Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PIPE-505 · 1 trial · 1 indication
Number of participants with TEAEs
| Arm | Type | Description |
|---|---|---|
| PIPE-505 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PIPE-505 | DRUG | Intratympanic injection |
| Placebo | DRUG | Intratympanic injection |
Inclusion Criteria: * Subject's primary language is English. * Male or female between 18 and 75 years of age, inclusive, at randomization. * Diagnosis of bilateral sensorineural hearing loss (SNHL). * Normal tympanogram in the ear intended for injection (as defined in protocol) at Screening. * Male...
PIPE-505 is an investigational small molecule being developed for sensorineural hearing loss. It is administered intratympanically, meaning it is injected into the middle ear. The drug is currently in clinical development and is not approved by the FDA.
PIPE-505 is being developed by Contineum Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CTNM. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for sensorineural hearing loss.
PIPE-505 is in Phase 1 clinical development. A Phase I/IIa study has been completed, evaluating the safety and efficacy of an intratympanic dose of PIPE-505 in subjects with hearing loss. The drug remains investigational and has not received FDA approval.
PIPE-505 has one completed clinical trial, NCT04462198, a Phase I/IIa study evaluating the safety and efficacy of an intratympanic dose of PIPE-505 in subjects with hearing loss. The trial enrolled 28 participants in the United States, was randomized, double-blind, and placebo-controlled.
No, PIPE-505 is not FDA approved. It is an investigational drug currently in clinical development for sensorineural hearing loss. A Phase I/IIa clinical trial has been completed, but the drug has not yet received regulatory approval for commercial use.