Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves XHANCE as First Medication for Chronic Rhinosinusitis Without Nasal Polyps
Details : Xhance (fluticasone propionate) is a drug-device combination product, which is approved for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 15, 2024
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Xhance (fluticasone propionate) is a glucocorticoid receptor agonist, steroid drug candidate administered via intranasal spray for the treatment of chronic rhinosinusitis.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 06, 2023
Lead Product(s) : Fluticasone Propionate
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) : Fluticasone Propionate
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 04, 2023
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 21, 2023
Lead Product(s) : Fluticasone Propionate
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) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Approved
Sponsor : Piper Sandler
Deal Size : $50.0 million
Deal Type : Public Offering
Optinose Announces Pricing of Public Offering of Common Stock and Warrants
Details : Optinose intends to use the net proceeds of the offering for working capital and general corporate purposes, including the commercialization of XHANCE, and the pursuit of a follow-on indication for XHANCE for the treatment of chronic sinusitis.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 21, 2022
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Sponsor : Piper Sandler
Deal Size : $50.0 million
Deal Type : Public Offering
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2022
Lead Product(s) : Fluticasone Propionate
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) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : XHANCE® (fluticasone propionate) nasal spray is a drug-device combination product combining its proprietary Exhalation Delivery System designed to uniquely deliver drug high and deep in nasal passages with an anti-inflammatory drug.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 08, 2022
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The safety profile and tolerability of Fluticasone Propionate in this trial were consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and common than the Exhalation Delivery System placebo ...
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 13, 2022
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : XHANCE® (fluticasone propionate), is a drug-device combination product that uses the Exhalation Delivery System met both co-primary endpoints in the ReOpen1 trial, demonstrating statistically significant benefits on symptoms and CT scans in patients wit...
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 07, 2022
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Study Phase : Phase III
Sponsor : Piper Sandler
Deal Size : $46.0 million
Deal Type : Public Offering
Optinose Announces Closing of $46.0 Million Public Offering of Common Stock
Details : Optinose intends to use the net proceeds of the offering for the commercialization of XHANCE, the clinical development of XHANCE for a follow-on indication for the treatment of chronic sinusitis and other potential development programs.
Brand Name : Xhance
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 18, 2021
Lead Product(s) : Fluticasone Propionate
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Sponsor : Piper Sandler
Deal Size : $46.0 million
Deal Type : Public Offering
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