What Acousia Therapeutics does

Acousia Therapeutics GmbH is a privately held, clinical-stage biotechnology company founded in 2012 and headquartered in Tübingen, Germany. The company develops small-molecule drug candidates that modulate the KCNQ4-encoded Kv7.4 potassium channel expressed in the outer hair cells of the cochlea, with a dual mode of action intended to both acutely enhance and chronically preserve natural hearing in patients with sensorineural hearing loss (SNHL). Its lead asset ACOU085 (international nonproprietary name: Bimokalner) is a first-in-class Kv7.4 activator formulated as a proprietary slow-release gel for transtympanic (local) administration, currently advancing through Phase 2 clinical development for the prevention of cisplatin-induced ototoxicity under the PROHEAR study conducted at 15 German university hospitals. A second pipeline candidate, ACOU082, is an orally bioavailable Kv7.4 activator in late preclinical development targeting chronic indications such as age-related hearing loss.

Acousia operates with a lean team of 1–10 employees and an exclusive research collaboration with the Translational Hearing Research Group of Tuebingen University Clinic under Prof. Dr. Hubert Löwenheim. The company is pre-revenue and funds operations through equity capital from a syndicate led by the Boehringer Ingelheim Venture Fund and including Axxam, Bregua, Creathor, KfW, LBBW Venture, and (since January 2024) Esperante Ventures; total disclosed equity raised is approximately $14.6 million across rounds in 2016 and 2018, with the 2024 round amount undisclosed. Its intellectual property position comprises two granted composition-of-matter patents and one pending formulation patent covering the sustained-release gel.

The company's go-to-market model is enterprise-style partnering rather than direct commercialization: it conducts clinical trials at major German university hospitals, engages key opinion leaders in otolaryngology, and targets late-stage development and commercialization partnerships with larger pharmaceutical companies. Pricing is not disclosed because no product is approved; revenue mechanics are expected to derive from either future direct sales or, more likely, licensing/out-licensing economics following Phase 3 and regulatory approval. Target end-user segments include cancer patients receiving ototoxic chemotherapy, patients with age-related hearing loss, noise-induced hearing loss, sudden sensorineural hearing loss, and hearing-aid or cochlear-implant users seeking adjunctive therapy.

Name

Acousia Therapeutics

Legal name

Acousia Therapeutics GmbH

Website

https://acousia.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Ownership category

akta.pro rank

Product category

Otolaryngology Pharmaceuticals

akta.pro primary industry

Otology & Neurotology (Ear/Hearing/Balance) (HLAKAMAC)

akta.pro secondary industry

Audiology & Hearing Services (ENT-Affiliated) (HLAKAMAI)

Keywords

• Otoprotective therapeutics
• Hearing loss drugs
• Small molecule pharmaceuticals
• Otology biotech
• Kv7.4 channel activators

Headquarters

HQ city

Tübingen

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical-stage biotech company. Revenue model expected to derive from sales of proprietary small molecule drug candidates upon regulatory approval. Target market includes acute hearing loss prevention (cisplatin-induced ototoxicity) and chronic hearing loss treatment (age-related hearing loss, noise-induced hearing loss).

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Acousia Therapeutics develops small molecule drug candidates that activate the Kv7.4 potassium channel in outer hair cells of the cochlea to enhance and preserve natural hearing in patients with sensorineural hearing loss. Its lead program ACOU085 (Bimokalner) is a locally administered otoprotectant in Phase 2 trials for cisplatin-induced hearing loss, and ACOU082 is an oral Kv7.4 activator in late preclinical development for chronic indications such as age-related hearing loss.

Product overview

Acousia Therapeutics develops a pipeline of small molecule drug candidates for the prevention and treatment of sensorineural hearing loss (SNHL). The core products are ACOU085 (Bimokalner), a locally-administered otoprotective agent in Phase 2 clinical development for acute hearing loss conditions like cisplatin-induced ototoxicity, and ACOU082, an orally-administered Kv7.4 activator in late preclinical development for chronic hearing loss conditions such as age-related hearing loss. Both candidates employ a unique dual mode of action targeting outer hair cells in the cochlea to enhance and preserve natural hearing.

Differentiator

Problem solved

Functional benefit

Products and services

• ACOU085 (INN: Bimokalner) First-in-class etiology-agnostic otoprotective small molecule that modulates the KCNQ4-encoded Kv7.4 potassium channel in cochlear outer hair cells, delivered locally via transtympanic injection using a proprietary sustained-release gel formulation. Currently in Phase 2 development for cisplatin-induced hearing loss (PROHEAR study) with planned indications including aminoglycoside ototoxicity, CI surgery hearing preservation, and sudden sensorineural hearing loss.
• ACOU082 Proprietary, orally administered small-molecule Kv7.4 activator designed for chronic progressive disorders such as age-related hearing loss, with potential to acutely enhance natural hearing and preserve hearing capacity. Currently in late preclinical stage targeting age-related hearing loss, broader chronic hearing loss, hearing aid synergistic enhancement, and chronic noise overexposure.

Quantifiable outcome

• More than 90% of participants developed ototoxicity after three cisplatin cycles; ACOU085-treated patients showed clinically meaningful prevention of pure-tone audiometry threshold increases compared to placebo
• +2 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and supporting.

• UKT Translational Hearing Research Group of Tuebingen UniversitycoreStrategic or Co-development PartnerExclusive collaboration agreement with the renowned Translational Hearing Research Group of Tuebingen University Clinic. This partnership provides exclusive access to best-in-class hearing research capabilities for preclinical and clinical development of Acousia's drug candidates. Prof. Dr. Hubert Löwenheim serves as Chair and Medical Director of OHNS University Clinic Tuebingen and Principal Investigator of the research group.
• Hearing Loss Association of America (HLAA)supportingStrategic or Co-development PartnerPartnership with the Hearing Loss Association of America, a leading patient advocacy organization providing support and resources for people with hearing loss.
• Royal National Institute for Deaf People (RNID, UK)supportingStrategic or Co-development PartnerCollaboration with RNID, a UK-based charity providing support for people with hearing loss. Acousia presented at the 2023 Hearing Therapeutics Summit organized in partnership with RNID, University College London Ear Institute, and National Institute for Health and Care Research.
• Stiftung Tinnitus und Hören Charité (Germany)supportingStrategic or Co-development PartnerPartnership with Stiftung Tinnitus und Hören Charité, a German foundation focused on tinnitus and hearing research based at Charité university hospital in Berlin.
• German Society of Otorhinolaryngology (DSZ-HNO)supportingStrategic or Co-development PartnerThe PROHEAR Study was formally endorsed by the Study Group of the German Society of Otorhinolaryngology (DSZ-HNO). The study is conducted at major university clinics across Germany under regulatory supervision.
• German Society of Urology (DGU)supportingStrategic or Co-development PartnerThe German Society of Urology highlighted Acousia's PROHEAR Study as 'Study of the Month,' acknowledging the urgent need for effective prevention of cisplatin-induced hearing loss in testicular cancer treatment.

Scale indicators7 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Sensorion: French clinical-stage biotech developing small-molecule therapies for hearing loss disorders including sudden SNHL and other inner ear conditions. Closely comparable to Acousia in therapeutic focus (SNHL pharma) and stage (Phase 2).
• Decibel Therapeutics: Clinical-stage biotech developing gene therapies for hearing and balance disorders, acquired by Eli Lilly in 2023. Directly comparable to Acousia in pursuing therapeutics that target the inner ear for hearing loss.
• Otonomy: Clinical-stage biotech specializing in otic (ear) therapeutics for hearing loss and balance disorders, with a portfolio of locally-delivered ear drugs. Comparable to Acousia in therapeutic area and specialty ear drug delivery focus.
• Frequency Therapeutics: Previously a clinical-stage biotech developing small-molecule regenerative therapies (FX-322) for sensorineural hearing loss. Highly comparable to Acousia as a prior direct competitor in SNHL small-molecule drug development.
• Sound Pharmaceuticals: Clinical-stage biotech developing oral small-molecule therapeutics such as SPI-1005 for noise-induced and ototoxicity-related hearing loss. Comparable to Acousia in small-molecule modality and overlapping SNHL indications.
• AudioCure Pharma: Clinical-stage German biotech developing small-molecule therapeutics for acute and chronic inner ear disorders. Directly comparable to Acousia in geography, therapeutic focus, and small-molecule drug development approach.
• Rinri Therapeutics: UK clinical-stage biotech developing cell-based therapies for hearing loss, including auditory neuropathy. Comparable to Acousia as a Europe-based emerging player in SNHL therapeutics with a differentiated modality.

Broad incumbents

• Eli Lilly: Major global pharmaceutical company that acquired Decibel Therapeutics in 2023, signaling strategic commitment to hearing therapeutics. Broad incumbent with the resources to develop and commercialize SNHL treatments globally.
• Boehringer Ingelheim: Major global pharmaceutical company whose venture arm (BIVF) is the lead investor in Acousia Therapeutics. Broad incumbent with a direct strategic interest in Acousia's success and potential to be a future acquirer of the company.
• Novartis: Major global pharmaceutical company with historical programs and partnerships in hearing therapeutics. Broad incumbent that could compete with or partner with Acousia in the SNHL therapeutics space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/acousia-therapeutics-gmbh

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds4 records

Investors7 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Acousia Therapeutics