Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sound Pharma Announces Positive Phase 3 Data for SPI-1005 in Menière’s Disease
Details : SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx).
Product Name : SPI-1005
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 10, 2024
Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Kaizen Bioscience Preparing Lead Asset for NDA Submission in 2025
Details : LP-001 (amoxicillin/clavulanate) oral suspension is currently being investigated as an effective antimicrobial for the treatment of children with acute otitis media in 3-12 moth age pediatric.
Product Name : LP-001
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 14, 2024
Lead Product(s) : Amoxicillin Trihydrate,Clavulanic Acid
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sound Pharma Announces Phase 3 Study Completion of SPI-1005 for Meniere’s Disease
Details : SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx).
Product Name : SPI-1005
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2024
Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Optinose Announces FDA Acceptance of Supplemental New Drug Application for XHANCE
Details : Xhance (fluticasone propionate) is a drug-device combination product that uses the Exhalation Delivery System designed to deliver a topical anti-inflammatory to the high and deep regions of the nasal cavity where sinuses ventilate and drain.
Product Name : Xhance
Product Type : Steroid
Upfront Cash : Inapplicable
April 05, 2023
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 h...
Product Name : SPI-1005
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 05, 2023
Lead Product(s) : Ebselen
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Optinose Submits Supplemental New Drug Application for XHANCE Label Expansion
Details : Xhance is a drug-device combination with fluticasone propionate which is a synthetic trifluorinated corticosteroid which exhibits great binding affinity for the human glucocorticoid receptor and shows anti-inflammatory activity.
Product Name : Xhance
Product Type : Steroid
Upfront Cash : Inapplicable
February 21, 2023
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sodium Thiosulfate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pedmark® (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Product Name : Pedmark
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
January 25, 2023
Lead Product(s) : Sodium Thiosulfate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Mepolizumab
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.
Product Name : Nucala
Product Type : Antibody
Upfront Cash : Inapplicable
January 09, 2023
Lead Product(s) : Mepolizumab
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Esketamine Hydrochloride
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Altamira Therapeutics
Deal Size : $82.0 million
Deal Type : Divestment
Altamira Therapeutics Announces Divestiture of Inner Ear Development Assets
Details : Zilentin will purchase from Altamira, an option that entitles Zilentin to acquire Altamira’s remaining legacy assets in inner ear therapeutics, including AM-101 (tinnitus), AM-111, Keyzilen and Sonsuvi (hearing loss) and AM-125 (vertigo), for an upfron...
Product Name : Keyzilen
Product Type : Controlled Substance
Upfront Cash : $27.0 million
October 21, 2022
Lead Product(s) : Esketamine Hydrochloride
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Altamira Therapeutics
Deal Size : $82.0 million
Deal Type : Divestment
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ReOpen2 was the second of two phase 3 clinical trials in its ReOpen Program which evaluated XHANCE, also referred to as the Exhalation Delivery System with fluticasone (EDS-FLU), as a potential treatment for chronic sinusitis.
Product Name : Xhance
Product Type : Steroid
Upfront Cash : Inapplicable
September 11, 2022
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable