WHO granted the international nonproprietary name "izicopan" to InflaRx N.V.’s oral C5a receptor inhibitor INF904, marking a key regulatory milestone for the company’s complement‑inhibitor program.
The INN designation provides a globally recognized name that will be used in clinical trials and regulatory submissions, but it does not equate to marketing approval. It is a critical step that can streamline future filings with agencies such as the FDA and EMA.
Early‑phase data from Phase 2a studies in hidradenitis suppurativa and chronic spontaneous urticaria show rapid reductions in abscesses, nodules, and patient‑reported pain, supporting the drug’s therapeutic potential.
InflaRx reported a Q3 2025 net loss of EUR 12.26 million, an improvement from EUR 17.45 million in Q3 2024, while sales fell to EUR 0.02383 million from EUR 0.123819 million. The company remains in a loss position and faces a Nasdaq bid‑price compliance deadline of January 7 2026, underscoring the need for additional financing.
CEO Niels Riedemann said the INN milestone confirms the potential of izicopan as a best‑in‑class oral complement inhibitor, but emphasized that regulatory approvals and capital raising remain critical to bring the drug to market.
Analysts have expressed caution regarding the company’s funding trajectory and regulatory path, noting that while the INN milestone is a positive regulatory step, the company’s financial position and need for further capital raise could temper enthusiasm.
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