Trial Profile

A trial assessing Budesonide (Budenofalk) in patients with autoimmune hepatitis

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 16 Aug 2019

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At a glance

Drugs Budesonide (Primary)
Indications Autoimmune hepatitis
Focus Therapeutic Use

Most Recent Events

16 Aug 2019 New trial record
12 Aug 2019 According to a Calliditas Therapeutics media release, the company is now preparing for a meeting with the FDA,which preliminarily is planned for Q1 of 2020. Based on positive feedback regarding the regulatory path for the product from the FDA. This trial could then be initiated in 2020.

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