Clinical Trials
21
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2004
Active, not recruiting
2
9.5%
Available
1
4.8%
Completed
9
42.9%
Recruiting
4
19.1%
Terminated
2
9.5%
Withdrawn
3
14.3%
No approval data available
• The ENVISION trial results, published in the _Journal of Urology_, demonstrate an 82.3% duration of response at 12 months in patients treated with UGN-102 who achieved complete response. • UGN-102 showed a 79.6% complete response rate at three months in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC). • UroGen's NDA for UGN-102 has been accepted by the FDA, with a PDUFA goal date of June 13, 2025, potentially offering a non-surgical option for LG-IR-NMIBC.
- The FDA has accepted UroGen's New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution, a potential first-in-class treatment. - UGN-102 targets low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), addressing a significant unmet need. - The NDA is supported by robust data, including the ENVISION trial, which demonstrated a 79.6% complete response rate at three months. - The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025, for a potential decision on UGN-102.
