Research & Development
Inmagene Biopharmaceuticals' IMG-004 investigational new drug application receives US FDA approval
16 May 2022 -

Inmagene Biopharmaceuticals, a China-based global clinical-stage biotechnology company, announced on Sunday that it has received approval from the United States Food and Drug Administration (FDA) for its investigational new drug (IND) application for the drug candidate IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase (BTK) inhibitor, to proceed to a Phase one clinical trial.

The company is producing the drug candidate to potentially treat immunological diseases.

The proposed Phase one study, a double-blind, randomised, placebo-controlled, single and multiple dose escalation study in healthy subjects, intends to explore the product's safety, tolerability, pharmacokinetics, and pharmacodynamics.

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