Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FX-322 · 1 trial · 1 indication
To assess the incidence of adverse safety events (vertigo, tinnitus, perforation) including severe adverse events.
| Arm | Type | Description |
|---|---|---|
| Active | ACTIVE_COMPARATOR | Subjects will receive FX-322 as an intratympanic injection |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive Placebo as an intratympanic injection |
| Name | Type | Description |
|---|---|---|
| FX-322 | DRUG | intratympanic injection |
| Placebo | DRUG | intratympanic injection |
Inclusion Criteria: 1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE1 | AAVAnc80-hOTOF via Akouos Delivery Device |
| Envoy Medical, Inc. Class A | COCH | 1 | N/A | Undisclosed |
FX-322 is an investigational small molecule being developed for hearing loss. It is administered to adults undergoing cochlear implantation. The drug is in early clinical development, with a completed Phase 1 trial, and is not yet approved by regulatory authorities.
FX-322 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The drug is in Phase 1 clinical development for hearing loss.
FX-322 is in Phase 1 clinical development. A first-in-human safety study has been completed, and the drug remains investigational. It has not been approved by the FDA or any other regulatory agency.
FX-322 has one completed clinical trial, NCT03300687, titled "First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation." This early Phase 1 study enrolled 9 participants in Australia and was placebo-controlled.
No, FX-322 is not the same as cbdMD. FX-322 is an investigational drug candidate for hearing loss, while cbdMD, Inc. is the company developing it. The company's stock trades under the ticker YCBD.