A Single-center, Single-arm, Open-label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria

The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU). CSU is hives and itching lasting over six weeks. Ritlecitinib is approved by the Food and Drug Administration (FDA) to treat another condition, but it is not approved for treating CSU. Participation is expected to last 20 weeks and include 7 clinic visits. This study will involve physical examinations, blood tests, looking at and taking pictures of participant's skin and hives, optional skin biopsies, and hearing tests. Eligible participants for this study will take ritlecitinib for 12 weeks and complete a daily diary about their skin and hives. The main risks of being in this study are side effects from ritlecitinib. Less than 1 in 10 people taking ritlecitinib experience diarrhea, acne, hives, rash, inflammation of hair follicles, dizziness, and increased blood levels of creatine phosphokinase (a muscle protein). Participants could also experience a rare but serious side effect, such as shingles, unusual infection, cancer, or blood clot. Benefits of participating in this study include a potential improvement in participant's condition and quality of life. Participating in this study may also help researchers develop new ways of helping future patients.

Start Date30 Sep 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

NCT07029828

/ Not yet recruitingPhase 3

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

Start Date15 Aug 2025

Sponsor / Collaborator

Pfizer Inc.

NCT07029711

/ RecruitingPhase 3

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.
This study is seeking participants who have:
* at least 50% scalp hair loss due to alopecia areata.
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
* history of clinical response failure to alopecia areata treatment (for children in EU/UK only).
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken once each day at home.
The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.

Start Date31 Jul 2025

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Ritlecitinib Tosilate

100 Translational Medicine associated with Ritlecitinib Tosilate

100 Patents (Medical) associated with Ritlecitinib Tosilate

176

Literatures (Medical) associated with Ritlecitinib Tosilate

01 Sep 2025·JAAD case reports

Erosive oral lichen planus successfully treated with JAK3/TEC inhibitor ritlecitinib: A case report

Article

Author: Katz, Abigail ; Talia, Jordan ; Patel, Deep ; Ahmed, Areeba ; Soto-Canetti, Gabriela ; Lambert, Raphaella ; Adalsteinsson, Jonas A

13 Aug 2025·Journal of the American Chemical Society

Modular Synthetic Platform for the Elaboration of Fragments in Three Dimensions for Fragment-Based Drug Discovery

Article

Author: Lucas, Simon C. C. ; Firth, James D. ; Klein, Hanna F. ; Gomez-Angel, Andres R. ; Palmer, Cameron J. ; Donald, James R. ; Storer, R. Ian ; Yao, Stephen Y. ; Lincoln, Joshua ; Fusani, Lucia ; O’Brien, Peter ; Appiani, Rebecca

Fragment-based drug discovery (FBDD) is a key strategy employed in the hit-to-lead phase of pharmaceutical development. The rate-limiting step of this process is often identifying and optimizing synthetic chemistry suitable for fragment elaboration, especially in three dimensions (3-D). To address this limitation, we herein present a modular platform for the systematic and programmable elaboration of two-dimensional (2-D) fragment hits into lead-like 3-D compounds, utilizing nine bifunctional building blocks that explore a range of vectors in 3-D. The building blocks comprise (i) rigid sp³-rich bicyclic cyclopropane-based structures to fix the vectors and (ii) two synthetic handles─a protected cyclic amine and a cyclopropyl N-methyliminodiacetic acid (MIDA) boronate. To validate our approach, we present (i) multigram-scale synthesis of each 3-D building block; (ii) Suzuki-Miyaura cross-coupling reactions of the cyclopropyl BMIDA functionality with aryl bromides; and (iii) N-functionalization (via commonplace medicinal chemistry toolkit reactions) of arylated products to deliver 3-D lead-like compounds. Each building block accesses a distinct 3-D exit vector, as shown by analysis of the lowest energy conformations of lead-like molecules using RDKit, and by X-ray crystallography of pyrimidine methanesulfonamide derivatives. Since the synthetic methodology is established in advance of fragment screening and utilizes robust chemistry, the elaboration of fragment hits in 3-D for biochemical screening can be achieved rapidly. To provide proof-of-concept, starting from the drug Ritlecitinib, the development of inhibitors of Janus kinase 3 (JAK3) around a putative pyrrolopyrimidine 2-D fragment hit was explored, streamlining the discovery of a novel and selective JAK3 inhibitor with IC₅₀ = 69 nM.

12 Aug 2025·Dermatology and Therapy

Evaluating Current and Emergent JAK Inhibitors for Alopecia Areata: A Narrative Review.

Review

Author: Englander, Hanna ; Gregoire, Samantha ; Sanchez, Katherine ; Ershadi, Sherry ; Biba, Ursula ; Mostaghimi, Arash ; Salloum, Lana

Alopecia areata (AA) is an autoimmune condition characterized by non-scarring hair loss on the scalp, face, and body, affecting approximately 2% of the global population. Current treatments, including topical corticosteroids, topical immunotherapies, and systemic immunosuppressants, often demonstrate inconsistent efficacy and raise concerns about long-term safety, emphasizing the need for safer and more effective therapies. Janus kinase (JAK) inhibitors have emerged as a promising treatment option, offering a targeted approach by addressing the immune-mediated mechanisms driving hair follicle destruction in AA. Recent clinical advances have led to FDA approval of three JAK inhibitors-baricitinib, ritlecitinib, and deuruxolitinib-based on pivotal trials showing significant hair regrowth. Baricitinib has demonstrated durable efficacy, with 35-40% of patients achieving a Severity of Alopecia Tool (SALT) score ≤ 20 at 36 weeks. Ritlecitinib similarly reported 23% of patients achieving a SALT score ≤ 20 at week 24. Deuruxolitinib has also shown efficacy with 31% of patients achieving a SALT score ≤ 20 at 24 weeks. Off-label use of JAK inhibitors like tofacitinib and ruxolitinib have also demonstrated efficacy in limited studies. This review aims to consolidate and summarize the latest clinical evidence and trial data on JAK inhibitors for AA, providing an up-to-date resource for clinicians and researchers to guide evidence-based management and optimize therapeutic outcomes.

News (Medical) associated with Ritlecitinib Tosilate

04 Aug 2025

·www.fiercepharma.com

AbbVie flashes eye-opening results for Rinvoq in alopecia areata

There are three oral JAK inhibitors on the market to treat alopecia areata. AbbVie has shown data for Rinvoq that shows it may be set up to become the fourth entrant in the indication. While the JAK inhibitor market for alopecia areata (AA) has grown increasingly crowded in recent years, Rinvoq’s clinical performance in the hair follicle-attacking autoimmune disease could earn AbbVie a prominent seat at the table.After 24 weeks of treatment, Rinvoq (upadacitinib) at two doses—15 mg and 30 mg—helped 44.6% and 54.3% of adult alopecia patients achieve 80% or more scalp hair coverage, respectively, in a phase 3 trial. That compared to just 3.4% of patients on placebo who achieved the same level of hair growth.Patients enrolled in the study entered at a baseline of roughly 16% scalp hair coverage, as determined by the severity of alopecia tool (SALT), AbbVie said in a July 30 press release.Meanwhile, across the same two Rinvoq doses, 36% and 47.1% of patients achieved 90% or more scalp hair coverage versus just 1.4% of patients in the trial’s control arm, AbbVie said.Rinvoq also met several secondary endpoints in the study by improving eyebrow and eyelash coverage and helping a certain percentage of patients on both doses achieve complete scalp hair coverage at the trial’s 24-week mark."Often misunderstood as a cosmetic issue, AA is a systemic immune-mediated disease that can cause total hair loss, involving the scalp, eyebrows and eyelashes," Kori Wallace, M.D., Ph.D., AbbVie's vice global head of immunology clinical development, said in a release. "UP-AA is the first pivotal program to have ranked and met the rigorous standard of SALT=0, indicating complete scalp hair regrowth."AbbVie did not indicate a regulatory plan for Rinvoq in the indication. The company is awaiting results from a parallel replicate study, which are expected later this quarter. While cross-trial comparisons are often problematic because of differences in timing, patient populations and other variables, Rinvoq appears to provide better results than three other JAK inhibitors currently on the market in the indication.The most recently approved treatment for alopecia, Sun Pharma’s Leqselvi, was tested on 1,220 patients in two trials with an average scalp coverage of 13%. At the 24-week mark, more than 30% of patients saw their scalp coverage increase to at least 80%.Eli Lilly’s Olumiant was approved in 2022 for alopecia based on trials that showed between 17% and 22% of patients taking a 2 mg daily dose achieve 80% scalp coverage after 36 weeks, while 32% to 35% of patients taking a 4 mg daily dose reached the same standard. Pfizer’s Litfulo was approved in 2023 after a study showed 23% of patients reached 80% or more of scalp coverage after six months of treatment.Last week, AbbVie reported Rinvoq’s second-quarter sales at $2.03 billion for a 42% year-over-year increase. The product generated $5.97 billion in revenue last year. The treatment hit the market in 2019 to treat patients with rheumatoid arthritis. Since then, it has been cleared in several other indications, including psoriatic arthritis, atopic dermatitis, Crohn’s disease and ulcerative colitis.

Clinical ResultPhase 3Drug Approval

14 Jul 2025

·www.fiercepharma.com

Sun Pharma's alopecia med Leqselvi hits US market after Incyte patent settlement

Incyte's lawsuit claiming patent infringement had previously prevented Sun Pharma from launching its Leqselvi. After resolving a patent dispute with Incyte, Sun Pharma has officially launched its JAK inhibitor Leqselvi in the U.S.Sun’s Leqselvi is now available for prescription to eligible patients with severe alopecia areata nationwide, the company announced on Monday. The drug is poised to compete with Pfizer’s rivaling Litfulo and Eli Lilly and Incyte’s first-to-market Olumiant.“Adding Leqselvi to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community,” Sun’s CEO Richard Ascroft said in the company’s release.The launch comes after a legal back-and-forth with Incyte has now ended in a settlement agreement. While the specific terms of the settlement and license agreement are confidential, Incyte offered Sun a limited, non-exclusive license to certain patents for Leqselvi’s U.S. use in agreed-upon non-hematology/oncology indications, including alopecia areata. In exchange, Sun will pay Incyte an upfront plus royalty payments until the patents expire.The two will “mutually release” each other of claims stemming from the litigation and are to seek dismissal of the pending lawsuit at a New Jersey U.S. District Court, Sun announced in a separate press release.Incyte calls the agreement a “successful settlement” and a “positive outcome” that “aligns with Incyte’s long-term business objectives,” the company said in its own press release.Incyte had come after Sun and its Leqselvi with a 2024 lawsuit claiming that the drug is structurally identical to its own blockbuster JAK inhibitor franchise ruxolitinib, which is marketed as oral Jakafi and topical Opzelura. The patent in question covers ruxolitinib’s use in immune-related diseases, skin disorders, myeloid proliferative disorders and cancer.One main concern of Incyte’s suit was that Leqselvi would be sold at a lower price than Jakafi, potentially leading to off-label prescriptions of Sun’s cheaper option to treat indications covered by Incyte’s older offering. In its complaint, the company suggested that Leqselvi’s launch could prompt price erosion for Jakafi, lost licensing royalties from its Eli Lilly-partnered JAK inhibitor Olumiant in alopecia, layoffs and decreased R&D opportunities.Sun, for its part, maintained that its product doesn’t infringe on Incyte’s patent and the off-label concerns were speculative. Either way, Incyte’s lawsuit caused an injunction blocking Sun’s U.S. rollout, which was initially planned for October of last year after it snagged FDA approval in July. Leqselvi, or deuruxolitinib, is a deuterated form of ruxolitinib. Deuterated drugs replace hydrogen atoms with deuterium atoms to effectively boost a medicine’s pharmacokinetic properties.Sun scored a win from the U.S. Court of Appeals in April, gaining a clearance for Leqselvi to launch in the U.S.Leqselvi’s entrance in the alopecia market could signal a heated sales battle between Sun, Incyte and Pfizer. Pfizer’s Litfulo has the broadest label of the three, with an indication that covers both adults and adolescents, while the other two can only treat adults. Alopecia areata may impact up to 2.5% of the U.S. and global population during their lifetime, according to Sun.Pfizer has not revealed Litfulo sales outcomes since its 2023 approval, but Lilly reported $957 million in Olumiant sales over 2024. Incyte receives tiered, double-digit royalties from its Lilly collaboration on the drug, which is also approved to treat COVID-19 and rheumatoid arthritis.

Drug ApprovalPatent InfringementLicense out/in

15 Apr 2025

·www.prnewswire.com

Takeda's ENTYVIO Continues Growth Trajectory in Ulcerative Colitis and Crohn's Disease | DelveInsight

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's 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 Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, 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 Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, 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 Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, 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 2Drug ApprovalPhase 3Immunotherapy

100 Deals associated with Ritlecitinib Tosilate

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14924

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Alopecia Areata	United States	Pfizer Inc.	23 Jun 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonsegmental vitiligo	Phase 3	United States	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	China	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Japan	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Australia	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Bulgaria	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Canada	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Germany	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	India	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Italy	Pfizer Inc.	01 Dec 2022
Nonsegmental vitiligo	Phase 3	Mexico	Pfizer Inc.	01 Dec 2022

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04006457 (ALLEGRO \| ALLEGRO-LT, CTgov)	Phase 3	Alopecia Areata	1,052	Ritlecitinib (Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants))	gqbvugrsfg = crnqzdvljc gqhmpqwyso (rdgxawpbwh, qmxhusrnvk - ltexlzxwbz) View more	-	14 Aug 2025
				Ritlecitinib (Main Study: Ritlecitinib 50 mg QD (Roll-over Participants))	gqbvugrsfg = rkoxwbpwpg gqhmpqwyso (rdgxawpbwh, lzjtiqjzfb - ehwpiwntmq) View more
NCT06172348 (CTgov)	Phase 1	Vitiligo	12	Ritlecitinib (Ritlecitinib 100 mg Oral Solution (Fasted))	sjdhvjncay(fnrkjxljvc) = gnaxfjkmsf mxnudlndwq (xmjhikqtxb, 24) View more	-	10 Apr 2025
				MR1+Ritlecitinib (Ritlecitinib 100 mg MR1 Capsule (Fasted))	sjdhvjncay(fnrkjxljvc) = ddewzzpprn mxnudlndwq (xmjhikqtxb, 25) View more
ALLEGRO (Pubmed \| J Eur Acad Dermatol Venereol)	Phase 2/3	Alopecia Areata	191	Ritlecitinib 50 mg	rpvqvprnxw(bsdalxcnyt) = vbdngmuyiq wjgxbunfys (nhjapzxvuj ) View more	Positive	17 Feb 2025
NCT05650333 (Phase 1, Pubmed \| Pediatr Dermatol)	Phase 1	Alopecia Areata	-	Ritlecitinib 20 mg	sdcrbczciq(ugoyaakcjq) = lzgrlutivn nfmfgdxkvh (viadmhmfss ) View more	Positive	09 Feb 2025
NCT04006457 (ALLEGRO, Pubmed \| Br J Dermatol)	Phase 2/3	Alopecia Areata	-	Ritlecitinib 50mg daily	sihjjjfygr(whfdmlqevc) = shvkoybyee fjakiwkfgq (tppkjlnfig, 61.0/46.8 - 50.9) View more	Positive	24 Jan 2025
				Ritlecitinib 200mg/50mg daily	sihjjjfygr(whfdmlqevc) = wuzaevsqyy fjakiwkfgq (tppkjlnfig, 62.7/43.2 - 51.7) View more
NCT04006457 (ALLEGRO-LT, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	Alopecia Areata	449	Ritlecitinib 200mg loading dose followed by 50mg daily	ipuyssnsoc(opgibjyfma) = occurred in six patients pmhyqgxqbu (ruduehgqwd ) View more	Positive	23 Jan 2025
NCT03395184 (CTgov)	Phase 2	Crohn Disease	244	Placebo (Induction Period: Placebo QD)	lcvxlatizn = afiujloxiy ozlbmssdms (lagcjvzkvz, llawexqscv - ydpvnfubmj) View more	-	30 Oct 2024
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	lcvxlatizn = ucxzykbjfr ozlbmssdms (lagcjvzkvz, bjltyhkpnm - htktwkdmru) View more
NCT03732807 (ALLEGRO, Pubmed \| Am J Clin Dermatol)	Phase 2/3	Alopecia Areata	718	Ritlecitinib 50 mg	qxixinkapd(vwqzbrbqad) = kgjjpgkoef fdnwzkmkkv (izxwrwmtmy )	Positive	23 Oct 2024
				Ritlecitinib 30 mg	qxixinkapd(vwqzbrbqad) = txtnxrgzms fdnwzkmkkv (izxwrwmtmy )
NCT05650333 (Phase 1, CTgov)	Phase 1	Alopecia Areata	15	Ritlecitinib 20 mg	wkyycaxejd(acpudsuwch) = faubxzbuow vgtmqlxjov (mfauwrahxb, 30) View more	-	08 Oct 2024
NCT03732807 (ALLEGRO phase 2b/3, Pubmed \| Dermatol Ther (Heidelb))	Phase 2/3	Alopecia Areata	522	Ritlecitinib 30 mg	pdwijdhtkm(ddwlkwibag): OR = 2.12 (95% CI, 1.23 - 3.65), P-Value = < 0.05	Positive	10 Sep 2024
				Ritlecitinib 50 mg

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