CClinicalTrials.gg
AvailableNCT05494411Updated Sep 15, 2026

Named Patient Program for Mitomycin for Pyelocalyceal Solution

An expanded access record providing Mitomycin for pyelocalyceal solution in Urothelial Cancer of Renal Pelvis, Urothelial Carcinoma of the Renal Pelvis and Ureter and Urothelial Carcinoma Ureter, sponsored by UroGen Pharma Ltd.. Available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by UroGen Pharma Ltd. · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
18 Years and older
Sex
All
01

Study summary

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

02

Conditions studied

  • Urothelial Cancer of Renal Pelvis
  • Urothelial Carcinoma of the Renal Pelvis and Ureter
  • Urothelial Carcinoma Ureter
  • Urothelial Carcinoma Ureter Recurrent
  • Urothelial Carcinoma
  • Urothelial Carcinoma Recurrent

Keywords

  • Low-grade Upper Tract Urothelial Cancer
  • LG-UTUC
  • UGN-101
  • Mitomycin
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Eligibility criteria

Inclusion Criteria:

  • Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.
04

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • DrugMitomycin for pyelocalyceal solution

    Also known as: JELMYTO

05

Where to request access

No study locations are listed for this record.

06

Registry details

Key details

Study ID
NCT05494411
Lead sponsor
UroGen Pharma Ltd.
Collaborators
Tanner Pharma Group
Responsible party
Sponsor
First posted
Aug 10, 2022
Last update
Sep 15, 2026

Study contacts

Michael Louie, MD, MPH, MSC
Contact
michael.louie@urogen.com
+1-855-987-6436
View the source record on ClinicalTrials.gov ↗

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