Trials / Approved For Marketing
Approved For MarketingNCT06877676
Pre-Approval Expanded Access Study for TAR-200 Treating Physician Use
Pre-Approval Access US Intermediate Size Expanded Access Protocol for TAR-200 Treating Physician Use
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this pre-approval access program is to provide access to TAR-200 prior to its marketing authorization for the treatment of participant(s) with high-risk non-muscle invasive bladder cancer (HR-NMIBC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAR-200 | Participants will undergo insertion of TAR-200 transurethrally into the bladder via catherization using the co-packed urinary placement catheter only in accordance with the Instructions for Use (IFU). |
Timeline
- First posted
- 2025-03-14
- Last updated
- 2026-04-13
Source: ClinicalTrials.gov record NCT06877676. Inclusion in this directory is not an endorsement.