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Named Patient Program for Mitomycin for Pyelocalyceal Solution

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05494411
Enrollment
Unknown
Registered
2022-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief 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.

Interventions

DRUGMitomycin for pyelocalyceal solution

Sponsors

UroGen Pharma Ltd.
Lead SponsorINDUSTRY
Tanner Pharma Group
CollaboratorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Contacts

CONTACTMichael Louie, MD, MPH, MSC
michael.louie@urogen.com+1-855-987-6436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026