Rheumatoid Arthritis Clinical Trials 2025: Medication, EMA, PMDA, FDA Approvals, Therapies, Treatment Market, MOA, ROA, and Companies by DelveInsight

Rheumatoid Arthritis Clinical Trials 2025: Medication, EMA, PMDA, FDA Approvals, Therapies, Treatment Market, MOA, ROA, and Companies by DelveInsight
Rheumatoid Arthritis Clinical Trials
Promising Rheumatoid Arthritis Pipeline Therapies such as BMS-582949, Etanercept, Lutikizumab, Ravagalimab, Filgotinib Maleate, IMVT-1402, TLL-018, CPL409116, LY3541860 and others.

(Albany, USA) “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.

Rheumatoid Arthritis pipeline report including 75+ key companies and 80+ Rheumatoid Arthritis treatment therapies, analyses DelveInsight. 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.

 

To know more about the Rheumatoid Arthritis Pipeline Analysis, click here: Rheumatoid Arthritis Pipeline Insight

 

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

  • Rheumatoid Arthritis 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 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., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others, are developing therapies for the Rheumatoid Arthritis treatment.
  • Emerging Rheumatoid Arthritis therapies such as TS152, HS-016, SM03, SHR0302, RC18, Otilimab, NI-0101, MBS2320, KN019, JTE-051, Interleukin 2, HL237, GLPG3970, Elsubrutinib, CKD-506, Branebrutinib, AZD9567, ATI-450, ABX464, ABBV 3373, ABBV 154, AP1189, F8IL10, AMT-101, GS-9876, CR 6086, LY 3462817, KPL-404, Orticumab, Rabeximod, YRA 1909, VIB4920, Varicella Zoster Vaccine, TAS5315, SKI-O-703, SAN-300, PF-06650833, Nipocalimab, CF-101, A223, IRL 201805, LNK 01001, PRTX-100, hUC-MSC infusion, HB-adMSC, LABP-104, VAY736, TJ003234 , SYN060, GS-5718, PF-06835375, Nivolumab, MH004, ORTD-1, ART-I02, FB704A, Amilo 5MER, CKD-374 , CFZ-533, BAY 1830839, AMG 570, JNJ-4703, CT-P47, BZ068, Invossa, LABP-69, ICM-203-R, NX-5948, KT-474 , Clarithromycin/clofazimine/rifabutin (RHB-104), Research programme: small molecule TYK2 inhibitors, MRx0006, CV6 1271, VYN201, MYMD-1, BBI 02, Research Programme: Immune mediated diseases, Foralumab, SPU-21, SFA002, NTR-441, Research programme: autoimmune disease therapeutics, AT_1001, MSB11456, MabionCD20, DMB-3113, GB232, GBS 005, TX17, BX 2922, Cinnora, AVT02, MYL-1401A, and others are expected to have a significant impact on the Rheumatoid Arthritis market in the coming years.
  • In July 2025, AbbVie conducted a study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide.
  • In June 2025, AnaptysBio, Inc. announced that investigational rosnilimab, a depleter and agonist targeting PD1+ T cells, demonstrated a best-in-disease profile in patients with moderate-to-severe rheumatoid arthritis (RA). In the robust, global 424-patient Phase IIb trial, rosnilimab achieved JAK-like efficacy on multiple clinically meaningful measures, including low disease activity (LDA) and remission on the Clinical Disease Activity Index (CDAI), as well as ACR70 response, over a six-month period.
  • In March 2025, SynAct Pharma AB announced that the United States Patent and Trademark Office (USPTO) had issued US patent 12,239,631 with claims covering the crystal form of resomelagon (AP1189) currently undergoing development in clinical Phase IIb. The US patent is a major cornerstone in the strategy to further protect SynAct’s intellectual property rights with respect to resomelagon and will add to the layers of protection ensuring exclusivity in the US of its lead asset as composition of matter until 2042.
  • On January 2024, Rise Therapeutics LLC announced results of a Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients with Rheumatoid Arthritis.
  • On March 2024, Sonoma Biotherapeutics, Inc announced results of a Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis.
  • On March 2024, Lynk Pharmaceuticals Co., Ltd announced results of a Randomized, Double-blind Study to Compare LNK01001 to Placebo in Adults with Rheumatoid Arthritis (RA) on a Stable Dose of csDMARDs Who Have an Inadequate Response or Intolerance to bDMARDs.
  • On February 2024, Eli Lilly and Company announced results of an Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis.
  • On April 2024, AbbVie announced results of a Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH).
  • On March 2024, AstraZeneca announced results of a Phase I, Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Subcutaneous AZD6912 in Healthy Participants.

 

Rheumatoid Arthritis Overview:

Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects the joints, causing inflammation, pain, stiffness, and potential joint damage and deformity over time. It occurs when the immune system mistakenly attacks the body’s own tissues, particularly the synovium—the lining of the membranes that surround the joints. Rheumatoid arthritis commonly affects smaller joints like those in the hands and feet, but it can also impact larger joints and other organs. Rheumatoid arthritis Symptoms often fluctuate in severity and can include fatigue, joint swelling, and reduced range of motion. Early Rheumatoid arthritis diagnosis and aggressive treatment are vital in managing Rheumatoid arthritis to slow disease progression, alleviate symptoms, and preserve joint function. Rheumatoid arthritis Treatment typically involves a combination of medications (such as disease-modifying anti-rheumatic drugs and biologics), physical therapy, lifestyle modifications, and sometimes surgery to repair or replace severely damaged joints.

 

Stay ahead with the most recent pipeline outlook for Rheumatoid Arthritis. Get insights into clinical trials, emerging therapies, and leading companies with Rheumatoid Arthritis @ Rheumatoid Arthritis Treatment Drugs and Manufacturers

 

Rheumatoid Arthritis Emerging Drugs Profile

  • RGB-19: Gedeon Richter

RGB-19, developed by Gedeon Richter in collaboration with Mochida Pharmaceutical, is a biosimilar version of tocilizumab, a monoclonal antibody that inhibits interleukin-6 (IL-6) signaling, which plays a central role in the inflammation associated with rheumatoid arthritis. By targeting IL-6, RGB-19 aims to reduce inflammation and alleviate symptoms in patients with rheumatoid arthritis and other immune-mediated conditions. As a biosimilar to the reference product RoActemra®, RGB-19 is designed to offer comparable efficacy and safety, while providing a more affordable therapeutic option to patients worldwide, thereby expanding access to this important biological treatmentCurrently, the drug is registered for the treatment of Rheumatoid Arthritis (RA).

  • MB04: mAbxience Research S.L.

MB04, developed by mAbxience Research S.L., is a biosimilar to etanercept designed for the treatment of rheumatoid arthritis and other autoimmune diseases. It is an Fc fusion protein that targets and inhibits both tumor necrosis factor alpha (TNF-α) and lymphotoxin alpha (LTα, also known as TNF-β), key cytokines involved in the inflammatory processes underlying rheumatoid arthritis. By blocking these cytokines, MB04 aims to reduce inflammation and alleviate symptoms associated with immune-mediated joint damage. As a biosimilar, MB04 is intended to offer comparable efficacy and safety to the reference biologic (Enbrel®), while potentially improving access and affordability for patients requiring long-term management of rheumatoid arthritis. Currently, the drug is in Phase III stage of its development for the treatment of Rheumatoid Arthritis (RA).

  • Rosnilimab: AnaptysBio, Inc

Rosnilimab is a novel therapeutic antibody that directly targets PD-1, a co-inhibitory receptor preferentially expressed on the surface of activated T cells, which broadly impacts the pathogenic drivers of inflammatory diseases such as RA and UC. Rosnilimab is a targeted therapy designed to deplete PD-1high T cells and agonize the remaining PD-1+ T cells to restore the immune system back to a state of homeostasis. This is anticipated to result in specific immunological outcomes in both inflamed tissue and the periphery, such as reduction in T cell proliferation, migration and cytokine secretion, and reduction of plasma cell generation and autoantibody levels. Currently, the drug is in Phase II stage of its development for the treatment of Rheumatoid Arthritis (RA).

  • Leramistat: Istesso

Leramistat is an oral treatment that selectively modulates inflammation at the level of tissue damage, adapting to stimulus strength. By avoiding outright inhibition of inflammatory cytokine cascades and promoting a pro-repair environment, leramistat fine-tunes control of subclinical inflammation and restores normal bone dynamics to resolve rheumatoid pathology at its source. With its unique “pro-repair” mechanism, leramistat offers a new foundational option for combination therapy, enabling other disease-modifying treatments to work better for longer and elevating the definition of remission. Currently, the drug is in Phase II stage of its development for the treatment of Rheumatoid Arthritis (RA).

  • AP1189: Synact Pharma

SynAct Pharma’s drug candidate, resomelagon (AP1189), is a once-daily oral biased melanocortin receptor type 1 and 3 (MC1r and MC3r) agonist. The pharmacological effects of the compound are mediated by its ability to balance ongoing inflammation and bringing the immune system in a given inflamed tissue, organ, or circulation to a new homeostatic state with less proinflammatory activity and activation of pro-resolving pathways. This effect is distinct from suppression of the immune system, which may cause unwanted side effects, such as increased risk of infections and other side effects. The mode of action is specifically interesting to apply in active inflammation, including early active states of chronic inflammatory/autoimmune diseases and in hyperinflammatory states of infectious diseases where the benefit of applying immunosuppressive drugs is outweighed by the risk of use. The selectivity of resomelagon (AP1189) to MC1r and MC3r means that MC2r mediated glucocorticoid release from the adrenal gland is avoided. Thus, the compound induces its pharmacological effects in a steroid-free manner without the significant safety, tolerability, and side effect issues associated with adrenocorticotropic hormone (ACTH) based therapies. Further to that, the compound stimulates the MC1r through biased agonism, activating an alternative pathway, so the compound can be given without the unwanted side effect of skin hyperpigmentation that classical MC1r agonists will induce though cAMP activation in melanocytes. Currently, the drug is in Phase II stage of its development for the treatment of Rheumatoid Arthritis (RA).

  • LPX-TI641: LAPIX Therapeutics

LPX-TI641 is an oral, small-molecule designed to bind the phosphatidylserine binding pocket on the T cell/transmembrane, immunoglobulin, and mucin (Tim) family of receptors. It is currently under clinical development for autoimmune indications such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and multiple sclerosis with plans to expand to other autoimmune indications where the underlying pathology involves immune imbalances and loss of self-tolerance. LPX-TI641’s primary pharmacology works to restore the adaptive immune system’s self-tolerance rather than suppressing immunity, enabling patients to more effectively and gently combat autoimmune disease. Toxicological studies and emerging clinical data show that LPX-TI641 does not induce neutropenia or lymphocytopenia, suggesting a potentially improved safety profile compared to current therapies. Currently, the drug is in Phase I stage of its development for the treatment of Rheumatoid Arthritis (RA).

 

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

  • Late-stage Rheumatoid Arthritis products (Phase III)
  • Mid-stage Rheumatoid Arthritis products (Phase II)
  • Early-stage Rheumatoid Arthritis product (Phase I)
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Rheumatoid Arthritis Route of Administration

 

Explore DelveInsight’s Rheumatoid Arthritis Pipeline Drugs Report featuring 80+ promising therapies across various stages of clinical development @ Rheumatoid Arthritis Medication and FDA Approvals

 

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

  • TS152: Taisho Pharmaceutical
  • SM03: SinoMab
  • SHR0302: Jiangsu Hengrui Medicine
  • RC18: RemeGen
  • Otilimab: GlaxoSmithKline
  • ATI-450: Aclaris Therapeutics
  • MBS2320: Modern Biosciences
  • PF-06651600: Pfizer
  • Obefazimod: Abivax
  • ABBV-154: AbbVie
  • Branebrutinib: Bristol Myers Squibb
  • KPL-404: Kiniksa Pharmaceuticals
  • ORTD-1: Oryn Therapeutics
  • MRx0006: 4D pharma plc.
  • LABP-69: Landos Biopharma, Inc
  • BZ068: Biozeus
  • And Many Others.

 

Further Rheumatoid Arthritis product details are provided in the report. Download the Rheumatoid Arthritis report to learn more about the emerging Rheumatoid Arthritis therapies @ Rheumatoid Arthritis Drugs and Therapies

 

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 the Rheumatoid Arthritis Treatment.
  • Rheumatoid Arthritis key companies 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 Rheumatoid Arthritis therapeutics 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.

 

Key companies in the Rheumatoid Arthritis Therapeutics Market:

Some of the Rheumatoid Arthritis Companies working in the market 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., KLUS Pharma Inc., Revolo Biotherapeutics, Lynk Pharmaceuticals, Beijing Baylx Biotech, Hope Biosciences, Kangstem Biotech, Celltex Therapeutics, I-Mab Biopharma Co. Ltd., Synermore Biologics Co., Ltd, Oryn Therapeutics, Arthrogen, Bayer, Amgen, Draconis Pharma, Biozeus, Landos Biopharma, Imcyse, Kymera Therapeutics, RedHill Biopharma, 4D Pharma, CV6 Therapeutics, VYNE Therapeutics, MyMD Pharmaceuticals, Brickell Biotech Inc, Worg Pharmaceuticals, Almirall, Standigm, Metrion Biosciences, Jnana Therapeutics, Silo Pharma, SFA Therapeutics, Neutrolis Therapeutics, Ahead Therapeutics, Fresenius Kabi, Kidswell Bio, BioXpress Therapeutics, CinnaGen, Alvotech, Hetero Biopharma, Shanghai Henlius Biotech, Cadila Pharmaceuticals, Innovent Biologics, Torrent Pharmaceuticals, Emcure Pharmaceuticals, mAbxience, Shanghai Junshi Biosciences, Enosi Therapeutics, and others.

 

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Table of Content (TOC)

1. Report Introduction

2. Executive Summary

3. Rheumatoid Arthritis Current Treatment Patterns

4. Rheumatoid Arthritis – DelveInsight’s Analytical Perspective

5. Therapeutic Assessment

6. Rheumatoid Arthritis Late Stage Products (Phase-III)

7. Rheumatoid Arthritis Mid-Stage Products (Phase-II)

8. Rheumatoid Arthritis Early Stage Products (Phase-I)

9. Pre-clinical Products and Discovery Stage Products

10. Inactive Rheumatoid Arthritis Products

11. Dormant Rheumatoid Arthritis Products

12. Rheumatoid Arthritis Discontinued Products

13. Rheumatoid Arthritis Product Profiles

14. Key Companies in the Rheumatoid Arthritis Market

15. Key Products in the Rheumatoid Arthritis Therapeutics Segment

16. Dormant and Discontinued Products

17. Rheumatoid Arthritis Unmet Needs

18. Rheumatoid Arthritis Future Perspectives

19. Rheumatoid Arthritis Analyst Review

20. Appendix

21. Report Methodology

 

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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