Organization (Industry)
Otonomy (United States)
ClinicalTrials.gov lists Otonomy (United States) as lead sponsor of 22 trials. It has 4 active development programs and 1 approved asset.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Otonomy (United States): 22 lead-sponsored trials and 1 legal-entity registration.
Disease areas (10)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Meniere Disease | 9 |
| Otitis Media | 5 |
| Vertigo | 5 |
| Vestibular Diseases | 5 |
| Tinnitus | 4 |
Showing 5 of 10 disease areas.
Trials by start year as sponsor or collaborator (9)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2021 | 1 |
| 2019 | 2 |
| 2018 | 1 |
| 2016 | 7 |
| 2015 | 5 |
| 2014 | 1 |
| 2013 | 3 |
| 2012 | 1 |
| 2010 | 1 |
Recruitment duration, a model prediction: none of the 22 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (4)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| DEXAMETHASONE | Meniere Disease | Phase 3 | 8 |
| DEXAMETHASONE | Vertigo | Phase 3 | 4 |
| DEXAMETHASONE | Vestibular Diseases | Phase 3 | 4 |
| OTO-313 | Tinnitus | Phase 2 | 2 |
Approved assets (1)
| Drug | Trials |
|---|---|
| DEXAMETHASONE | 9 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 1 of 3 hit target (n=3) | 2 of 4 on time (n=4) |
Journals published in (3)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Audiology & neuro-otology | 1 |
| JAMA otolaryngology-- head & neck surgery | 1 |
| Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 42 | 0 | 2021-09-21 |
Latest dated events (64)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2021-09-21 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2021-09-21 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2021-06-22 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2021-06-15 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2021-03-22 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
Showing 5 of 64 events.
Biomarker capability evidence (7)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| FAS | Trial sponsor | Primary endpoint in a Phase 3 trial |
| FASN | Trial sponsor | Primary endpoint in a Phase 3 trial |
| TFF3 | Trial sponsor | Exploratory endpoint in a trial |
| FAS | Trial sponsor | Mentioned in trial text |
| FASN | Trial sponsor | Mentioned in trial text |
Showing 5 of 7 evidence rows.
On Scientist.com
Otonomy (United States) is listed as a research supplier in the Scientist.com network.
Service areas
Otonomy was founded in 2008 by Avalon Ventures and experts in the otology field in order to build the premier company dedicated to the treatment of otic disorders via localized drug delivery. This approach has already been widely adopted for the delivery of short-acting antibiotics to treat otitis media through a tympanostomy tube. In addition, otolaryngologists have demonstrated that the injection of steroids into the middle ear cavity can provide a therapeutic effect for patients with acute inner ear disorders such as Ménière’s disease and sudden sensorineural hearing loss. Expansion...
Show the full description
Otonomy was founded in 2008 by Avalon Ventures and experts in the otology field in order to build the premier company dedicated to the treatment of otic disorders via localized drug delivery. This approach has already been widely adopted for the delivery of short-acting antibiotics to treat otitis media through a tympanostomy tube. In addition, otolaryngologists have demonstrated that the injection of steroids into the middle ear cavity can provide a therapeutic effect for patients with acute inner ear disorders such as Ménière’s disease and sudden sensorineural hearing loss. Expansion of this effort holds great promise for the treatment of chronic hearing loss, severe vertigo, and even tinnitus.
The key to Otonomy's leading position in this nascent field is the development of a proprietary formulation platform that provides sustained drug exposure from a single administration. Broad application of this technology has already been established across a number of therapeutic classes and from these, three product candidates have been advanced into development. OTO-104 is a steroid which is relevant for a wide range of hearing loss and balance disorders. A phase 1b clinical trial of OTO-104 has been completed in patients with Ménière’s disease and future studies are also anticipated for acute hearing loss. OTO-201 is an antibiotic intended to treat various middle ear conditions including recurrent or persistent otitis media. A phase 1b clinical trial of OTO-201 has been completed in pediatric patients with middle ear effusion at the time of tympanostomy tube replacement surgery. OTO-311 is a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. Emerging clinical data, including pilot studies conducted with gacyclidine, support the use of NMDA antagonists as treatments for tinnitus. All three product candidates are covered by an extensive patent estate filed by Otonomy to broadly protect the delivery of sustained-exposure drug treatments for otic disorders.
Since its inception, Otonomy has raised approximately $95 million from leading healthcare investors including OrbiMed Advisors, Novo Ventures, TPG Biotech, Domain Associates, Avalon Ventures, RiverVest Venture Partners, Aperture Venture Partners and Osage University Partners.
- Website
- www.otonomy.com
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda inspection record, fda recalls, fda import refusals, manufacturing and distribution sites, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.
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