InflaRx Announces International Nonproprietary Name of “Izicopan” for INF904

Rhea-AI Summary

InflaRx (Nasdaq: IFRX) announced the World Health Organization has granted the international nonproprietary name izicopan for its oral C5aR inhibitor formerly known as INF904; the name will be published in the WHO recommended INN list.

Izicopan has shown tolerability in first‑in‑human single doses (3–240 mg) and multiple doses (30 mg once daily to 90 mg twice daily), pharmacokinetic/pharmacodynamic support with a ≥90% blockade of C5a‑induced neutrophil activation over 14 days, and topline Phase 2a signals of clinical activity in hidradenitis suppurativa and chronic spontaneous urticaria.

Positive

• WHO granted INN izicopan for INF904
• ≥90% C5a blockade achieved over 14 days
• First‑in‑human dosing tolerated at 3–240 mg single doses
• Multiple dosing tolerated at 30 mg once–90 mg twice daily

Negative

• None.

Key Figures

Single-dose range 3 mg to 240 mg First-in-human study single doses of izicopan

Multiple-dose range 30 mg QD to 90 mg BID First-in-human multiple dosing for 14 days

Dosing duration 14 days Multiple-dose first-in-human izicopan study

C5a blockade ≥90% Blockade of C5a-induced neutrophil activation over 14 days

Treatment period 4 weeks Therapy duration in hidradenitis suppurativa patients

Study duration CSU 7-day UAS7 Urticaria Activity Score assessment period

Share price $1.05 Price before INN naming announcement

52-week range $0.7113 to $2.77 52-week low and high prior to this news

Market Reality Check

$1.05 Last Close

Volume Volume 553,526 vs 20-day average 1,465,915 ahead of this naming update. low

Technical Shares at 1.05, trading below 200-day MA of 1.18 before this news.

Peers on Argus 1 Up

Peers in Biotechnology showed mixed moves (e.g., SRZN +7.16%, XBIT +6.22%, MGNX -0.71%), suggesting stock-specific trading rather than a uniform sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 10	Phase 2a results	Positive	+28.5%	Positive topline INF904 Phase 2a efficacy and safety data in HS and CSU.
Nov 07	Data timing update	Positive	+2.5%	Announcement of upcoming Phase 2a topline data and webcast schedule.
Oct 21	Conference participation	Neutral	+1.5%	Planned participation in Guggenheim healthcare innovation conference and meetings.
Sep 12	Nasdaq compliance	Positive	-14.3%	Regained compliance with Nasdaq minimum bid price requirement over 10 days.
Aug 21	Investor conferences	Neutral	+0.6%	Announcement of participation in two September investor conferences.

Pattern Detected

News tied to INF904 and corporate events has more often coincided with positive price reactions, with a notable divergence on the Nasdaq compliance update.

Recent Company History

Over the last few months, InflaRx has focused on advancing its anti-C5a/C5aR programs and investor visibility. On Nov 10, 2025, positive Phase 2a data for INF904 in HS and CSU coincided with a 28.46% gain, following a modest rise after the data timing announcement on Nov 7. Conference participation updates in August and October were associated with small positive moves. In contrast, the Sep 12 announcement of regaining Nasdaq minimum bid price compliance saw a -14.29% reaction, marking a divergence from otherwise constructive responses.

Market Pulse Summary

This announcement gives INF904 the INN “izicopan,” formalizing its identity as an oral C5aR inhibitor after earlier Phase 1 and Phase 2a data. Prior news highlighted favorable safety across doses from 3 mg to 240 mg and ≥90% C5a blockade over 14 days, with clinically meaningful signals in HS and CSU. With shares at 1.05, below the 1.18 200-day MA and the 2.77 52-week high, future updates on trial design, timing, and regulatory interactions around izicopan remain key watch points.

Key Terms

international nonproprietary name regulatory

"WHO has granted the international nonproprietary (generic) name (INN) of “izicopan”"

International nonproprietary name (INN) is the official generic name assigned to an active pharmaceutical substance that is recognized worldwide and distinct from company brand names. Investors care because an INN creates a common label for comparing products, tracking regulatory approvals, and measuring market demand and competition—like a universal model number that prevents confusion between different brands and helps assess commercial prospects.

monoclonal antibody medical

"vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

AI-generated analysis. Not financial advice.

JENA, Germany, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the World Health Organization (WHO) has granted the international nonproprietary (generic) name (INN) of “izicopan” to the Company for its orally available C5aR inhibitor, formerly known as INF904, in accordance with the WHO's Procedure for the Selection of Recommended International Nonproprietary Names (INN) for Pharmaceutical Substances. In the next step of this process, the name “izicopan” will be published in the recommended list of INNs.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “InflaRx welcomes the granting of izicopan as the INN for INF904. We believe the promising clinical data recently reported in hidradenitis suppurativa and chronic spontaneous urticaria indicate the tremendous potential izicopan has, as a best-in-class oral agent with a novel mechanism of action, to address significant unmet need in both diseases and also to address sizable commercial markets in additional inflammatory conditions.”

About izicopan (INF904)
Izicopan (INF904) is an orally administered, small molecule inhibitor of the C5a receptor Ca5R1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that izicopan was well tolerated and exhibited no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7).

About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies. InflaRx is also developing izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor.

InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

Contacts:

InflaRx N.V.	MC Services AG
Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de	Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this press release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things: the receptiveness of izicopan as a treatment for HS and CSU by patients and hospitals and related treatment recommendations by medical/healthcare institutes and other third-party organizations; our ability to successfully secure distribution channels and commercialize GOHIBIC (vilobelimab) as a treatment for COVID-19 patients and our ability to positively influence treatment recommendations by U.S. and European hospitals, guideline bodies and other third-party organizations; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for, estimated returns and return accruals for, and clinical utility of GOHIBIC (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under the Emergency Use Authorization and in the future if approved for commercial use in the United States, Europe or elsewhere; our ability to successfully implement The InflaRx Commitment Program, the success of our future clinical trials for vilobelimab’s treatment of debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome and other indications, and any other product candidates, including izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other product candidates, including for the development of vilobelimab in several indications, including to obtain full approval of GOHIBIC (vilobelimab) for COVID-19 and other virally induced ARDS, to treat HS and CSU, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with and the receptiveness and approval by regulators regarding the results of clinical trials and potential regulatory approval or authorization pathways, including our biologics license application submission for GOHIBIC (vilobelimab); the timing and outcome of any discussions or submission of filings for regulatory approval or authorization of vilobelimab, izicopan or any other product candidate, and the timing of and our ability to obtain and maintain full regulatory approval, the EUA and/or market authorization of vilobelimab or GOHIBIC (vilobelimab) for any indication; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; whether the U.S. Food and Drug Administration, the European Medicines Agency or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; the success of our future clinical trials for vilobelimab, izicopan and any other product candidates and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; our expectations regarding the size of the patient populations for, the market opportunity for, the medical need for and clinical utility of vilobelimab, izicopan or any other product candidates, if approved or authorized for commercial use; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab) in the United States and Europe; our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our expectations regarding the scope of any approved indication for vilobelimab; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved or authorized, any commercial sales; if any of our product candidates obtain regulatory approval or authorization, our ability to comply with and satisfy ongoing drug regulatory obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or authorization and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors and other therapeutic products being developed in similar medical conditions in which vilobelimab, izicopan or any other of our product candidates is being developed or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

FAQ

What does the WHO granting the INN izicopan mean for InflaRx (IFRX)?

WHO assignment means izicopan is the recognized international generic name and will appear in the WHO recommended INN list.

What dosing ranges were tested for izicopan (INF904) in human studies?

Single doses ranged from 3 mg to 240 mg; multiple doses ranged from 30 mg once daily to 90 mg twice daily.

What pharmacodynamic effect did izicopan show in studies announced on Dec 11, 2025?

Pharmacokinetic/pharmacodynamic data showed a ≥90% blockade of C5a‑induced neutrophil activation over a 14‑day dosing period.

Did izicopan show safety concerns in clinical testing reported in the announcement?

Reported results indicated izicopan was well tolerated with no safety signals of concern in the described studies.

What clinical effects did izicopan demonstrate in hidradenitis suppurativa (HS)?

Topline Phase 2a reported rapid, clinically meaningful reductions in abscesses and nodules and draining tunnels, plus reduced patient‑reported pain over 4 weeks.

How did izicopan perform in chronic spontaneous urticaria according to the release?

The company reported substantial reductions in UAS7 scores and improved disease control measured by UCT7, especially in severe patients.