Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : OTO-413
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
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
Lead Product(s) : OTO-825
Therapeutic Area : Genetic Disease
Study Phase : Preclinical
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Otonomy Announces OTO-825 Presentation at the American Society of Gene & Cell Therapy Annual Meeting
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
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
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
Lead Product(s) : Brain-Derived Neurotrophic Factor
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Otonomy Initiates Expansion of Phase 1/2 Clinical Trial for OTO-413 in Hearing Loss
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
Lead Product(s) : Ciprofloxacin
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Approved
Sponsor : ALK
Deal Size : Undisclosed
Deal Type : Acquisition
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
Lead Product(s) : Dexamethasone
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Otonomy Eyes Clinical Trial of Hearing Loss Gene Therapy
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
Lead Product(s) : Gacyclidine
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
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
Lead Product(s) : Dexamethasone
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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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