What Happened?

Onconik Therapeutics announced on September 15, 2025, that it received approval from the Ministry of Food and Drug Safety (MFDS) for a modification to its Phase 1 clinical trial plan for Zastaprazan (Zacuvo), a treatment for digestive diseases caused by excessive gastric acid secretion. The purpose of this clinical trial is to evaluate the safety and efficacy of Zacuvo when administered in combination with other medications.

Why is This Approval Important?

This clinical trial modification approval is more than just a procedural step. It holds the key to Onconik Therapeutics’ future, influencing Zacuvo’s safety verification, potential expansion of indications, and even its global market entry.

  • Enhanced Safety and Increased Trust: Securing safety data on combination therapy with various drugs can enhance trust among medical professionals and patients.
  • Expansion of Indications and Enhanced Competitiveness: Securing additional indications and developing combination therapies can give Zacuvo a competitive edge over other drugs.
  • Accelerated Technology Export and Global Market Entry: Robust clinical data can positively influence negotiations for overseas market entry and technology export.

So, What’s the Investment Strategy?

In the short term, a buy or hold strategy is valid due to the positive momentum and the high potential for stock price increase. In the medium to long term, continuous monitoring of clinical results, sales growth trends, and Nesuparib’s development status is necessary.

Investment Considerations

  • Pay attention to the timing and content of clinical trial results announcements.
  • Understand Zacuvo’s market share and competitive landscape.
  • Analyze the progress and likelihood of success of Nesuparib development.