AQUAVIT


Associated tags: Patient, Health, Aquavit, FDA, Physician, Pharmaceutical industry, Hyperhidrosis, IND, Safety, Dermatology, Knowledge, Clostridium botulinum, MD, Neurotoxin, AB toxin, Botulinum toxin, History, Efficacy

Aquavit Receives FDA Clearance for Two INDs to Initiate Clinical Trials With Its Botulinum Toxin

Retrieved on: 
Saturday, April 29, 2023

NEW YORK, April 29, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational New Drug Applications.

Key Points: 
  • NEW YORK, April 29, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has received FDA clearance to initiate clinical trials for DTX-023 and DTX-024, following its submission of Investigational New Drug Applications.
  • Aquavit will begin its Phase II/Phase III trials for DTX-023 (aqubotulinumtoxinA) and DTX-024 (aqubotulinumtoxinA with intradermal microinjector) under the study protocol titled S.W.E.A.T.
  • Aquavit is the first company in history to pursue an FDA approval for intradermal injection of botulinum toxin for the treatment of palmar hyperhidrosis.
  • Aquavit is currently on the forefront of botulinum toxin application development and currently has a third IND approval pending before the FDA and will continue to expand its role in the industry.

Aquavit Files Investigational New Drug Application for its Flagship Intradermal Injection of Botulinum Toxin

Retrieved on: 
Friday, April 28, 2023

NEW YORK, April 28, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has filed an Investigational New Drug Application with the FDA for its flagship intradermal injection of botulinum toxin, Dermatox™ (aqubotulinumtoxinA).

Key Points: 
  • NEW YORK, April 28, 2023 /PRNewswire/ -- Aquavit Holdings (Aquavit), a biotechnology company focused on the development of botulinum toxin applications, announced today that it has filed an Investigational New Drug Application with the FDA for its flagship intradermal injection of botulinum toxin, Dermatox™ (aqubotulinumtoxinA).
  • Botulinum toxins have been widely utilized for aesthetic and therapeutic indications for over three decades.
  • Aquavit is the first company in history to pursue an FDA approval for intradermal injection of botulinum toxin for the improvement of skin quality and reduction of fine lines for face and neck.
  • The global botulinum toxin market was valued at USD 4.6 billion in 2021 and is expected to reach USD 7.9 billion by 2026.

Aquavit Awarded 10M in Damages on Intellectual Property Against Counterfeiters

Retrieved on: 
Wednesday, March 22, 2023

The total damages included trademark infringement, counterfeiting, defamation and attorney fees and costs.

Key Points: 
  • The total damages included trademark infringement, counterfeiting, defamation and attorney fees and costs.
  • They used social media sites to promote their counterfeit products, while defaming Aquavit and attempting to damage Aquavit's good will in the pharmaceutical industry.
  • U-Biomed was also defeated in the Korean civil court recently on allegations stemming from the intellectual property.
  • "Aquavit prides itself on its outstanding technology and reputation in the pharmaceutical industry and will continue to police misconduct to safeguard itself as well as its assets."

Aquavit Files Additional IND for DTX-024, a New Botulinum Toxin With Microchannel Technology™ for Palmar Hyperhidrosis

Retrieved on: 
Saturday, March 18, 2023

NEW YORK, March 18, 2023 /PRNewswire/ -- Aquavit Holdings has submitted to FDA an IND for its DTX-024, for the treatment of palmar hyperhidrosis using its patented microchannel technology™.

Key Points: 
  • NEW YORK, March 18, 2023 /PRNewswire/ -- Aquavit Holdings has submitted to FDA an IND for its DTX-024, for the treatment of palmar hyperhidrosis using its patented microchannel technology™.
  • Alongside Aquavit's biosimilar program for its botulinum toxin, this will be the first in the world, indicated for palmar hyperhidrosis, approved by FDA.
  • Aquavit has been investing in proprietary delivery technologies and related intellectual property for botulinum toxin.
  • This is a strategic move that puts them ahead of the curve in the fast-growing multi-billion-dollar botulinum toxin market.

Aquavit Files Two IND's For Its Botulinum Toxin With FDA

Retrieved on: 
Friday, March 17, 2023

NEW YORK, March 17, 2023 /PRNewswire/ -- Aquavit Holdings, the exclusive licensee of Huons Global's Botulinum Toxin in the USA and Canada, will officially unveil the Aquatox™ program at the Annual American Academy of Dermatology - 2023, the world's largest dermatology conference scheduled from March 17-21, 2023, in New Orleans, LA.

Key Points: 
  • According to The Aesthetic Society and the Global Market Insights, botulinum toxin has been the #1 non-surgical aesthetic procedure since 1999 and is still growing rapidly with only 4 companies with approved botulinum toxin in the US.
  • With a projected CAGR of 7-9%, the global botulinum toxin market in 2026 is expected to be $8.9B.
  • For several years, Aquavit has been investing in its proprietary delivery technologies and related intellectual property for botulinum toxin.
  • We plan to introduce the most innovative botulinum toxin products, uplift and modernize the treatment paradigm" said Sobin Chang, CEO of Aquavit.