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AM-101
AM-101 is an intratympanic injection that delivers a small-molecule NMDA receptor antagonist to the inner ear to reduce tinnitus perception.
AM-101 is an intratympanic injection that delivers a small-molecule NMDA receptor antagonist to the inner ear to reduce tinnitus perception. Used for Acute noise-induced tinnitus, Sudden sensorineural hearing loss with tinnitus.
At a glance
| Generic name | AM-101 |
|---|---|
| Sponsor | Auris Medical AG |
| Drug class | NMDA receptor antagonist |
| Target | NMDA receptor |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology / Neurology |
| Phase | Phase 3 |
Mechanism of action
AM-101 works by modulating glutamatergic neurotransmission in the cochlea and auditory pathways, specifically targeting NMDA receptors involved in tinnitus generation. The drug is administered directly into the middle ear via intratympanic injection, allowing it to reach the inner ear and suppress abnormal neural activity associated with tinnitus perception.
Approved indications
- Acute noise-induced tinnitus
- Sudden sensorineural hearing loss with tinnitus
Common side effects
- Ear pain or discomfort
- Temporary hearing changes
- Ear fullness sensation
- Vertigo or dizziness
Key clinical trials
- AM-101 in the Treatment of Post-Acute Tinnitus 2 (PHASE3)
- AM-101 in the Treatment of Acute Tinnitus 3 (PHASE3)
- AM-101 in the Treatment of Acute Tinnitus 2 (PHASE3)
- AM-101 in the Treatment of Post-Acute Tinnitus 1 (PHASE3)
- Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (PHASE2)
- Efficacy of AM 101 in Patients With Acute Inner Ear Tinnitus (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AM-101 CI brief — competitive landscape report
- AM-101 updates RSS · CI watch RSS
- Auris Medical AG portfolio CI