate patients. |
| 2021-10-05 | UroGen Pharma Ltd. | Results The Journal of Urology Publishes Results of UroGen Pharma’s Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC) urogen.com ↗
The OPTIMA II Phase 2b results showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC. |
| 2020-12-03 | UroGen Pharma Ltd. | Results UroGen Pharma Announces Podium Presentation of Final Jelmyto® Data From Pivotal OLYMPUS Trial at the Annual Meeting of the Society of Urologic Oncology urogen.com ↗
Median Time to Recurrence was Not Reached |
| 2020-11-17 | UroGen Pharma Ltd. | Results Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
In this subset of patients, duration of response at nine months (12-months from start of therapy) was estimated by Kaplan-Meier analysis to be 72.5%. |
| 2020-11-11 | UroGen Pharma Ltd. | Regulatory Centers for Medicare & Medicaid Services (CMS) Issues Permanent J-Code for UroGen’s Jelmyto® Effective January 1, 2021 urogen.com ↗
The J-code for Jelmyto (J9281) has been published online in the CMS Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions (page 36). |
| 2020-05-15 | UroGen Pharma Ltd. | Results UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer urogen.com ↗
UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 ( Jelmyto™ (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC). |
| 2020-04-30 | UroGen Pharma Ltd. | Results The Lancet Oncology Publishes Details of UroGen Pharma’s Pivotal OLYMPUS Trial urogen.com ↗
Additionally, in the publication, durability at 12 months (based on interim data) was estimated to be 84% by Kaplan-Meier analysis. |
| 2020-04-15 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer urogen.com ↗ |
| 2020-04-03 | UroGen Pharma Ltd. | Results UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer urogen.com ↗
The Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients). |
| 2019-11-12 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Reports Third Quarter 2019 Financial Results and Recent Corporate Developments urogen.com ↗ |
| 2019-09-24 | UroGen Pharma Ltd. | Results UroGen Reports Positive Data from Two Important Studies: UGN-101 OLYMPUS Pivotal Trial in LG UTUC and UGN-102 Phase 2b OPTIMA II Trial in LG Bladder Cancer urogen.com ↗
Results from a final analysis of the primary endpoint for pivotal Phase 3 OLYMPUS showed that investigational UGN-101 (mitomycin gel) for instillation demonstrated a 59 percent CR rate in patients with LG UTUC. |
| 2019-09-24 | UroGen Pharma Ltd. | Results UroGen Investor Day Details Positive Clinical Updates, UGN-101 Launch Preparedness, and Pipeline Advances urogen.com ↗
Complete response (CR) rate of 59 percent observed in 71 patients with LG UTUC from Phase 3 OLYMPUS trial. |
| 2019-05-05 | UroGen Pharma Ltd. | Results UroGen Delivers Updated Complete Response (CR) and Durability Data from the UGN-101 Phase 3 OLYMPUS Trial urogen.com ↗
The analysis showed that in the OLYMPUS intent-to-treat population, 71 patients had undergone PDE at the time of the analysis and 42 of the 71 patients (59 percent) achieved a CR. |
| 2019-01-08 | UroGen Pharma Ltd. | Results UroGen Pharma Announces Positive Results of UGN-101 from Pivotal Phase 3 OLYMPUS Trial for the Non-Surgical Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) urogen.com ↗
This analysis showed that on an intent-to-treat basis, 57 percent of patients achieved a complete response (CR) rate at their primary disease evaluation (PDE, or the primary endpoint) which was conducted four to six weeks after completion of UGN-101 treatment. |
| 2018-12-17 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer (LG UTUC) urogen.com ↗ |
| 2018-10-30 | UroGen Pharma Ltd. | Regulatory FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC) urogen.com ↗
today announced that the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation. |
| 2018-07-11 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Submits Investigational New Drug (IND) Application for UGN-102 (VesiGel™) for the Treatment of Low-Grade Non-Muscle Invasive Bladder Cancer (LG NMIBC) urogen.com ↗
today announced that it submitted to the U.S. Food and Drug Administration ( FDA ) an Investigational New Drug (IND) application for UGN-102 |
| 2018-05-21 | UroGen Pharma Ltd. | Results UroGen Pharma Announces Positive Interim Results from Pivotal Phase 3 OLYMPUS Trial of UGN-101 (MitoGel™) for Non-Surgical Treatment of Upper Tract Urothelial Cancer (UTUC) urogen.com ↗
The interim analysis from this international, multi-center trial showed a complete response (CR) rate of 59 percent in 34 patients who were evaluated for primary disease evaluation (PDE, or the primary endpoint). |
| 2017-08-29 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Receives FDA Fast Track Designation for MitoGel™ for the Treatment of Upper Tract Urothelial Carcinoma (UTUC) urogen.com ↗
The U.S. Food and Drug Administration ( FDA ) has granted both Orphan Drug and Fast Track designations to MitoGel for the treatment of low-grade UTUC. |
| 2016-12-12 | UroGen Pharma Ltd. | Regulatory UroGen Pharma Announces FDA Acceptance of Investigational New Drug Application for MitoGel, a Novel Sustained Release Formulation of Mitomycin C, for the Treatment of Low-Grade Upper Tract Urothelial Carcinoma urogen.com ↗
UroGen Pharma Ltd., a privately held, clinical stage biopharmaceutical company, today announced the acceptance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for MitoGel™ for the treatment of low-grade upper tract urothelial carcinoma (UTUC). |
| 2014-12-10 | UroGen Pharma Ltd. | Regulatory Urogen has been Granted Orphan Drug Designation from the US FDA for its Innovative Treatment of UTUC urogen.com ↗
MitoGel, a sustained release formulation of Mitomcin C, has been granted orphan-drug designation by the U.S Food and Drug Administration ("FDA") for the treatment of Urinary Upper Tract Urothelial Carcinoma (UTUC). |
| 2008-06-30 | Halozyme Therapeutics | Results Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial halozyme.com ↗
The study also provided support for future pivotal trial development that will incorporate the highest combination dose studied in the current trial, mitomycin plus 800,000 Units of rHuPH20. |
All press releases naming this drug 79 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 184 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mitomycin c | “A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS...” NCT03335059 ↗184“MitoGel is a novel investigational product composed of RTGel, a unique hydrogel polymer which exists as liquid at cold temperatures and a viscous gel at body temperatures, and...” NCT02701023 ↗ “Mitomycin C or epirubicin may be used as protocol-allowed alternatives when gemcitabine is unavailable, contraindicated, or not routinely used at the participating center.” NCT07749924 ↗ “A Randomized Multi-center Phase I/II Trial of ICM (Irinotecan, Cisplatin, Mitomycin C) With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer” NCT01296763 ↗ “UGN-101 (Jelmyto™) is a novel formulation of mitomycin C that uses a unique hydrogel designed to increase urinary dwell time, and thereby efficacy of treatment.” PMID 32670424 ↗ Jul 2020 “A closed technique will be utilized to deliver mitomycin C (MMC) over the first 60 minutes followed by an additional smaller dose over an additional 30 minutes.” NCT05430035 ↗ “0.02% mitomycin C (MMC) was applied to the bare sclera for two minutes using a soaked sponge, followed by thorough irrigation with balanced salt solution.” NCT06944132 ↗ “As part of the subjects' treatment, 10 mg/meters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29.” NCT05838391 ↗ “After enrollment, patients will be randomized into two groups: trabeculectomy with ologen (OculusGen) implant or trabeculectomy with mitomycin-C.” NCT00449098 ↗ “Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery” NCT00524758 ↗ “Efficacy of Hyaluronic Acid as Intraoperative Adjuvant in External Dacryocystorhinostomy Compared to Mitomycin-C: A Randomized Controlled Trial” NCT07504250 ↗ |
| Known as | Jelmyto | “UGN-101 (Jelmyto™) is a novel formulation of mitomycin C that uses a unique hydrogel designed to increase urinary dwell time, and thereby efficacy of treatment.” PMID 32670424 ↗ Jul 2020 |
| Known as | MITO | “plus Mitomycin, MITO, NSC-26980” NCT00002507 ↗ |
| Known as | Mitolem | “using intraoperative mitomycin C (Mitolem, LEMERY, S.A. de C.V. Mexico D.F. Reg. 136M92 SSA)” NCT00599950 ↗ |
| Known as | mitomycin | “determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin (mitomycin C, MMC) administered...” NCT00318643 ↗4“PURPOSE: This study aimed to assess long-term follow-up after chemoresection with mitomycin (MMC), a nonsurgical treatment modality for recurrent nonmuscle invasive bladder...” PMID 36223555 ↗ Oct 2022 “fluorouracil (1000 mg/m2 on days 1-4 and 29-32) plus mitomycin (10 mg/m2 on days 1 and 29) and radiotherapy (45-59 Gy)” PMID 18430910 ↗ Apr 2008 “intraperitoneal (IP) mitomycin on day 0” NCT00005944 ↗ “plus Mitomycin, MITO, NSC-26980” NCT00002507 ↗ |
| Known as | Mitomycin C (Mutamycin) | “Mitomycin C (Mutamycin)” NCT01196455 ↗ |
| Known as | MMC | “To obtain estimates of the effect on intraocular pressure and side effects of three delivery methods of Mitomycin C (MMC) compared among each other: preoperative...” NCT03875911 ↗41“Based on the observation of topoisomerase-1, upregulation by mitomycin C (MMC), and the phase I antitumor activity of sequential MMC/irinotecan in esophageal cancer, we...” PMID 20354452 ↗ May 2010 “A Multicenter, Single-Arm Study Evaluating the Efficacy of Synergo® Radiofrequency-Induced Thermochemotherapy Effect (RITE) With Mitomycin C (Synergo® RITE + MMC) in CIS...” NCT03335059 ↗ “determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of escalating doses of Chemophase in combination with mitomycin (mitomycin C, MMC) administered...” NCT00318643 ↗ “To investigate effect of intravesical mitomycin-C(MMC) applied with bladder wall thermotherapy system on reccurrence and progression status of intermediate and high risk non...” NCT03694535 ↗ “The surgical procedure includes a low dose, short duration mitomycin C (MMC) treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of...” NCT03126877 ↗ “PURPOSE: This study aimed to assess long-term follow-up after chemoresection with mitomycin (MMC), a nonsurgical treatment modality for recurrent nonmuscle invasive bladder...” PMID 36223555 ↗ Oct 2022 “Our aim was to assess if sequential mitomycin C (MMC) plus BCG after transurethral resection (TUR) is worthy of further study in non-muscle-invasive bladder cancer patients with CIS.” PMID 21156335 ↗ Dec 2010 “Although other adjuvant treatments such as steroids and antibiotics have been investigated in LTS, much attention in recent years has turned to the use of topical mitomycin-C (MMC).” NCT01523275 ↗ “The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid” NCT00289445 ↗ “A closed technique will be utilized to deliver mitomycin C (MMC) over the first 60 minutes followed by an additional smaller dose over an additional 30 minutes.” NCT05430035 ↗ |
| Known as | Mytomycin C | “Topical application of Mytomycin C (MMC)” NCT04037072 ↗ |
| Known as | NSC-26980 | “plus Mitomycin, MITO, NSC-26980” NCT00002507 ↗ |
| Action | Inhibit | “MMC has been shown to inhibit fibroblast proliferation in wound-healing processes.” NCT01523275 ↗ |
| Modality | Other / unclassified | “It is an alkylating drug that inhibits DNA from being transcribed into RNA” NCT07504250 ↗ |
| Route | Intravenous | “mitomycin C by IV bolus” NCT00003003 ↗ |