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[{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"University of Oxford and Sound Pharmaceuticals Complete Phase 2 Bipolar Disorder Study with SPI-1005","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharma Advances Pivotal Phase 3 Clinical Trials in Meniere's Disease","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharmaceuticals Files IND to Test SPI-1005 in Phase 2 COVID-19 Trials","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Clears SPI\u2019s Ebselen for Phase II COVID-19 Trials","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"National Center for Advancing Translational Sciences","pharmaFlowCategory":"D","amount":"$3.1 million","upfrontCash":"Undisclosed","newsHeadline":"Sound Pharmaceuticals to Launch NIH-Funded Covid-19 Oral Therapeutic Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"National Center for Advancing Translational Sciences","pharmaFlowCategory":"D","amount":"$4.2 million","upfrontCash":"Undisclosed","newsHeadline":"Sound Pharmaceuticals' NIH Grant For a Novel Oral COVID-19 Treatment Increases to $4.2M","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharma Initiates Enrollment in Pivotal Phase 3 Clinical Trial of SPI-1005 For the Treatment of Hearing Loss and Tinnitus in Meniere's Disease","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Sound Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Sound Pharma Completes Enrollment in Pivotal Phase 3 Clinical Trial Of SPI-1005 For the Treatment of Meniere's Disease Involving Hearing Loss, Tinnitus, and Dizziness","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Sound Pharmaceuticals
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Details:
SPI-1005 is a new drug that contains ebselen, a selenorganic compound that mimics and induces glutathione peroxidase activity and is effective in reducing neuroinflammation across the CNS and PNS. It is being developed for meniere’s disease involving hearing loss, etc.
Lead Product(s):
Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: SPI-1005
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 03, 2023
Details:
SPI-1005 is investigational drug that contains ebselen, a small molecule that is new chemical entity, under FDA classification. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase activity and represents novel class of anti-inflammatory.
Lead Product(s):
Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: SPI-1005
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 28, 2022
Details:
SPI-1005 (ebselen) is a novel class of anti-inflammatory compound with Glutathione Peroxidase (GPx) activity and has been tested in more than 450 patients in six completed randomized controlled trials and in four ongoing studies in the US and UK.
Lead Product(s):
Ebselen
Therapeutic Area: Infections and Infectious Diseases
Product Name: SPI-1005
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
National Center for Advancing Translational Sciences
Deal Size: $4.2 million
Upfront Cash: Undisclosed
Deal Type: Funding
May 11, 2022
Details:
SPI-1005 is an oral capsule containing ebselen, a small molecule with novel anti-inflammatory properties being developed for several neurotologic, neuropsychiatric, and respiratory indications.
Lead Product(s):
Ebselen
Therapeutic Area: Infections and Infectious Diseases
Product Name: SPI-1005
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
National Center for Advancing Translational Sciences
Deal Size: $3.1 million
Upfront Cash: Undisclosed
Deal Type: Funding
April 06, 2021
Details:
SPI-1005 is an investigational new drug that contains ebselen, a novel small molecule that mimics and induces the activity of Glutathione Peroxidase (GPx) in the inner ear, retina, brain, lung, and kidney.
Lead Product(s):
Ebselen
Therapeutic Area: Infections and Infectious Diseases
Product Name: SPI-1005
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
August 31, 2020
Details:
In the initial safety and exploratory efficacy studies, two different oral doses of SPI-1005 (400 and 800 mg, twice daily) will be tested and compared to placebo over a 30-day period of follow-up.
Lead Product(s):
Ebselen
Therapeutic Area: Infections and Infectious Diseases
Product Name: SPI-1005
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 30, 2020
Details:
SPI's clinical data from two completed multi-center, randomized, placebo-controlled studies (Phase 1b and Phase 2b clinical trials) showed that oral delivery of SPI-1005 for 21 or 28 days improved sensorineural hearing loss and tinnitus in patients affected by MD.
Lead Product(s):
Ebselen
Therapeutic Area: Otolaryngology (Ear, Nose, Throat)
Product Name: Undisclosed
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
June 08, 2020
Details:
The study shows important preliminary evidence of therapeutic activity for SPI-1005 in bipolar disorder. SPI-1005 treated patients had a 11.8-point reduction in Young Mania Rating Scale scores.
Lead Product(s):
Ebselen
Therapeutic Area: Psychiatry/Psychology
Product Name: Undisclosed
Highest Development Status: Phase II
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 04, 2020