[{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","country":"","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":"","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":"","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":"","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"}]

Find Clinical Drug Pipeline Developments & Deals for Gacyclidine

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                          01

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          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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                          02

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          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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                          03

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          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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                          04

                          CPhI India 2024
                          Not Confirmed
                          CPhI India 2024
                          Not Confirmed

                          Details : The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile.

                          Brand Name : OTO-313

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          July 06, 2020

                          Lead Product(s) : Gacyclidine

                          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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