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, registry) + 741 randomized (TACTT3; EU register and sponsor; the ClinicalTrials.gov record lists 893)
- 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; EudraCT 2012-004099-20; 741 randomized — 373 acute, 368 post-acute per the sponsor — while the ClinicalTrials.gov record lists 893) also missed its primary endpoint (TFI change, baseline to Day 84): the EU Clinical Trials Register results (first posted 4 October 2019) show least-squares mean changes of 10.95 with AM-101 vs 12.44 with placebo in the main stratum (p=0.42); no journal publication was found. 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 (EU register results; no journal publication found).
Funding / conflicts: Sponsor-run (Auris Medical).
Corrections to this record
- 2026-10-19: TACTT3 'results never posted' corrected: results are posted on the EU Clinical Trials Register (first posted 4 October 2019); primary-endpoint figures added.
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.