Keyzilen (AM-101) TACTT2 & TACTT3 Phase 3 failures (registry records)
Record details
- Authors: Auris Medical (sponsor)
- Journal / source: ClinicalTrials.gov posted results (no peer-reviewed Phase 3 publication exists) (2018)
- Design: Randomized placebo-controlled Phase 3 trials (intratympanic esketamine gel)
- Sample: 343 (TACTT2) + TACTT3 (NCT02040194)
- Primary endpoint: TACTT2: tinnitus loudness (TLQ) and TFI
- Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No
What this research found
FAILED. TACTT2 posted results: loudness change 0.80 vs 0.63 placebo (p=0.32); TFI 10.4 vs 9.6 (p=0.63) — both endpoints failed. TACTT3 (NCT02040194) also missed its primary endpoint; results never posted or published. Sponsor exited otology (now Altamira Therapeutics).
Failed on both a loudness construct and a distress construct. That no Phase 3 results were ever peer-review published is itself informative.
Limitations and conflicts of interest
Registry-only reporting for TACTT3.
Funding / conflicts: Sponsor-run (Auris Medical).
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.