TheraRadar
Data updated: May 26, 2026

INLEXZO (gemcitabine hydrochloride)

Nucleic Acid Synthesis Inhibitors Trial Activity: Stable 350 active trials
Oncology Approved 2025-09-09

INLEXZO is an intravesical system used for adults with a specific type of bladder cancer that has not responded to Bacillus Calmette-Guérin (BCG) therapy. It helps patients with non-muscle invasive bladder cancer (NMIBC) who have carcinoma in situ, regardless of whether papillary tumors are also present. This medication provides a therapeutic option for those whose cancer remains or returns after standard initial treatments.

Source: FDA Label • Johnson & Johnson • Nucleoside Metabolic Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How INLEXZO Works

This drug works by interfering with the DNA synthesis process in cancer cells, which prevents them from growing and dividing. Once metabolized, it blocks the production of necessary genetic building blocks and incorporates itself into the DNA strand, eventually triggering programmed cell death.

Source: FDA Label

Development Insights

Hoffmann-La Roche conducting 39 trials (4%)
946 indications explored (Broad Platform)
→ pancreatic cancer (132 trials)
→ non-small cell lung cancer (38 trials)
→ pancreatic ductal adenocarcinoma (37 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2025-09-09
Patent Cliff
2034

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVESICAL
Dosage Forms
SYSTEM

Companies

Johnson & Johnson
Active Ingredient: GEMCITABINE HYDROCHLORIDE

INLEXZO Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Sep 2025 ORIGINAL Priority
New Form · Type 3 - New Dosage Form
FDA Letter Label

What INLEXZO Treats

2 indications

INLEXZO is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Non-Muscle Invasive Bladder Cancer
  • Carcinoma In Situ
Source: FDA Label

INLEXZO Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

5

Same target(s), different indications — where else is this mechanism being explored?

XROMI
NOVA LABS
2024 1 indic.
SIKLOS
THERAVIA
2017 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

RYBREVANT FASPRO
Johnson &
2025 1 indic.
HYRNUO
Bayer
2025 1 indic.
Unlock 11 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in INLEXZO's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INLEXZO treats. First-in-class if their pivotal trials read out positive.

Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Brigimadlin BI 907828
Boehringer Ingelheim
MDM2 · small-molecule MDM2-p53 inhibitor · 3 Phase 3 trials

Drugs Similar to INLEXZO

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANKTIVA
nogapendekin alfa inbakicept-pmln
1 shared
ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
Shared indications:
Carcinoma In Situ
CYSVIEW KIT
HEXAMINOLEVULINATE HYDROCHLORIDE
1 shared
PHOTOCURE ASA
Shared indications:
Carcinoma In Situ
ZUSDURI
MITOMYCIN
1 shared
UROGEN PHARMA
Shared indications:
Non-Muscle Invasive Bladder Cancer
📋

Clinical Trial Registry

133 trials
Trial Sponsor ID Phase Status Title
NCT04310007 NCI-2020-01541 NCI-2020-01541, EA5191 Ph 2 active not recruiting Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer
NCT04164082 NCI-2019-07573 NCI-2019-07573, A031803 Ph 2 active not recruiting Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
NCT03606967 NCI-2018-01581 NCI-2018-01581, 10146 Ph 2 recruiting Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT04628767 NCI-2020-09850 NCI-2020-09850, EA8192 Ph 2, Ph 3 recruiting Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
NCT05211323 NCI-2022-00151 NCI-2022-00151, EA2205 Ph 2 active not recruiting A Study to Determine Whether Chemotherapy and Atezolizumab is Better Than Chemotherapy, Bevacizumab and Atezolizumab in Patients With Advanced Liver Cancer
NCT06591650 GCND Huashan010 Ph 2 recruiting Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
NCT03816358 NCI-2019-00242 NCI-2019-00242, PJC-026 Ph 1 active not recruiting Testing the Combination of Anetumab Ravtansine With Either Nivolumab, Nivolumab and Ipilimumab, or Gemcitabine and Nivolumab in Advanced Pancreatic Cancer
NCT04579224 NCI-2020-07651 NCI-2020-07651, S1937 Ph 3 active not recruiting Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
NCT05685602 NCI-2022-08984 NCI-2022-08984, 202304010 Ph 1 suspended CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer
NCT04216290 NCI-2019-08628 NCI-2019-08628, EA8185 Ph 2 active not recruiting A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial
NCT03907475 NCI-2019-01886 NCI-2019-01886, 10292 Ph 2 recruiting Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial
NCT04267848 NCI-2020-00751 NCI-2020-00751, A081801 Ph 3 recruiting Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])
NCT02135042 NRG-HN001 U10CA180868, U10CA021661 Ph 2, Ph 3 active not recruiting Individualized Treatment Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA
NCT04233866 EA2186 NCI-2019-08286, EA2186 Ph 2 active not recruiting Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread
NCT02446600 results posted NCI-2015-00606 NCI-2015-00606, s16-01480 Ph 3 active not recruiting Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT04559139 EA2197 NCI-2020-05162, EA2197 Ph 2, Ph 3 active not recruiting Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer
NCT07529483 ERASE-Chemo OSU-25163 NCI-2026-01895, OSU-25163 Ph 2 not yet recruiting Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms
NCT02495896 0S-15-5 NCI-2015-00987, 0S-15-5 Ph 1 active not recruiting Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
NCT00885066 2007/36 CALACASS-CAPERGEM, ROCHE-CALACASS-CAPERGEM Ph 1 completed Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer
NCT03967977 BGB-A317-310 CTR20190543 Ph 3 active not recruiting Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma
NCT03418038 LS1781 P50CA097274, NCI-2018-00057 Ph 2 recruiting Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
NCT04216316 results posted NCI-2019-08660 NCI-2019-08660, 20-134 Ph 1, Ph 2 active not recruiting Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer
NCT04491942 NCI-2020-05428 NCI-2020-05428, PHI-117 Ph 1 active not recruiting Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer
NCT03609216 A031701 NCI-2018-01531, U10CA180821 Ph 2 active not recruiting Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
NCT02627443 results posted NCI-2015-02064 NCI-2015-02064, MC1563 Ph 1 active not recruiting Carboplatin, Gemcitabine Hydrochloride, and Berzosertib in Treating Patients With Recurrent and Metastatic Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT01660971 NCI-2012-01290 NCI-2012-01290, VICCGI1173 Ph 1 active not recruiting Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT00878163 NCI-2011-01400 NCI-2011-01400, CDR0000638302 Ph 1 active not recruiting GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery
NCT02101775 results posted NCI-2014-00620 NCI-2014-00620, PHL-093 Ph 2 active not recruiting Gemcitabine Hydrochloride With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT02595892 results posted NCI-2015-01910 NCI-2015-01910, 16-724 Ph 2 active not recruiting Gemcitabine Hydrochloride Alone or With M6620 in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT01970722 12316 NCI-2013-01948, 122550 Ph 1 active not recruiting Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
NCT01013649 results posted NCI-2011-01987 NCI-2011-01987, 11-00773 Ph 3 completed Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
NCT03366766 results posted 17P.556 JT 11371 Ph 2 terminated Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer
NCT02336087 14122 NCI-2014-02612, 14122 Ph 1 active not recruiting Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Pancreatic Cancer That Cannot be Removed by Surgery
NCT03768414 results posted S1815 NCI-2018-01920, S1815 Ph 3 completed Gemcitabine Hydrochloride and Cisplatin With or Without Nab-Paclitaxel in Treating Patients With Newly Diagnosed Advanced Biliary Tract Cancers
NCT03587662 2018-0065 NCI-2018-01292, 2018-0065 Ph 2 active not recruiting Ixazomib, Gemcitabine, and Doxorubicin in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
NCT02364713 results posted MC1365 NCI-2015-00133, MC1365 Ph 2 terminated MV-NIS or Investigator's Choice Chemotherapy in Treating Patients With Ovarian, Fallopian, or Peritoneal Cancer
NCT02420847 2014-0661 NCI-2015-00682, 2014-0661 Ph 1, Ph 2 active not recruiting Ixazomib Citrate With Gemcitabine Hydrochloride and Doxorubicin Hydrochloride in Treating Patients With Urothelial Cancer That is Metastatic or Cannot Be Removed by Surgery
NCT04821284 20F.1207 R01CA199646, JT 15477 Ph 1, Ph 2 active not recruiting Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer
NCT06255392 SYSKY-2023-1016-04 Ph 3 recruiting Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
NCT03432741 MC1689 NCI-2018-00149, MC1689 Ph 1 terminated Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
NCT05342194 JS001-039-III-ICC Ph 3 recruiting Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study
NCT02506959 results posted 2014-0516 NCI-2015-01308, 2014-0516 Ph 2 completed Panobinostat, Gemcitabine Hydrochloride, Busulfan, and Melphalan Before Stem Cell Transplant in Treating Patients With Refractory or Relapsed Multiple Myeloma
NCT01585805 results posted NCI-2012-00864 NCI-2012-00864, CDR0000732189 Ph 2 active not recruiting Gemcitabine Hydrochloride and Cisplatin With or Without Veliparib or Veliparib Alone in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT02567409 results posted NCI-2015-01642 NCI-2015-01642, PHII-135 Ph 2 completed Cisplatin and Gemcitabine Hydrochloride With or Without Berzosertib in Treating Patients With Metastatic Urothelial Cancer
NCT01701986 results posted 2012-0506 NCI-2012-02055, 2012-0506 Ph 1, Ph 2 completed Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
NCT02671890 MC1512 R01CA195473, NCI-2016-00007 Ph 1 terminated Disulfiram and Chemotherapy in Treating Patients With Refractory Solid Tumors or Metastatic Pancreatic Cancer
NCT04871529 results posted S2011 NCI-2021-02265 Ph 2 terminated Testing the Addition of an Anti-Cancer Immunotherapy Drug, Avelumab, to Gemcitabine and Carboplatin Chemotherapy Prior to Surgery in Muscle Invasive Urinary Tract Cancer vs. Surgery Alone in Patients Who Are Not Able to Receive Cisplatin Therapy (SWOG GAP TRIAL)
NCT02312245 results posted MC1463 NCI-2014-02399, 14-002986 Ph 2 completed Avatar-Directed Chemotherapy in Treating Patients With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT01064622 results posted NCI-2011-01454 NCI-2011-01454, 10-00099 Ph 2 completed Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer
NCT03971474 results posted S1800A NCI-2019-00703, S1800A Ph 2 completed Ramucirumab and Pembrolizumab Versus Standard of Care in Treating Patients With Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Non-Match Treatment Trial)

Showing 50 of 133 trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

INLEXZO FDA Label Details

Indications & Usage

FDA Label (PDF)

INLEXZO is indicated for the treatment of Non-Muscle Invasive Bladder Cancer; Carcinoma In Situ.

View full patent landscape →
4 OB patents · 3 families · 189 international docs across 28 countries

INLEXZO Patents & Exclusivity

Latest Patent: Aug 2034
Exclusivity: Sep 2028

Patents (5 active)

US10729823 Expires Aug 19, 2034
US12447241 Expires Aug 19, 2034
US8679094 Expires Apr 15, 2032
US12576253 Expires Dec 17, 2030
US12403086 Expires Jun 28, 2030

Exclusivity

NP Until Sep 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for INLEXZO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2034
  • • 5 active patents

Trial Analysis

  • • 996 total trials
  • • Stage: Stable

Competitive Landscape

  • • 3 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA219683 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment