Targeted therapeutics for inner ear disorders
Encased in the densest bone in the body and shielded by the blood-labyrinth barrier, the inner ear has resisted drug therapy for decades.Spiral is changing that.
Hearing loss is one of the largest modifiable risk factors for dementia.Lancet Commission, 2024
Inner ear diseases have treatable biology but almost no approved drugs
of inner ear disorders involve inflammation or neurodegeneration, biology that drugs can target.
improve hearing but don't treat the underlying disease.
steroids are the default treatment, though they were never developed or approved for the ear.
MICS™ and our local formulations
Ophthalmology changed when drugs could be delivered straight to the eye. We are bringing that approach to the ear: local formulations delivered to the inner ear with MICS™ (Minimally Invasive Cochlear System).
One platform across anti-inflammatory, otoprotective and neuroprotective drugs.
Explore the platformPrecision
Each formulation is placed where it needs to act, under direct visualization.
Versatility
Formulations matched to each drug substance, from small molecules to biologics.
In clinic
Designed for the ENT office, not the operating room.
A platform-enabled portfolio
Programs advancing across hearing loss and balance disorders.
SPT-2101
Ménière's disease
Dexamethasone otic suspension
2027 US IND clearance
The product
SPT-2101 is an investigational dexamethasone otic suspension that forms a crosslinked hydrogel at the round window membrane. It is placed under direct visualization with MICS™ (Minimally Invasive Cochlear System), by intratympanic administration in the clinic under local anesthesia.
Learn about Ménière's diseaseClinical data
70%of patients had complete resolution of definitive vertigo days at three months after a single administration, the study's primary endpoint. Phase 1b/2a, four sites in Australia, with no serious adverse events.
View trial registration (ANZCTR)What's next
US IND clearance in 2027, followed by a registrational trial with a design informed by our analysis of prior Ménière's programs. Sudden hearing loss follows as a second indication in Europe.
Built by category leaders
Our team combines drug-delivery expertise with deep otology and clinical-development experience.
News, press releases & publications
Spiral Therapeutics Announces $27 Million Series B Financing and Strategic Partnership with Advanced Bionics
SOUTH SAN FRANCISCO, Calif., April 14, 2026 — Spiral Therapeutics, Inc. (“Spiral Therapeutics” or “Spiral”), a clinical-stage company developing novel therapies for inner ear…
Read more
Spiral Therapeutics Announces Successful Completion of the SPT-2101 PHASE 1b/2a Clinical Trial for Meniere’s Disease, Data Presented During the 2024 AAO Annual Meeting
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 — Spiral Therapeutics, Inc. (Spiral), a clinical-stage company focused on developing novel therapies for inner ear disorders, announced the…
Read more
Spiral Therapeutics To Present At The Barany Society Meeting 2024
SOUTH SAN FRANCISCO, Calif., Aug. 21, 2024 — Spiral Therapeutics, Inc. (Spiral), a pharmaceutical company committed to developing advanced treatments for balance disorders and hearing loss,…
Read more