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Details:
Radicava ORS (edaravone) is a free radical scavenger available in the form of oral suspension, which is approved by USFDA for the treatment of amyotrophic lateral sclerosis.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Details:
Sanbexin (a combination of edaravone and dexborneol) is a small molecule, sublingual tablet, which is being evaluated for the treatment of acute ischemic stroke.
Lead Product(s): Edaravone,Dexborneol
Therapeutic Area: Neurology Product Name: Sanbexin
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neurodawn Pharmaceutical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2024
Details:
Under the licensing agreement, ST will be responsible for all marketing, regulatory and distribution activities of TW001, a unique oral formulation of edaravone which works by reducing the oxidative damage associated with neuron death in ALS, in Australia and New Zealand.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: TW001
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Specialised Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 28, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2023
Details:
Radicava ORS (edaravone) is a free radical scavenger used to delay the progression of amyotrophic lateral sclerosis (ALS) due to the therapeutic effect of its known antioxidant properties as oxidative stress kills neurons in patients with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2023
Details:
RADICAVA ORS® (edaravone) is an ORAL administration option of RADICAVA (edaravone), an ALS treatment shown to slow the loss of physical function. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
In clinical trials, the most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion, gait disturbance and headache. In an open-label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS (edaravone).
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2022
Details:
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) and the oral formulation RADICAVA ORS® (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) and is administered in 28-day cycles by IV infusion.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2022
Details:
RADICAVA® (edaravone) in a real-world setting during the first three years of availability in the United States (U.S.) for the treatment of amyotrophic lateral sclerosis (ALS).
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2022
Details:
RADICAVA ORS is an oral suspension form of edaravone, gives people with ALS an oral treatment option that offers the same efficacy as the IV formulation of edaravone.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
Specialty pharmacy partners to dispense nationwide RADICAVA ORS® (edaravone) oral suspension, commercialized by Mitsubishi Tanabe Pharma America, Inc. (MTPA), which commercializes approved pharmaceutical products in North America.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mitsubishi Tanabe Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 07, 2022
Details:
The FDA approval of RADICAVA ORS (Edaravone) was supported by several studies, including 24-week results from the global Phase 3 trial (MT-1186-A01) demonstrating the safety and tolerability profile of the treatment in 185 ALS patients.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava ORS
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
After fasting overnight, Radicava ORS (edaravone) should be taken in the morning orally or via feeding tube. The oral medication has the same dosing regimen as Radicava for intravenous infusion—an initial treatment cycle of daily dosing for 14 days.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Brand Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2022
Details:
The analysis of real-world data suggest continued treatment of amyotrophic lateral sclerosis (ALS) patients with intravenous (IV) RADICAVA® (edaravone) resulted in a six-month longer median survival, compared to those not treated with the drug.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2022
Details:
FNP122 as an oral formulation of edaravone in ALS patients. Edaravone is an antioxidant and free radical scavenger that has been shown to reduce excess oxidative stress and cell death1, playing an important role in the pathology of ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: FNP122
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2021
Details:
FNP122 is an oral formulation of edaravone, a compound that prevents oxidative stress on a cellular level. Therefore, reducing oxidative stress can delay the progression of ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: FNP122
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Treeway
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 20, 2021
Details:
The analysis, funded and conducted by MTPA, utilized a real-world de-identified database of administrative health claims across the U.S. to evaluate data on overall survival among commercially insured ALS patients treated with RADICAVA.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 12, 2021
Details:
Mitsubishi Tanabe Pharma will present an analysis of the timing of disease progression milestones among commercially insured amyotrophic lateral sclerosis (ALS) patients treated with intravenous (IV) RADICAVA® (edaravone).
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2021
Details:
This post-hoc analysis assessed the double-blind, placebo-controlled 24-week Phase 3 study of edaravone, including an additional 24-week open-label period with all patients receiving IV edaravone.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
Soleo Health's ability to collect specific data through its proprietary SoleMetrics patient outcomes program proved valuable in helping to elucidate real-world treatment patterns with IV edaravone in the U.S.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
The global multi-center, open-label study (MT-1186-A01), is evaluating approximately 185 ALS patients across approximately 50 sites in the U.S., Canada, Europe and Japan over the course of 48 weeks of treatment.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
MTPA will present details on the REFINE-ALS study, assessing RADICAVA® (edaravone), for which MTPA aims to identify and measure specific biomarkers and clinical assessments in people with ALS.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2020
Details:
Global Phase 3 study to evaluate the long-term safety and tolerability of an investigational oral suspension formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS) has resumed screening and enrollment.
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: MT-1186
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2020
Details:
Mitsubishi Tanabe Pharma Canada announced today that RADICAVA® (edaravone), an infusion treatment for amyotrophic lateral sclerosis (ALS), is now listed on the Nova Scotia Formulary (special authorization).
Lead Product(s): Edaravone
Therapeutic Area: Neurology Product Name: Radicava
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
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