# Gemcitabine intravesical system (TAR-200)

Source: https://onco.cc/drugs/tar-200/  
OnCo record `tar-200` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TAR-200 is a small pretzel-shaped device placed in the bladder that releases gemcitabine for three weeks at a time. It was approved in 2025 for early bladder cancer that no longer responds to BCG.

## Summary

TAR-200 is a small pretzel-shaped osmotic mini-tablet system placed in the bladder via a urinary catheter in the clinic; it releases gemcitabine continuously into urine, giving sustained local exposure without systemic levels. The FDA approved it on 9 September 2025 for BCG-unresponsive NMIBC with carcinoma in situ on the basis of SunRISe-1, where monotherapy produced a complete response in 82% of patients and 51% remained in CR at 1 year. Urinary tract infection and dysuria were the common side effects, with grade 3 or higher treatment-related events in 12%. Phase 3 trials cover BCG-naive NMIBC (SunRISe-3) and muscle-invasive disease (SunRISe-4 with cetrelimab, SunRISe-2 versus chemoradiation); Johnson & Johnson develops it after acquiring Taris. It offers slow-release chemotherapy from inside the bladder as an alternative to bladder removal when BCG fails.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Inlexzo
- Code: TAR-200
- Modality: Intravesical drug-eluting device
- Mechanism: Osmotic mini-tablet system continuously releases gemcitabine into urine, achieving sustained local exposure without systemic levels.
- Approvals: US 2025: BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumours
- Dosing: Intravesical (indwelling device); 225 mg gemcitabine device every 3 weeks for 24 weeks, then every 12 weeks up to 3 years
- Toxicity (grade 3+): Grade 3+ treatment-related 12%

## Sources

- ClinicalTrials.gov NCT04640623 (SunRISe-1): https://clinicaltrials.gov/study/NCT04640623

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- technologies: [Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)](https://onco.cc/technologies/bcg-and-intravesical-therapy/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [BCG-unresponsive](https://onco.cc/terms/bcg-unresponsive/)
- trials: [A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)](https://onco.cc/trials/nct06211764/), [SunRISe-1](https://onco.cc/trials/sunrise-1/)
- roadmaps: [Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants](https://onco.cc/roadmaps/devices-roadmap/)

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