oral edaravone

Note: This story was updated Sept. 25, 2023, to correct that TW001 uses the same active ingredient as Radicava and Radicava ORS but is a different therapy. Treeway has chosen Specialised Therapeutics Asia, known as ST, as its partner to market TW001, an oral formulation of edaravone, for…

A Phase 3 clinical trial that’s testing FNP122, Ferrer’s oral formulation of edaravone, in people with amyotrophic lateral sclerosis (ALS) is now rolling participants into its open-label extension study. The ADORE trial (NCT05178810) is testing FNP122 against a placebo in about 300 patients across Europe whose…

An oral suspension form of Radicava (edaravone), an approved treatment of amyotrophic lateral sclerosis (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH). The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral…

The U.S. Food and Drug Administration (FDA) has approved Mitsubishi Tanabe Pharma America (MTPA)’s oral suspension formulation of edaravone, Radicava ORS, for the treatment of amyotrophic lateral sclerosis (ALS). The oral therapy is designed to offer the same efficacy as MTPA’s Radicava (edaravone) — an FDA-approved, into-the-vein therapy…

Mitsubishi Tanabe Pharma Corporation (MTPC) is seeking approval to manufacture and market MT-1186, an oral formulation of edaravone, in Japan for amyotrophic lateral sclerosis (ALS). A similar application recently gained priority review in the U.S., which reduced regulatory review time from the standard 10 months to six months. A…

The ALS Association has formally objected to the use of two controversial measures of cost-effectiveness in the upcoming evaluations of AMX0035 and oral edaravone, which are being reviewed as treatments for amyotrophic lateral sclerosis (ALS) in the U.S. These cost-effectiveness measures fail to value the lives of ALS…

An oral suspension formulation of edaravone (MT-1186) is safe and well-tolerated in adults with amyotrophic lateral sclerosis (ALS), according to interim, six-month data from a Phase 3 clinical trial. In addition, exploratory efficacy results suggest that edaravone’s experimental oral formulation may slow patients’ functional decline to a similar level…

A first patient has been enrolled in a Phase 3 clinical trial investigating FNP122, an oral formulation of edaravone being developed by Ferrer to treat amyotrophic lateral sclerosis (ALS). The ADORE trial aims to enroll 300 patients across Europe to assess the safety and efficacy of FNP122, as well as its…

Mitsubishi Tanabe Pharma America (MTPA) has launched an extension study to assess the long-term effects of an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS). “As a company, we strive to always put patients first in our efforts to understand this debilitating…

The Phase 3 clinical trial investigating an oral suspension formulation of edaravone (MT-1186) in treating amyotrophic lateral sclerosis (ALS) is now fully enrolled, the therapy’s developer, Mitsubishi Tanabe Pharma America, announced. This open-label study (NCT04165824) first opened in…