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Small Molecule

FX-322 for Sensorineural Hearing Loss

Phase 2
Waitlist Available
Research Sponsored by Frequency Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90

Summary

This trial tests FX-322, a drug injected into the ear, in adults aged 18 to 65 with acquired hearing loss. The drug aims to improve hearing by repairing or regenerating cells in the ear. FX-322, a combination of CHIR99021 and valproic acid, has been shown to regenerate mammalian cochlear hair cells.

Eligible Conditions
  • Sensorineural Hearing Loss
  • Sudden Deafness
  • Noise-Induced Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Word Recognition in Quiet
Secondary study objectives
Patient Global Impression of Change (PGI-C) Daily Impacts Scale
Patient Global Impression of Change (PGI-C) Hearing Loss Scale
Standard Pure Tone Audiometry
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FX-322Active Control1 Intervention
FX-322, 1 dose
Group II: PlaceboPlacebo Group1 Intervention
Placebo, 1 dose

Find a Location

Who is running the clinical trial?

Frequency TherapeuticsLead Sponsor
6 Previous Clinical Trials
194 Total Patients Enrolled
Carl LeBel, PhDStudy DirectorFrequency Therapeutics
15 Previous Clinical Trials
1,607 Total Patients Enrolled
~35 spots leftby Dec 2025
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