Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus
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...
Product Name : OTO-313
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 22, 2022
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otonomy Reports Results from Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus
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.
Product Name : OTO-313
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 08, 2022
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus
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...
Product Name : OTO-313
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 25, 2021
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : OTO-313
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 07, 2020
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable