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Details:
Through the agreement, the company will prioritize the clinical development of FW-UP (niclosamide), currently undergoing Phase I/II clinical trial studies for the treatment of ulcerative colitis.
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-UP
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 27, 2023
Details:
Xafty is a novel broad-spectrum antiviral with niclosamide's mechanism that eliminates viruses that infiltrated cells and can solve RNA virus infections, capable of treating both COVID-19 and Dengue fever or Dengue virus infection.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Xafty
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Details:
Xafty's active ingredient, niclosamide's mechanism is to remove viruses by activating cell autophagy, it is being investigated for COVID-19 as an antiviral drug candidate.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Xafty
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2023
Details:
Niclosamide is an antiviral, that shows potent activity against SARS-CoV-2. Niclosamide targets human cell pathways and the host’s ability to control viral replication as its MOA and is therefore resistant to mutation of the SARS-CoV-2 spike protein.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 11, 2022
Details:
Niclosamide, is a Potent Inhibitor of SARS-CoV-2 with Activity Against Multiple Variants for the treatment of COVID-2019 infections, was recently shown to exhibit potent antiviral activity against SARS-CoV-2.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2022
Details:
The PCT application, filed with the USPTO, covers methods of treating patients with multiple formulations of niclosamide for GI infections related to post-acute COVID-19 syndrome, also known as “long haul” COVID-19, in most major market countries throughout the world.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
FW-UP is a niclosamide-based, small molecule anti-inflammatory inhibitor therapy under development for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS).
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-UP
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2022
Details:
The Company intends to use the net proceeds from the offering to pay a portion of the cash purchase price for its acquisition of First Wave Bio, Inc. and for FW-UP for ulcerative proctitis, manufacturing, clinical development and/or increases in working capital.
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-UP
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $9.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 02, 2022
Details:
TFF previously completed a preclinical in vivo efficacy study that showed a seven-fold reduction in lung viral load in a hamster model when dry powder niclosamide was administered 24 hours after inoculation with SARS-CoV-2 when the disease was already severe.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: TFF Niclosamide
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Union Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2022
Details:
Company believes that FW-COV (Niclosamide). Part 2 of RESERVOIR Trial has the potential to contribute to global need for new therapies against SARS2 based on the positive safety data observed with earlier published in vitro COVID efficacy data. Topline Data Expected 1H 2022.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FW-COV
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 06, 2022
Details:
Inhaled niclosamide powder, has been shown to reduce COVID-19 viral load in vivo and offers both direct delivery to the site of infection in the lung and more convenient outpatient administration compared to the IV administered approved antibody COVID-19 treatments.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: TFF Niclosamide
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2021
Details:
FW-ICI-AC is a niclosamide-based small molecule anti-inflammatory inhibitor therapy for the treatment of immune checkpoint inhibitor-associated colitis (ICI-AC) and diarrhea in advanced cancer patients.
Lead Product(s): Niclosamide
Therapeutic Area: Oncology Product Name: FW-ICI-AC
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
ANA001 is a proprietary oral niclosamide formulation in development as a treatment for patients with COVID-19. Niclosamide has antiviral and anti-inflammatory properties, and a well-understood safety profile in humans.
Lead Product(s): Niclosamide,Gemcabene
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA001
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2021
Details:
FW-UP is niclosamide-based, small molecule anti-inflammatory inhibitor therapy for the treatment of ulcerative proctitis (UP) and ulcerative proctosigmoiditis (UPS). Company begun screening patients for enrollment in a Phase 2b investigating topical formulation of FW-UP.
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-UP
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
As per the definitive agreement, AzurRx will wholly own all rights to First Wave Bio’s proprietary formulations of niclosamide, a small molecule drug which features anti-viral and anti-inflammatory properties that are designed to address multiple GI conditions.
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-UP
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: First Wave BioPharma
Deal Size: $229.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition September 13, 2021
Details:
The trial’s primary objectives are to confirm the safety of FW-1022 in the treatment of patients with COVID-19-related GI infections and to evaluate its efficacy in clearing SARS-CoV-2 from the GI tract.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FW-1022
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 10, 2021
Details:
CSIR and Laxai Life Sciences have been given the regulatory approval by DCGI to undertake a two-arm phase-II clinical trial to assess the safety and efficacy of the drug Colchicine in improvement of clinical outcomes during the treatment of COVID-19 patients.
Lead Product(s): Colchicine,Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: LAXAI Life Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 12, 2021
Details:
The trial is a multi-centric, phase-II, randomized, open label clinical study to evaluate efficacy, safety and tolerability of NIclosamide for the treatment of hospitalized Covid-19 patients.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CSIR-Indian Institute of Chemical Technology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2021
Details:
PPD will manage the Phase 1b/2a clinical trial using both oral immediate-release tablet and topical rectal enema foam formulations of micronized oral niclosamide, also known as FW-420.
Lead Product(s): Niclosamide
Therapeutic Area: Gastroenterology Product Name: FW-420
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: First Wave BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 13, 2021
Details:
The paper published in SCI journal reveals the mechanism of repurposed Niclosamide. This is the first time that a paper demonstrating drug repurposing through various study results has been published in an SCI-level international journal.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI91103
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
NeuroBo Pharmaceuticals has received approval of an amendment to its Contingent Value Rights (CVR) agreement from a majority of the holders of a majority of the outstanding CVRs, incentivizing the evaluation of Gemcabene as a treatment for COVID-19.
Lead Product(s): Niclosamide,Gemcabene
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA001
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 24, 2021
Details:
UNION therapeutics A/S (UNION) has been selected by Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge to trial UNI91103 as a prophylactic treatment of COVID-19 in kidney patients, a vulnerable and high-risk patient population.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI91103
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Under the terms of the agreement, PPD will manage the Phase 2 clinical trial for an immediate-release capsule formulation of micronized oral niclosamide, also known as FW-1022.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: FW-1022
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: First Wave BioPharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 09, 2021
Details:
Transformative acquisition deepens pipeline with In-process phase 2/3 clinical study of proprietary oral formulation of Niclosamide for the treatment of covid-19 development timeline supports multiple value drivers over next 12-18 months.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA-001
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: NeuroBo Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 06, 2021
Details:
When injecting a single dose of DWRX2003 to hamsters as part of animal testing, a strong antiviral effect of the drug by the third day was observed and viral genome was barely found by the fifth day.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: DWRX2003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
Harry Selker of Tufts Medical Center has agreed to be Daewoong’s principal investigator along with his Tufts Niclosamide Team’s current work in a separate phase 2 clinical trial evaluating the efficacy of oral niclosamide for COVID-19.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: DWRX2003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Daewoong Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 29, 2020
Details:
The trial is the first in the U.S. to test the potential of niclosamide for COVID-19. Company begun Phase 2/3 clinical trial to evaluate the safety and efficacy of oral niclosamide (ANA001) formulation for the treatment of patients with moderate COVID-19 disease.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA001
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Niclosamide based nasal spray (UNI91103) will first be investigated in high risk patients to test its ability to prevent infection with COVID-19 and to reduce the severity of the disease for those already infected.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI91103
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
Daewoong plans to enter phase 2/3 trial in multiple nations before this year ends, and aims to apply for conditional approval or emergency use of the drug upon phase 2 clinical trial results.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: DWRX2003
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
TFF Pharmaceuticals contracted with Irisys to manufacture an inhalable lung medication with the potential to treat COVID-19. IRISYS will be responsible for the initial production and testing of TFF’s investigational powder product for inhalation.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: TFF Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 30, 2020
Details:
UNION has successfully completed inhalation dosing of 44 healthy volunteers, confirming the safety and tolerability of UNI911. UNI911 utilizes an optimized salt form of niclosamide, an existing potent inhibitor of SARS-Cov-2 by Institut Pasteur Korea.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI911
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2020
Details:
UNION therapeutics completed an agreement with TFF Pharmaceuticals to acquire an option to obtain a worldwide exclusive license for the use of their Thin Film Freezing technology in combination with niclosamide to focus on treatments for COVID-19.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI911
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Union Therapeutics
Deal Size: $210.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 13, 2020
Details:
Partnership to support the manufacturing of ANA Therapeutics’ drug candidate, ANA001 (niclosamide capsules), which they are developing as a potential treatment for COVID-19.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA001
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Quotient Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 11, 2020
Details:
ANA will evaluate both the safety of niclosamide as well as its ability to show a clinical improvement in hospitalized patients with COVID-19. This study will focus on patients with less severe symptoms who are not on ventilators.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: ANA001
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2020
Details:
Danish Medicines Agency has approved initiation of a clinical study with an optimized salt form of niclosamide as a new treatment candidate for COVID-19.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: UNI911
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
The company added that the drug completely cleared the infection in ferrets’ lung tissues and inhibited inflammation, according to Reuters. The testing on ferrets was carried out for approximately three months.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
Purdue University scientist Yuan Yao’s laboratory has developed a solution, a plant-based, highly potent nanoparticle called OHPP (octenylsuccinate hydroxypropyl phytoglycogen) that can solubilize and enable niclosamide.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2020
Details:
Data presented on repurposing the existing, broad-spectrum antiviral agent using Thin Film Freezing and other techniques to enhance its effect for COVID-19 therapy.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 30, 2020
Details:
UNION therapeutics launch of a program to test an optimized salt form of niclosamide as a treatment of COVID-19, in collaboration with Institut Pasteur Korea.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Institut Pasteur Korea
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 12, 2020
Details:
Proprietary formulation of approved antiviral medicine targets viral “reservoir” in the gut believed responsible for prolonged infection and transmission.
Lead Product(s): Niclosamide
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
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