{"entity":{"id":"tar-200","kind":"drug","name":"Gemcitabine intravesical system (TAR-200)","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04640623 (SunRISe-1)","url":"https://clinicaltrials.gov/study/NCT04640623"}],"tags":[],"related":[],"cancers":["urothelial","non-muscle-invasive-bladder-cancer"],"sections":[],"technologies":["bcg-and-intravesical-therapy"],"targets":[],"drugs":[],"companies":["johnson-johnson"],"institutions":[],"pathways":[],"terms":["bcg-unresponsive"],"trials":["sunrise-1","nct06211764"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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":[{"region":"US","year":2025,"indication":"BCG-unresponsive high-risk NMIBC with CIS, with or without papillary tumours"}],"mechanismSteps":["Device inserted through a urinary placement catheter and coils in the bladder","Osmotic pump releases gemcitabine continuously for ~3 weeks","Sustained urothelial drug exposure kills CIS and papillary cells","Device removed cystoscopically; repeated every 3 weeks then every 12 weeks"],"dosing":{"route":"Intravesical (indwelling device)","schedule":"225 mg gemcitabine device every 3 weeks for 24 weeks, then every 12 weeks up to 3 years","monitoring":"Cystoscopy and cytology at 3-month intervals"},"toxicity":[{"event":"Urinary tract infection","anyGradePct":24},{"event":"Dysuria","anyGradePct":22},{"event":"Pollakiuria","anyGradePct":20},{"event":"Grade 3+ treatment-related","grade3PlusPct":12}],"access":[],"regulatoryEvents":[{"date":"2025-09-09","type":"approval","region":"US","note":"FDA approval of Inlexzo","source":"https://www.onclive.com/view/fda-approves-tar-200-in-bcg-unresponsive-nmibc-with-cis"}]},"route":"/drugs/tar-200/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","route":"/cancers/non-muscle-invasive-bladder-cancer/"}],"technology":[{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"}],"company":[{"id":"johnson-johnson","kind":"company","name":"Johnson & Johnson","route":"/companies/johnson-johnson/"}],"term":[{"id":"bcg-unresponsive","kind":"term","name":"BCG-unresponsive","route":"/terms/bcg-unresponsive/"}],"trial":[{"id":"nct06211764","kind":"trial","name":"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)","route":"/trials/nct06211764/"},{"id":"sunrise-1","kind":"trial","name":"SunRISe-1","route":"/trials/sunrise-1/"}],"roadmap":[{"id":"devices-roadmap","kind":"roadmap","name":"Devices and physical therapies roadmap: heat and light → electric fields and focused sound → drug-releasing implants","route":"/roadmaps/devices-roadmap/"}]}}