The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

Start Date01 Sep 2025

Sponsor / Collaborator

NYU Langone Health

NCT07071519

/ RecruitingPhase 3

A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.
Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.
Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date28 Jul 2025

Sponsor / Collaborator

AbbVie, Inc.

NCT06880744

/ RecruitingPhase 3

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will evaluate how safe and effective risankizumab is compared to vedolizumab in treating adult participants with moderate to severe UC who are naive to targeted therapies (TaTs).
Risankizumab and vedolizumab are approved medications for moderate to severe UC in multiple countries. Participants who meet the eligibility criteria will be randomized in a 1:1 ratio to receive open label risankizumab or vedolizumab. Approximately 530 adult participants with moderate to severe UC who are naïve to targeted therapies (TaTs) will be enrolled at 285 sites worldwide.
For participants randomized to risankizumab, drug will be administered intravenous(IV) during the induction period followed by subcutaneous injection during the maintenance period. Participants randomized to vedolizumab will receive drug IV throughout the study.
The duration of the study is approximately 69 weeks for participants randomized to risankizumab and 71 weeks for participants randomized to vedolizumab. This includes up to a 35-day screening period followed by a treatment period of 44 weeks for risankizumab and 46 weeks for vedolizumab.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect and safety of the treatment will be checked by medical assessments, evaluation of side effects and completing questionnaires.

Start Date17 Jun 2025

Sponsor / Collaborator

AbbVie, Inc.

100 Clinical Results associated with Risankizumab-RZAA

100 Translational Medicine associated with Risankizumab-RZAA

100 Patents (Medical) associated with Risankizumab-RZAA

660

Literatures (Medical) associated with Risankizumab-RZAA

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Switching biologic agent in patients with psoriasis: a systematic review and meta-analysis

Review

Author: Sun, YuanQiang ; Zhao, XiTong ; Li, WenChao ; Liu, Hong ; Zhang, LiHong

BACKGROUND:

Multiple biologics are available for psoriasis treatment, but switching treatments is often necessary at some point. The choice between intraclass or interclass biologic switching has not been extensively investigated.

METHODS:

Two independent authors searched the databases PubMed and EMBASE for studies reporting on biologic switching in psoriasis patients. Our study was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines.

RESULTS:

A total of 19 publications, comprising 679 patients, were included. The intraclass switching group consisted of 519 patients, while the interclass switching group included 139 patients. For intraclass switching, there are respectively 160, 326 and 33 patients switched of TNF-α, IL-17, IL-23. For interclass switching, 11 patients switched from TNF-α to IL-17, 6 from IL-17 to IL-23, 41 from IL-17 to IL-12/23, 29 from IL-17 to TNF-α, 15 from IL-12/23 to IL-17, 8 from IL-12/23 to IL-23. After 12 weeks, the proportion of patients achieving Psoriasis Area and Severity Index (PASI)75 was significantly higher in the intraclass switching group compared to the interclass switching group. However, after 16-52 weeks, the PASI75 proportions were comparable between the groups.

CONCLUSION:

Intraclass switching shows better short-term efficacy than interclass switching. However, in the long term, both switching strategies are effective and safe. This study also shows that adalimumab, ixekizumab, and risankizumab are the preferred agents for intraclass switching, whereas guselkumab serves as the primary agent for interclass transitions.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Interleukin-23p19 inhibitors for the treatment of moderate-to-severe psoriasis: an expert opinion of real-world evidence studies in Europe

Review

Author: Ständer, S. ; Thaçi, D.

Background: Psoriasis is a chronic inflammatory disease affecting about 2% of the global population, with moderate-to-severe forms requiring systemic treatment for successful disease management. By targeting the interleukin (IL)-23p19 subunit of IL-23, the master cytokine of psoriasis pathogenesis, guselkumab, tildrakizumab, and risankizumab offer improved risk-benefit profiles.Objective: While randomized clinical trials (RCTs) provide controlled data, real-world evidence (RWE) offers insights into the performance of these therapies in diverse patient populations, including those with comorbidities or difficult-to-treat areas affected. With RWE on these inhibitors constantly emerging, a comprehensive overview and expert interpretation are essential for providing key insights into psoriasis management in clinical practice.Methods: This review, therefore, examined RWE on the effectiveness and safety of IL-23p19 inhibitors compared to their pivotal RCTs.Results: Despite some gaps between RCT and RWE outcomes, particularly in underrepresented subpopulations, IL-23p19 inhibitors show strong effectiveness and favorable safety across both settings in the short- and especially in the long term, accompanied by an improvement in health-related quality of life and reduction of the main symptoms.Conclusion: Altogether, these factors make these medicines ideal treatment options. Future research should focus on improving patient-reported outcomes, specifically addressing psychological and quality-of-life aspects, to further optimize psoriasis management.

01 Sep 2025·Dermatology and Therapy

Time to Onset of Action for Biologics and Targeted Treatments in Psoriasis: Systematic Targeted Literature Review and Network Meta-Analysis.

Article

Author: Yang, Ya-Wen ; Grewal, Parbeer ; Purdy, Kerri ; Oroz, Irina ; Abbarin, Nastaran ; Vender, Ron ; Langley, Richard G ; Papp, Kim A ; Vigelis, Sandra ; Lansang, Perla ; Park-Wyllie, Laura ; Lovegrove, Fiona ; Hooper, Becky ; Disher, Tim

INTRODUCTION:

For some patients with plaque psoriasis (PsO), a rapid response (i.e. short interval to time to onset of action [TOA]) is desired. The primary objective was to determine average time to achieve a Psoriasis Area and Severity Index (PASI) 90 response (50% of patients) for individual biologics or targeted therapies. Secondary outcomes included the average time to achieve a PASI 75 response (50% of patients), as well as PASI 90 and PASI 75 responses over the first 16 weeks of therapy.

METHODS:

A systematic targeted literature review was conducted to identify phase III and IV randomised, double-blinded trials according to pre-specified eligibility criteria that investigated interleukin (IL)-12/23 inhibitors, IL-17 inhibitors, IL-23 inhibitors, Janus kinase (JAK) inhibitors, and phosphodiesterase (PDE) inhibitors. Using proportions of patients achieving PASI 90 or 75 responses over 16 weeks, network meta-analyses were conducted to estimate response over time. This was presented as curves, and TOA was summarized as median time to reach the 50th percentile.

RESULTS:

Forty-five trials were included in the main analyses. The IL-17 inhibitors bimekizumab, ixekizumab, brodalumab, and secukinumab 300 mg were estimated to provide the earliest onset of PASI 90 response at approximately 6 to 8 weeks. This was followed by the IL-23 inhibitors risankizumab and guselkumab at approximately 9-10 weeks, and the IL-12/23 inhibitor at 11-12 weeks. Although wide and overlapping credible intervals and similar point estimates were observed, these results suggest onset of action does not vary greatly across biologics in these classes. Onset of PASI 90 response could not be estimated by the model for tildrakizumab, and JAK and PDE4 inhibitors. Onset of PASI 75 response showed similar trends to PASI 90 response.

CONCLUSIONS:

IL-17 inhibitors, followed by IL-23 inhibitors, have the most rapid TOA among PsO biologics evaluated; any differences in onset of action between specific agents within the same drug class are not statistically or clinically significant. These analyses will allow clinicians to make more informed treatment decisions for their patients.

376

News (Medical) associated with Risankizumab-RZAA

25 Aug 2025

·www.prnewswire.com

Crohn's Disease Market Projected to Grow at 4.3% CAGR (2020-2034), Driven by Improved Diagnosis, Pediatric Label Expansion, and New Second-line Therapies | DelveInsight

The Crohn's disease pipeline includes several drugs in mid- and late-stage development, poised for approval in the near future in both adults and pediatrics. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including RHB-104, Tulisokibart, LITFULO (ritlecitinib), AGMB-129, Duvakitug, and others. The expected launch of these therapies shall further create a positive impact on the Crohn's disease market. LAS VEGAS, Aug. 25, 2025 /PRNewswire/ -- DelveInsight's Crohn's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Crohn's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Crohn's Disease Market Report According to DelveInsight's analysis, the market size for Crohn's disease was found to be USD 10.8 billion in the 7MM, with roughly 8-10% of it being the pediatric market in 2024. The United States accounted for the highest market size of Crohn's disease, approximately 78% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Adalimumab (HUMIRA and its generics) accounted for the highest market share of ~ USD 4 billion in 2024 for the treatment of Crohn's disease in the 7MM. Based on DelveInsight's assessment in 2024, the 7MM had 2.1 million diagnosed prevalent cases of Crohn's disease, out of which almost 200,000 cases are pediatric. In 2024, it was estimated that almost 60% of the cases were within the moderate-to-severe category as compared to mild severity in the US. Leading Crohn's disease companies developing emerging therapies, such as RedHill Biopharma, Merck, Teva Pharmaceutical, Pfizer, Agomab Therapeutics, Sanofi, Medibiofarma, Eli Lilly, NImmune, Avobis Bio, Abivax, Roche, Telavant, Mesoblast, Takeda, AstraZeneca, and others, are developing novel Crohn's disease drugs that can be available in the Crohn's disease market in the coming years. The promising Crohn's disease therapies in the pipeline include RHB-104, Tulisokibart (MK-7240, PRA023), Duvakitug (TEV-574), LITFULO (Ritlecitinib/PF-06651600), AGMB-129, Balinatunfib (SAR441566), MBF-118, MORF-057, Omilancor (BT-11), AVB-114, Obefazimod (ABX464), Afimkibart (RVT-3101 or RG6631), RYONCIL (Remestemcel-L), Zasocitinib (TAK-279), AZD7798, and others. Discover what is the best medicine for Crohn's disease @ Crohn's Disease Medication List Crohn's Disease Market Dynamics Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as budesonide, although 5-Aminosalicylates (5-ASA) are considered when steroids are not suitable. For moderate disease, immunomodulators like azathioprine, methotrexate, and 6-mercaptopurine are commonly used. However, long-term steroid use is generally avoided due to potential side effects. Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. REMICADE, the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. HUMIRA, introduced in 2007, provided an alternative for patients not responding to traditional treatments or REMICADE. In 2008, CIMZIA became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment. In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. ENTYVIO, approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. STELARA, launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks. SKYRIZI, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. RINVOQ, a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance. OMVOH, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks. While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. ALOFISEL (darvadstrocel), an allogeneic stem cell therapy, was approved in the EU (2018) and Japan (2021) for complex perianal fistulas in Crohn's disease patients. However, despite initial promise, Takeda discontinued its marketing authorization in the EU (December 2024), withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned pediatric trial for refractory complex perianal fistulas from its pipeline, limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the ongoing challenges in developing and commercializing advanced regenerative therapies for Crohn's disease, particularly in niche indications. Regarding the challenges for biologics, the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including INFLECTRA, RENFLEXIS, AVSOLA, and others. In 2023, biosimilars for HUMIRA, including AMJEVITA and CYLTEZO, entered the market, further enhancing affordability. TYRUKO, the first biosimilar for TYSABRI, was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With STELARA experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now TREMFYA. TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist. In the pediatric segment, treatment-related challenges are even more pronounced due to limited approved options. HUMIRA and REMICADE remain the primary TNF inhibitors, but early disease onset, aggressive progression, and long-term immunosuppression risks create significant unmet needs. Recently, in April 2025, the European Commission approved STELARA for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, immunogenicity and secondary loss of response remain key concerns. To address these gaps, pharmaceutical companies are advancing novel mechanisms of action, including integrin blockers, IL-12/IL-23 inhibitors, and JAK inhibitors, aiming for improved efficacy, safety, and durability in pediatric patients. The anticipated approvals of ENTYVIO in the near future, followed by RINVOQ and OMVOH for pediatric Crohn's disease patients, will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response. The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with TNF inhibitors (HUMIRA, REMICADE), IL-12/23 inhibitors (STELARA), and IL-23 inhibitors (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as JAK inhibitors, immunomodulators, and first-in-class therapies like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with improved clinical profiles, subcutaneous formulations, and greater convenience, driving higher penetration in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation. Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in next-generation biologics, oral small molecules, and novel combinations, the Crohn's disease treatment landscape is set to evolve significantly, reshaping the standard of care for both adult and pediatric patients. To know more about FDA-approved drugs for Crohn's disease, visit @ Crohn's Disease Treatment Crohn's Disease Pipeline Therapies and Key Companies The promising late- and mid-stage emerging pipeline assets for Crohn's disease include RHB-104 (RedHill Biopharma), Tulisokibart (Merck), LITFULO (Pfizer), AGMB-129 (Agomab Therapeutics), Duvakitug (Teva Pharmaceuticals and Sanofi), and others. RHB-104, developed by RedHill Biopharma, is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing RHB-204, a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104). Tulisokibart is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023, Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease. AGMB-129 is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024, the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025, Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The other therapies in the pipeline for Crohn's disease treatment include Omilancor (BT-11): NImmune AVB-114: Avobis Bio/Alimentiv Obefazimod (ABX464): Abivax RVT-3101 (RG6631): Roche RYONCIL (Remestemcel-L): Mesoblast Zasocitinib (TAK-279): Takeda AZD7798: AstraZeneca Balinatunfib (SAR441566): Sanofi MBF-118: Medibiofarma MORF-057: Eli Lilly/Morphic Therapeutic And others As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a significant portion of Crohn's disease patients remains refractory to multiple therapies, underscoring the need for breakthrough innovations beyond current biologic and small-molecule options; however, biological therapies remain expensive and face accessibility challenges, JAK inhibitors like RINVOQ are limited by serious safety concerns, and brand erosion following the patent expiry of market leaders such as REMICADE, HUMIRA, ENTYVIO, and STELARA is expected to lead to sales decline. Moreover, Crohn's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Crohn's disease market growth. Discover more about Crohn's disease drugs in development @ Crohn's Disease Clinical Trials Recent Developments in the Crohn's Disease Market In July 2025, the Phase III trial evaluating VELSIPITY (Etrasimod) a product of Arena (a wholly owned subsidiary of Pfizer), for the treatment of adult participants with moderately to severely active Crohn's disease, was terminated due to lack of efficacy in sub-study 1. In June 2025, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn's disease. In March 2025, the FDA approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease. In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers. In February 2025, Eli Lilly and Company announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderate-to-severely active Crohn's disease receiving 2 years of continuous treatment with OMVOH achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure at the Crohn's and Colitis Congress (CCC). In January 2025, the FDA approved OMVOH (mirikizumab) for Crohn's disease, further solidifying the IL-23 inhibitor class. With strong long-term efficacy, OMVOH is also being investigated for pediatric patients, potentially addressing a significant unmet need in this population. Crohn's Disease Overview Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities. Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected. Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections. Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning. Crohn's Disease Epidemiology Segmentation The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Crohn's Disease Prevalence Age-specific Diagnosed Crohn's Disease Prevalence Severity-specific Diagnosed Crohn's Disease Prevalence Scope of the Crohn's Disease Market Report Therapeutic Assessment: Crohn's Disease current marketed and emerging therapies Crohn's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Crohn's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Crohn's Disease Market Access and Reimbursement Download the report to understand which factors are driving Crohn's disease market trends @ Crohn's Disease Market Forecast Table of Contents Related Reports Inflammatory Bowel Disease Market Inflammatory Bowel Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IBD companies including Takeda Pharmaceutical, Janssen Pharmaceuticals, Hoffmann-La Roche, Genentech, AbbVie, Boehringer Ingelheim, Gilead Sciences, Arena Pharmaceuticals, Eli Lilly, AstraZeneca, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ulcerative colitis companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including TiumBio Co., Jiangsu Gensciences Inc., Pfizer, Novo Nordisk, Genzyme, AbbVie, Bayer, Spark Therapeutics, G & P Bioscience, Gritgen Therapeutics, Biocad, Belief Biomed, Chugai Pharmaceutical, Staidson Beijing BioPharmaceuticals, Jiangsu Gensciences, Poseida Therapeutics, Chia Tai Tianqing Pharmaceutical Group, Takeda, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalPhase 2Orphan Drug

25 Aug 2025

·www.biospace.com

Unswayed by Cerevel Failure, AbbVie Buys Gilgamesh’s Depression Drug for $1.2B

Brain doodle illustration, sketched colored concept about fresh ideas in human mind iStock/ LisaAlisa_ill The deal extends AbbVie’s commitment to the psychedelics space and depression, after emraclidine’s high-pro in schizophrenia last November. Not only is AbbVie jumping back into depression after a stunning failure last year, but the company is doing so with an eye-catching modality: psychedelics. After working closely with Gilgamesh Pharmaceuticals for over a year, AbbVie will buy the neuroscience biotech’s lead depression candidate for $1.2 billion. The deal was announced Monday morning, with AbbVie splitting the cash between an upfront payment and development milestones, which were not disclosed. The transaction will only include Gilgamesh’s lead asset, bretisilocin, which was not involved in the companies’ original May 2024 licensing partnership. The drug is being developed as a fast-acting, two-hour duration treatment option for major depressive disorder (MDD). The remaining assets in Gilagmesh’s stable—including those in the existing AbbVie collaboration—will be spun out into a new company called Gilgamesh Pharma Inc. This new entity will hold all of Gilgamesh’s employees and programs, which include an oral NMDA receptor antagonist called blixeprodil, a cardio-safe ibogaine analog and an M1/M4 agonist program. AbbVie will still have an option to license candidates from the new Gilgamesh entity, according to the terms of the original deal. The deal extends AbbVie’s commitment to the psychedelics space , one of the only Big Pharmas in the game. The other major player is Johnson & Johnson, which owns the esketamine-based Spravato, though the company has told BioSpace it doesn’t consider the depression drug to be a traditional psychedelic. AbbVie was cautious with the deal, reflecting the lower-than-expected valuation for the Gilgamesh asset, BMO Capital Markets said in a note Monday morning. “We believe the lower deal value could reflect conservatism around psychedelic valuations in light of regulatory backdrop for compounds, making today’s deal a well-balanced risk/reward acquisition for the company,” BMO’s Evan David Seigerman and colleagues wrote. Still, the deal reflects a vote of confidence in the psychedelics space. “Historically, large pharma has been less active exploring psychedelic compounds due to potential regulatory concerns surrounding approval, making today’s deal more significant, starting to validate that pharma could see a therapeutic outlet for some of these drugs,” BMO’s note read. And the deal makes sense for AbbVie, the analysts added, noting its existing neuroscience portfolio that features the MDD asset Vraylar. Others in the portfolio include Ubrelvy and Qulipta, which BMO said are under-appreciated compared to AbbVie’s headline-making immunology drugs Skyrizi and Rinvoq. Taking on Gilgamesh’s depression asset means that AbbVie is taking another shot at the condition after the failure of emraclidine . That asset was picked up at the end of 2023 in the nearly $9 billion acquisition of Cerevel Therapeutics but ultimately failed two Phase II trials last November. Meanwhile, a rival asset called Cobenfy from Bristol Myers Squibb’s acquisition of Karuna Therapeutics made its way to the market as the first new schizophrenia treatment in 35 years. In recent months, the drug has struggled to live up to expectations, failing a Phase III test testing it as an add-on treatment to atypical antipsychotics for schizophrenia. AbbVie will now take over development of bretisilocin, a short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser, which is being tested in a Phase II trial for moderate-to-severe MDD. In Phase IIa data revealed in May, bretisilocin beat a low-dose psychoactive comparator in reducing symptoms of depression. The drug showed a rapid onset within 24 hours, and the results were durable out to day 74 without additional treatment. BMO called the data impressive. At the time, Gerard Sanacora, professor of Psychiatry at Yale University and the director of the Yale Depression Research Program, compared the treatment to J&J’s Spravato, which achieves rapid results in the clinic. “The treatment fits nicely in the two-hour in-clinic framework established by esketamine, but with the potential for significantly fewer annual visits,” Sanacora said in a statement included in Gilgamesh’s May 27 release.

Phase 2AcquisitionPhase 3Clinical ResultLicense out/in

06 Aug 2025

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Biopharma CEOs Can’t Dodge Policy Questions as Trump Lobs Wrench into Earnings Season

iStock, SergeyNivens From tariffs to drug pricing to the FDA, biopharma CEOs find themselves pulled into policy discussions on this year’s second quarter earnings calls. President Donald Trump has been re-raising many issues that pharmaceutical CEOs were happy to have left behind in the first quarter as earnings reporting season continues. Across the pharma landscape, CEOs are doing their best to project the idea that there is nothing to worry about as the pressure from Washington grows. Last week, the president sent a round of letters to a batch of pharma CEOs , asking them to get to work implementing Most Favored Nation drug pricing. Tariffs of 15% were placed on Europe , which could have implications on the industry, while the president threatened tariffs as high as 250% on imported pharmaceutical products specifically—although not any time soon. Then there was the high-profile resignation of an FDA official , which some reports say can be traced all the way back to the White House. Inevitably, these issues were raised as companies reported second quarter earnings over the past week. On the CEO Letters Pfizer CEO Albert Bourla couldn’t dodge the questions about those letters . Analyst after analyst tried to chip away at Bourla’s well-trained responses, seeking any inkling of how the high-pro leader is faring in discussions with the president. “I’m happy the way that they listen to us, in the way that we are trying collectively to find solutions that, from one hand, could make medicines affordable in the U.S., on the other hand, will make our industry even more competitive compared to China,” Bourla said. Bourla was one of very few pharma CEOs who was personally named by the president in the letters. While most were the same, Bourla’s had his full name scratched out and his first name written, apparently in Trump’s handwriting. This signaled to analysts that he had a close connection with the president, which traces back to Pfizer’s Operation Warp Speed effort to develop the COVID-19 vaccine during the pandemic. Bourla confirmed that he had spoken directly to Trump to discuss the matters in the letter. But who is Trump’s closest pharma pal? If you ask Regeneron CEO Leonard Schleifer, it isn’t him. Queried about the president’s personalization of the letters, Schleifer said he hasn’t been to Washington lately to discuss drug pricing or other issues. The Regeneron chief executive was asked if he, or any of his peers at Eli Lilly or Pfizer, might have some sway over policy these days. “I think the president probably knows Regeneron and my first name, given that it was Regeneron’s cocktail for COVID that may have saved his life,” Schleifer said. “Beyond that, I don’t have any great insights to the policies.” His counterparts at Lilly and Pfizer have been more active in attempting to influence policy at this time, Schleifer added. Bourla confirmed as much in his earnings comments days later, while Lilly has yet to report. On the specifics of the drug pricing plan, Schleifer said he agrees with the president that European nations are not paying their fair share for drugs. He said to change this “complicated” reality, policy and trade need to be adjusted, because companies can’t do it alone. “American consumers should not be paying for all of the innovation. The solution is simply not to lower prices in the U.S. without some equilibrating in Europe because then there’ll be no innovation,” Schleifer said. AstraZeneca’s Pascal Soriot agreed, saying that his company has been lobbying the Trump administration and offering some policy proposals that could achieve what the president is trying to do. But he also noted that access to new medications needs to be considered as the pricing discussion continues. “In many countries in Europe, patients wait for years to get access to medicines that could save their lives,” Soriot said on AstraZeneca’s earnings call last week. AbbVie’s Robert Michael, meanwhile, credited the president’s One Big Beautiful Bill Act with expanding the orphan drug exemption to the benefit of cancer therapy Venclexta. Michael said the company had assumed that drug would be subject to price negotiations soon under the Inflation Reduction Act, but with the change in the newer bill, Venclexta is not expected to be subject. “That’s an example of a good policy change where innovation is being rewarded and not penalized,” Michael said during AbbVie’s call last week. On FDA Disruption If anyone has insight into the inner workings of the FDA drug approval machine right now, it’s Moderna’s regulatory team. On a Friday earnings call , President Stephen Hoge said the company was pleased with the three approvals they received in the past quarter. “I will note that they happened on time, and that was through the incredibly diligent work of the folks at FDA to conduct those reviews in a rigorous way, and we continue to feel that those productive dialogues are going on now even on our existing files for the seasonal update,” he said. Hoge pledged to work closely with the FDA to transparently respond to any questions, even after the much-publicized changes within the Center for Biologics Evaluation and Research (CBER), and the CDC, including at the agency’s Advisory Committee on Immunization Practices . When any questions are received by the agencies to help inform public health, Hoge said that Moderna will make sure to provide that information. On Tariffs Many CEOs—of Vertex Pharmaceuticals, Moderna, Takeda, Regeneron and many more—brushed off the threat of tariffs to the pharmaceutical industry, especially for near term impacts this year. There’s still too much uncertainty on what exactly will be taxed, so the executives weren’t willing to speculate. But AbbVie’s Michael went a bit further, noting that one of his company’s largest products, Skyrizi, is made in the U.S. for the domestic market. Longer term, AbbVie plans to add even more U.S. manufacturing capacity, as part of a $10 billion capital investment announced on last quarter’s earnings call. This would include four sites for active pharmaceutical ingredients, peptide dug products and devices. Otherwise, Michael, like his fellow CEOs, will wait for the Section 232 process to complete before commenting further on how tariffs will impact AbbVie. Merck’s Robert Davis took a shot at providing some clarity to analysts about what a 15% tariff would be like for the Keytruda-maker. While he wouldn’t give specific guidance, he said that if 15% tariffs were implemented today, the impact would be minimal as Merck has conducted inventory management and moved manufacturing to the U.S. already. Similarly, AstraZeneca CFO Aradhana Sarin explained that since the first quarter, the company has been managing the potential tariff impact through inventory. AstraZeneca is also starting tech transfers for some products that are not currently manufactured in the U.S. Still, Sarin expects little impact. For its part, Pfizer included potential impacts of Most Favored Nation drug price changes and tariffs in its guidance this quarter—specifically factoring in the currently implemented tariffs on Canada, China and Mexico—but declined to provide actual numbers, to the chagrin of analysts on the call. Bourla, like his fellow pharma execs, said that Pfizer will await the conclusion of the Section 232 investigation before elaborating on tariffs’ impact to the company, though he did note that Pfizer is talking with trade officials about tariffs.

Vaccine

100 Deals associated with Risankizumab-RZAA

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KEGG	Wiki	ATC	Drug Bank
-	Risankizumab-RZAA	L04AC18	DB14762

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	AbbVie, Inc.	04 Mar 2025
Crohn's disease, active severe	China	AbbVie, Inc.	04 Mar 2025
Colitis, Ulcerative	Japan	AbbVie, Inc.	26 Sep 2022
Crohn Disease	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active moderate	Australia	AbbVie Pty Ltd.	16 Jul 2019
Ulcerative colitis, active severe	Australia	AbbVie Pty Ltd.	16 Jul 2019
Plaque psoriasis	Canada	AbbVie, Inc.	17 Apr 2019
Arthritis, Psoriatic	Japan	AbbVie, Inc.	26 Mar 2019
Erythrodermic psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Psoriasis vulgaris	Japan	AbbVie, Inc.	26 Mar 2019
Pustular psoriasis	Japan	AbbVie, Inc.	26 Mar 2019
Pustulosis of Palms and Soles	Japan	AbbVie, Inc.	26 Mar 2019

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	Phase 3	United States	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Australia	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Canada	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	France	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Germany	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Italy	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Poland	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	Spain	AbbVie, Inc.	08 Jul 2024
Juvenile Idiopathic Arthritis	Phase 3	United Kingdom	AbbVie, Inc.	08 Jul 2024
Keratoderma, Palmoplantar	Phase 3	United States	AbbVie, Inc.	26 Feb 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03047395 (LIMMitless, Pubmed \| Am J Clin Dermatol)	Phase 3	Plaque psoriasis	897	Risankizumab 150 mg	ensyzhtvij(aqtkabkefc) = vgojambjjy kqgrudmmtl (mlalqfbcaa ) View more	Positive	29 Jul 2025
NCT04435600 (OptIMMize-1, CTgov)	Phase 3	Plaque psoriasis \| Chronic large plaque psoriasis	139	Risankizumab (Part 1: Risankizumab)	ogmrjozhry = vfgfbzzglq oovsypchih (hnsxnjacwu, qddvydpyyp - opixsotdwb) View more	-	20 May 2025
				Ustekinumab (Part 2 Period A: Ustekinumab)	ogmrjozhry = erlgqgmmyi oovsypchih (hnsxnjacwu, jbamqdclcm - rbwqlsimcq) View more
ADVANCE, MOTIVATE, FORTIFY (Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease Maintenance high-sensitivity C-reactive protein (hs-CRP) \| fecal calprotectin (FCP)	748	Risankizumab 600 mg	khvxwrmyiv(zrjfjtzpsp) = ahgegvholc rkdwtewsli (olmijukrwj ) View more	Positive	04 Apr 2025
				Risankizumab 180 mg	khvxwrmyiv(zrjfjtzpsp) = aqjunvnqze rkdwtewsli (olmijukrwj ) View more
NCT03105128 (MOTIVATE, ADVANCE, FORTIFY, Pubmed \| Clin Gastroenterol Hepatol)	Phase 3	Perianal fistula due to Crohn's disease anti-interleukin-23 p19 monoclonal antibody	-	Risankizumab 1200 mg IV	utzcbzcyxn(qtahdkycet) = dpibwdoexn vbiztigbtw (ycwkxywdap ) View more	Positive	01 Feb 2025
				Risankizumab 180 mg SC	utzcbzcyxn(qtahdkycet) = pcdbaihpwv vbiztigbtw (ycwkxywdap ) View more
FORTIFY (Pubmed \| Gastro Hep Adv)	Phase 3	Crohn Disease Maintenance	-	Risankizumab	hwmbehhdqj(rqvsntrrmb) = lhyqzfmuph wnwfrturtz (mwunvlweyg )	Positive	01 Jan 2025
NCT03047395 (LIMMitless, CTgov)	Phase 3	Plaque psoriasis	2,170	Risankizumab	albcjpgwfm = jyzqdnehcr hkzexmiuph (iajvxejyeu, vqjbnbmzzg - ajbzqpjgjq) View more	-	11 Dec 2024
NCT03219437 (IMMbrace, Pubmed)	-	Plaque psoriasis	98	利生奇珠单抗	dfyzncbsyd(ffweogdwbc) = mwiytkorce ptylnyeigw (glytxnvhty ) View more	Superior	07 Dec 2024
				甲氨蝶呤	dfyzncbsyd(ffweogdwbc) = versnsjbni ptylnyeigw (glytxnvhty ) View more
RISANCROHN STUDY (UEGW2024)	Phase 3	Refractory sprue C-reactive protein (CRP) \| faecal calprotectine (FC)	417	Risankizumab	ckdouytrkw(wijfsfgmvn) = 23 patients (5.5%) presented adverse events including 6 infections hfnoismidq (rpjdulrhzo ) View more	Positive	13 Oct 2024
UEGW2024	Not Applicable	Ulcerative colitis, active severe	-	Risankizumab 1200 mg IV	klhficxibo(hpudfhbbpn) = ouvsygdpkm dfcukwovyr (zuzjikzbfl )	-	13 Oct 2024
				Placebo IV	klhficxibo(hpudfhbbpn) = ggomhivnvf dfcukwovyr (zuzjikzbfl )
UEGW2024	Not Applicable	Perianal fistula due to Crohn's disease	-	Risankizumab	lsopfloksg(kndsfurgri) = documented in 12.6% (32/253) of patients, including fatigue, pruritus, nausea, joint pain, and upper-respiratory tract infection gfsdqbhbaa (suldbuyfgn ) View more	-	13 Oct 2024
				Risankizumab (Ustekinumab-naïve patients)

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