Rheumatoid Arthritis Pipeline Insight

DelveInsight’s, “Rheumatoid Arthritis (RA) - Pipeline Insight, 2025” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Rheumatoid Arthritis (RA) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Geography Covered

• Global coverage

 

Rheumatoid Arthritis (RA): Understanding

Rheumatoid Arthritis (RA): Overview

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disorder primarily affecting synovial joints, often starting symmetrically in small peripheral joints and progressing to larger joints if left untreated. It results from a complex interaction between genetic predisposition and environmental factors such as smoking. RA leads to persistent inflammation, joint destruction, cartilage loss, and bone erosion, contributing to long-term disability and increased mortality if not adequately managed. The disease is classified as early RA when symptoms last fewer than six months, and as established RA when they persist longer. Diagnosis can be challenging due to the lack of a definitive laboratory test, necessitating a comprehensive clinical evaluation. Management includes both pharmacological interventions, particularly early use of disease-modifying anti-rheumatic drugs (DMARDs), and non-pharmacological strategies like physical therapy, counseling, and patient education to reduce morbidity and enhance quality of life.

The signs and symptoms of rheumatoid arthritis (RA) typically include joint pain, swelling, stiffness, and tenderness, especially in the small joints of the hands and feet, with a characteristic pattern of symmetry. Morning stiffness lasting more than 30 minutes is a common early feature. As the disease progresses, larger joints such as the knees, shoulders, and hips may become involved. Systemic symptoms like fatigue, low-grade fever, weight loss, and general malaise are also frequent. In advanced stages, joint deformities and reduced range of motion may occur, along with extra-articular manifestations such as rheumatoid nodules, lung involvement, vasculitis, and ocular inflammation, reflecting the systemic nature of the disease.

 

Rheumatoid arthritis (RA) is triggered by environmental factors like smoking in genetically predisposed individuals, particularly those with the HLA-DRB1 ""shared epitope."" These triggers lead to the modification of self-proteins through citrullination, carbamylation, and acetylation, resulting in the production of autoantibodies such as ACPA, RF, and anti-CarP. These autoantibodies can appear years before symptoms and initiate an immune response, primarily in mucosal sites like the lungs and gums. The disease progresses as both innate and adaptive immune systems contribute to chronic synovial inflammation. Activated fibroblast-like synoviocytes and immune cells release cytokines and enzymes that destroy cartilage and bone, leading to the hallmark joint damage of RA.

The primary goal in treating rheumatoid arthritis (RA) is early diagnosis and initiation of therapy to prevent irreversible joint damage and achieve long-term clinical remission or, if not possible, low disease activity. Disease activity is monitored using validated tools like DAS28, CDAI, and RAPID3. First-line treatment includes conventional DMARDs, primarily methotrexate, with alternatives like sulfasalazine and leflunomide. If these fail, biologic DMARDs (e.g., TNF inhibitors, IL-6 inhibitors, abatacept, rituximab) or targeted synthetic DMARDs (JAK inhibitors) may be added. NSAIDs and corticosteroids are used for symptom relief but carry risks and are not disease-modifying. Safety considerations are critical, with screening for infections like TB and hepatitis required before starting biologics or JAK inhibitors. The choice of therapy depends on disease severity, response to prior treatments, and comorbidities, following guidelines from the ACR and EULAR.

 

"Rheumatoid Arthritis (RA)- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Rheumatoid Arthritis (RA) pipeline landscape is provided which includes the disease overview and Rheumatoid Arthritis (RA) treatment guidelines. The assessment part of the report embraces, in depth Rheumatoid Arthritis (RA) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Rheumatoid Arthritis (RA) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Rheumatoid Arthritis (RA) R&D. The therapies under development are focused on novel approaches to treat/improve Rheumatoid Arthritis (RA).

 

Rheumatoid Arthritis (RA) Emerging Drugs Chapters

This segment of the Rheumatoid Arthritis (RA) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Rheumatoid Arthritis (RA) Emerging Drugs

• 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).

Further product details are provided in the report……..

 

Rheumatoid Arthritis (RA): Therapeutic Assessment

This segment of the report provides insights about the different Rheumatoid Arthritis (RA) drugs segregated based on following parameters that define the scope of the report, such as:

Major  Players in Rheumatoid Arthritis (RA)

There are approx. 75+ key companies which are developing the therapies for Rheumatoid Arthritis (RA). The companies which have their Rheumatoid Arthritis (RA) drug candidates in the most advanced stage, i.e. Registration include, Gedeon Richter.

 

Phases

DelveInsight’s 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

 

Route of Administration

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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

 

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Rheumatoid Arthritis (RA): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Rheumatoid Arthritis (RA) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Rheumatoid Arthritis (RA) drugs.

 

Rheumatoid Arthritis (RA) Report Insights

• Rheumatoid Arthritis (RA) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Rheumatoid Arthritis (RA) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Rheumatoid Arthritis (RA) drugs?
• How many Rheumatoid Arthritis (RA) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Rheumatoid Arthritis (RA)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Rheumatoid Arthritis (RA) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Rheumatoid Arthritis (RA) and their status?
• What are the key designations that have been granted to the emerging drugs?