MITOSOL

Peak

mitomycin

NDATOPICALFOR SOLUTIONPriority Review
Approved
Feb 2012
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
8

Mechanism of Action

(DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. Cellular RNA and protein synthesis may also be suppressed.

Clinical Trials (5)

NCT03844256Phase 1/2Recruiting

A Study of Mitomycin-c/ Capecitabine ChemoRadiotherapy Combined With Nivolumab Monotherapy or Ipilumimab and Nivolumab, as Bladder Sparing Curative Treatment for Muscle Invasive Bladder Cancer: the CRIMI Study

Started Jan 2019
50 enrolled
Urinary Bladder CancerInvasive Bladder Cancer
NCT02701088Phase 2Active Not Recruiting

Study of SIB-IMRT in Combination With 5-FU and Mitomycin-C Among Patients With Locally Advanced Anal Canal Cancer: Efficacy, Safety and Quality of Life

Started Dec 2015
71 enrolled
Locally Advanced Anal Canal Cancer
NCT01621217Phase 1Completed

Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

Started Jun 2012
21 enrolled
Locally Advanced Cancer in the Anal Region
NCT01167725Phase 3Terminated

Standard Therapy With or Without Surgery and Mitomycin C in Treating Patients With Advanced Limited Peritoneal Dissemination of Colon Cancer

Started Aug 2010
340 enrolled
Colorectal Cancer
NCT00892398N/ACompleted

Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

Started Mar 2009
242 enrolled
Glaucoma

Loss of Exclusivity

LOE Date
May 21, 2029
39 months away
Patent Expiry
May 21, 2029

Patent Records (5)

Patent #ExpiryTypeUse Code
8186511
Jul 19, 2026
Product
9205075
Jul 19, 2026
Product
9539241
Jan 2, 2028
SubstanceProduct
U-2095
7806265
Feb 1, 2029
Product
9649428
May 21, 2029
U-2095