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Vanda Pharma issues developmental plans for tradipitant

September 1, 2020

Vanda Pharmaceuticals (NASDAQ:VNDA) provides an update on its development program for tradipitant.

Tradipitant is advancing in a Phase III study for the treatment of both diabetic and idiopathic gastroparesis.  The study is expected to complete target enrollment of 200 patients in H1 2021.

A robust package of preclinical work for tradipitant has been completed, including a 2-year carcinogenicity study.

Vanda believes this entire preclinical package is adequate to support NDA filings for the short-term indications. However, the FDA has recommended that for treating patients beyond 12 weeks, the company would require to conduct a standard 9-month non-rodent chronic toxicity study.

Potential timeline and estimated milestones for tradipitant in gastroparesis:

Q3 2020, Expanded Access individual patient program

H1 2021, Enrollment completion of the Phase III study

H2 2021, NDA submission for tradipitant in gastroparesis

H2 2022, Commercial launch of tradipitant for the treatment of gastroparesis, if approved.

Interim analysis from ODYSSEY study shows tradipitant may accelerate clinical improvement in patients with COVID-19 pneumonia.

Vanda is pursuing multiple short-term and long-term indications for tradipitant, including treatment of gastroparesis, motion sickness, and atopic dermatitis.

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