
Rheumatoid Arthritis Pipeline 2025: Latest FDA Approvals, Clinical Trials, And Emerging Therapies Assessment By Delveinsight Eli Lilly And Company, Philogen, I-Mab Biopharma Co. Ltd., Teijin Pharma

(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.
Some of the key takeaways from the Rheumatoid Arthritis Pipeline Report:
Companies across the globe are diligently working toward developing novel Rheumatoid Arthritis treatment therapies with a considerable amount of success over the years.
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
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.
In September 2025, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (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® 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.
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.
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.
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.
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.
In July 2024, Navidea Biopharma has decided to discontinue its rheumatoid arthritis (RA) program following unsatisfactory findings from an exploratory analysis of the NAV3-33 trial. The Phase III study (NCT05246280), which included 523 participants, aimed to validate the effectiveness of intravenous (IV) Lymphoseek (Tc 99m tilmanocept) imaging in predicting clinical outcomes in RA patients starting anti-tumor necrosis factor alpha (TNFα) therapy.
In July 2024, Dutch biotech firm Citryll has completed subject dosing in the repeat-dose phase of its Phase I clinical trial for CIT-013, an anti-inflammatory drug candidate. This first-in-human study focuses on evaluating the safety and tolerability of the antibody. In the trial's part D segment, the safety and tolerability of CIT-013 are further assessed through repeat dosing in a group of nine rheumatoid arthritis (RA) patients and three healthy volunteers.
Rheumatoid Arthritis Overview
Rheumatoid Arthritis (RA) is a chronic autoimmune disorder where the immune system mistakenly attacks the joints, causing inflammation. This leads to symptoms such as joint pain, swelling, stiffness, and reduced mobility, typically affecting both sides of the body (e.g., both hands or knees). Over time, RA can damage joint tissues, resulting in deformities and loss of function. It may also affect other organs, including the lungs, heart, and eyes. While the exact cause is unknown, genetics, environmental factors, and lifestyle may contribute. Treatment includes medications (like DMARDs and biologics), physical therapy, and lifestyle changes to manage symptoms and prevent progression.
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Emerging Rheumatoid Arthritis Drugs Under Different Phases of Clinical Development Include:
OLUMIANT (barticinib): Eli Lilly and Company/Incyte Corporation
RINVOQ (upadacitinib): AbbVie
Rabeximod (Rob 803): Cyxone
Imvotamab: IGM Biosciences
Sarilumab (Kevzara): Regeneron/Sanofi
Baricitinib: Eli Lilly and Company
Certolizumab pegol: UCB BIOSCIENCES GmbH
Upadacitinib: AbbVie
Tofacitinib: Pfizer
Sarilumab SAR153191 (REGN88): Sanofi
GenaKumab: Changchun GeneScience Pharma
AIN457: Novartis
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
Intra-articular
Intraocular
Intrathecal
Intravenous
Ophthalmic
Oral
Parenteral
Subcutaneous
Topical
Transdermal
Rheumatoid Arthritis Molecule Type
Rheumatoid Arthritis Products have been categorized under various Molecule types, such as
Oligonucleotide
Peptide
Small molecule
Rheumatoid Arthritis Pipeline Therapeutics Assessment
Rheumatoid Arthritis Assessment by Product Type
Rheumatoid Arthritis By Stage and Product Type
Rheumatoid Arthritis Assessment by Route of Administration
Rheumatoid Arthritis By Stage and Route of Administration
Rheumatoid Arthritis Assessment by Molecule Type
Rheumatoid Arthritis by Stage and Molecule Type
DelveInsight's Rheumatoid Arthritis Report covers around 80+ products under different phases of clinical development like
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
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
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
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.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Rheumatoid Arthritis Treatment.
Rheumatoid Arthritis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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.
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.
Download Sample PDF Report to know more about Rheumatoid Arthritis drugs and therapies
Rheumatoid Arthritis Pipeline Market Drivers
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
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
Coverage: Global
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
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
Rheumatoid Arthritis Therapeutic Assessment: Rheumatoid Arthritis current marketed and Rheumatoid Arthritis emerging therapies
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
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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