Drug

OTO-201 clinical trials

Also written OTO-201.

studies test it: 5
open now: 0
in phase 3: 3
first study started: 2012

How each study uses OTO-201 is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Approvals

The first approval found in each region, with its record

United States: Not in FDA's approval records
European Union: Not in EMA's list of EU-wide authorisations

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Development codes

OTO-201: 5

Studies by the year they started

5 studies that test it; most in 2013 (2)

Studies that test OTO-201, by start year
Year	Studies
2012	1
2013	2
2015	2

By phase

A phase 1/2 study counts in both.

Phase 1: 1
Phase 2: 1
Phase 3: 3

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Otitis Media with Effusion: 2
Otitis Media: 1

Who runs them

Industry 5 · Other 0

Otonomy, Inc. (5)

Studies

Open first, then newest update. How each study uses OTO-201 is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.