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
An ophthalmology-style approach to otology. We match each drug substance to a formulation built for its delivery needs, then place it at the round window membrane under direct visualization with MICS™ (Minimally Invasive Cochlear System).
We are applying this approach to anti-inflammatory, otoprotective and neuroprotective drugs.
Explore the platformPrecision
The single-use MICS Applicator combines a camera, illumination and an injection cannula to place the formulation at the round window membrane under direct visualization.
Residence
Our formulations are designed to stay in the round window niche after a single administration, keeping the drug at the entry point to the inner ear.
In clinic
Intratympanic administration under local anesthesia, with no 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…
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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…
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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,…
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