Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904, an Oral C5aR1 Inhibitor, in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa

The study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. All subjects will receive IMP for 28 days followed by one End of Study (EOS) visit, 4 weeks after EOT visit.

Start Date02 Jan 2025

Sponsor / Collaborator

InflaRx GmbH

CTIS2024-510915-31-00

/ CompletedPhase 1

A Phase 1, Randomized, Open Label, Single-Dose Crossover Study to Assess the Relative Bioavailability, Food Effect, and Safety of Capsule Formulations of INF904.

Start Date14 Jun 2024

Sponsor / Collaborator

InflaRx GmbH

NL-OMON53655

/ CompletedNot Applicable

A randomised, investigator and subject blinded, placebo-controlled study to determine the safety, tolerability, and pharmacokinetics of INF904 in healthy subjects after single and multiple ascending doses - SAD and MAD to assess safety, tolerability and PK of INF904

Start Date19 Oct 2022

Sponsor / Collaborator

InflaRx GmbH

100 Clinical Results associated with Izicopan

100 Translational Medicine associated with Izicopan

100 Patents (Medical) associated with Izicopan

News (Medical) associated with Izicopan

11 Jan 2026

·www.globenewswire.com

InflaRx Announces Strategy Focused on Capital-Efficient Execution with Izicopan and Near-Term Value Creation

InflaRx to prioritize izicopan as its leading pipeline asset, with a goal of continuing toward Phase 2b readiness in hidradenitis suppurativa (HS) To broaden signal-finding activities for izicopan in additional I&I (inflammation and immunology) indications, InflaRx intends to conduct a PK bridging study in China in 2026 to enable expedited proof of concept studies in China and additional geographies Toward the goal of fast-tracking izicopan development across all applicable I&I indications, InflaRx continues its concurrent strategy to foster discussions with potential collaborators InflaRx is executing an approximately 30% workforce reduction, leading to a significant reduction of the Company’s cost structure, and extension of its cash runway to mid-2027 The Company intends to host a virtual Capital Markets Day to highlight the clinical utility and commercial potential of izicopan in HS and I&I broadly in spring 2026 Jan. 08, 2026 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced it is undertaking measures to reduce spending, extend the Company’s cash runway, and align resources to enable further development of izicopan in HS and other I&I indications as a potential best-in-class C5aR inhibitor and pipeline-in-a-product. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “In an effort to enable the long-term success of InflaRx we have made the decision to increase our capital efficiency and tightly focus the Company. Our goal with this realignment is to prioritize resources toward izicopan in hidradenitis suppurativa and additional areas in inflammation and immunology, allowing us to maximize its value as a significantly differentiated oral inhibitor of C5aR and pipeline-in-a-product. We are very optimistic about our strategy and the sizable potential of izicopan, and look forward to reporting additional progress during the year.” As part of its strategic focusing, InflaRx is streamlining its organizational structure and largely discontinuing non-essential activities outside the development of izicopan. These actions are designed to sharpen the Company’s strategic execution, concentrate resources on its highest-value asset, and materially improve capital efficiency. InflaRx has initiated a workforce reduction of approximately 30% and substantial spending reductions, including significant reductions in Gohibic (vilobelimab) commercial spending and related functions. The Company estimates these activities will result in a one-time charge of approximately $7 million. The majority of this charge will be a non-cash charge related to the write-off of vilobelimab inventory, with a smaller portion associated with the restructuring, including personnel-related costs and the termination or modification of certain third-party contracts. Upon completion, InflaRx expects a significantly leaner cost structure, enabling substantial and sustained reductions in operating expenses and a meaningful extension of its cash runway to mid-2027. InflaRx will maintain the operational capability needed to support the ongoing BARDA “Just Breathe” Phase 2 clinical platform study in ARDS and does not expect these actions to negatively impact the trial. InflaRx will keep Gohibic (vilobelimab) available for ordering inside the US under its emergency use authorization and maintain the ability to satisfy Gohibic (vilobelimab) demand in the US on a reactive basis. InflaRx will continue to review partnering opportunities for Gohibic in the US and Europe. In addition, as previously disclosed, the Company anticipates meeting with the FDA to determine a potential development path forward for vilobelimab in pyoderma gangrenosum, which it anticipates would only be conducted in collaboration with a partner. Given data demonstrating its advantageous PK/PD profile, meaningful differentiation as an inhibitor of the C5a/C5aR axis, and potential to address HS, chronic spontaneous urticaria (CSU) and other I&I indications, the Company will prioritize resource allocation and clinical development toward izicopan while continuing active dialog with potential partners across all geographies to expedite and maximize value. In HS InflaRx continues to make progress toward Phase 2b readiness. InflaRx is in active dialogue with the FDA related to the Phase 2b study design and potential endpoints. The aim is to align on a development path and endpoints expected to meaningfully differentiate izicopan from existing therapies, while also addressing variability inherent in some HS trial outcomes. InflaRx is moving as quickly as is feasible in this effort and intends to provide an update on its HS Phase 2b planning and readiness in due course. InflaRx sees significant potential for izicopan to address unmet needs in multiple I&I indications beyond HS, including CSU, where InflaRx continues data analysis and active dialog with thought leaders to determine next steps. Given the supportive nature of the Phase 2a data collected to-date from the two main CSU (all-comer) dosing cohorts, and low enrollment trends in the third (anti-IgE refractory) dosing cohort, InflaRx has decided to close the third treatment cohort. InflaRx will utilize the existing data set to determine next steps for izicopan in CSU, which the Company expects to communicate later this year. InflaRx intends to submit the izicopan Phase 2a datasets in HS and CSU for presentation at medical conferences later this year. Toward the goal of generating proof of concept data in additional I&I indications as efficiently as possible, InflaRx intends to conduct a PK bridging study with izicopan in China this year in order to expedite subsequent proof of concept studies in China and elsewhere. The Company intends to provide an update on these efforts, and on efforts in additional potential I&I indications, later this year. InflaRx expects to host a virtual capital markets day this spring. During this event the Company plans to highlight the clinical utility of izicopan in HS and I&I more broadly, including izicopan’s role in respective I&I treatment algorithms, and its emerging commercial potential. 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 in treated subjects 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). 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‘s lead program is izicopan (INF904), an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa (HS). The Company has also 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 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). The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

04 Jan 2026

·www.globenewswire.com

InflaRx Provides Update on Phase 3 Data Analyses for Vilobelimab in Pyoderma Gangrenosum

While the Phase 3 trial of vilobelimab in ulcerative pyoderma gangrenosum (PG) was terminated earlier this year due to futility regarding its prespecified primary endpoint (as previously disclosed), subsequent post-hoc analyses suggest a positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect InflaRx anticipates meeting with the FDA to determine a potential development path forward in PG, which the Company anticipates would only be conducted in collaboration with a partner Dec. 30, 2025 -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today outlined multiple data analyses of the Phase 3 study for vilobelimab in pyoderma gangrenosum (PG), which was terminated earlier this year after an Independent Data Monitoring Committee (IDMC) recommended the trial be stopped early due to futility. The analyses disclosed today include the primary intent-to-treat analysis and several post-hoc analyses on the 54 patients enrolled in the trial at the time of study termination. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, said: “Our Phase 3 study was the first randomized placebo-controlled study in pyoderma gangrenosum using complete target ulcer closure on two consecutive visits as a stringent primary clinical endpoint, which has not been tested before in this rare disease. Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG. Depending on the outcome of our anticipated FDA interactions, our results may provide an opportunity to advance development in collaboration with a partner, which we may pursue in the future.” The Phase 3 study had recruited a total of 54 patients at the time the interim analysis was conducted, including 30 patients who had completed 6 months of treatment. The primary clinical endpoint of complete target ulcer closure on two consecutive visits showed a difference in favor of vilobelimab over placebo of 20.8% versus 16.7% (p=NS (not significant)). Key secondary endpoints such as complete disease remission (complete closure of all ulcers) showed improvement in favor of vilobelimab over placebo (20.8% versus 5.6%, p=NS) and those with >50% reduction of target ulcer volume at week 26 (36.4% versus 16.7%, p=NS). In addition, patients reported feeling better as measured by the Dermatology Life Quality Index (DLQI) mean percentage change at the end of treatment visit (-31.1% versus 3.4%). Overall, vilobelimab was well tolerated. Observed treatment-emergent adverse events (TEAEs) were mostly mild to moderate, and patients with serious related on-treatment TEAEs were similarly distributed (6.3% in vilobelimab arm and 4.5% in placebo arm). In addition, further post-hoc analyses showed that there is an overall treatment effect with vilobelimab when compared to placebo. These include an MMRM (mixed model repeated measures) for percent change in target ulcer volume, which showed an average effect over all visits in favor of vilobelimab over placebo (-45.4%, p=0.0428, Weeks 2 – 26 overall) when imputing patients with treatment-related discontinuation reasons, including patient level stopping criteria (PLSC) with a last observation carried forward (LOCF) approach. This analysis yielded a significant treatment difference for every week from Week 14 (-57.6%, p=0.0357) to Week 26 (-63.2%, p=0.0122) for vilobelimab over placebo. In addition, ANCOVAs (analyses of covariance) for mean of percentage changes from baseline in volume and area from Week 12 until Week 26 were also in favor of vilobelimab, including mean of percentage change from baseline in volume (p=0.0111) and area (p=0.0072). These analyses suggest that treatment longer than 26 weeks with vilobelimab may provide improved treatment outcomes in this difficult-to-treat ulcerative PG population. Alex G. Ortega Loayza, MD, MCR, CWSP, Professor and Interim Chair, Department of Dermatology, Oregon Health and Science University, said: “I am encouraged by the signals of efficacy observed from the Phase 3 post-hoc analyses of vilobelimab in pyoderma gangrenosum. The role of targeting C5a/C5aR aligns with prior mechanistic work supporting its use for this devastating inflammatory dermatological disease, which has no FDA-approved therapy. Given the significant unmet need and lack of approved therapies, I am hopeful these findings will motivate further investigation of this targeted approach.” Benjamin Kaffenberger, MD, Associate Professor, Dermatology, The Ohio State University Wexner Medical Center, said: “Pyoderma gangrenosum remains a difficult-to-treat rare disease with high unmet medical need. The data for vilobelimab suggest an overall treatment effect, even if the primary endpoint may not have been achieved within the six-month timeframe required in this first-of-its-kind Phase 3 trial. Unfortunately, there is not a successful precedent for conducting a pivotal Phase 3 placebo-controlled study in PG, and I believe the futility leading to early discontinuation relates to challenges in trial design rather than lack of efficacy of the therapy. I believe that blocking C5a/C5aR in this neutrophilic disease continues to make scientific and clinical sense and that there is a strong justification to move forward.” As next steps, InflaRx anticipates meeting with the FDA to discuss a potential path forward for vilobelimab in PG, including the use of alternative endpoints that could be utilized for potential future clinical studies. At this time, in an effort to prioritize izicopan (INF904) development, InflaRx does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner. Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response. 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). The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultImmunotherapy

02 Jan 2026

·www.fiercepharma.com

After scrapped trial, InflaRx could tap partner to revive development of COVID drug in rare skin disorder

Less than a year ago, InflaRx nixed its pyoderma gangrenosum study of vilobelimab after an independent data monitoring committee called for the trial’s early termination. Although it looked to be lights out for InflaRx’s C5a antibody vilobelimab in the rare skin disorder pyoderma gangrenosum (PG) last year, the German drugmaker ended 2025 with a glimmer of hope for the asset, thanks to multiple analyses of a terminated phase 3 trial.Following the end of the late-stage study in ulcerative PG last May over futility, post hoc analyses have pointed to a “positive trend in favor of vilobelimab, with signals indicating a potentially consistent treatment effect,” InflaRx said in a Dec. 30 press release.In turn, the company—which is broadly seeking to develop inflammatory drugs targeting the complement system—anticipates meeting with the FDA to hash out a potential development path forward for its drug in PG. InflaRx said it expects that any revamped development efforts in the indication “would only be conducted in collaboration with a partner.”“Our in-depth data analysis reveals signals of efficacy, particularly regarding ulcer volume reduction, which further supports the potential role of the C5a/C5aR pathway in certain neutrophilic skin diseases, such as PG,” Niels Riedemann, M.D., Ph.D., InflaRx’s chief executive, said in a statement.“Depending on the outcome of our anticipated FDA interactions, our results may provide an opportunity to advance development in collaboration with a partner, which we may pursue in the future,” he continued. PG is a rare skin condition that causes large, painful sores to form on the skin, frequently on the legs. The exact cause of the condition isn’t fully understood, though it is believed to be an immune disorder, according to the Mayo Clinic.For its part, vilobelimab is designed to block the activity of C5a—a fragment of the immune system’s complement cascade—and has demonstrated “high selectivity towards its targets in human blood,” InflaRx noted in its release. The company stressed that, unlike drugs designed to block C5, vilobelimab leaves the formation of the membrane attack complex intact, recognizing it as an “important defense mechanism of the innate immune system.”Less than a year ago, InflaRx nixed its PG study of vilobelimab after an independent data monitoring committee called for the trial’s early termination, citing futility. The recommendation, which the data monitoring committee leveled after analyzing results on the first 30 patients enrolled in the trial, prompted InflaRx to declare it was stopping development of vilobelimab in the indication.While InflaRx has no drugs with full FDA approvals, vilobelimab boasts an emergency use authorization (EUA) to treat certain critically ill COVID-19 patients. The termination of the PG study in May had no bearing on the EUA or on vilobelimab’s status in the U.S. as a COVID treatment, InflaRx clarified last year. The antibody drug is marketed under the name Gohibic in its COVID-19 niche.As for the latest interpretation of the PG data, InflaRx said it leveraged its primary intent-to-treat analysis and several more post hoc assessments on the 54 participants enrolled in the study at the time of termination. That patient pool included 30 who had completed half a year of treatment on vilobelimab, the company pointed out.Notably, the primary clinical endpoint of complete target ulcer closure on two consecutive visits revealed a difference favoring vilobelimab (20.8%) over placebo (16.7%), despite not being significant enough to satisfy the trial as designed, InflaRx said.InflaRx also flagged trends favoring its drug across several key secondary endpoints in the terminated study.For instance, nearly 30% of patients on vilobelimab achieved complete disease remission—defined by the complete closure of all ulcers—versus just 5.6% of patients in the study’s control cohort. Vilobelimab further helped 36.4% of patients reduce their ulcer volume by 50% or more at 26 weeks, compared to 16.7% of patients on placebo.InflaRx additionally flagged further post hoc analyses that suggest “there is an overall treatment effect with vilobelimab when compared to placebo.”The German drugmaker said it used a mixed model for repeated measures for percent change in target ulcer volume and analyses of covariance for mean of percentage changes from baseline in volume over a certain time span to further crack open the data. Those subsequent analyses yielded a “significant treatment difference” for vilobelimab over placebo from Week 14 to Week 26 of treatment and suggested vilobelimab dosing beyond 26 weeks “may provide improved treatment outcomes.”“Unfortunately, there is not a successful precedent for conducting a pivotal Phase 3 placebo-controlled study in PG, and I believe the futility leading to early discontinuation relates to challenges in trial design rather than lack of efficacy of the therapy,” Benjamin Kaffenberger, M.D., of The Ohio State University Wexner Medical Center, said in InflaRx’s release.“I believe that blocking C5a/C5aR in this neutrophilic disease continues to make scientific and clinical sense and that there is a strong justification to move forward,” he added.As for what comes next, InflaRx is expecting to meet with the FDA to discuss a potential development path forward in PG, possibly through the use of alternative endpoints.At the time of last year’s trial termination, InflaRx noted that it would focus its resources on its oral small molecule candidate izicopan, which is also a CFa inhibitor. That remains the case heading into 2026, as well.In a bid to prioritize izicopan’s development in conditions like chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), the company noted that it “does not expect to deploy significant resources towards future vilobelimab development in PG on its own and will instead consider doing so in collaboration with a partner.” Back in November, InflaRx unveiled positive phase 2a basket data on izicopan—then coded INF904—in both HS and CSU, flagging the drug’s prospects as a “potentially transformational and best-in-class immunomodulatory agent” in the indications.Meanwhile, over the summer, InflaRx indicated that it believes CSU and HS could each represent markets of $1 billion or more for izicopan. At the time, the company noted that it had around 53.7 million euros in cash and equivalents, plus about 40.7 million euros in marketable securities. That should provide InflaRx with a cash runway stretching into 2027, InflaRx said in August.

Phase 3Phase 2Clinical Result

100 Deals associated with Izicopan

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Urticaria	Phase 2	United States	InflaRx GmbH	02 Jan 2025
Chronic Urticaria	Phase 2	Bulgaria	InflaRx GmbH	02 Jan 2025
Chronic Urticaria	Phase 2	Germany	InflaRx GmbH	02 Jan 2025
Chronic Urticaria	Phase 2	Greece	InflaRx GmbH	02 Jan 2025
Chronic Urticaria	Phase 2	Poland	InflaRx GmbH	02 Jan 2025
Hidradenitis Suppurativa	Phase 2	United States	InflaRx GmbH	02 Jan 2025
Hidradenitis Suppurativa	Phase 2	Bulgaria	InflaRx GmbH	02 Jan 2025
Hidradenitis Suppurativa	Phase 2	Germany	InflaRx GmbH	02 Jan 2025
Hidradenitis Suppurativa	Phase 2	Greece	InflaRx GmbH	02 Jan 2025
Hidradenitis Suppurativa	Phase 2	Poland	InflaRx GmbH	02 Jan 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GlobeNewswire Manual	Phase 2	Chronic Urticaria	30	60 mg INF904	axkbnrljig(kmopapliik) = gyqetkgvuc dygqhptdld (mubaghloom ) View more	Positive	10 Nov 2025
				120 mg INF904	axkbnrljig(kmopapliik) = fojwgzslbc dygqhptdld (mubaghloom ) View more
GlobeNewswire Manual	Phase 2	Hidradenitis Suppurativa	29	60 mg INF904	jkeafjixcr(ztqnxgdkyy) = mshmafrxlh zdewwdfexc (eefkixsbcv ) View more	Positive	10 Nov 2025
				90 mg INF904	jkeafjixcr(ztqnxgdkyy) = xodkjzcstg zdewwdfexc (eefkixsbcv ) View more
GlobeNewswire Manual	Phase 1	-	24	INF904	rtngzirnak(rphwbbicsj) = pgmztofmmv pjqjewvhqm (drwsabcwfm ) View more	Positive	04 Jan 2024

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