J&J Medical Connect
INLEXZO™

(gemcitabine intravesical system)

+ Save link
J&J Medical Connect

Connect with us

Connect with us

This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

INLEXZO™ (gemcitabine intravesical system)

Medical Information

INLEXZO - General Overview

Last Updated: 09/10/2025

BACKGROUND

  • INLEXZO (gemcitabine intravesical system) is an intravesical drug releasing system (iDRS), referred to as TAR-200 in literature.1 
  • INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.2 
  • INLEXZO is designed to provide local release of gemcitabine in the bladder. INLEXZO contains gemcitabine and urea minitablets within a dual-lumen silicone tube for sustained release of gemcitabine by an osmotic delivery mechanism throughout the prescribed indwelling period.2-9
  • INLEXZO is inserted intravesically via urinary placement catheter, after which it self-coils into a bi-oval shape (see Figure: INLEXZO iDRS). Removal of INLEXZO can be achieved using grasping forceps and cystoscopy.2,9,10   
  • Results from the pivotal SunRISe-1 (NCT04640623) study were published in the Journal of Clinical Oncology.1 Additionally, safety and efficacy results from SunRISe-4 (NCT04919512), TAR-200-101 (NCT02722538), and TAR-200-103 (NCT03404791) studies conducted in patients with muscle invasive bladder cancer (MIBC) have been published.5-7,11 Safety and efficacy results from TAR-200-102 (NCT02720367) study conducted in patients with NMIBC have been published.8 A preclinical study comparing tissue penetration, distribution, and retention of gemcitabine and its active metabolites with INLEXZO vs. traditional standard intravesical instillation methods in minipigs has been presented.12 

INLEXZO iDRS3,4,13,14  

Product labeling

U.S. Regulatory status

  • On September 9, 2025, the U.S. Food and Drug Administration (FDA) approved INLEXZO (gemcitabine intravesical system) for the treatment of adult patients with BCG-unresponsive, NMIBC with CIS, with or without papillary tumors.15 
  • INLEXZO’s approval follows its FDA Breakthrough Therapy Designation on December 4, 2023 and New Drug Application submission through the Real-Time Oncology Review program on January 15, 2025.16,17 
    • The Real-Time Oncology Review program allows the FDA to review data before the complete application is formally submitted and helps ensure treatments are available for patients as soon as possible.17,18 
  • The approval was based on the phase 2b SunRISe-1 study results presented at the 2025 American Urological Association Annual (AUA) Meeting and published in the Journal of Clinical Oncology.1,15,19
    • Additionally, SunRISe-1 data have been featured at the European Society for Medical Oncology Annual Congress (ESMO) and the American Urological Association (AUA) Annual Meetings in 2023, 2024, and 2025.16,17,19-25 

CLINICAL STUDIES

  • INLEXZO is currently being evaluated by Janssen Research & Development, LLC in patients with NMIBC and MIBC in the clinical studies described in Table: Ongoing Clinical Studies.
  • Completed clinical studies evaluating the use of INLEXZO in patients with MIBC and NMIBC are described in Table: Completed Clinical Studies.

Ongoing Clinical Studies1,11,19-38 
Phase/Study
Study Design
NCT Identifier
Phase 3
A phase 3, multicenter, randomized, open-label study evaluating efficacy and safety of TAR-200 in combination with cetrelimab or TAR-200 alone vs intravesical BCG in participants with BCG-naïve high-risk NMIBC
NCT05714202
A phase 3, multicenter, randomized, open-label study evaluating efficacy and safety of TAR-200 vs investigator’s choice of intravesical chemotherapy in participants with recurrent high-risk NMIBC who received BCG therapy and are ineligible for or have elected not to undergo RC
NCT06211764
Phase 2
A phase 2b, clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk NMIBC unresponsive to intravesical BCG who are ineligible for or have elected not to undergo RC
NCT04640623
A phase 2, randomized, multicenter, open-label study of TAR-200 in combination with cetrelimab and cetrelimab alone in participants with MIBC who are scheduled for RC and are ineligible for or refuse platinum-based neoadjuvant chemotherapy
NCT04919512
Abbreviations: BCG, Bacillus Calmette-Guérin; MIBC, muscle invasive bladder cancer; NCT, national clinical trial; NMIBC, non-muscle invasive bladder cancer; RC, radical cystectomy.

Completed Clinical Studies5-8,39-41
Phase/Study
Study Design
NCT Identifier
Phase 1
  • TAR-200-1037,39
A multicenter study evaluating safety and efficacy of TAR-200 in subjects with MIBC who are ineligible for or refuse cisplatin-based chemotherapy and who are unfit for RC
NCT03404791
  • TAR-200-1028,40
A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of TAR-200 in subjects with NMIBC
NCT02720367
A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of TAR-200 in subjects with MIBC
NCT02722538
Preclinical
  • Project Penelope12 
A preclinical study comparing tissue penetration, distribution, and retention of gemcitabine and its active metabolites with TAR-200 vs. traditional standard intravesical instillation methods in minipigs
-
Abbreviations: MIBC, muscle invasive bladder cancer; NCT, national clinical trial; NMIBC, non-muscle invasive bladder cancer; RC, radical cystectomy.

For more information regarding ongoing and completed clinical studies, please visit clinicaltrials.gov.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 09 September 2025.

 

References

Show
1 Daneshmand S, Van der Heijden MS, Jacob JM, et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
2 INLEXZO (gemcitabine intravesical system) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/INLEXZO-pi.pdf
3 Douglass L, Schoenberg M. The future of intravesical drug delivery for non-muscle invasive bladder cancer. Bladder Cancer. 2016;2(3):285-292.  
4 Tan WS, Kelly JD. Intravesical device-assisted therapies for non-muscle-invasive bladder cancer. Nat Rev Urol. 2018;15(11):667-685.  
5 Daneshmand S, Pohar KS, Steinberg GD, et al. Effect of GemRIS (gemcitabine-releasing intravesical system, TAR-200) on antitumor activity in muscle-invasive bladder cancer (MIBC) [abstract]. J Clin Oncol. 2017;35(Suppl. 15). Abstract e16000.  
6 Daneshmand S, Brummelhuis ISG, Pohar KS, et al. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol. 2022;40(7):344.e1-344.e9.  
7 Tyson MD, Morris D, Palou J, et al. Safety, tolerability, and preliminary efficacy of TAR-200 in patients with muscle-invasive bladder cancer who refused or were unfit for curative-intent therapy: a phase 1 study. J Urol. 2023;209(5):890-900.  
8 van Valenberg FJP, van der Heijden AG, Cutie CJ, et al. The safety, tolerability, and preliminary efficacy of a gemcitabine-releasing intravesical system (TAR-200) in American Urological Association-defined intermediate-risk non-muscle-invasive bladder cancer patients: a phase 1b study. Eur Urol Open Sci. 2024;62:8-15.  
9 Daneshmand S, Kamat AM, Shore ND, et al. Development of TAR-200: a novel targeted releasing system designed to provide sustained delivery of gemcitabine for patients with bladder cancer. Urol Oncol. 2025;43(5):286-296.  
10 Daneshmand S, van der Hejiden MS, Jacob JM, et al. Clinical protocol for: TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from the phase IIb SunRISe-1 study. [published online ahead of print July 30, 2025]. J Clin Oncol. doi:10.1200/jco-25-01651.  
11 Necchi A, Guerrero-Ramos F, Crispen PL, et al. TAR-200 plus cetrelimab versus cetrelimab monotherapy as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or decline neoadjuvant cisplatin-based chemotherapy (SunRISe-4): interim analysis of a randomised, open-label phase 2 trial. [published online ahead of print August 27, 2025]. Lancet Oncol. 2025:1-11. doi:10.1016/s1470-2045(25)00358-4.  
12 Daneshmand S, Wuyts K, Meulder MD, et al. Penelope: tissue penetration of gemcitabine phosphate metabolites following TAR-200 administration vs standard intravesical installation in mini pigs. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, TX.  
13 Daneshmand S, Brummelhuis ISG, Pohar KS, et al. The safety, tolerability, and efficacy of a neoadjuvant gemcitabine intravesical drug delivery system (TAR-200) in muscle-invasive bladder cancer patients: a phase I trial. Urol Oncol: Semin Orig Investig. 2022;40(7):344.e1-344.e9.  
14 Grimberg DC, Shah A, Inman BA. Overview of Taris GemRIS, a novel drug delivery system for bladder cancer. Eur Urol Focus. 2020;6(4):620-622.  
15 Johnson & Johnson. U.S. FDA approval of INLEXZOTM (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. Accessed September 9, 2025. Available via: https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated
16 Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer. 2023-12-18. Available via: https://www.jnj.com/johnson-johnsons-investigational-tar-200-granted-u-s-fda-breakthrough-therapy-designation-for-the-treatment-of-high-risk-non-muscle-invasive-bladder-cancer
17 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. 2025-01-15. Available via: https://www.jnj.com/media-center/press-releases/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
18 Johnson & Johnson receives U.S. FDA Priority Review for TAR-200 NDA in high-risk non-muscle invasive bladder cancer. 2025-07-21. Available via: https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-u-s-fda-priority-review-for-tar-200-nda-in-high-risk-non-muscle-invasive-bladder-cancer
19 Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.  
20 Necchi A, Jacob JM, Daneshmand S. Results from SunRISe-1 in patients (pts) with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) receiving TAR-200 monotherapy. Oral Presentation presented at: European Society for Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.  
21 Daneshmand S, Van der Heijden MS, Jacob JM, et al. First results from SunRISe-1 in patients with BCG-unresponsive high-risk non-muscle-invasive bladder cancer receiving TAR-200 in combination with cetrelimab, TAR-200, or cetrelimab alone. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 28-May 1, 2023; Chicago, IL.  
22 Jacob JM, Necchi A, Daneshmand S, et al. TAR-200 in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: results from SunRISe-1 study. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; May 03-06, 2024; San Antonio, TX.  
23 van der Heijden MS, Cutie CJ, Hampras S, et al. SunRISe-1: phase 2b study of TAR-200 plus cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guérin who are ineligible for or decline radical cystectomy. Poster presented at: American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU); February 17-19, 2022; San Francisco, CA and Virtual.  
24 van der Heijden MS, Simone G, Bögemann M, et al. TAR-200 in combination with cetrelimab (CET), TAR-200 alone, or CET alone in patients with Bacillus Calmette–Guérin (BCG)-unresponsive high-risk non–muscle-invasive bladder cancer (HR NMIBC): results from SunRISe-1. Oral Presentation presented at: European Society for Medical Oncology (ESMO) Congress; September 13–17, 2024; Barcelona, Spain.  
25 Guerrero-Ramos F, Jacob JM, van M der Heijden, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive papillary disease-only high-risk non–muscle-invasive bladder cancer: first results from cohort 4 of SunRISe-1. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.  
26 Necchi A, Catto J, Powles T, et al. SunRISe-3: TAR-200 plus cetrelimab or TAR-200 versus intravesical Bacillus Calmette-Guérin (BCG) in patients with BCG-naïve high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Poster presented at: European Society for Medical Oncology (ESMO) Congress; October 20-24, 2023; Madrid, Spain.  
27 Porten S, Bhanvadia S, Najmi S, et al. SunRISe-5: a phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after Bacillus Calmette-Guérin in recurrent high-risk non-muscle-invasive bladder cancer. Oral Presentation presented at: American Urological Association (AUA) Annual Meeting; May 3-6, 2024; San Antonio, TX.  
28 Psutka SP, Cutie CJ, Bhanvadia SK, et al. SunRISe-4: TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant platinum-based chemotherapy. Poster presented at: American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU); February 16-18, 2023; San Francisco, CA and Virtual.  
29 Necchi A, Guerrero-Ramos F, Crispen PL, et al. TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with muscle-invasive bladder cancer who are ineligible for or refuse neoadjuvant platinum-based chemotherapy: interim analysis of SunRISe-4. Oral Presentation presented at: European Society for Medical Oncology (ESMO) Congress; September 13–17, 2024; Barcelona, Spain.  
30 Porten S, Bhanvadia S, Najmi S, et al. SunRISe-5: a phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after Bacillus Calmette-Guerin in recurrent high-risk non-muscle invasive bladder cancer. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, Tx.  
31 Daneshmand S, Zainfeld D, Pieczonka C, et al. Safety and tolerability of TAR-200 monotherapy in patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer in SunRISe-1. Poster presented at: Society of Urologic Oncology (SUO) Annual Meeting; December 4-6, 2024; Dallas, TX.  
32 Porten S, Bhanvadia S, Najmi S, et al. SunRISe-5: a phase 3, randomized, open-label study of TAR-200 compared with intravesical chemotherapy after Bacillus Calmette-Guérin in recurrent high-risk non-muscle-invasive bladder cancer. Abstract presented at: American Urological Association (AUA) Annual Meeting; April 26-29, 2025; Las Vegas, NV.  
33 Janssen Research & Development, LLC. A phase 3, open-label, multi-center, randomized study evaluating the efficacy and safety of TAR-200 in combination with cetrelimab or TAR-200 alone versus intravesical Bacillus Calmette-Guérin (BCG) in participants with BCG-naïve high-non-muscle invasive bladder cancer. In: Clinical Trials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/ct2/show/NCT05714202 NLM Identifier: NCT05714202.  
34 Janssen Research & Development, LLC. 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) (SunRISe-5). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/study/NCT06211764 NLM Identifier: NCT06211764.  
35 Xylinas E, Pieczonka CM, Jacob JM, et al. Association of PD-L1 expression with clinical response to TAR-200 in the phase 2b SunRISe-1 trial. Poster presented at: European Society for Medical Oncology (ESMO) Congress; September 13-17, 2024; Barcelona, Spain.  
36 Janssen Research & Development, LLC. Phase 2b clinical study evaluating efficacy and safety of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab alone in participants with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to intravesical Bacillus Calmette-Guerin (BCG) who are ineligible for or elected not to undergo radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/ct2/show/NCT04640623 NLM Identifier: NCT04640623.  
37 Janssen Research & Development, LLC. A phase 2, open-Label, multi-center, randomized study of TAR-200 in combination with cetrelimab and cetrelimab alone in participants with muscle-invasive urothelial carcinoma of the bladder who are scheduled for radical cystectomy and are ineligible for or refusing platinum-based neoadjuvant chemotherapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/ct2/show/NCT04919512 NLM Identifier: NCT0491952. 2025.  
38 Psutka S, Herrera-Imbroda B, Crispen P, et al. Perioperative outcomes of neoadjuvant TAR-200 plus cetrelimab or cetrelimab alone in patients with muscle-invasive bladder cancer ineligible for or refusing neoadjuvant cisplatin-based chemotherapy. Oral Presentation presented at: European Association of Urology (EAU) Congress; March 21-24, 2025; Madrid, Spain.  
39 Janssen Research & Development, LLC. A multicenter study evaluating safety and efficacy of TAR-200 in subjects with muscle-invasive urothelial carcinoma of the bladder who are ineligible for or refuse cisplatin-based chemotherapy and who are unfit for radical cystectomy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000 - [cited 2025 September 9]. Available from: https://clinicaltrials.gov/study/NCT03404791 NLM Identifier: NCT03404791.  
40 Taris Biomedical LLC. A phase 1b, multicenter, open-label study evaluating safety, tolerability and preliminary efficacy of GemRIS 225 mg in subjects with non-muscle-invasive urothelial carcinoma of the bladder. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/study/NCT02720367 NLM Identifier: NCT02720367.  
41 Janssen Research & Development, LLC. A phase 1b, multicenter, open label study evaluating safety, tolerability and preliminary efficacy of GemRIS 225 mg in subjects with muscle-invasive transitional cell carcinoma of the bladder. In: Clinical Trials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 September 9]. Available from: https://clinicaltrials.gov/study/NCT02722538 NLM Identifier: NCT02722538.