MITOSOL (mitomycin)
Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is applied topically to the surgical site during the procedure to inhibit fibroblast proliferation and subsequent scarring, thereby improving the long-term success of the surgical drainage site (bleb). It is intended for use as a one-time supplemental treatment during the primary surgical intervention.
How MITOSOL Works
Mitosol inhibits the synthesis of deoxyribonucleic acid (DNA) through the cross-linking of complementary strands. The degree of cross-linking is proportional to the guanine and cytosine content of the DNA. At higher concentrations, cellular RNA and protein synthesis may also be suppressed.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-02-07
- Patent Cliff
- 2029
- Routes
- TOPICAL
- Dosage Forms
- FOR SOLUTION
MITOSOL Approval History
What MITOSOL Treats
1 indicationsMITOSOL is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glaucoma
MITOSOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MITOSOL
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06770582 | NCI-2025-00008 NCI-2025-00008, NRG-GU014 | Ph 2 | recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial |
| NCT04929028 | NCI-2021-06041 NCI-2021-06041, AMC-110 | Ph 2 | active not recruiting | Therapy Adapted for High Risk and Low Risk HIV-Associated Anal 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 |
| NCT07579195 | RG1126354 NCI-2026-02920, FHIRB0021260 | Ph 1, Ph 2 | not yet recruiting | Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial |
| NCT04166318 | EA2182 NCI-2019-02259, EA2182 | Ph 2 | active not recruiting | Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study |
| NCT07097142 | NRG-GU015 NCI-2025-04136, NRG-GU015 | Ph 3 | recruiting | Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study |
| NCT03775265 | NCI-2018-03264 NCI-2018-03264, S1806 | Ph 3 | active not recruiting | Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer |
| NCT06704191 | MC240502 UL1TR002377, NCI-2024-09555 | Ph 1, Ph 2 | recruiting | In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial |
| NCT05672108 | 22067 P30CA033572, NCI-2022-10436 | Ph 2 | recruiting | Phase II Trial of Lung Chemoemobolization |
| NCT04329494 | 19184 NCI-2020-01254, 19184 | Ph 1 | recruiting | PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer |
| NCT07271355 | 24756 NCI-2025-08527, 24756 | Ph 3 | not yet recruiting | Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial |
| NCT04107077 | IRB19-0160 | Ph 2 | recruiting | Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer |
| NCT05024734 GAIN INST | SZB-URO-21-001 | Ph 2 | recruiting | Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids |
| NCT02891447 results posted | 2016-0269 NCI-2018-02341, 2016-0269 | Ph 2 | completed | Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer |
| NCT00981656 results posted | RTOG 0926 CDR0000654727, NCI-2011-01974 | Ph 2 | completed | Radiation Therapy and Chemotherapy in Treating Patients With Stage I Bladder Cancer |
| NCT06462001 | 18UR004 | Ph 3 | active not recruiting | BCG + MMC: Adding Mitomycin C to BCG in High-risk, Non-muscle-invasive Bladder Cancer |
| NCT06227065 POLO | SZB-URO-24-001 | Ph 2 | not yet recruiting | Precise Neoadjuvant Chemoresection of Low Grade NMIBC |
| NCT01004978 results posted | NCI-2011-01981 NCI-2011-01981, ECOG-E1208 | Ph 3 | completed | Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery |
| NCT03617913 results posted | MC1752 NCI-2018-01539, MC1752 | Ph 2 | completed | Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer |
| NCT04845490 WUHIPEC02 | UHCT-IEC-SOP-016-21-02 | Ph 2 | not yet recruiting | Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy |
| NCT01671488 276 results posted | BrUOG 276 | Ph 1, Ph 2 | terminated | A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer |
| NCT01171482 | 07-2010-010 | Ph 2 | terminated | Comparison Study of Sorafenib and 5-fluorouracil/Mitomycin for Metastatic Hepatocellular Carcinoma |
| NCT01017640 | NCI-2012-01473 NCI-2012-01473, OSU-09100 | Ph 1 | completed | Veliparib With or Without Mitomycin C in Treating Patients With Metastatic, Unresectable, or Recurrent Solid Tumors |
| NCT01843452 | CHUV 20080214 | Ph 2 | terminated | Phase II Study of Concomitant Intensity-modulated Radiotherapy Combined to Capecitabine, Mitomycin and Panitumumab in Patients With Stage II-IIIB Squamous-cell Carcinoma of the Anal Canal |
| NCT01953406 | LUNG M_FM | Ph 2 | withdrawn | The Efficacy of 5-fluorouracil/Mitomycin for the Patients With Pulmonary Metastasis of Hepatocellular Carcinoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
MITOSOL FDA Label Details
Indications & Usage
FDA Label (PDF)MITOSOL is indicated for the treatment of Glaucoma.
Pro Intelligence Preview
Deep insights for MITOSOL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 5 active patents
Trial Analysis
- • 24 total trials
- • Stage: Growth
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
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