A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO-CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.
Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose.
This study is seeking participants who:
* Are 12 years of age or older
* Have a diagnosis of alopecia areata
* Have lost 50% or more of the hair on their scalp
* Do not have any other conditions that causes hair loss
* Are willing to stop all other treatments that they may be taking for alopecia areata
About 550 participants will take part in in this study.
Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily.
The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective.
People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as:
* alopecia areata assessment,
* physical examinations,
* hearing tests,
* blood tests,
* x-ray,
* ECG (electrocardiogram),
* photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

Start Date19 Mar 2025

Sponsor / Collaborator

Pfizer Inc.

NCT06795373

/ RecruitingPhase 2IIT

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 Date01 Feb 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

ChiCTR2500095989

/ SuspendedPhase 4IIT

Real-world study on the efficacy and safety of Ritlecitinib in Chinese patients with severe alopecia areata: A single-center, prospective, observational study

Start Date01 Feb 2025

Sponsor / Collaborator

Xiangya Hospital Central South University

100 Clinical Results associated with Ritlecitinib Tosilate

100 Translational Medicine associated with Ritlecitinib Tosilate

100 Patents (Medical) associated with Ritlecitinib Tosilate

157

Literatures (Medical) associated with Ritlecitinib Tosilate

01 Jun 2025·PHARMACOLOGICAL RESEARCH

Properties of FDA-approved small molecule protein kinase inhibitors: A 2025 update

Review

Author: Roskoski, Robert

Because of the deregulation of protein kinase action in many inflammatory diseases and cancer, the protein kinase family has become one of the most significant drug targets in the 21^st century. There are 85 FDA-approved protein kinase antagonists that target about two dozen different enzymes and four of these drugs were approved in 2024 and a fifth was approved in 2025. Of these drugs, five target dual specificity protein kinases (MEK1/2), fourteen inhibit protein-serine/threonine protein kinases, twenty-one block nonreceptor protein-tyrosine kinases, and 45 target receptor protein-tyrosine kinases. The data indicate that 75 of these drugs are prescribed for the treatment of neoplasms. Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis). Of the 85 FDA-approved agents, about two dozen are used in the treatment of multiple diseases. The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85 FDA-approved drugs have a least one Lipinski rule of 5 violation.

01 Apr 2025·JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY

Response to ritlecitinib with or without narrow-band ultraviolet B add-on therapy in patients with active nonsegmental vitiligo: Results from a phase 2b extension study

Article

Author: Adiri, Roni ; Napatalung, Lynne ; Shore, Ronald N ; Pandya, Amit G ; Peeva, Elena ; Guttman-Yassky, Emma ; Ezzedine, Khaled ; Hamzavi, Iltefat ; Ghosh, Pranab ; Yamaguchi, Yuji

BACKGROUND:

Ritlecitinib demonstrated efficacy in a phase 2b trial of nonsegmental vitiligo.

OBJECTIVE:

To evaluate the efficacy and tolerability of ritlecitinib with add-on narrow-band ultraviolet B (nbUVB) phototherapy in patients with nonsegmental vitiligo.

METHODS:

Following a 24-week, placebo-controlled, dose-ranging period, patients received ritlecitinib 200 mg for 4 weeks then 50 mg for 20 weeks, with or without nbUVB phototherapy 2x/week. Missing data were handled using last observation carried forward and observed case (OC).

RESULTS:

Forty-three patients received ritlecitinib + nbUVB and 187 received ritlecitinib-monotherapy. Nine patients receiving ritlecitinib + nbUVB discontinued due to nbUVB group-specific efficacy criteria requiring >10% improvement in % change from baseline (% change from baseline) in Total-Vitiligo Area Scoring Index at week 12. At week 24, mean % change from baseline in Facial-VASI score was -57.0 vs -51.5 (last observation carried forward; P = .158) and -69.6 vs -55.1 (OC; P = .009), for ritlecitinib + nbUVB vs ritlecitinib-monotherapy, respectively. Mean % change from baseline in Total-Vitiligo Area Scoring Index at week 24 was -29.4 vs -21.2 (last observation carried forward; P = .043) and -46.8 vs -24.5 (OC; P < .001), respectively. nbUVB addition to ritlecitinib was well tolerated with no new safety signals.

LIMITATIONS:

Exploratory analysis; discontinuation criterion applied only to the ritlecitinib + nbUVB group; small sample size.

CONCLUSION:

Ritlecitinib alone and with nbUVB therapy improved facial and total body repigmentation and was well tolerated. Adding nbUVB may improve ritlecitinib efficacy.

01 Apr 2025·CLINICAL IMMUNOLOGY

Novel janus kinase 3 inhibitor ritlecitinib suppresses T and B cell responses to prevent acute cardiac allograft rejection in mice

Article

Author: Xu, Jian ; Hui, Jialiang ; Deng, Wenfeng ; Xia, Renfei ; Yan, Ziyan ; Wang, Yuchen ; Miao, Yun ; Zeng, Wenli ; Liu, Rumin ; Mo, Liqian ; Liao, Tao ; Shi, Xiaoyi

Acute rejection is the main contributor to early allograft failure. Current immunosuppressive regimens have shortcomings, such as toxicity and minimal inhibitory effects on B cells. Hence, developing novel, effective, and selective anti-acute rejection drugs is crucial. Therefore, this study aimed to investigate the inhibitory effect of ritlecitinib (PF-06651600), a new janus kinase 3 inhibitor, on T and B cells, as well its preventive effects on acute allograft rejection. A murine cardiac transplantation model coupled with cell culture- and immunohistochemistry-based techniques was used. In vitro assays demonstrated that ritlecitinib inhibits naïve CD4⁺ T cell differentiation into T helper (Th)1 and Th17 cells, reduces relative inflammatory cytokines, and suppresses CD4⁺ and CD8⁺ T cell proliferation. Furthermore, ritlecitinib inhibited B cell activation and differentiation and antibody production. In vivo experiments revealed that ritlecitinib significantly prolongs allograft survival, decreases serum donor-specific antibody immunoglobulin G levels, alleviats allograft damage, and reduces C4d deposition and T, B, and plasma cell infiltration in allografts. Moreover, B and plasma cell percentages and counts were significantly decreased in recipient spleen, lymph nodes, bone marrow, and blood. Overall, ritlecitinib prevented acute rejection in cardiac transplantation by inhibiting T and B cells, suggesting its potential as a novel clinical immunosuppressant.

News (Medical) associated with Ritlecitinib Tosilate

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

09 Mar 2025

·firstwordpharma.com

AAD25: Lilly, Incyte's Olumiant gains ground in severe adolescent alopecia with late-stage success

Eli Lilly and Incyte’s once-daily oral JAK1/2 inhibitor Olumiant (baricitinib) demonstrated notable improvements in hair regrowth on the scalp, eyebrows and eyelashes in a Phase III study of adolescents with severe alopecia areata (AA), moving the drug a step closer to taking on Pfizer’s JAK3/TEC kinase inhibitor Litfulo (ritlecitinib) — the first alopecia medication approved for the younger age group in the US and EU. The findings were presented over the weekend at the American Academy of Dermatology (AAD) annual meeting.Backed by the BRAVE-AA1 and BRAVE-AA2 trials, Olumiant secured FDA authorisation in 2022 for adults with severe AA, making it the first systemic treatment approved in the US for the condition.The BRAVE-AA-PEDS study randomised 257 participants aged 12 to under 18 to receive daily baricitinib 2 mg, 4 mg or placebo — the primary efficacy goal being Severity of Alopecia Tool (SALT) score ≤20 at 36 weeks. Results showed that at this timepoint, 42.4% of patients receiving the 4-mg dose achieved the main goal, compared with 4.5% in the placebo group. Moreover, Olumiant 4 mg led to at least a 50% disease improvement in 60% of patients, while the 2 mg dose achieved the same in 36.9%, and placebo in 5.7%.Specifically, Olumiant 4 mg achieved 90% scalp hair coverage in 36.5% of patients, significant eyebrow regrowth in 50.0%, and eyelash regrowth in 42.9%, while the 2 mg dose showed 21.4%, 24.1%, and 25.5% improvement, respectively. In contrast, placebo results were 2.3% for scalp, 0% for eyebrows and 14.0% for eyelashes. Notably, outcomes in adolescents achieved at 36 weeks were comparable to those seen in adult studies at 52 weeks, suggesting faster hair regrowth in the former. Meanwhile, the safety profile in adolescents was consistent with previous Olumiant trials in juvenile idiopathic arthritis and atopic dermatitis. "With these data, baricitinib is the most well-studied JAK inhibitor in severe alopecia areata," remarked Anabela Cardoso, senior vice president of immunology medical affairs at Lilly. The drugmaker plans to present additional data from BRAVE-AA-PEDS later this year, whilst also discussing the findings with global regulators.Following the footsteps of Olumiant and Litfulo, Sun Pharmaceutical’s oral JAK1/2 inhibitor Leqselvi (deuruxolitinib) entered the severe AA market last year, albeit only approved for adults. Also at AAD this year, Q32 Bio unveiled upbeat mid-stage data for its IL-7/TSLP bifunctional receptor antagonist, bempikibart, in severe to very severe disease. For more on the severe AA space, read: Spotlight On: AAD25 – Lilly's data puts Pfizer on notice while Q32 Bio plays long game in alopecia areata.

Clinical ResultDrug ApprovalPhase 3

19 Nov 2024

·www.prnewswire.com

Celiac Disease Pipeline Grows as 25+ Key Pharma Companies Join the Fight for Innovative Treatments | DelveInsight

The growing comprehension of the pathogenesis of celiac disease has paved the way for the exploration of alternative treatment strategies. These novel approaches are aimed at addressing the condition at its root cause, targeting the underlying mechanisms that trigger the immune response in individuals with celiac disease. These innovative approaches hold the promise of transforming the landscape of celiac disease treatment in the near future. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Celiac Disease Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline celiac disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the celiac disease pipeline domain. Key Takeaways from the Celiac Disease Pipeline Report DelveInsight's celiac disease pipeline report depicts a robust space with 25+ active players working to develop 30+ pipeline therapies for celiac disease treatment. Key celiac disease companies such as Takeda, Sanofi, Entero Therapeutics, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, Theriva Biologics, Chugai Pharmaceutical, Novartis, Immunic, Mozart Therapeutics, Nemysis Ltd, Barinthus Biotherapeutics, Parvus Therapeutics, Kallyope, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Allero Therapeutics, STEMCELL Technologies, IM Therapeutics, Provid Pharmaceuticals, Sigmoid Pharma, Janssen Biotech, Inc., Lumen Bioscience, IGY Life Sciences, Ahead Therapeutics, ANTOLRX, Imcyse, and others are evaluating new celiac disease drugs to improve the treatment landscape. Promising Celiac Disease pipeline therapies such as TAK-101, TAK-062, PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, SYN-020, DONQ52, CALY-002, IMU-856, MTX-101, E 40-02, VTP-1000, PVT-301, Research Program: Celiac disease, AMY02, FB 102, LPX-TIGI, AT 1718, ALL-001, SQZ TACs, Research Program: small molecule therapeutics, Research Program: DQ2/8, Research Program: SmPillformulations, Research Program: autoimmune disease therapeutics, IgY-112, AT 1715, Research programme: Celiac disease, and others are under different phases of Celiac Disease clinical trials. In October 2024, Topas Therapeutics announced positive topline results from its Phase IIa trial of TPM502, in patients with celiac disease. The study data serves as the first clinical proof of concept for Topas' proprietary nanoparticle platform and its potential to induce targeted, antigen-specific tolerogenic effects. In September 2024, Barinthus Biotherapeutics plc, a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates that guide T cells to control disease, announced the initiation of its first-in-human Phase I trial of VTP-1000 in adults with coeliac disease. In May 2024, Entero Therapeutics, Inc. (formerly First Wave BioPharma, Inc.) unveiled its new corporate name and website. The rebranding follows the recent business combination with ImmunogenX and reflects the Company's focus on addressing unmet needs in GI health that include celiac disease, an indication for which there are no approved medicines today. In March 2024, First Wave BioPharma announced the acquisition of ImmunogenX in an all-stock transaction with the combined company focused on advancing a GI pipeline comprised of multiple, late-stage clinical assets, including latiglutenase, a potentially first-in-class, near Phase III-ready, targeted, oral biotherapeutic for celiac disease. In February 2024, with the approval of the SQZ transaction, STEMCELL acquired substantially all of SQZ's assets including its entire portfolio of over 400 patents and trademarks, other intellectual property such as copyrights and trade secrets, proprietary equipment, and its head license with the Massachusetts Institute of Technology. In January 2024, Calypso Biotech BV announced that it had entered into an agreement to be acquired by Novartis AG ('Novartis'). Calypso's shareholders received an upfront payment of $250 million upon closing and are eligible to receive development milestones of up to $175 million based on the achievement of certain predetermined milestones. The acquisition gives Novartis full rights to CALY-002. Novartis intends to further explore CALY-002 across a wide variety of autoimmune indications with high unmet medical needs. Request a sample and discover the recent advances in celiac disease treatment drugs @ Celiac Disease Pipeline Report The celiac disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage celiac disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the celiac disease clinical trial landscape. Celiac Disease Overview Celiac disease is a chronic autoimmune disorder triggered by the ingestion of gluten, a protein found in wheat, barley, and rye. In individuals with celiac disease, the immune system mistakenly attacks the small intestine upon gluten consumption, leading to inflammation and damage to the intestinal lining, specifically the villi, which are essential for nutrient absorption. The exact cause of celiac disease is not fully understood, but it is known to involve a combination of genetic predisposition (usually associated with HLA-DQ2 or HLA-DQ8 genes) and environmental factors. Common symptoms of celiac disease include digestive issues such as diarrhea, bloating, gas, constipation, and abdominal pain. However, some individuals experience non-digestive symptoms, like fatigue, anemia, joint pain, skin rashes, and even neurological issues such as headaches or depression. Because of this broad symptom range, celiac disease is often underdiagnosed or misdiagnosed as other conditions. Diagnosis typically involves blood tests to detect specific antibodies (like tissue transglutaminase antibodies) and, if positive, is followed by an intestinal biopsy to confirm damage to the villi. Genetic testing may also be conducted in some cases to identify predispositions. The primary treatment for celiac disease is a strict, lifelong gluten-free diet. By avoiding gluten, individuals with celiac disease can heal intestinal damage and prevent symptoms and complications. However, adherence to this diet requires vigilance, as even small amounts of gluten can trigger symptoms and damage. Find out more about celiac disease treatment drugs @ Drugs for Celiac Disease Treatment A snapshot of the Celiac Disease Pipeline Drugs mentioned in the report: Learn more about the emerging celiac disease pipeline therapies @ Celiac Disease Clinical Trials Celiac Disease Therapeutics Assessment The celiac disease pipeline report proffers an integral view of the celiac disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Celiac Disease Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Gliadin inhibitors, Gluten modulators, Transglutaminase 2 inhibitors, Emt protein-tyrosine kinase inhibitors, Janus kinase 3 inhibitors, Alpha4beta7 integrin antagonists, Interleukin 15 inhibitors, Interleukin 21 inhibitors, Alkaline phosphatase replacements, HLA-DQ antigen inhibitors Key Celiac Disease Companies: Takeda, Sanofi, Entero Therapeutics, Pfizer, Topas Therapeutics, Anokion SA, Protagonist Therapeutics, Equillium, Theriva Biologics, Chugai Pharmaceutical, Novartis, Immunic, Mozart Therapeutics, Nemysis Ltd, Barinthus Biotherapeutics, Parvus Therapeutics, Kallyope, AMYRA Biotech AG, Forte Biosciences, LAPIX Therapeutics, Ahead Therapeutics, Allero Therapeutics, STEMCELL Technologies, IM Therapeutics, Provid Pharmaceuticals, Sigmoid Pharma, Janssen Biotech, Inc., Lumen Bioscience, IGY Life Sciences, Ahead Therapeutics, ANTOLRX, Imcyse, and others. Key Celiac Disease Pipeline Therapies: TAK-101, TAK-062, PRV-015, Latiglutenase, TAK-227, Ritlecitinib, TPM-502, KAN 101, PTG-100, EQ 102, SYN-020, DONQ52, CALY-002, IMU-856, MTX-101, E 40-02, VTP-1000, PVT-301, Research Program: Celiac disease, AMY02, FB 102, LPX-TIGI, AT 1718, ALL-001, SQZ TACs, Research Program: small molecule therapeutics, Research Program: DQ2/8, Research Program: SmPillformulations, Research Program: autoimmune disease therapeutics, IgY-112, AT 1715, Research programme: Celiac disease, and others. Dive deep into rich insights for new drugs for celiac disease treatment, visit @ Celiac Disease Drugs Table of Contents For further information on the celiac disease pipeline therapeutics, reach out @ Celiac Disease Treatment Drugs Related Reports Celiac Disease Epidemiology Celiac Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted celiac disease epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Celiac Disease Market Celiac Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key celiac disease companies including Entero Therapeutics, Amgen, Provention Bio, Takeda, among others. Sjogren's Syndrome Market Sjogren's Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Sjogren's syndrome companies including Horizon Therapeutics (Amgen), Dompe Farmaceutici, Sylentis, MorphoSys, Resolve Therapeutics, OSE Immunotherapeutics, Servier, Novartis, Johnson & Johnson , among others. Sjogren's Syndrome Pipeline Sjogren's Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Sjogren's syndrome companies, including Novartis, Horizon Therapeutics, Bristol-Myers Squibb, Rise Therapeutics, Resolve Therapeutics, Dompe Farmaceutici, 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

Clinical ResultPhase 2AcquisitionPhase 1Immunotherapy

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R&D Status

Approved

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

Developing

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06172348 (CTgov)	Phase 1	Vitiligo	12	Ritlecitinib (Ritlecitinib 100 mg Oral Solution (Fasted))	tybhsidybj(gxurxxvfab) = aifrbbrkkc iulbknqbmo (xlzsnuvbdv, 24) View more	-	10 Apr 2025
				MR1+Ritlecitinib (Ritlecitinib 100 mg MR1 Capsule (Fasted))	tybhsidybj(gxurxxvfab) = jixbekxibe iulbknqbmo (xlzsnuvbdv, 25) View more
NCT04006457 (ALLEGRO-LT, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	Alopecia Areata	449	Ritlecitinib 200mg loading dose followed by 50mg daily	tsbjfquywt(awbtxbyddy) = occurred in six patients qtfalngnvi (twicgcnzjn ) View more	Positive	23 Jan 2025
NCT03395184 (CTgov)	Phase 2	Crohn Disease	244	Placebo (Induction Period: Placebo QD)	jsantbpmqs = tyyolouzev fugayduwrq (grxcshgptn, kyzgjocyeg - bnmregwmva) View more	-	30 Oct 2024
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	jsantbpmqs = sgkqvxsttt fugayduwrq (grxcshgptn, bqutguxbnk - qdbqiqzhaj) View more
NCT03732807 (ALLEGRO, Pubmed \| Am J Clin Dermatol)	Phase 2/3	Alopecia Areata	718	Ritlecitinib 50 mg	gechofkbpg(sjlcotrfwl) = unkmtktjay gwnprwgfbg (hvdpjrtnlx )	Positive	23 Oct 2024
				Ritlecitinib 30 mg	gechofkbpg(sjlcotrfwl) = litnmhvmlw gwnprwgfbg (hvdpjrtnlx )
NCT03732807 \| NCT04006457 (ALLEGRO-2b/3 \| ALLEGRO Phase 2b/3 \| ALLEGRO phase 2b/3 study \| ALLEGRO, Pubmed \| Br J Dermatol) Manual	Phase 2/3	Alopecia Areata	385	Ritlecitinib 50 mg	degfllstjw(rlbjkywpdg) = cvjwlgjuhh jxzmlmyzbi (dacunyrzhc ) View more	Positive	21 Oct 2024
				Ritlecitinib 200/50 mg	degfllstjw(rlbjkywpdg) = dhnntxymmo jxzmlmyzbi (dacunyrzhc ) View more
NCT05650333 (Phase 1, CTgov)	Phase 1	Alopecia Areata	15	Ritlecitinib 20 mg	lriqksexjm(epdgmtajbq) = whrhcctzcj hytckdgdub (zqkaksyqwz, 30) View more	-	08 Oct 2024
NCT03732807 (ALLEGRO phase 2b/3, Pubmed \| Dermatol Ther (Heidelb))	Phase 2/3	Alopecia Areata	522	Ritlecitinib 30 mg	wjrvuaabyi(lrcvsigita): OR = 2.12 (95% CI, 1.23 - 3.65), P-Value = < 0.05	Positive	10 Sep 2024
				Ritlecitinib 50 mg
NCT05128058 (CTgov)	Phase 1	-	16	RITLECITINIB (RITLECITINIB 50 MG CAPSULE)	ccgwnhkqwp(jkzgzqmmjp) = dteamwxczc cbfbgfqttd (xanvmfrivz, kwjnvvvula - oacrfzfsrn) View more	-	13 Nov 2023
				RITLECITINIB (RITLECITINIB 200 MG CAPSULE)	ccgwnhkqwp(jkzgzqmmjp) = kolycgwjmg cbfbgfqttd (xanvmfrivz, hfyydeqcpr - ehipcanzeo) View more
NCT04006457 (ALLEGRO-LT, EADV2023)	Phase 3	Alopecia Areata	447	Ritlecitinib 200 mg	grvgwoqmug(jztanlznoe) = eppmapyowo lwkbfimqbe (dhmjjbxybv ) View more	-	11 Oct 2023
				Ritlecitinib 50 mg	grvgwoqmug(jztanlznoe) = rjwlxwyunu lwkbfimqbe (dhmjjbxybv ) View more
NCT03732807 (ALLEGRO phase 2b/3, EADV2023)	Phase 2/3	Alopecia Areata	191	Ritlecitinib 50mg QD	jzglpirmoy(ounhbulkja) = zddxwcelzv cvqjjjmfei (oaizcpshls ) View more	-	11 Oct 2023

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