Latest news with #HearingLossPipelineReport
Globe and Mail
31-03-2025
- Health
- Globe and Mail
Hearing Loss Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment by DelveInsight
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Hearing Loss pipeline constitutes 32+ key companies continuously working towards developing 35+ Hearing Loss treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. ' Hearing Loss Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Hearing Loss Market. The Hearing Loss Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details. Some of the key takeaways from the Hearing Loss Pipeline Report: Companies across the globe are diligently working toward developing novel Hearing Loss treatment therapies with a considerable amount of success over the years. Hearing Loss companies working in the treatment market are Acousia Therapeutics, Decibel Therapeutics, Suzhou Pharmaceutical Technology Co.,Ltd, AudioCure Pharma GmbH, Sensorion, and others, are developing therapies for the Hearing Loss treatment Emerging Hearing Loss therapies in the different phases of clinical trials are- ACOU085, Cochlear Hair Cell Regeneration, HY01, AC102, SENS-401, and others are expected to have a significant impact on the Hearing Loss market in the coming years. In February 2025, Sound Pharmaceuticals is excited to share that it will deliver four presentations at the upcoming Association for Research in Otolaryngology MidWinter Meeting. One of the key presentations, titled "The Development of SPI-1005 for the Treatment of Hearing Loss and Tinnitus," will be featured at the Pharmaceutical Interventions for Hearing Loss (PIHL) Satellite Symposium. Organized by the Defense Health Agency (DHA) Hearing Center of Excellence (HCE) committee, this symposium will offer an in-depth review of investigational treatments aimed at preventing hearing loss and promoting hearing restoration. In January 2025, US-based dermatology biopharma Eirion Therapeutics reported positive findings from its first-in-human, double-blind, placebo-controlled study of its topical treatment for age-related hair loss, demonstrating a six-fold increase in hair count over placebo. ET-02, the company's most advanced therapy for androgenic alopecia, was evaluated in a trial involving 24 male patients across three US sites, successfully meeting its primary safety and tolerability endpoints. Additionally, Eirion Therapeutics is advancing a preclinical oral version of ET-02, further expanding its pipeline for hair loss treatments. In August 2024, Pelage Pharmaceuticals, a clinical-stage company specializing in regenerative medicine for hair loss, commenced its Phase 2a clinical trial for PP405, a novel topical small molecule aimed at treating androgenetic alopecia (pattern baldness). The first patients have been dosed, and the study will evaluate the drug's safety and effectiveness. The trial plans to enroll 60 men and women, with PP405 designed to activate dormant hair follicle stem cells, promoting hair growth Hearing Loss Overview Hearing Loss (SNHL) occurs due to damage to inner ear structures or the auditory nerve. It accounts for over 90 percent of hearing impairment in adults. Typical causes of SNHL include prolonged exposure to loud noises, genetic predisposition, or the natural aging process. Emerging Hearing Loss Drugs Under Different Phases of Clinical Development Include: ACOU085: Acousia Therapeutics Cochlear Hair Cell Regeneration: Decibel Therapeutics HY01: Suzhou Pharmaceutical Technology Co.,Ltd AC102: AudioCure Pharma GmbH SENS-401: Sensorion Hearing Loss Route of Administration 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 Intra-articular Intraocular Intrathecal Intravenous Ophthalmic Oral Parenteral Subcutaneous Topical Transdermal Hearing Loss Molecule Type Hearing Loss Products have been categorized under various Molecule types, such as Products have been categorized under various Molecule types such as Oligonucleotide Peptide Small molecule Hearing Loss Pipeline Therapeutics Assessment Hearing Loss Assessment by Product Type Hearing Loss By Stage and Product Type Hearing Loss Assessment by Route of Administration Hearing Loss By Stage and Route of Administration Hearing Loss Assessment by Molecule Type Hearing Loss by Stage and Molecule Type DelveInsight's Hearing Loss Report covers around 35+ products under different phases of clinical development like Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Some of the key companies in the Hearing Loss Therapeutics Market include: Key companies developing therapies for Hearing Loss are - Sensorion, Fennec Pharmaceuticals, Sound Pharmaceuticals, Decibel Therapeutics, Akouos, and others. Hearing Loss Pipeline Analysis: The Hearing Loss pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Hearing Loss with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hearing Loss Treatment. Hearing Loss key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Hearing Loss Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hearing Loss market. The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc. Download Sample PDF Report to know more about Hearing Loss drugs and therapies Hearing Loss Pipeline Market Drivers Rise in the Incidence of Hearing Loss, rising Awareness and Initiatives about Hearing loss are some of the important factors that are fueling the Hearing Loss Market. Hearing Loss Pipeline Market Barriers However, high Cost of treatment, presence of Substitute Products and other factors are creating obstacles in the Hearing Loss Market growth. Scope of Hearing Loss Pipeline Drug Insight Table of Contents 1. Hearing Loss Report Introduction 2. Hearing Loss Executive Summary 3. Hearing Loss Overview 4. Hearing Loss- Analytical Perspective In-depth Commercial Assessment 5. Hearing Loss Pipeline Therapeutics 6. Hearing Loss Late Stage Products (Phase II/III) 7. Hearing Loss Mid Stage Products (Phase II) 8. Hearing Loss Early Stage Products (Phase I) 9. Hearing Loss Preclinical Stage Products 10. Hearing Loss Therapeutics Assessment 11. Hearing Loss Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Hearing Loss Key Companies 14. Hearing Loss Key Products 15. Hearing Loss Unmet Needs 16 . Hearing Loss Market Drivers and Barriers 17. Hearing Loss Future Perspectives and Conclusion 18. Hearing Loss Analyst Views 19. Appendix 20. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Contact Person: Gaurav Bora Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
Globe and Mail
06-02-2025
- Health
- Globe and Mail
Hearing Loss Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight
DelveInsight's, 'Hearing Loss Pipeline Insight' report provides comprehensive insights about 32+ 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. 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. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 9650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: Nevada Country: United States Website:
