FDA Clears MicuRx IND for MRX-5 to Enter Phase 2a Trial in M. abscessus Pulmonary Disease

FDA Clears MicuRx IND for MRX-5 to Enter Phase 2a Trial in M. abscessus Pulmonary Disease

By, Admin 30 January 2026

MicuRx Pharmaceuticals, Inc. has received U.S. FDA clearance for its Investigational New Drug (IND) application for MRX-5, enabling initiation of a Phase 2a clinical trial in patients with Mycobacterium abscessus pulmonary disease.

The clearance marks a key step forward for a program targeting a serious and difficult-to-treat non-tuberculous mycobacterial (NTM) infection with limited effective therapies.

Why M. abscessus Pulmonary Disease Needs Better Treatments?

M. abscessus pulmonary disease is associated with:

  • High morbidity and progressive lung damage
  • Long, complex multi-drug treatment regimens
  • Poor tolerability and frequent adverse effects
  • Suboptimal clinical outcomes

There are currently few effective oral options and no reliably curative therapies.

About MRX-5

MRX-5 is a novel, oral antibacterial agent designed to target NTM infections.

Preclinical and early clinical data show that MRX-5:

  • Demonstrates potent activity against clinical isolates of M. abscessus
  • Remains active against strains resistant to standard-of-care therapies
  • Exhibits favorable pharmacokinetic properties
  • Shows an encouraging safety profile

In 2024, the FDA granted Orphan Drug Designation to MRX-5 for the treatment of NTM infections.

Phase 2a Trial Overview

The Phase 2a study will be:

  • Multicenter
  • Conducted in the United States
  • Enrolling adults with confirmed M. abscessus pulmonary disease

Primary objectives include evaluating:

  • Safety and tolerability
  • Preliminary efficacy

Results will guide subsequent development and later-stage trial design.

Company Perspective

Jerry (Zhiyue) Li, President of MicuRx, stated:

The FDA’s clearance of our IND for MRX-5 represents an important milestone for MicuRx and for patients suffering from M. abscessus pulmonary disease. This approval allows us to advance MRX-5 into a Phase 2a clinical trial to assess its safety and efficacy.

Expanding MicuRx’s Anti-Infective Pipeline

The IND clearance strengthens MicuRx’s clinical pipeline focused on:

  • Drug-resistant bacterial infections
  • Antimicrobial resistance challenges
  • Hard-to-treat NTM diseases

MicuRx continues to leverage its expertise in medicinal chemistry and anti-infective drug development to address major global unmet medical needs.

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