Emcitate (tiratricol)

MCT8 deficiency

Manufacturer: Egetis Therapeutics
Regulatory submission: NDA submitted January 2026 and approved September 2026
Launch: Anticipated eight to ten weeks after the September 2026 approval
Last updated: September 29, 2026

Section

Product information and disease description Place of product in therapy Approaches to treatment

Other product development or post-marketing obligations required by the FDA

1 evidence topic · 1 source

Pre-approval expanded access requested by the FDA

“At FDA’s request, Egetis has implemented an Expanded Access Program (EAP) in the U.S. Currently, 17 hospitals are included and approximately 60 patients are receiving tiratricol in the EAP. The EAP allows physicians to access tiratricol for patients not eligible for clinical trials prior to marketing approval, as well as for continued treatment of patients who completed the ReTRIACt and Triac Trial II studies.” (opens the source at this quote in a new tab)

FDA post-marketing obligations

No evidence found.