Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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[{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics to Present at the 43rd Annual Association for Research in Otolaryngology (ARO) Conference","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Publishes Results from Early-Stage Study of Therapy Designed to Prevent Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small 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Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Acousia Therapeutics"},{"orgOrder":0,"company":"Acousia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acousia Therapeutics to Present Its First-in-class Hearing Loss Treatment Program With ACOU085 at the 2nd Inner Ear Therapeutics Summit in Boston","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Acousia Therapeutics"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces Approval in France to Initiate Proof of Concept Clinical Trial of SENS-401 for Residual Hearing Preservation During Cochlear Implantation","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Decibel Therapeutics Reports Positive Data from Interim Analysis of Ongoing Phase 1b Clinical Trial of DB-020 in Patients Receiving Cisplatin Chemotherapy","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Decibel Therapeutics"},{"orgOrder":0,"company":"Acousia Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Hearing Loss Company Acousia Therapeutics to Present Data for Lead Candidates ACOU085 & ACOU082 at ARO 2023 Mid Winter Meeting February 11-15","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Acousia Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Announces First Patient Dosed in Phase 1b Study of FX-345, the Company\u2019s Second Therapeutic Candidate for Sensorineural Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Spiral Therapeutics","sponsor":"Savoir Capital","pharmaFlowCategory":"D","amount":"$8.2 million","upfrontCash":"Undisclosed","newsHeadline":"Spiral Therapeutics Completes $8.25M Financing and Initiates Phase 2 Trial in Meniere's Disease","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Spiral Therapeutics"}]

Find Drugs for Otolaryngology (Ear, Nose, Throat) in Phase I Clinical Development

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            Details:

            SPT-2101 is a sustained-release steroid formulation designed for precise inner ear administration using Spiral's novel delivery procedure. Spiral recently completed enrollment of an open label pilot clinical study of SPT-2101 in 10 patients with Meniere's disease.

            Lead Product(s): SPT-2101

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPT-2101

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Savoir Capital

            Deal Size: $8.2 million Upfront Cash: Undisclosed

            Deal Type: Financing January 10, 2023

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            FX-345 is a combination of two small molecules and, similar to Frequency’s lead hearing candidate FX-322, is designed to restore inner ear cells needed for hearing.

            Lead Product(s): FX-345

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-345

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2022

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            ACOU085 is a proprietary small molecule, etiology-agnostic otoprotective drug candidate, expected to finish a first-in-man clinical Phase 1b study by late 2022 using standard transtympanic administration of a slow-release gel formulation.

            Lead Product(s): ACOU085

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: ACOU085

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 24, 2022

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            87% of patients who experienced ototoxicity in their placebo-treated ear were protected from ototoxicity in their DB-020, a novel, proprietary formulation of sodium thiosulfate treated ear.

            Lead Product(s): Sodium Thiosulfate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-020

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 28, 2022

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            SENS-401 (R-azasetron Besylate) is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment.

            Lead Product(s): R-Azasetron Besylate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-401

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 07, 2022

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            ACOU085 is a proprietary, first-in-class, small-molecule otoprotective drug candidate, which is currently being tested in a Phase 1b clinical trial involving age-related hearing loss (ARHL) patients.

            Lead Product(s): ACOU085

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: ACOU085

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2022

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            ACOU085 is a proprietary small-molecule, otoprotective drug candidate that modulates a well-defined molecular target preferentially expressed in the sensory cells of the inner ear, the so-called outer hair cells (OHC).

            Lead Product(s): ACOU085

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: ACOU085

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 05, 2022

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            Boehringer Ingelheim will not be exercising its Option under the Option for Asset Purchase Agreement which was signed by the two companies in December 2017. Autifony has regained full rights to its Kv3 programme.

            Lead Product(s): AUT00206

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AUT00206

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Boehringer Ingelheim GmbH

            Deal Size: $50.1 million Upfront Cash: $29.5 million

            Deal Type: Termination August 26, 2020

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            Details:

            The Phase 1a trial showed that DB-020 was safe and well-tolerated in healthy volunteers and confirmed that administration of DB-020.

            Lead Product(s): Sodium Thiosulfate

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 26, 2020

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            These developments demonstrate the strength of Decibel's unique approach and will continue to enable our efforts in restoration and regenerative medicine approaches to the inner ear.

            Lead Product(s): DB-020

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 24, 2020

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