Hearing Loss Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight
Stay ahead with the latest insights! Download DelveInsight's comprehensive Hearing Loss Pipeline Report to explore emerging therapies, key Hearing Loss Companies, and future Hearing Loss treatment landscapes @ Hearing Loss Pipeline Outlook Report
Key Takeaways from the Hearing Loss Pipeline Report
In January 2025:- AudioCure Pharma GmbH- The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
In January 2025:- Laboratoires Thea:- The purpose of this 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.
In January 2025:- Akouos Inc.:- This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
DelveInsight's Hearing Loss pipeline report depicts a robust space with 32+ 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, andothers.
Discover how the Hearing Loss treatment paradigm is evolving. Access DelveInsight's in-depth Hearing Loss Pipeline Analysis for a closer look at promising breakthroughs @ Hearing Loss Clinical Trials and Studies
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.
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
Which companies are leading the race in Hearing Loss drug development? 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
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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Mid Stage Products (Phase II) Lurbinectedin: PharmaMar Drug profiles in the detailed report….. Early Stage Products (Phase I) XL 092: Exelixis Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug name : Company name Inactive Products Metastatic Urothelial Carcinoma Key Companies Metastatic Urothelial Carcinoma Key Products Metastatic Urothelial Carcinoma- Unmet Needs Metastatic Urothelial Carcinoma- Market Drivers and Barriers Metastatic Urothelial Carcinoma- Future Perspectives and Conclusion Metastatic Urothelial Carcinoma Analyst Views Metastatic Urothelial Carcinoma Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. 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