Drugs / TAR-200
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | BCG-unresponsive high-risk non-muscle-invasive bladder cancer | 2025-01-15 | “initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200” jnj.com ↗ “submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200” jnj.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03404791 | Nov 2017 → Dec 2019 | urinary bladder neoplasm | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04640623 | Dec 2020 → Jul 2025 overdue | urinary bladder neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06211764 | Apr 2024 → Nov 2030 expected | urinary bladder neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05714202 | Mar 2023 → Sep 2029 expected | urinary bladder cancer | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04658862 | Dec 2020 → Dec 2026 expected | urinary bladder neoplasm | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06877676 | — | urinary bladder neoplasm | Janssen Research & Development, LLC | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2025-12-05 | Janssen Research & Development, LLC | Results Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system) delivers 74 percent disease-free survival at one year in BCG-unresponsive, high-risk, papillary-only NMIBC jnj.com ↗ |
| 2025-12-05 | Janssen Research & Development, LLC | Results Johnson & Johnson's INLEXZO™ (gemcitabine intravesical system) delivers 74 percent disease-free survival at one year in BCG-unresponsive, high-risk, papillary-only NMIBC jnj.com ↗
Johnson & Johnson's INLEXZO™ (gemcitabine intravesical system) delivers 74 percent disease-free survival at one year in BCG-unresponsive, high-risk, papillary-only NMIBC |
| 2025-10-20 | Janssen Research & Development, LLC | Results Johnson & Johnson’s INLEXZO™ (gemcitabine intravesical system) plus cetrelimab delivers strong pre-surgical results in patients with muscle invasive bladder cancer scheduled for radical cystectomy jnj.com ↗
These early results support the potential role of neoadjuvant combination therapy in future muscle invasive trials. |
| 2025-09-09 | Janssen Research & Development, LLC | Regulatory U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated jnj.com ↗ |
| 2025-09-09 | Janssen Research & Development, LLC | Regulatory U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated jnj.com ↗
U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated |
| 2025-07-17 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer jnj.com ↗
The FDA Priority Review for TAR-200 underscores our mission to fundamentally change the way urologists treat certain types of bladder cancer. |
| 2025-07-17 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer jnj.com ↗
Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer |
| 2025-04-26 | Janssen Research & Development, LLC | Results Johnson & Johnson’s TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer jnj.com ↗
The findings demonstrate the highest complete response rate without reinduction with more than half of responders remaining cancer-free for at least 12 months. |
| 2025-04-26 | Janssen Research & Development, LLC | Results Johnson & Johnson’s TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC jnj.com ↗
These first results show the promise of TAR-200 in this patient population with more than an 80 percent disease-free survival (DFS) rate without the need for reinduction and 94 percent of patients able to preserve their bladder. |
| 2025-04-26 | Janssen Research & Development, LLC | Results Johnson & Johnson's TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer jnj.com ↗
Phase 2b SunRISe-1 study shows more than 82 percent of patients achieved complete response (CR) with more than half of responders remaining cancer-free at one year after CR |
| 2025-04-26 | Janssen Research & Development, LLC | Results Johnson & Johnson's TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC jnj.com ↗
First results from SunRISe-1 (Cohort 4) show strong disease-free survival rates across high-grade papillary tumors, demonstrating the potential for bladder preservation with 94 percent of patients avoiding radical cystectomy |
| 2025-04-21 | Janssen Research & Development, LLC | Results Johnson & Johnson unveils highly anticipated and potential practice-changing data in bladder cancer treatment at AUA jnj.com ↗ |
| 2025-01-15 | Janssen Research & Development, LLC | Regulatory New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer jnj.com ↗
Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. |
| 2025-01-15 | Janssen Research & Development, LLC | Regulatory New Drug Application initiated with U.S. FDA for TAR-200, the first and only intravesical drug releasing system for patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer jnj.com ↗ |
| 2024-10-07 | Janssen Research & Development, LLC | Results Johnson & Johnson Statement on the SunRISe-2 Study jnj.com ↗
Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued for not showing superiority versus chemoradiation. |
| 2024-09-16 | Janssen Research & Development, LLC | Results New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer jnj.com ↗ |
| 2024-09-16 | Janssen Research & Development, LLC | Results Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer jnj.com ↗ |
| 2024-09-16 | Janssen Research & Development, LLC | Results Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer jnj.com ↗
Neoadjuvant TAR-200 plus cetrelimab nearly doubles the pathological complete response rate compared to cetrelimab alone in patients with muscle-invasive bladder cancer |
| 2024-09-15 | Janssen Research & Development, LLC | Results New data from TAR-200 Phase 2b SunRISe-1 study show 84 percent complete response rate in patients with high-risk non-muscle-invasive bladder cancer jnj.com ↗ |
| 2024-05-03 | Janssen Research & Development, LLC | Results TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non–muscle-invasive bladder cancer jnj.com ↗
The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI], 70.6-91.4). |
| 2024-05-03 | Janssen Research & Development, LLC | Results TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non–muscle-invasive bladder cancer jnj.com ↗ |
| 2023-12-04 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer jnj.com ↗
This Breakthrough Therapy Designation recognizes TAR-200 as a promising advancement and marks an important step forward in our innovative focus to transform the treatment of bladder cancer. |
| 2023-12-04 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer jnj.com ↗
Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted TAR-200 Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy (surgical removal of the bladder). |
| 2023-10-22 | Janssen Research & Development, LLC | Results TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer jnj.com ↗
Centrally confirmed CR by urine cytology and/or biopsy was achieved in 23 of 30 patients (CR 77 percent; 95 percent CI, 58-90) and investigator-confirmed CR was achieved in 24 out of 30 patients (CR 80 percent; 95 percent CI, 61-92). |
| 2023-10-22 | Janssen Research & Development, LLC | Results TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer jnj.com ↗
TAR-200 Intravesical Delivery System Results Show 77 Percent Complete Response Rate in Patients with Bacillus-Calmette-Guérin Unresponsive, High-Risk Non-Muscle-Invasive Bladder Cancer |
| 2023-04-30 | Janssen Research & Development, LLC | Results Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer jnj.com ↗
The study demonstrated that 72.7 percent of patients treated with TAR-200 alone (95 percent confidence interval [CI] 49.8-89.3) and 38.1 percent of patients treated with cetrelimab alone (CI 18.1-61.6) achieved the primary endpoint of a complete response (CR). |
| 2023-04-30 | Janssen Research & Development, LLC | Results Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and AntiPD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer jnj.com ↗ |
All press releases naming this drug 27 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAR-200 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04640623 ↗ |
| Modality | Other / unclassified | “TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder.” PMID 40737582 ↗ Jul 2025 |
| Route | Other | “receive the TAR-200 transuretherally” NCT03404791 ↗ |