Rheumatoid Arthritis - Pipeline Insight, 2025

DelveInsight’s, “Rheumatoid Arthritis - Pipeline Insight, 2025” report provides comprehensive insights about 75+ companies and 80+ pipeline drugs in Rheumatoid Arthritis 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: Understanding

Rheumatoid Arthritis: Overview

Rheumatoid Arthritis (RA) is an autoimmune disorder of the joints characterized by inflammatory arthritis as well as extra-articular involvement. It commonly involves multiple joints of both hands with morning stiffness that may last for several hours. The worldwide prevalence of RA is about 0.24%. The annual incidence of RA in the United States and other western nations of northern Europe is about 40 per 100,000 persons.

Rheumatoid arthritis patients contain antibodies to citrullinated proteins. Citrulline is an amino acid generated by post-translational modification of arginyl residues by peptidyl arginine deaminases. These antibodies are called anti-citrullinated protein antibodies (ACPA). ACPA can be IgG, IgM, or IgA isotypes. ACPA can bind citrullinated residues on self-proteins like vimentin, fibronectin, fibrinogen, histones, and type 2 collagen. The binding of antibodies to proteins leads to complement activation. The presence of antibodies in rheumatoid arthritis is referred to as seropositive RA. ACPA can be present in the serum up to 10 years before the onset of clinical symptoms. With time the concentration of ACPA and serum cytokine level increases.

In rheumatoid arthritis, joint complaints are in the foreground. The most common clinical presentation of RA is:

• Polyarthritis of small joints of hands: proximal interphalangeal (PIP), metacarpophalangeal (MCP) joints and wrist. Some patients may present with monoarticular joint involvement.
• Commonly joint involvement occurs insidiously over a period of months, however, in some cases, joint involvement may occur over weeks or overnight.
• Other commonly affected joints include wrist, elbows, shoulders, hips, knees, ankles and metatarsophalangeal (MTP) joints.

RA is diagnosed by examining blood test results, examining the joints and organs, and reviewing x-ray or ultrasound images. There is no single test to diagnose RA. Blood tests are run to look for antibodies in the blood that can been seen in RA. Antibodies are small proteins in the bloodstream that help fight against foreign substances called antigens. Sometimes these antibodies are found in people without RA. This is called a false positive result. Blood tests are also run to look for high levels of inflammation. The symptoms of RA can be very mild making the diagnosis more difficult. Some viral infections can cause symptoms that can be mistaken for RA. A rheumatologist is a physician with the skill and knowledge to reach a correct diagnosis of RA and to recommend a treatment plan. Therapy for RA has improved greatly in the past 30 years. Current treatments give most patients good or excellent relief of symptoms and let them keep functioning at, or near, normal levels. With the right medications, many patients can have no signs of active disease. When the symptoms are completely controlled, the disease is in “remission”. There is no cure for RA. The goal of treatment is to improve your joint pain and swelling and to improve your ability to perform day-to-day activities. Starting medication as soon as possible helps prevent your joints from having lasting or possibly permanent damage. DMARDs have greatly improved the pain, swelling, and quality of life for nearly all patients with RA. Common DMARDs include methotrexate (Rheumatrex, Trexall, Otrexup, Rasuvo), leflunomide (Arava), hydroxychloroquine (Plaquenil) and sulfasalazine (Azulfidine).

""Rheumatoid Arthritis - 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 pipeline landscape is provided which includes the disease overview and Rheumatoid Arthritis treatment guidelines. The assessment part of the report embraces, in depth Rheumatoid Arthritis 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 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 R&D. The therapies under development are focused on novel approaches to treat/improve Rheumatoid Arthritis.

Rheumatoid Arthritis Emerging Drugs Chapters

This segment of the Rheumatoid Arthritis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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 Emerging Drugs

• SM03: SinoMab Bioscience

SM03 is a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases. CD22, an inhibitory coreceptor of the BCR, is a potential immunotherapeutic target against autoimmune diseases. SM03 could disturb the CD22 homomultimeric configuration through disrupting cis binding to α2, 6-linked sialic acids, induce rapid internalization of CD22 from the cell surface of human B cells, and facilitate Trans binding between CD22 to human autologous cells. This in turn increased the activity of the downstream immunomodulatory molecule Src homology region 2 domain-containing phosphatase 1 (SHP-1) and decreased BCR-induced NF-κB activation in human B cells and B cell proliferation. This mechanism of action gives rationale to support the significant amelioration of disease and good safety profile in clinical trials, as by enabling the “self” recognition mechanism of CD22 via trans binding to α2, 6 sialic acid ligands on autologous cells, SM03 specifically restores immune tolerance of B cells to host tissues without affecting the normal B cell immune response to pathogens. In September 2023, SinoMab BioScience Limited announced that the National Medical Products Administration (NMPA) had accepted the biologics license application (BLA) for the company’s flagship product, SM03 (Suciraslimab), in the treatment of rheumatoid arthritis. Currently, the drug is been Registered for the treatment of Rheumatoid Arthritis.

• Telitacicept (RC18): RemeGen Co. Ltd.

Telitacicept is a proprietary novel fusion protein from RemeGen to treat autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-cell lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. Currently, the drug is in Preregistration stage of its development for the treatment of Rheumatoid Arthritis.

• IRL201805: Immune Regulation

IRL201805 is a first-in-class compound derived from the endogenous immuno-regulatory protein IRL201805 has demonstrated long duration of activity and disease remission with a good tolerability profile in a phase I/IIA study in patients with rheumatoid arthritis who have failed previous therapies. IRL201805 is a modified analogue of the endogenous immune-regulatory binding immunoglobulin protein (BiP), a key player in immune function that resets the immune system for long-term disease remission. Its mechanism of action creates vast optionality across multiple indications and routes of administration. Currently, the drug is in Phase II stage of its development for the treatment of Rheumatoid Arthritis.

• ORYN 1001: Oryn Therapeutics

Orynotide ORYN 1001 is being developed as a novel treatment for rheumatoid arthritis, COVID-19, and other systemic inflammatory diseases. With the successful completion of Phase IB trial for the treatment of Rheumatoid Arthritis (A Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD 1 in Rheumatoid Arthritis Patients with Mild Disease Managed with DMARDs), the systemic safety profile of the first Orynotide therapeutic drug candidate has been validated. Currently, the drug is in Phase I/II stage of its development for the treatment of Rheumatoid Arthritis

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

Rheumatoid Arthritis: Therapeutic Assessment

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

• Major Players in Rheumatoid Arthritis
• There are approx. 75+ key companies which are developing the therapies for Rheumatoid Arthritis. The companies which have their Rheumatoid Arthritis drug candidates in the most advanced stage, i.e. Registration include, SinoMab Bioscience.
• 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 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: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Rheumatoid Arthritis 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 drugs.

Rheumatoid Arthritis Report Insights

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

Rheumatoid Arthritis 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 drugs?
• How many Rheumatoid Arthritis 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?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Rheumatoid Arthritis 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 and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• SinoMab Bioscience
• RemeGen Co. Ltd.
• Immune Regulation
• Oryn Therapeutics
• OncoOne
• Sonoma Biotherapeutics
• Teijin Pharma
• Eli Lilly and Company
• SynAct Pharma
• Jiangsu Hengrui Medicine Co
• SynAct Pharma Aps
• I-Mab Biopharma US Limited
• Celon Pharma SA
• Lipum
• Sonoma Biotherapeutics, Inc.
• Incannex Healthcare Ltd
• AbbVie
• Lynk Pharmaceuticals Co., Ltd
• Sanofi
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Key Products

• SM03
• Telitacicept (RC18)
• IRL201805
• ORYN 1001
• ON104
• SBT-77-7101
• TCK-276
• LY3462817
• AP1189
• SHR0302
• LY3871801
• AP1189
• TJ003234
• CPL409116
• SOL 116
• SBT777101
• IHL-675A
• Upadacitinib
• LNK01001
• SAR441566
• TQH3821

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