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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.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2022
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 treatment of tinnitus.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022
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 primary efficacy endpoint.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2021
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.
Lead Product(s): Gacyclidine
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
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