Hearing Loss Clinical Trial Pipeline Shows Potential with Active Contributions from 30+ Key Companies | DelveInsight
DelveInsight’s, “Hearing Loss Pipeline Insight 2026” report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Hearing Loss pipeline landscape. It covers the Hearing Loss pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hearing Loss therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the Hearing Loss Pipeline Report
- On March 30, 2026- Laboratoires Thea initiated a Phase 2b study is to evaluate the safety and tolerability of ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene. This is a multicenter Double-masked, Randomized, Sham-controlled study which will enroll 81 subjects.
- On March 18, 2026- Regeneron Pharmaceuticals announced a Phase 1/2 study will evaluate REGN5093 for the treatment of Non-Small Cell Lung Cancer (NSCLC) with MET alteration. The main purpose of this study is to determine the safety, tolerability, and effectiveness of REGN5093.
- DelveInsight’s Hearing Loss pipeline report depicts a robust space with 30+ active players working to develop 35+ pipeline therapies for Hearing Loss treatment.
- The leading Hearing Loss Companies such as Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others.
- Promising Hearing Loss Therapies such as AM-111, FX-322, AUT00063, FX-322 (One Dose), AC102 Gel, Prednisolone, OTO-413, and others.
Access DelveInsight’s in-depth Hearing Loss Pipeline Analysis for a closer look at promising breakthroughs @ Hearing Loss Clinical Trials and Studies
Hearing Loss Overview
Hearing loss refers to a partial or total inability to hear, which can be present at birth or develop later in life. It can affect one or both ears and is categorized into three main types: conductive hearing loss, caused by issues in the outer or middle ear; sensorineural hearing loss, stemming from damage to the inner ear or auditory nerve; and mixed hearing loss, which involves both conductive and sensorineural components. Hearing loss can manifest through various signs and symptoms, often developing gradually and becoming noticeable over time. Common indicators include difficulty hearing conversations, especially in noisy environments, frequently asking others to repeat themselves, and needing to increase the volume on devices like televisions or radios compared to others. Individuals may also experience muffled sounds, misunderstandings during conversations, and fatigue from concentrating on listening.
Hearing Loss Emerging Drugs Profile
- SENS-401: Sensorion
SENS-401 (Arazasetron), Sensorion’s clinical stage lead drug candidate, is an orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment. Sensorion is currently developing SENS-401 in a Phase IIa clinical trial for the prevention of residual hearing loss in patients scheduled for cochlear implantation, and in a Phase II clinical trial for the prevention of Cisplatin-Induced Ototoxicity. SENS-401 has been granted Orphan Drug Designation by the EMA in Europe for the treatment of sudden sensorineural hearing loss, and by the FDA in the US for the prevention of platinum-induced ototoxicity in pediatric population. It is currently being evaluated in Phase II/III stage of development.
- ACOU085: Acousia Therapeutics
ACOU085 is a proprietary small-molecule drug candidate under clinical development, with a particular focus on its use as an etiology-agnostic otoprotectant for patients with acute forms of sensorineural hearing loss. The company has successful completed Phase Ib study, following the final visit of the last patient treated with the highest ACOU085 dose. The next step is a clinical Phase II study using ACOU085 to protect the inner ears of testicular cancer patients undergoing chemotherapy from cisplatin-induced ototoxicity. It will be initiated in early 2023.
- OTO-413: Otonomy Inc.
OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair. Nonclinical studies have demonstrated that local administration of BDNF repairs the connections between inner hair cells and auditory nerve fibers in the cochlea that are damaged due to noise trauma or exposure to ototoxic chemicals. Furthermore, Otonomy has demonstrated in preclinical studies that repair of synaptic connections is associated with a restoration of hearing function. Initial clinical studies have demonstrated that a single intratympanic injection of OTO-413 is well-tolerated and improves hearing function across multiple clinically validated speech-in-noise hearing tests. Currently, the drug is being evaluated in the Phase I/II stage of development.
- DB-020: Decibel Therapeutics
DB-020 is a proprietary formulation of sodium thiosulfate (STS) optimized for local delivery to the ear and is being investigated for its potential to protect against cisplatin-induced hearing loss without impacting the beneficial effect of cisplatin. DB-020 is designed to achieve high cochlear concentrations of STS following a local injection through the ear drum, or transtympanically, into the middle ear. Transtympanic injection is a brief, minimally invasive, routine, office-based procedure performed by ENTs and is generally well-tolerated. A randomized, double-blind, placebo-controlled Phase I clinical trial of DB-020 in normal healthy volunteers was completed in 2019. A randomized, double-blind, placebo-controlled, multicenter Phase Ib clinical trial of DB-020 in patients undergoing treatment with cisplatin is ongoing. DB-020 has been granted Fast Track designation by the US Food and Drug Administration (FDA). DB-020 is an investigational therapy for the prevention of cisplatin-induced hearing loss, a serious and debilitating condition for which there are no currently approved therapies. Currently, the drug is in the Phase I stage of development.
Get a detailed analysis of the latest innovations in the Hearing Loss pipeline @ Hearing Loss Unmet Needs
Hearing Loss Companies
Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others.
Hearing Loss pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Hearing Loss Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
Download DelveInsight’s latest report to gain strategic insights into upcoming therapies and key developments @ Hearing Loss Market Drivers and Barriers, and Future Perspectives
Scope of the Hearing Loss Pipeline Report
- Coverage- Global
- Hearing Loss Companies- Acousia Therapeutics, Decibel Therapeutics, Otonomy Inc., Sensorion, Autifony Therapeutics, Auris Medical, Sound Pharmaceuticals, Anida Pharma Inc., Gateway Biotechnology, Myrtelle Inc., Lineage Cell Therapeutics, Inc., Altamira Therapeutics, Hoba Therapeutics, Rinri Therapeutics, Autifony Therapeutics, Otologic Pharmaceutics, Audion Therapeutics, Perha Pharmaceuticals, Applied Genetic Technologies Corporation, Akouos, Inc., Oricula Therapeutics, Spiral Therapeutics, Pipeline Therapeutics, Prime Medicine, Boehringer Ingelheim, Autigen, Heyu (Suzhou) Pharmaceutical Technology Co., Ltd, Astellas Pharma, Mogrify Limited and others.
- Hearing Loss Therapies- AM-111, FX-322, AUT00063, FX-322 (One Dose), AC102 Gel, Prednisolone, OTO-413, andothers.
- Hearing Loss Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Hearing Loss Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Find out in DelveInsight’s exclusive Hearing Loss Pipeline Report—access it now! @ Hearing Loss Emerging Drugs and Major Companies
Table of Content
- Introduction
- Executive Summary
- Hearing Loss: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Hearing Loss– DelveInsight’s Analytical Perspective
- Mid Stage Products (Phase II/III)
- SENS-401: Sensorion
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I/II)
- OTO-413: Otonomy Inc.
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- ACOU085: Acousia Therapeutics
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Research programme: Hearing Loss: Autifony Therapeutics
- Drug profiles in the detailed report…..
- Inactive Products
- Hearing Loss- Unmet Needs
- Hearing Loss- Market Drivers and Barriers
- Appendix
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