Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ciprodex · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FST201 | ACTIVE_COMPARATOR | - |
| Ciprodex | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FST201 (dexamethasone 0.1% with povidone-iodine 1%) | DRUG | 4 gtt BID (twice a day) |
| Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) | DRUG | 4 gtt BID (twice a day) |
Inclusion Criteria: Study participants must: * Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) * Be at least 18 years of age at Visit 1 (Day 1, S...
Ciprodex is used for the treatment of Acute Otitis Externa, an infection of the outer ear canal. It is a small molecule being developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 3 clinical development for this indication.
Ciprodex is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its therapeutic effect in Acute Otitis Externa, an outer ear infection, without a defined biomarker-selected patient population.
Ciprodex is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of Acute Otitis Externa.
Ciprodex is in Phase 3 clinical development for Acute Otitis Externa. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed as part of its clinical program.
Ciprodex has one completed Phase 3 clinical trial, identified as NCT00961675, titled "FST-201 in the Treatment of Acute Otitis Externa." This randomized, double-blind, active-controlled study enrolled 70 male participants aged 18 years and older in American Samoa.
Ciprodex is also known as FST-201, as indicated by the clinical trial title. The trial NCT00961675 evaluated FST-201, which is the same drug as Ciprodex, for the treatment of Acute Otitis Externa.