TUL321 / United Laboratories - LARVOL DELTA

To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants. (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Zhuhai United Laboratories Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants. (clinicaltrials.gov) - P1 | N=94 | Not yet recruiting | Sponsor: Zhuhai United Laboratories Co., Ltd.

New P1 trial • Complement-mediated Rare Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

UNITED LAB…announced that the applications for the clinical trial of TUL321 Capsules, a Class 1 new drug self-developed by Zhuhai United Laboratories Co., Ltd., a wholly-owned subsidiary of the Company, were approved by China National Medical Products Administration (iis.aastocks.com)

New trial • Immunology

The United Laboratories International Holdings has obtained U.S. FDA approval for an investigational new drug application for TUL321 Capsules, a self-developed Class 1 complement factor B inhibitor, while its clinical trial registration in China has also been accepted. (TipRanks) - "Preclinical data suggest the drug has strong therapeutic potential for conditions including paroxysmal nocturnal hemoglobinuria, IgA nephropathy, age-related macular degeneration, multiple sclerosis and myasthenia gravis, bolstering the group’s R&D pipeline in autoimmune diseases and enhancing its competitive position in innovative pharmaceuticals."

IND • Preclinical • Age-related Macular Degeneration • IgA Nephropathy • Multiple Sclerosis • Myasthenia Gravis