Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FST201 · 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...
FST201 is being developed for the treatment of acute otitis externa, an infection of the outer ear canal. It is a small molecule combination product containing dexamethasone 0.1% and povidone-iodine 1%. Takeda Pharmaceutical Company Limited is developing FST201, which has completed a Phase 3 clinical trial in this indication.
FST201 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 3 trial evaluating FST201 in acute otitis externa. The drug is a small molecule combination product containing dexamethasone 0.1% and povidone-iodine 1%.
FST201 has completed a Phase 3 clinical trial. The trial, NCT00961675, titled FST-201 in the Treatment of Acute Otitis Externa, was a randomized, double-blind, active-controlled study that enrolled 70 male participants aged 18 years and older. FST201 is an investigational product and is not approved.
FST201 has been studied in one completed Phase 3 trial, NCT00961675, titled FST-201 in the Treatment of Acute Otitis Externa. The trial was randomized, double-blind, and active-controlled, with 70 participants enrolled. It was conducted in American Samoa and restricted to male participants aged 18 years and older.