Rheumatoid Arthritis Pipeline 2025: FDA Updates, Therapy Innovations, and Clinical Trial Landscape Analysis by DelveInsight | Eli Lilly and Company, Philogen, I-Mab Biopharma, Teijin Pharma, Revolo

(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Rheumatoid Arthritis pipeline constitutes 75+ key companies continuously working towards developing 80+ Rheumatoid Arthritis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

"Rheumatoid Arthritis Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Rheumatoid Arthritis Market.

The Rheumatoid Arthritis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Some of the key takeaways from the Rheumatoid Arthritis Pipeline Report:

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Companies across the globe are diligently working toward developing novel Rheumatoid Arthritis treatment therapies with a considerable amount of success over the years.

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Rheumatoid Arthritis companies working in the treatment market are Eli Lilly and Company/Incyte Corporation, AbbVie, Cyxone, IGM Biosciences, Regeneron/Sanofi, UCB BIOSCIENCES GmbH, AbbVie, Pfizer, Changchun GeneScience Pharma, Novartis, Istituto Giannina Gaslini, and others, are developing therapies for the Rheumatoid Arthritis treatment

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Emerging Rheumatoid Arthritis therapies in the different phases of clinical trials are- OLUMIANT (barticinib), RINVOQ (upadacitinib), Rabeximod (Rob 803), Imvotamab, Sarilumab (Kevzara), Baricitinib, Certolizumab pegol, Upadacitinib, Tofacitinib, Sarilumab SAR153191 (REGN88), GenaKumab, AIN457, Etanercept, and others are expected to have a significant impact on the Rheumatoid Arthritis market in the coming years.

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In January 2026, SetPoint Medical, a biotechnology company focused on innovative treatments for chronic autoimmune conditions, announced the publication of results from its RESET-RA study in Nature Medicine. This pivotal, double-blind, randomized, sham-controlled trial assessed the safety and effectiveness of the SetPoint System, an implantable neuroimmune modulation device that targets the vagus nerve. The therapy is designed for adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to, or are unable to tolerate, currently available advanced RA treatments, including biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

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In September 2025, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA Registered (guselkumab) for children aged six years and older weighing at least 40 kg with moderate to severe plaque psoriasis (PsO) who are eligible for systemic therapy or phototherapy, as well as for active psoriatic arthritis (PsA). This approval marks TREMFYA Registered as the first and only IL-23 inhibitor authorized for these pediatric indications, expanding upon its prior FDA approvals for adults with moderate to severe plaque PsO in 2017 and active PsA in 2020.

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In April 2025, The European Medicines Agency (EMA) granted approval for Cullinan Therapeutics' clinical trial application of CLN-978, a potential treatment for rheumatoid arthritis (RA). This Phase I open-label study will enroll patients with active, treatment-resistant RA, as defined by the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria. The trial is designed to evaluate the drug's pharmacokinetics, pharmacodynamics, safety profile, and its effect on disease activity.

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In February 2025, AnaptysBio's Phase IIb trial evaluating rosinilimab for rheumatoid arthritis (RA) has delivered promising results, with some patients achieving the highest recorded response rates by week 14. Remarkably, 69% of participants attained low disease activity. The U.S.-based company presented findings from its randomized RENOIR trial (NCT06041269), which assessed the safety and tolerability of rosinilimab in moderate-to-severe RA patients previously treated with conventional disease-modifying drugs. The study successfully met its primary endpoint, demonstrating a statistically significant improvement in DAS28-CRP scores compared to placebo, reinforcing rosinilimab's potential as an effective RA treatment.

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In December 2024, XBiotech's stock price dropped significantly after the company announced the termination of its clinical program in rheumatological diseases. This decision follows the evaluation of a Phase II trial for its arthritis treatment, Natrunix, which did not meet its primary endpoint. The Austin, Texas-based biotech firm saw a 27% decline in stock value after the trial (NCT05363917) revealed substantial irregularities, making it difficult to draw definitive conclusions from the study results.

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In October 2024, SetPoint Medical has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), allowing it to start a clinical trial to test its modulation platform in relapsing-remitting multiple sclerosis (RRMS) patients. The multicenter, randomized, double-blind, sham-controlled pilot study will take place in the US and is set to begin in 2025. The US-based company plans to enroll 60 patients with the autoimmune disorder for the trial.

Rheumatoid Arthritis Overview

Rheumatoid Arthritis is a chronic autoimmune disorder in which the immune system mistakenly attacks the joints, causing inflammation, pain, stiffness, and swelling. Over time, it can lead to joint damage, deformities, and reduced mobility. RA can also affect other organs, including the heart, lungs, and eyes. Early diagnosis and treatment are essential to manage symptoms, slow disease progression, and improve quality of life.

Explore the latest Rheumatoid Arthritis pipeline insights 2025, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Rheumatoid Arthritis Clinical Trials [https://www.delveinsight.com/sample-request/rheumatoid-arthritis-ra-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Emerging Rheumatoid Arthritis Drugs Under Different Phases of Clinical Development Include:

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OLUMIANT (barticinib): Eli Lilly and Company/Incyte Corporation

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RINVOQ (upadacitinib): AbbVie

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Rabeximod (Rob 803): Cyxone

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Imvotamab: IGM Biosciences

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Sarilumab (Kevzara): Regeneron/Sanofi

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Baricitinib: Eli Lilly and Company

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Certolizumab pegol: UCB BIOSCIENCES GmbH

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Upadacitinib: AbbVie

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Tofacitinib: Pfizer

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Sarilumab SAR153191 (REGN88): Sanofi

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GenaKumab: Changchun GeneScience Pharma

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AIN457: Novartis

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Etanercept: Istituto Giannina Gaslini

Rheumatoid Arthritis Route of Administration

Rheumatoid Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

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Intra-articular

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Intraocular

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Intrathecal

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Intravenous

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Ophthalmic

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Oral

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Parenteral

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Subcutaneous

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Topical

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Transdermal

Rheumatoid Arthritis Molecule Type

Rheumatoid Arthritis Products have been categorized under various Molecule types, such as

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Oligonucleotide

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Peptide

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Small molecule

Rheumatoid Arthritis Pipeline Therapeutics Assessment

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Rheumatoid Arthritis Assessment by Product Type

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Rheumatoid Arthritis By Stage and Product Type

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Rheumatoid Arthritis Assessment by Route of Administration

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Rheumatoid Arthritis By Stage and Route of Administration

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Rheumatoid Arthritis Assessment by Molecule Type

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Rheumatoid Arthritis by Stage and Molecule Type

DelveInsight's Rheumatoid Arthritis Report covers around 80+ products under different phases of clinical development like

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Late-stage products (Phase III)

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Mid-stage products (Phase II)

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Early-stage product (Phase I)

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Pre-clinical and Discovery stage candidates

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Discontinued & Inactive candidates

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Route of Administration

Further Rheumatoid Arthritis product details are provided in the report. Download the Rheumatoid Arthritis pipeline report to learn more about the emerging Rheumatoid Arthritis therapies [https://www.delveinsight.com/sample-request/rheumatoid-arthritis-ra-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key companies in the Rheumatoid Arthritis Therapeutics Market include:

Key companies developing therapies for Rheumatoid Arthritis are - Taisho Pharmaceutical, Zhejiang Hisun Pharmaceutical, SinoMab, Jiangsu Hengrui Medicine, RemeGen, GlaxoSmithKline, Modern Biosciences, Jiangsu Alphamab Biopharmaceuticals, Akros Pharma, Hanlim Pharm, Galapagos NV, Chong Kun Dang Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Aclaris Therapeutics, Abivax, AbbVie, Synact Pharma, Gilead sciences, Mesoblast, Rottapharm Biotech, Eli Lilly and Company, Kiniksa Pharmaceuticals, Abcentra, Cyxone, Yungjin Pharm. Co., Ltd. Taiho Pharmaceutical, Oscotec Inc., Pfizer, Janssen Research & Development, Cipher Pharmaceuticals Inc., and others.

Rheumatoid Arthritis Pipeline Analysis:

The Rheumatoid Arthritis pipeline report provides insights into

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The report provides detailed insights about companies that are developing therapies for the treatment of Rheumatoid Arthritis with aggregate therapies developed by each company for the same.

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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Rheumatoid Arthritis Treatment.

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Rheumatoid Arthritis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

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Rheumatoid Arthritis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Rheumatoid Arthritis market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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Rheumatoid Arthritis Pipeline Market Drivers

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Rising prevalence of arthritis and other joint disorders, rising combinational therapy of biologics for the treatment of Rheumatoid Arthritis, rich emerging pipeline, acceptance of biosimilars for treatment of Rheumatoid Arthritis are some of the important factors that are fueling the Rheumatoid Arthritis Market.

Rheumatoid Arthritis Pipeline Market Barriers

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However, high cost of biologics, low adherence to the drugs, lack of daily assessment of RA - Delay in RA diagnosis and other factors are creating obstacles in the Rheumatoid Arthritis Market growth.

Scope of Rheumatoid Arthritis Pipeline Drug Insight

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Coverage: Global

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Key Rheumatoid Arthritis Companies: Eli Lilly and Company/Incyte Corporation, AbbVie, Cyxone, IGM Biosciences, Regeneron/Sanofi, UCB BIOSCIENCES GmbH, AbbVie, Pfizer, Changchun GeneScience Pharma, Novartis, Istituto Giannina Gaslini, and others

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Key Rheumatoid Arthritis Therapies: OLUMIANT (barticinib), RINVOQ (upadacitinib), Rabeximod (Rob 803), Imvotamab, Sarilumab (Kevzara), Baricitinib, Certolizumab pegol, Upadacitinib, Tofacitinib, Sarilumab SAR153191 (REGN88), GenaKumab, AIN457, Etanercept, and others

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Rheumatoid Arthritis Therapeutic Assessment: Rheumatoid Arthritis current marketed and Rheumatoid Arthritis emerging therapies

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Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and Rheumatoid Arthritis market barriers

Request for Sample PDF Report for Rheumatoid Arthritis Pipeline Assessment and clinical trials [https://www.delveinsight.com/sample-request/rheumatoid-arthritis-ra-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Rheumatoid Arthritis Report Introduction

2. Rheumatoid Arthritis Executive Summary

3. Rheumatoid Arthritis Overview

4. Rheumatoid Arthritis- Analytical Perspective In-depth Commercial Assessment

5. Rheumatoid Arthritis Pipeline Therapeutics

6. Rheumatoid Arthritis Late Stage Products (Phase II/III)

7. Rheumatoid Arthritis Mid Stage Products (Phase II)

8. Rheumatoid Arthritis Early Stage Products (Phase I)

9. Rheumatoid Arthritis Preclinical Stage Products

10. Rheumatoid Arthritis Therapeutics Assessment

11. Rheumatoid Arthritis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Rheumatoid Arthritis Key Companies

14. Rheumatoid Arthritis Key Products

15. Rheumatoid Arthritis Unmet Needs

16 . Rheumatoid Arthritis Market Drivers and Barriers

17. Rheumatoid Arthritis Future Perspectives and Conclusion

18. Rheumatoid Arthritis Analyst Views

19. Appendix

20. About DelveInsight

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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