Ritlecitinib Tosilate

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

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED