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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Shilpa Medicare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Shilpa Medicare Receives UKMHRA Approval for Mouth-dissolving Strips to Treat Illnesses","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase IV","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Decibel Therapeutics","sponsor":"Regeneron Pharmaceuticals","pharmaFlowCategory":"D","amount":"$213.0 million","upfrontCash":"$213.0 million","newsHeadline":"Regeneron Completes Acquisition of Decibel Therapeutics, Adding Promising Gene Therapy Programs for Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase II"},{"orgOrder":0,"company":"MeiraGTx","sponsor":"Sanofi","pharmaFlowCategory":"D","amount":"$30.0 million","upfrontCash":"Undisclosed","newsHeadline":"MeiraGTx Announces $30 Million Strategic Investment from Sanofi; Company Pursuing Multiple Additional Strategic Opportunities","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Phase II"},{"orgOrder":0,"company":"Regeneron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Regeneron Shares Preliminary Results Showing Gene Therapy Improves Auditory Responses in Child with Profound Genetic Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2023","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase II"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Petrichor","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"Undisclosed","newsHeadline":"Fennec Announces Incremental $5 Million Investment from Petrichor","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Sensorion","sponsor":"Institut Pasteur","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sensorion Announces Partnership with the Institut Pasteur to Accelerate Gene Therapy Programs Targeting Hearing Disorders has been Extended for Five Years","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"IND Enabling"},{"orgOrder":0,"company":"Cyrano Therapeutics","sponsor":"DeepWork Capital","pharmaFlowCategory":"D","amount":"$9.0 million","upfrontCash":"Undisclosed","newsHeadline":"Cyrano Therapeutics Secures $9.0 Million Series B Financing to Advance Clinical Development of CYR-064 for Treatment of Post-Viral Smell Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sensorion","sponsor":"Redmile Group","pharmaFlowCategory":"D","amount":"$54.4 million","upfrontCash":"Undisclosed","newsHeadline":"Sensorion Announces a \u20ac50.5 Million Financing With Participation From New and Existing US and European Healthcare Specialist Investors","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase I"},{"orgOrder":0,"company":"SaNOtize","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SaNOtize to Evaluate Nitric Oxide Nasal Spray for the Treatment of Sinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Norgine","pharmaFlowCategory":"D","amount":"$271.6 million","upfrontCash":"$43.4 million","newsHeadline":"Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Provides an Update on NOTOXIS, its Proof of Concept Phase 2a Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity (CIO)","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces Approval to Initiate Lead Gene Therapy Candidate SENS-501 (OTOF-GT) into a Phase 1\/2 Clinical Trial in some European Countries","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase I"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces the Completion of Patient Inclusion in Phase 2a Clinical Trial of SENS-401 for Residual Hearing Preservation After Cochlear Implantation","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces it Has Met Primary Endpoint for SENS-401 Phase 2a Clinical Study for Residual Hearing Preservation","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Eisai","sponsor":"Kaken Pharmaceuticals","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"Eisai to Divest Rights for Merislon and Myonal in Japan to Kaken Pharmaceutical","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase IV","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase IV"},{"orgOrder":0,"company":"Optinose","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Optinose Announces 3-Month Extension of FDA Review Period for the Supplemental New Drug Application for XHANCE","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Preclinical"},{"orgOrder":0,"company":"AudioCure Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sudden Hearing Loss: AudioCure's Novel Compound AC102 Restores Hearing in Preclinical Models, Published in PNAS","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II\/ Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sensorion","sponsor":"Redmile Group","pharmaFlowCategory":"D","amount":"$16.2 million","upfrontCash":"Undisclosed","newsHeadline":"Sensorion Announces a \u20ac15 Million Financing, Extending Cash Runway Until the End of 2025","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase I"},{"orgOrder":0,"company":"Regeneron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness within 24 Weeks and Initial Hearing Improvements in a Second Child at 6 Weeks","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Phase II"},{"orgOrder":0,"company":"Novasep","sponsor":"Sensorion","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sensorion and Novasep Sign Agreement","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"IND Enabling","country":"GERMANY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"IND Enabling"},{"orgOrder":0,"company":"Delix Therapeutics","sponsor":"U.S. Department of Defense","pharmaFlowCategory":"D","amount":"$0.8 million","upfrontCash":"Undisclosed","newsHeadline":"Delix Therapeutics Awarded Grant from the U.S. Department of Defense to Advance Neuroplastogen for Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Approved"},{"orgOrder":0,"company":"Cilcare","sponsor":"Shionogi","pharmaFlowCategory":"D","amount":"$16.0 million","upfrontCash":"$16.0 million","newsHeadline":"Japan's Shionogi Inks \u20ac400 M Deal with French Firm Cilcare","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharmaceuticals\u2019 IND Involving Cochlear Implantation Allowed by the FDA","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Phase I"}]

Find Clinical Drug Pipelines for Otolaryngology (Ear, Nose, Throat)

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            Details:

            The agreement aims for the manufacturing of adeno-associated virus (AAV) vectors, covering the gene therapy program targeting OTOF (OTOF-GT), the gene encoding the otoferlin protein and aims to restore the expression of Otoferlin.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTOF-GT

            Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Sensorion

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 11, 2020

            Axplora Novasep

            BIO Asia-Taiwan

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            envelop Contact Supplier

            Details:

            Through the agreement with Cilcare to acquire the exclusive license to develop, manufacture, and commercialize CIL001 for the treatment of patients with hearing loss.

            Lead Product(s): CIL001

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: CIL001

            Highest Development Status: Phase I/ Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Shionogi

            Deal Size: $16.0 million Upfront Cash: $16.0 million

            Deal Type: Agreement June 10, 2024

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            The financing will support the advancement of a neuroplastogen, a novel, first-in-class, non-toxic, that has been found to repair cochlear synaptopathy that contribute to hidden hearing loss.

            Lead Product(s): Neuroplastogen

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

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: U.S. Department of Defense

            Deal Size: $0.8 million Upfront Cash: Undisclosed

            Deal Type: Funding June 04, 2024

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            SPI-1005 (ebselen) is a novel anti-inflammatory Glutathione Peroxidase mimetic, an enzyme critical to hearing and balance. It is being tested for residual hearing loss reduction during and after CI.

            Lead Product(s): Ebselen

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SPI-1005

            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 20, 2024

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            DB-OTO is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by variants of the otoferlin gene.

            Lead Product(s): DB-OTO

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

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 08, 2024

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            The financing aims to fund the clinical development of SENS-501 (OTOF-GT) small molecule programs for the treatment and prevention of hearing loss disorders.

            Lead Product(s): OTOF-GT

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-501

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Redmile Group

            Deal Size: $16.2 million Upfront Cash: Undisclosed

            Deal Type: Financing April 08, 2024

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            AC102 targets the two suspected main causes of sudden hearing loss in the inner ear: It prevents the death of outer hair sensory cells and protects the connections between neurons and the auditory nerve. It is being evaluated for sensorineural hearing loss.

            Lead Product(s): AC102

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AC102

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 01, 2024

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            Eisai divested its rights for vertigo and equilibrium disturbance treatment Merislon (betahistine mesilate), used to treat Meniere's syndrome, and muscle relaxant Myonal (eperisone hydrochloride) in Japan to Kaken.

            Lead Product(s): Betahistine Dimesilate

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

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Kaken Pharmaceuticals

            Deal Size: $25.0 million Upfront Cash: Undisclosed

            Deal Type: Divestment March 29, 2024

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            Ciprofloxacin and dexamethasone otic suspension is a combination product which is indicated for the treatment of Acute Otitis Externa in pediatric (age 6 months and older), adult & elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.

            Lead Product(s): Ciprofloxacin,Dexamethasone

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Ciprodex-Generic

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 25, 2024

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            Norgine will commercialize Pedmarqsi (sodium thiosulfate) in Europe, Australia and New Zealand. Pedmarqsi is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity induced by cisplatin chemotherapy in patients with localized, non-metastatic solid tumors.

            Lead Product(s): Sodium Thiosulfate

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

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Norgine

            Deal Size: $271.6 million Upfront Cash: $43.4 million

            Deal Type: Licensing Agreement March 18, 2024

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