X
[{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics Announces FDA Clearance of Investigational New Drug Application for a Phase 2 Clinical Trial of LYR-210 for Chronic Rhinosinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Presents New SENS-401 Preclinical Data at ARO Midwinter Meeting 2020","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Receives Ethics Committee Approval to Include New Military Sites in SENS-401 Phase 2 study","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion gets approval to add new sites to Phase II trial of SENS-401","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$58.0 million","upfrontCash":"Undisclosed","newsHeadline":"Lyra Therapeutics wants a $58M IPO\n","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Novus Therapeutics, Inc","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novus Therapeutics Completes Enrollment of Phase 2a Trial of OP0201 in Pediatric Patients with Acute Otitis Media","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Novus Therapeutics, Inc"},{"orgOrder":0,"company":"Auditus","sponsor":"Oblato","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Oblato Biotech Company Acquires Hearing Loss Drug","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Auditus"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Shares Clinical Data From Exploratory Study Confirming Delivery of FX-322 to the Cochlea","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Novus Therapeutics, Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novus Therapeutics Announces Topline Results of Phase 2a Clinical Trial of OP0201 in Acute Otitis Media","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Novus Therapeutics, Inc"},{"orgOrder":0,"company":"Altamira Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Auris Medical Announces Completion of Enrollment into First Part of TRAVERS Phase 2 Study with AM-125 in Vertigo","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Altamira Therapeutics"},{"orgOrder":0,"company":"AnaptysBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AnaptysBio's Etokimab Provides More Disappointing Results, Raising Questions About Compound's Future","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"AnaptysBio"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics to Present Data Supporting LYR-210 for the Treatment of Chronic Rhinosinusitis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Altamira Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Auris Medical Announces Positive Interim Data from TRAVERS Phase 2 Study with AM-125 in Vertigo","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Altamira Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Presents Results Demonstrating Sustained Improvement in Hearing Loss Patients Treated with FX-322","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Completes Enrollment of FX-322 Phase 2a Study for Sensorineural Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Altamira Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Altamira Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Cyrano Therapeutics","sponsor":"Remiges Ventures","pharmaFlowCategory":"D","amount":"$12.8 million","upfrontCash":"Undisclosed","newsHeadline":"Cyrano Therapeutics Raises $12.8 Million to Complete Phase 2 Trial of CYR-064 for the Restoration of Chronic Smell and Flavor Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Undisclosed","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Undisclosed","graph2":"Cyrano Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Published Data from Phase 1\/2 Clinical Trial in Acquired Sensorineural Hearing Loss Patients Receiving FX-322","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Releases New Data from Two FX-322 Clinical Studies; Plans to Advance Single-Dose Regimen","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Initiates Phase 2 Clinical Trial of OTO-313 in Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics to Present LANTERN Phase 2 Study Results for LYR\u2011210 in Oral Presentation at COSM 2021 Virtual","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics Presents Positive Full Data Set from LANTERN Phase 2 Study of LYR-210 at COSM 2021 Virtual","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Altamira Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Auris Medical Reaches Midpoint for Enrollment in Part B of AM-125 Phase 2 TRAVERS Trial in Acute Peripheral Vertigo","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Altamira Therapeutics"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"LianBio","pharmaFlowCategory":"D","amount":"$147.0 million","upfrontCash":"$12.0 million","newsHeadline":"Lyra Therapeutics and LianBio Announce Strategic Partnership and Exclusive License Agreement for LYR-210","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics to Highlight LYR-210 and LYR-220 Clinical Programs at Virtual Event with Leading Clinical CRS Experts","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Virtual R&D Event to Detail FX-322 Clinical Advances, a New Program for Hearing Restoration and In Vivo Data from its MS Remyelination Program","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Announces First Subject Dosed in FX-322 Phase 2b Acquired Sensorineural Hearing Loss (SNHL) Study and FDA Agreement on Speech Perception as Primary Endpoint","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Holds Virtual R&D Event Highlighting Clinical Advancement of FX-322, a New Potential Restorative Treatment for Hearing Loss and In Vivo Data for Its Remyelination Program in Multiple Sclerosis","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Shares Results from FX-322-113 Severe Sensorineural Hearing Loss Study Showing Speech Perception Improvements in Noise","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Completes Enrollment in Phase 2 Clinical Trial of OTO-313 in Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Lyra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lyra Therapeutics Announces First Patient Treated in Phase 2 BEACON Clinical Trial of LYR-220 in Post-Surgical Chronic Rhinosinusitis Patients","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Lyra Therapeutics"},{"orgOrder":0,"company":"Otonomy","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Otonomy Reports Results from Phase 2 Clinical Trial of OTO-313 in Patients with Tinnitus","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Otonomy"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces First Patient Enrolled in Proof-of-Concept Clinical Trial of SENS-401 for Residual Hearing Preservation During Cochlear Implantation","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"},{"orgOrder":0,"company":"Frequency Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of Sensorineural Hearing Loss","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Frequency Therapeutics"},{"orgOrder":0,"company":"Sensorion","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sensorion Announces First Patient Enrolled in Phase 2a Proof of Concept Clinical Trial of SENS-401 in Cisplatin-Induced Ototoxicity","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase II","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Sensorion"}]
Find Drugs for Otolaryngology (Ear, Nose, Throat) in Phase II Clinical Development
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SENS-401 (R-azasetron besylate), is a 5-HT3 receptor antagonist and calcineurin inhibitor, orally available small molecule that aims to protect and preserve inner ear tissue from damage responsible of progressive or sequelae hearing impairment.
Lead Product(s):
R-Azasetron Besylate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-401
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableJanuary 03, 2023
Details:
FX-322, is a small-molecule combination product candidate that is the first to show statistically significant and clinically meaningful hearing improvements in clinical trials for sensorineural hearing loss.
Lead Product(s):
FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableOctober 12, 2022
Details:
SENS-401 (Arazasetron) is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelae hearing impairment.
Lead Product(s):
R-Azasetron Besylate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: SENS-401
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableSeptember 14, 2022
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 II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableAugust 01, 2022
Details:
LYR-220, an investigational product candidate that utilizes Lyra's proprietary XTreo™ platform to enable six months of single treatment for chronic rhinosinusitis in patients with post-surgical anatomy.
Lead Product(s):
Mometasone Furoate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: LYR-220
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableApril 25, 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 II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableFebruary 22, 2022
Details:
FX-322 lead hearing restoration product candidate showed improvement by four subjects in a sentence-in-noise test is designed to regenerate auditory hair cells to restore hearing function.
Lead Product(s):
FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableDecember 09, 2021
Details:
Clinical data review from four completed FX-322 clinical studies, including 169 subjects with a range of hearing loss severities and SNHL etiologies (sudden, noise-induced, age-related).
Lead Product(s):
FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableNovember 09, 2021
Details:
The U.S. Food and Drug Administration (FDA) recently agreed with speech perception as the primary endpoint for FX-322 development, including for the FX-322-208 study and all future FX-322 studies.
Lead Product(s):
FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableOctober 27, 2021
Details:
FX-322 is a thermoreversible poloxamer that is injected intratympanically as a liquid and transitions to a gel used in adults With severe sensorineural hearing loss.
Lead Product(s):
FX-322
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: FX-322
Highest Development Status: Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not ApplicableUpfront Cash: Not Applicable
Deal Type: Not ApplicableOctober 21, 2021
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