YH35995 / Yuhan Corp - LARVOL DELTA

A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=94 | Active, not recruiting | Sponsor: Yuhan Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Jun 2027 ➔ Mar 2027 | Trial primary completion date: Jun 2027 ➔ Mar 2027

Enrollment closed • First-in-human • Trial completion date • Trial primary completion date

Yuhan marks centennial, drives second Leclaza with heavy R&D and AI push (Chosun Biz) - "Lesigercept, a candidate allergy treatment, is in a multinational phase 2 trial. Lesigercept inhibits immunoglobulin E (IgE), which triggers allergic reactions. Allergies have at times not been controlled even with conventional antihistamines. The company expects Lesigercept could replace them. Yuhan's Gaucher disease treatment candidate YH35995 was designated an orphan drug in the United States and Europe in the first half of this year. The candidate is an oral therapy designed to cross the blood–brain barrier. It is expected to help Gaucher patients with accompanying neurological symptoms."

Clinical • Allergy • Gaucher Disease

Yuhan said on the 23rd that its candidate treatment for Gaucher disease, 'YH35995', was designated an orphan drug by the European Medicines Agency (Chosun Biz)

Orphan drug • Gaucher Disease

Yuhan said on the 13th that its Gaucher disease drug candidate 'YH35995' received orphan drug designation from the U.S. Food and Drug Administration (FDA) (Chosun Biz) - "The candidate is an oral therapy designed to cross the blood-brain barrier."

Orphan drug • Gaucher Disease

A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=86 | Recruiting | Sponsor: Yuhan Corporation | Trial completion date: Jun 2026 ➔ Jun 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

First-in-human • Trial completion date • Trial primary completion date

A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Yuhan Corporation

New P1 trial