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INLEXZO™ (TAR-200)

Learn how INLEXZO is changing the bladder cancer landscape.

What is INLEXZO and what sets it apart

INLEXZO is the first approved intravesical drug delivery system engineered to provide extended, continuous, local cytotoxic therapy (i.e., gemcitabine) release directly into the bladder, enabling a high local drug concentration with reduced systemic toxicity. In the pivotal phase 2b trial, patients with high-risk non-muscle invasive bladder cancer (HR-NMIBC) had a complete response rate of 82.4%.

This addresses the significant unmet medical need for effective, less-invasive, bladder-preserving therapies in these patients, particularly when unresponsive to Bacillus Calmette-Guérin (BCG), and could transform the treatment paradigm.

About INLEXZO

  • Company: Johnson & Johnson
  • Type: Antimetabolite (nucleoside analog)
  • Usage: Intravesical administration of gemcitabine via the TAR-200 drug delivery system every 3 weeks for up to 6 months (induction) followed by once every 12 weeks for up to 18 months (maintenance) to treat BCG-unresponsive HR-NMIBC with carcinoma in situ (CIS) with or without papillary tumors
    Also being evaluated for muscle-invasive bladder cancer (MIBC)
  • When will INLEXZO be available?
    Actual launch 2025: United States
    Expected launch 2026: European Union, Japan

INLEXZO sales and success forecasts

$1.80bn
expected sales in the G7 markets in 2031
95%
probability of success for INLEXZO in the United States

TAR-200 isn’t a weekly treatment, which adds convenience for patients. The toxicity profile is very favorable, and there are several positives. This is probably the most exciting development right now.

Medical oncologist United States

Drugs in the 2026 list

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