Trial Profile

A phase 1 study of HT-KIT in adult patients with advanced systemic mastocytosis (AdvSM)

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 08 Jun 2025

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At a glance

12 May 2025 According to a Hoth Therapeutics media release, company expects to file an Investigational New Drug (IND) application with the FDA in early 2026, with first-in-human Phase 1 trials planned shortly thereafter. The company is actively engaging regulatory advisors and contract research partners to accelerate clinical development.
18 Mar 2025 According to a Hoth Therapeutics media release, company has plans to initiate regulatory discussions for first-in-human trials.
02 Oct 2023 According to a Hoth Therapeutics media release, the Pre-IND meeting requested on September 8th for HT-KIT with the U.S. Food and Drug Administration (FDA) has been granted to receive written responses only from the FDA that are targeted for delivery on November 7, 2023.

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