This is a Phase IV, open-label, multicenter study evaluating the impact of upadacitinib on the frequency of acute anterior uveitis (AAU) in adults with axial spondyloarthritis (axSpA) and a documented history of AAU in the prior 52 weeks. Approximately 200 participants will be enrolled across North America and Europe, including both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. The primary objective is to assess the change in exposure-adjusted AAU event rate during 52 weeks of treatment with upadacitinib 15 mg once daily. Secondary objectives include evaluating the effect of upadacitinib on disease activity, pain, physical function, quality of life, and sleep. Safety and tolerability will also be assessed throughout the study.

Start Date01 Nov 2025

Sponsor / Collaborator

Canadian Research and Education (CaRE Arthritis).

NCT07138898

/ Not yet recruitingPhase 2IIT

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

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

NCT06016517

/ Not yet recruitingNot ApplicableIIT

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
* What are the effects of different treatments on RA symptoms and condition for each individual patient
* What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life fortnightly, monthly and/or quarterly (either in clinic or remotely) and report their level of pain on alternate days (remotely).

Start Date15 Aug 2025

Sponsor / Collaborator

Tufts Medical Center, Inc.

100 Clinical Results associated with Upadacitinib hemihydrate

100 Translational Medicine associated with Upadacitinib hemihydrate

100 Patents (Medical) associated with Upadacitinib hemihydrate

1,406

Literatures (Medical) associated with Upadacitinib hemihydrate

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Clinical observation of 10 cases of stable non-segmental vitiligo in adults treated with upadacitinib

Article

Author: Li, Ruyi ; Zhang, Wen ; Yuan, Mingzhu ; Sun, Yi

OBJECTIVE:

To evaluate the efficacy and safety of upadacitinib in treating stable nonsegmental vitiligo in adults.

METHODS:

Data were collected from adult patients with stable nonsegmental vitiligo treated with upadacitinib at Jingzhou Hospital of Yangtze University between November 2023 and November 2024. Treatment efficacy was compared at 8 and 16 weeks and any adverse reactions were recorded.

RESULTS:

A total of 10 patients were included, 6 of whom also received 308 nm excimer laser therapy. A total of 200 lesions were observed, with 146 receiving additional laser therapy. After 8 weeks of treatment, 60.0% of lesions achieved at least 25% pigmentation, while 27.0% achieved more than 50% pigmentation. After 16 weeks, these rates increased to 78.0% and 52.5%, respectively. Treatment efficacy was greater at 16 weeks compared to 8 weeks (p < 0.001). Acral lesions showed lower response rates compared to lesions on the face, neck, trunk, and limbs (p < 0.05). There was no statistically significant difference in efficacy between upadacitinib monotherapy and combination therapy with phototherapy (p > 0.05). Among the 10 patients, 6 achieved over 50% improvement in total VASI score after 16 weeks, while 4 showed more than 75% improvement.

CONCLUSION:

Upadacitinib is safe and effective treatment for stable non-segmental vitiligo in adults.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Upadacitinib in daily practice for refractory atopic dermatitis in adolescents: a case series of the BioDay registry

Article

Author: Vroman, Florence ; Loman, Laura ; de Bruin-Weller, Marjolein S. ; Schuttelaar, Marie-Louise L. A. ; Zuithoff, Nicolaas P. A. ; Kamsteeg, Marijke ; van der Rijst, Lisa P. ; Bacoş-Cosma, Octavian I. ; de Graaf, Marlies ; van Lumig, Paula P. M.

PURPOSE:

Upadacitinib is approved for treating moderate-to-severe atopic dermatitis (AD) aged ≥12 years. We evaluated upadacitinib's effectiveness and safety in AD adolescents in daily practice.

MATERIALS AND METHODS:

Fifteen adolescent AD patients from the BioDay registry, treated with upadacitinib 15 mg once daily were evaluated at baseline and after 4, 8, 16, and 28 weeks. Effectiveness was assessed using Eczema Area and Severity Index (EASI) score and Investigator Global Assessment (IGA) score. Patient-reported outcomes included Numeric Rating Scale (NRS) for pruritus and presence of sleep disturbance. Adverse events (AEs) were evaluated at each visit.

RESULTS:

Mean EASI score significantly decreased from 13.4 (95% CI 8.5-18.3) to 7.8 (95% CI 2.4-13.3) after 28 weeks (p = .002). Mean NRS pruritus significantly decreased from 6.5 (95% CI 4.9-8.2) to 4.8 (95% CI 3.0-6.6) after 28 weeks (p = .003). At week 16, 75.0% (95% CI 46.8-91.1) achieved EASI ≤7, and 50.0% (95% CI 25.4-74.6) achieved NRS pruritus ≤4. Overall, 31 AEs were reported in 10 patients (66.7%). Five patients (33.3%) discontinued treatment: two due to ineffectiveness, two due to AEs, and one due to laboratory monitoring problems.

CONCLUSIONS:

Our findings indicate that upadacitinib is effective and relatively safe for adolescents with moderate-to-severe AD; however, 33.3% discontinued treatment.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Vitiligo exacerbation during upadacitinib treatment for atopic dermatitis and improvement following a switch to abrocitinib: a case report

Article

Author: Wang, Zhaoyang ; Wang, Meng ; Sun, Yonghu

AIM:

Janus kinase (JAK) inhibitors have emerged as targeted therapies for atopic dermatitis (AD), and increasing evidence suggests their potential benefit in vitiligo. While both diseases are considered immunologically distinct, recent insights point to overlapping cytokine pathways that may be modulated by JAK1-selective inhibitors.

MATERIALS AND METHODS:

We present a case of a 37-year-old male with moderate-to-severe AD and stable vitiligo who developed worsening of vitiligo following treatment with upadacitinib. Although AD symptoms resolved, vitiligo lesions progressed despite phototherapy.

RESULTS:

After switching from upadacitinib to abrocitinib, the patient experienced marked repigmentation of vitiligo lesions within three months, along with continued control of AD symptoms.

CONCLUSIONS:

This case highlights the differential effects of upadacitinib and abrocitinib, possibly due to their distinct JAK2 inhibition profiles. The findings underscore the importance of considering kinase selectivity when using JAK inhibitors in patients with overlapping immune-mediated skin disorders.

442

News (Medical) associated with Upadacitinib hemihydrate

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

22 Aug 2025

·pipelinereview.com

AbbVie Announces Positive Topline Results from Second Phase 3 UP-AA Trial Evaluating Upadacitinib (RINVOQ®) for Alopecia Areata

NORTH CHICAGO, IL, USA I August 21, 2025 I AbbVie (NYSE: ABBV ) today announced positive topline results from the second of two pivotal studies of the Phase 3 UP-AA clinical program evaluating the safety and efficacy of upadacitinib (RINVOQ ® ; 15 mg and 30 mg, once daily) in adult and adolescent patients with severe alopecia areata (AA) with a mean baseline SALT score of 84.0 (approximately 16% scalp hair coverage). 1 In Study 1, both doses of upadacitinib achieved the primary endpoint, with 45.2% and 55.0% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reaching 80% or more scalp hair coverage (SALT score ≤ 20) at week 24, compared to 1.5% of patients receiving placebo (p<0.001). 1 These results are consistent with the topline results previously announced from the first parallel replicate study (Study 2) of the Phase 3 UP-AA clinical program. “These positive results strengthen the growing body of evidence supporting the potential of upadacitinib to improve the lives of people with AA,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “We are very encouraged by the improvements in both scalp and non-scalp hair regrowth observed with both doses of upadacitinib and look forward to submitting these data to regulatory bodies, bringing us one step closer to delivering upadacitinib to those living with this complex immune-mediated disease.” 35.2% and 45.8% of patients treated with upadacitinib 15 mg and 30 mg, respectively, reached 90% or more scalp hair coverage (SALT ≤ 10), compared to 0.7% of patients receiving placebo at week 24 (p<0.001). 1 Additional key secondary endpoints that were met included percentage of subjects with improvements in eyebrows and eyelashes, as well as the percentage of subjects with complete scalp hair coverage (SALT=0) with both doses of upadacitinib at week 24. 1 “People living with AA often face considerable uncertainty related to both the severity and duration of hair loss, despite current treatment options,” said Arash Mostaghimi, M.D., M.P.A., M.P.H., associate professor of dermatology and vice chair of clinical trials and innovation, Brigham & Women’s Hospital, Harvard Medical School. “These encouraging results are consistent with and reinforce the outcomes observed in the first pivotal trial. Together, these findings underscore the potential of upadacitinib to provide meaningful hair regrowth, offering hope for those enduring the psychosocial burden associated with this disease.” The safety profile of both doses of upadacitinib in the 24-week, placebo-controlled period (Period A) was generally consistent with that observed in approved indications. 1 Treatment-emergent serious adverse events occurred in 1.9% and 1.8% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and 0.7% in the placebo group. 1 Discontinuations due to treatment-emergent adverse events (TEAEs) occurred in 1.1% and 1.5% of patients in the upadacitinib 15 mg and 30 mg groups, respectively, and none in the placebo group. 1 The most common TEAEs observed were upper respiratory tract infection, acne, blood creatine phosphokinase increased and nasopharyngitis. 1 Serious infections were reported infrequently with one in the placebo group and one in the upadacitinib 30 mg group, and none in the upadacitinib 15 mg group group. 1 There were no adjudicated MACE, adjudicated venous thromboembolic events or deaths reported. 1 One malignancy (breast cancer) was reported in the upadacitinib 15 mg group. 1 Use of upadacitinib in AA is not approved and its safety and efficacy have not been evaluated by regulatory authorities. About UP-AA Clinical Trial UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. The Phase 3 randomized, placebo-controlled, double-blind studies evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata. In Study 1 and Study 2 Period A, participants are randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A will continue their same treatment in Period B for 28 weeks. Participants originally randomized to placebo in Period A will either remain on placebo in Period B, or be randomized in one of two groups, based off of their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. The two trials randomized 1,399 participants with severe AA ages 12 to 64 across 248 sites worldwide. More information on this trial can be found at www.clinicaltrials.gov ( NCT06012240 ). About RINVOQ Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. 2 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. 3,4,5,6,7 RINVOQ (upadacitinib) U.S. Uses and Important Safety Information 1 RINVOQ is a prescription medicine used to treat: Please click here for the Full Prescribing Information and Medication Guide . Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X (formerly Twitter) and YouTube. 1 AbbVie. Data on file ABVRRTI81580. 2 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025. 3 A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898 . Accessed January 15, 2025. 4 Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643 . Accessed January 15, 2025. 5 A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182 . Accessed January 15, 2025. 6 A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411 . Accessed January 15, 2025. 7 A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240 . Accessed January 15, 2025. SOURCE: AbbVie

Clinical ResultPhase 3Phase 2

100 Deals associated with Upadacitinib hemihydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10994 D11048	Upadacitinib hemihydrate	L04AA44	DB15091

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Giant Cell Arteritis	European Union	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Iceland	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Norway	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Polyarticular Juvenile Idiopathic Arthritis	United States	AbbVie, Inc.	26 Apr 2024
Crohn's disease, active moderate	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Moderate Atopic Dermatitis	United States	AbbVie, Inc.	14 Jan 2022
Severe Atopic Dermatitis	United States	AbbVie, Inc.	14 Jan 2022
Crohn Disease	Canada	AbbVie AS	16 Jan 2020
Ankylosing Spondylitis	European Union	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Iceland	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Norway	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Dyssomnias	Phase 3	-	AbbVie, Inc.	23 May 2024
Nonsegmental vitiligo	Phase 3	United States	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	China	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Japan	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Argentina	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Belgium	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Bulgaria	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Canada	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	Chile	AbbVie, Inc.	19 Dec 2023
Nonsegmental vitiligo	Phase 3	France	AbbVie, Inc.	19 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06012240 (UP-AA, Company_Website) Manual	Phase 3	Alopecia Areata	397	Upadacitinib 15 mg (Study 1)	bjumkqdnhu(ugrmafknbw) = jwbrluruso ftpzvblmav (whfntcuzzo ) Met View more	Positive	22 Aug 2025
				Upadacitinib 30 mg (Study 1)	bjumkqdnhu(ugrmafknbw) = hvxdzkxjjf ftpzvblmav (whfntcuzzo ) Met View more
NCT06012240 (UP-AA M23-716, Company_Website) Manual	Phase 3	Alopecia Areata	1,399	Upadacitinib 15 mg (Study 2)	cutbgpnpmd(jfzjeypeua) = vwvfxkwvzp avmmwxocki (evponpknzq ) Met View more	Positive	30 Jul 2025
				Upadacitinib 30 mg (Study 2)	cutbgpnpmd(jfzjeypeua) = aotxlldngb avmmwxocki (evponpknzq ) Met View more
NCT05507580 (Flex-Up, CTgov)	Phase 4	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	461	Upadacitinib (UPA 15 mg Double-Blind Treatment Period --> UPA 15 mg Single-Blind Treatment Period)	ebutsgmvqn = ahbhuyszwh jpcsvdodxf (cpjgomzodb, fbelbqkkmj - ofpqhhlpby) View more	-	29 Jul 2025
				Upadacitinib (UPA 15 mg Double-Blind Treatment Period --> UPA 30 mg Single-Blind Treatment Period)	ebutsgmvqn = wjqyziztxh jpcsvdodxf (cpjgomzodb, nulgbtngmv - rrnwdliwve) View more
NCT03345823 (U-ENDURE, Pubmed \| J Crohns Colitis)	Phase 3	Perianal fistula due to Crohn's disease Maintenance	228	Upadacitinib 15 mg	prxchnunqt(ejoautigys) = ≥ 5.0 events/100 person-years whblctzwjy (vxmircwgvk ) View more	Positive	24 Jul 2025
				Upadacitinib 30 mg
["Measure Up 2"] (Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Dermatitis, Atopic	1,683	Upadacitinib 15 mg	drojsgizew(kjefzluopb) = mokubsxkbk nvnpvgavvl (eokmlpmsov ) View more	Positive	14 Jul 2025
				Upadacitinib 30 mg	drojsgizew(kjefzluopb) = jqkfqhpgwd nvnpvgavvl (eokmlpmsov ) View more
U-ACHIEVE and U-ACCOMPLISH (Pubmed \| J Crohns Colitis)	Phase 3	Ulcerative colitis, active severe Maintenance	-	Upadacitinib 45 mg	mtdrtiatxb(prnorvcjht) = blcffxoayg krewaenkhh (dqwrvdfbcl ) View more	Positive	03 Jul 2025
				Upadacitinib 30 mg	mtdrtiatxb(prnorvcjht) = arwrzzczec krewaenkhh (dqwrvdfbcl ) View more
NCT03006068 (U-ACTIVATE, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 3	Ulcerative colitis, active severe	414	Upadacitinib 15 mg	zoiqzkrsfb(rhdkdryhmq) = nxskxvbser tajwufexup (grnckpohpn ) View more	Positive	01 Jun 2025
				Upadacitinib 30 mg	zoiqzkrsfb(rhdkdryhmq) = gmjsifbzfk tajwufexup (grnckpohpn ) View more
NCT03725202 (SELECT-GCA, Pubmed \| N Engl J Med)	Phase 3	Giant Cell Arteritis	-	Upadacitinib 15 mg	aprqvubbps(ekmmenpfea) = hgnyadlpkm cxfhuylgsq (xqxwagmisg, 39.6 - 53.2)	Positive	29 May 2025
				Placebo	aprqvubbps(ekmmenpfea) = wceerarslh cxfhuylgsq (xqxwagmisg, 20.6 - 37.5)
NCT03725202 (SELECT-GCA, FDA_CDER) Manual	Phase 3	Giant Cell Arteritis	321	RINVOQ 15 mg +26-week corticosteroid taper	ozxvmlyuvf(vumtxdrztz) = qxeyusvoqh ywphkebibj (xztkjvxvir ) View more	Positive	28 Apr 2025
				Placebo + 52-week corticosteroid taper	ozxvmlyuvf(vumtxdrztz) = ouhkymxrll ywphkebibj (xztkjvxvir ) View more
NCT02706951 (SELECT-MONOTHERAPY, Pubmed \| RMD Open)	Phase 3	Rheumatoid Arthritis methotrexate	648	Upadacitinib 15 mg	ouybwypcbe(uxyrpperot) = 0.7% nucwnujvob (xftaecfzlg )	Positive	01 Apr 2025

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