[{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"ALK","pharmaFlowCategory":"D","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"DENMARK","productType":"Small molecule","year":"2020","type":"Agreement","leadProduct":"Ciprofloxacin","moa":"DNA gyrase","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"","sponsorNew":"Otonomy \/ Otonomy","highestDevelopmentStatusID":"12","companyTruncated":"Otonomy \/ Otonomy"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Gacyclidine","moa":"NMDA receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"KYORIN PHARMACEUTICAL CO LTD","pharmaFlowCategory":"D","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"JAPAN","productType":"Small molecule","year":"2020","type":"Licensing Agreement","leadProduct":"OTO-6XX","moa":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Preclinical","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"","sponsorNew":"Otonomy \/ Otonomy","highestDevelopmentStatusID":"4","companyTruncated":"Otonomy \/ Otonomy"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Undisclosed","year":"2020","type":"Not Applicable","leadProduct":"Brain-Derived Neurotrophic Factor","moa":"BDNF","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Gacyclidine","moa":"NMDA","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Dexamethasone","moa":"Glucocorticoid receptor","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph III","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"10","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"ALK","pharmaFlowCategory":"D","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Acquisition","leadProduct":"Ciprofloxacin","moa":"DNA gyrase","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Approved","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Otic Suspension","sponsorNew":"Otonomy \/ ALK","highestDevelopmentStatusID":"12","companyTruncated":"Otonomy \/ ALK"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Undisclosed","year":"2021","type":"Not Applicable","leadProduct":"Brain-Derived Neurotrophic Factor","moa":"BDNF","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Gacyclidine","moa":"NMDA","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Large molecule","year":"2022","type":"Not Applicable","leadProduct":"Brain-Derived Neurotrophic Factor","moa":"BDNF","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Intratympanic Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Genetic Disease","country":"U.S.A","productType":"Cell and Gene therapy","year":"2022","type":"Not Applicable","leadProduct":"OTO-825","moa":"","graph1":"Genetic Disease","graph2":"Preclinical","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Preclinical","therapeuticAreaShortName":"Genetic Disease","amount2New":0,"dosageForm":"","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"4","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Small molecule","year":"2022","type":"Not Applicable","leadProduct":"Gacyclidine","moa":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Otonomy \/ Not Applicable"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"U.S.A","productType":"Cell and Gene therapy","year":"2022","type":"Not Applicable","leadProduct":"OTO-413","moa":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase I\/ Phase II","graph3":"Otonomy","amount2":0,"highestDevelopmentShortName":"Ph I\/II","therapeuticAreaShortName":"Otolaryngology","amount2New":0,"dosageForm":"Injectable\/Injection","sponsorNew":"Otonomy \/ Not Applicable","highestDevelopmentStatusID":"7","companyTruncated":"Otonomy \/ Not Applicable"}]

Find Clinical Drug Pipeline Developments & Deals by Otonomy

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                          Therapeutic Area by Lead Product

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                          01

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : 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.

                          Brand Name : OTO-413

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          October 13, 2022

                          Lead Product(s) : OTO-413

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          02

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : OTO-313 did show a higher response rate than placebo in a prospectively defined patient subgroup with tinnitus duration of less than 6 months (population studied in Phase 1/2 trial), the overall results do not support further development of OTO-313.

                          Brand Name : OTO-313

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          August 01, 2022

                          Lead Product(s) : Gacyclidine

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          03

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : OTO-825, is an AAV-mediated gene therapy targeting the gap junction beta-2 (GJB2) administration rescues hearing and cochlear damage in two preclinical models of congenital hearing loss caused by GJB2 deficiency.

                          Brand Name : OTO-825

                          Molecule Type : Cell and Gene therapy

                          Upfront Cash : Not Applicable

                          May 12, 2022

                          Lead Product(s) : OTO-825

                          Therapeutic Area : Genetic Disease

                          Highest Development Status : Preclinical

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : 40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.

                          Brand Name : OTO-413

                          Molecule Type : Large molecule

                          Upfront Cash : Not Applicable

                          April 20, 2022

                          Lead Product(s) : Brain-Derived Neurotrophic Factor

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Patients were randomized 1:1 to a single intratympanic injection of OTO-313 or placebo and are being followed for 4 months in Phase 2 trial. OTO-313, a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine for tr...

                          Brand Name : OTO-313

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 22, 2022

                          Lead Product(s) : Gacyclidine

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.

                          Brand Name : OTO-413

                          Molecule Type : Undisclosed

                          Upfront Cash : Not Applicable

                          June 15, 2021

                          Lead Product(s) : Brain-Derived Neurotrophic Factor

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase I/ Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : OTIPRIO is a sterile, preservative-free, otic suspension of 6 percent ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

                          Brand Name : Otiprio

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          June 03, 2021

                          Lead Product(s) : Ciprofloxacin

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Approved

                          Sponsor : ALK

                          Deal Size : Undisclosed

                          Deal Type : Acquisition

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                          08

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : Results demonstrate that a single administration of OTO-825 rescues hearing loss and cochlear damage in two preclinical models that represent a range of hearing loss severity caused by GJB2 deficiency.

                          Brand Name : Otividex

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          May 14, 2021

                          Lead Product(s) : Dexamethasone

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          09

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : OTO-313 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate receptor antagonist gacyclidine. Phase 2 study design based on successful Phase 1/2 trial including use of Tinnitus Functional Index responder analysis for prima...

                          Brand Name : OTO-313

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          March 25, 2021

                          Lead Product(s) : Gacyclidine

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          10

                          Pharma, Lab & Chemical Expo
                          Not Confirmed
                          Pharma, Lab & Chemical Expo
                          Not Confirmed

                          Details : The Phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease did not achieve the primary endpoint, which was the count of definitive vertigo days in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat population using the Negative B...

                          Brand Name : Otividex

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 22, 2021

                          Lead Product(s) : Dexamethasone

                          Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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