Drug name
Last update: Jul 2026Gemcitabine Intravesical LAI
Developer(s)
Drug information
Gemcitabine
INLEXZO
Small molecule
Not provided
Gemcitabine (INLEXZO) is a nucleoside metabolic inhibitor-containing intravesical system, 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. Gemcitabine in-situ is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Thus, the plasma gemcitabine remains below quantification, and plasma 2′,2′-Difluorodeoxyuridine appears only at very low levels. High urinary concentrations persist through the indwelling period, with 77% excreted by Day 7 and 99% by Day 21. Bladder tissue studies show sustained penetration of active metabolites for up to 96 hours, achieving high local exposure with low systemic risk.
INLEXZO (gemcitabine intravesical system) has been approved in United States of America on 09 September 2025. This product received Breakthrough Therapy Designation from USFDA in 2023.
Gemcitabine Intravesical System (INLEZXO) 225 mg is approved by USFDA only.
Therapeutic area(s)
- Oncology : "Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors"
- Treatment
Administration route
Intravesical
Associated long-acting platforms
bi-oval-shaped osmotic urinary catheter based delivery system
Use of drug
- Administered by a community health worker
- Administered by a nurse
- Administered by a specialty health worker
- Every 3 months
- Every 3 weeks
INLEXZO is contraindicated in patients with a perforated bladder. Administration in such cases can lead to severe systemic exposure to Gemcitabine.
Systemic exposure may cause fetal harm. Females of reproductive potential should use effective contraception during treatment and for 6 months following final removal. Males with partners of reproductive potential should use effective contraception during treatment and for 3 months following final removal.
Dosage
225 mg every 3 weeks
225 mg
Gemcitabine Intravesical System (225 mg of gemcitabine) into the bladder once every 3 weeks for up to 6 months (8 doses), followed by once every 12 weeks for up to 18 months (6 doses), or until persistent or recurrent NMIBC, disease progression, or unacceptable toxicity.
Not provided
Associated compounds, formulations and regimens
Not provided
Associated technologies
Not provided
Additional information
Developer(s)
Johnson & Johnson
Janssen Biotech, Inc. is a leading biotechnology subsidiary of Johnson & Johnson (J&J) that specializes in developing, manufacturing, and commercializing therapeutic products to treat serious medical conditions. As of 2026, the company is part of the Johnson & Johnson Innovative Medicine division, following a global rebranding initiative to unite J&J's pharmaceutical segments under a single brand
Drug structure
Scale-up and manufacturing prospects
Projected revenue for INLEXZO is expected to reach $33 million in 2025 and increase significantly to $223 million in 2026.
Tablet equipments: 1. Precision analytical balances / weigh booths 2. Powder blender / tumble mixer 3. Mini‑tablet press 4. Controlled‑humidity storage cabinets Polymer Component Fabrication Equipment: 1. Medical‑grade silicone extrusion line 2. Hydrophilic TPU film extrusion / casting machines 3. Precision die‑cutters 4. Laser micromachining system 5. Nitinol wire forming and heat‑setting furnace
Process include (ISO‑classified cleanrooms required: Tablet handling/assembly: ISO 7–8; Device loading / open processes: ISO 5–7): 1. Mini‑Tablet Drug Core Production 2. Polymer Component Fabrication 3. Device Assembly 4. Sterilization & Packaging 5. In‑Vitro Release Testing (QC Lot Release)
1. HPLC‑UV 2. LC‑MS 3. Durometer tester, tensile tester, microscopy, contact‑angle/swelling measurement 4. Bioburden test kit
Excipients & delivery device(s)
No proprietary excipient used
1. Polyethylene glycol 8000 (8.0 mg) 2. Povidone K30 (13.4 mg) 3. Urea (42.6 mg) in a single intravesical implantable system
Not provided
intravesical implantable device containing solid gemcitabine tablets
Safety, Efficacy and Evidence Summary
Not provided
Not provided
Not provided
Not provided
Drug delivery device, for bladder delivery of 75% w/w gemcitabine HC1)
Implantable drug delivery devices include a housing defining a reservoir, a first unit within the reservoir, and a second unit within the reservoir. The first unit contains a drug and the second unit contains a functional agent that facilitates release of the drug. Intravesical drug delivery devices include a housing portion containing a drug formulation and a housing portion containing an excipient, and are configured to release the drug according to a first release profile and the excipient according to a second release profile.
WO2015026813
Device
WO2015026813
Not provided
August 19, 2034
Granted: AU, BR, CA, CN, EP (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), IL, IN, JP, KR, MX, NZ, RU, SG, US, VN, ZA
Drug delivery device wholly deployable within the bladder
Intravesical devices are provided that are wholly deployable within the bladder of a patient in need of treatment and are well tolerated by the patient.
WO2011084712
Device
TARIS BIOMEDICAL LLC
Not provided
December 17, 2030
Granted: AU, CA, EP (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), JP, US Pending: IL
Drug delivery device and drug tablet comprising a local anaesthetic agent
A drug delivery device is provided that includes a device body, a number of solid, compressed drug tablets, and a retention frame. The device body includes a drug reservoir lumen and a retention frame lumen. The number of solid, compressed drug tablets are positioned in the drug reservoir lumen, and the retention frame is positioned in the retention frame lumen. The drug tablets may be mini-tablets aligned in the drug reservoir lumen, with an interstice formed between any two adjacent drug tablets facilitating deformation of the device body. Systems and method are also provided for loading a drug delivery device.
WO2010151893, WO2010151896
Device
TARIS BIOMEDICAL LLC
Not provided
June 28, 2030
Granted: CA, CN, EP (CH, DE, FR, GB, IE, DK, FI, HU, NL, SE, ES, IT), EA (KZ, RU), IN, IL, JP, KR, MX, US Pending: AU, BR Not in force: EG, NZ, PH, SG, ZA, VN
Gemcitabine compound
This invention belongs to the field of pharmaceutical chemistry, and provides a new difluoro carbohydrate and new antiviral nucleosides prepared by coupling the new carbohydrate with appropriate bases.
US4808614
Compound
Eli Lilly and Company
Not provided
May 5, 2010
Expired