{"id":30871,"date":"2025-01-24T17:43:00","date_gmt":"2025-01-24T12:13:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30871"},"modified":"2025-09-10T10:31:19","modified_gmt":"2025-09-10T05:01:19","slug":"graves-disease-drugs-in-late-stage-development","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/graves-disease-drugs-in-late-stage-development","title":{"rendered":"Graves\u2019 Disease Drug Pipeline: 6 Late-Stage Therapies to Watch"},"content":{"rendered":"\n

The pipeline for Graves\u2019 disease drug treatments is rapidly expanding, with prominent companies such as Immunovant, Viridian Therapeutics, Argenx, Tourmaline Bio, Hoffmann-La Roche, and Sling Therapeutics<\/strong> spearheading the development of targeted therapies for thyroid disorders. Promising candidates in the late stages of Graves\u2019 disease treatment include veligrotug (VRDN-001), VRDN-003, batoclimab, Efgartigimod PH20 SC, ENSPRYNG (satralizumab, RG6168), and IMVT-1402<\/strong>.  <\/p>\n\n\n\n

These emerging therapies, which target various mechanisms and molecular pathways, offer innovative alternatives to current treatments. By providing novel approaches to managing autoimmune conditions such as thyroid eye disease, they highlight an increasing emphasis on more precise and targeted solutions for these complex disorders.<\/p>\n\n\n\n

For more insights into Graves\u2019 disease therapeutic segment, read our blog \u201cGraves\u2019 Disease Treatment Revolution: What\u2019s Next in Line?<\/a>\u201d<\/em><\/strong><\/p>\n\n\n\n

Now, let\u2019s look at the 6 promising late-stage therapies for Graves\u2019 disease that will be launched in the coming years.<\/em><\/p>\n\n\n\n

Immunovant, Samsung Biologics, HanAll Biopharma, and Roivant Sciences\u2019 IMVT-1401 and IMVT-1402<\/strong><\/p>\n\n\n\n

Immunovant\u2019s pipeline features two advanced anti-FcRn monoclonal antibodies<\/strong><\/a>, IMVT-1402 and batoclimab (formerly IMVT-1401)<\/strong>, both developed for subcutaneous administration with flexible dosing tailored to disease severity. These therapies target the neonatal Fc receptor to lower pathogenic IgG antibodies, addressing conditions associated with elevated IgG levels. <\/p>\n\n\n\n

Immunovant\u2019s lead investigational product, batoclimab (IMVT-1401)<\/strong>, is a novel, fully human monoclonal antibody designed to target the neonatal Fc receptor (FcRn). Research from nonclinical studies and clinical trials has shown that batoclimab can lower IgG antibody levels, which are often elevated in various autoimmune diseases. By reducing pathogenic IgG antibodies, this candidate therapy has the potential to treat a range of IgG-mediated autoimmune conditions as a self-administered subcutaneous (SC) injection.<\/p>\n\n\n\n

IMVT-1402<\/strong> is specifically designed to avoid the albumin reductions and LDL cholesterol increases observed with batoclimab while maintaining comparable IgG-lowering efficacy. Drawing from insights gained in ongoing batoclimab studies, Immunovant is fast-tracking the development of IMVT-1402 in critical areas such as rheumatology, endocrinology, and neurology, targeting diseases like Graves\u2019 disease, myasthenia gravis, CIDP, and rheumatoid arthritis.  <\/p>\n\n\n\n

Phase II data for batoclimab in Graves\u2019 disease demonstrate the potential of FcRn inhibition to counter disease pathology driven by thyroid-stimulating hormone receptor autoantibodies, with greater IgG reductions linked to improved clinical outcomes. <\/p>\n\n\n\n

Currently, batoclimab is being developed as a low-volume SC injection to address autoimmune disorders such as myasthenia gravis, thyroid eye disease<\/a>, CIDP, and Graves\u2019 disease.<\/p>\n\n\n\n

In September 2024, Immunovant secured Investigational New Drug (IND) clearance from the US FDA for IMVT-1402 to treat Graves\u2019 disease patients who remain hyperthyroid despite using antithyroid drugs. The company also plans to launch clinical trials of IMVT-1402 across ten indications by March 2026.  <\/p>\n\n\n\n

Viridian Therapeutics\u2019 VRDN-001 and VRDN-003 <\/strong><\/p>\n\n\n\n

Viridian Therapeutics<\/strong> distinguishes itself as the only company developing therapies for both moderate-to-severe active TED and chronic TED. Since chronic TED significantly contributes to the overall disease burden, addressing this segment could enable the company to secure a considerable market share. <\/p>\n\n\n\n

Viridian is advancing a robust IGF-1R antibody portfolio for TED, with its lead candidate, veligrotug (formerly VRDN-001)<\/strong>, an IV-administered monoclonal antibody. VRDN-001 is a unique monoclonal antibody targeting the Insulin-like Growth Factor-1 Receptor (IGF-1R), a clinically and commercially established target for treating Graves\u2019 ophthalmopathy<\/a>. Preclinical studies demonstrated that VRDN-001 acts as a full IGF-1R antagonist, achieving complete receptor blockade, surpassing other anti-IGF-1R antibodies, including the currently approved therapy for Graves\u2019 ophthalmopathy.<\/p>\n\n\n\n

Early data from Phase II trial cohorts confirmed the clinical proof-of-concept for VRDN-001 in patients with active Graves\u2019 ophthalmopathy. Preliminary results showed that VRDN-001 treatment significantly reduced proptosis, improved CAS scores, and resolved diplopia. The therapy was generally safe and well-tolerated throughout the trial.<\/p>\n\n\n\n

In September 2024, veligrotug demonstrated strong results in the Phase III THRIVE trial<\/strong>, achieving primary and secondary endpoints with high statistical significance. The treatment showed rapid efficacy, with 53% of patients experiencing a proptosis response after just one infusion, and it was well tolerated, with no treatment-related serious adverse events reported. Topline data from the THRIVE-2 trial<\/strong> (focused on chronic TED) is anticipated by the end of 2024, and a BLA submission is planned for the second half of 2025<\/strong>.<\/p>\n\n\n\n

VRDN-003 is also an IGF-1R antibody that shares the same binding domain as veligrotug. It is believed to be the only anti-IGF-1R therapy in development with an extended half-life. Viridian considers the topline results from the THRIVE study to strongly support a potential best-in-class profile for VRDN-003. This therapy offers clinical efficacy and safety comparable to veligrotug in a low-volume, infrequent, self-administered subcutaneous injection suitable for at-home use.  <\/p>\n\n\n\n

The pivotal REVEAL trials (REVEAL-1 for active TED and REVEAL-2 for chronic TED) are currently in progress. Topline results are anticipated in the first<\/strong> half<\/strong> of<\/strong> 2026<\/strong>, followed by the planned BLA submission by year-end<\/strong>. With Veligrotug and VRDN-003, the company is poised to establish itself as a leader in the TED market<\/a>, offering both intravenous and subcutaneous delivery options.<\/p>\n\n\n\n

\"Emerging-Therapies-for-Graves-Disease\"<\/figure>\n\n\n\n

Argenx\u2019s Efgartigimod PH20 SC<\/strong><\/p>\n\n\n\n

Efgartigimod PH20 SC<\/strong>, developed by Argenx<\/strong>, is an experimental treatment for thyroid eye disease. This fully human antibody fragment targets the neonatal Fc receptor (FcRn)<\/strong> to inhibit its function. By blocking FcRn, the drug lowers the levels of harmful immunoglobulin G (IgG) autoantibodies, which are thought to drive autoimmune conditions. <\/p>\n\n\n\n

Currently in Phase III proof-of-concept trials, the subcutaneous formulation (PH20 SC) is designed to enhance drug dispersion and absorption, potentially boosting its effectiveness and ease of use for patients. With its novel mechanism of action and user-friendly administration, Efgartigimod PH20 SC offers promising benefits over existing treatments. Argenx is advancing this thyroid eye disease drug toward regulatory approval to provide a new, effective solution for managing TED.<\/p>\n\n\n\n

Hoffmann-La Roche\u2019s ENSPRYNG <\/strong><\/p>\n\n\n\n

ENSPRYNG (satralizumab, RG6168)<\/strong>, developed by Roche<\/strong>, is a humanized monoclonal antibody designed to target the interleukin-6 (IL-6) receptor<\/strong>. IL-6 is a signaling protein produced by immune cells that plays a role in autoimmune disorders, including TED. Currently, in Phase III trials for TED<\/a>, Roche is working to progress ENSPRYNG toward regulatory approval, aiming to offer a new treatment option for this chronic condition.<\/p>\n\n\n\n

The anticipated launch of emerging therapies for Graves\u2019 disease is poised to significantly reshape its treatment landscape, offering new hope to patients and addressing unmet clinical needs. Traditional therapies, including antithyroid medications, radioactive iodine, and thyroidectomy, often come with limitations such as incomplete remission, recurrence, or long-term side effects.<\/p>\n\n\n\n

These novel Graves\u2019 disease drugs could reduce reliance on invasive procedures and improve the quality of life for patients by minimizing disease relapse and adverse effects. Furthermore, their introduction is likely to spur competition and innovation within the market, encouraging further research into personalized approaches and combination regimens, ultimately elevating the standard of care for Graves\u2019 disease.<\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n

FAQs<\/h2>\n\n\n\n
Which companies are leading the development of Graves\u2019 disease drugs?<\/strong><\/strong>

The pipeline for Graves\u2019 disease drug treatments is rapidly expanding, with prominent companies such as Immunovant, Viridian Therapeutics, Argenx, Tourmaline Bio, Hoffmann-La Roche, and Sling Therapeutics<\/strong> spearheading the development of targeted therapies for thyroid disorders.<\/p> <\/div>

What does Graves\u2019 disease late-stage pipeline look like?<\/strong><\/strong>

Promising candidates in the late stages of Graves\u2019 disease treatment include veligrotug (VRDN-001), VRDN-003, batoclimab, Efgartigimod PH20 SC, ENSPRYNG (satralizumab, RG6168), and IMVT-1402<\/strong>.<\/p> <\/div>

Where is the Graves\u2019 disease market headed?<\/strong><\/strong>

As per DelveInsight analysis, the Graves\u2019 disease market size in the 7MM was around USD 4.4 billion<\/strong> in 2023 and is expected to increase with a significant CAGR during the forecast period. Among the 7MM, the United States accounted for the largest market size, i.e., approximately 72%<\/strong> of the overall market in 2023.<\/p> <\/div> <\/div>\n","protected":false},"excerpt":{"rendered":"

The pipeline for Graves\u2019 disease drug treatments is rapidly expanding, with prominent companies such as Immunovant, Viridian Therapeutics, Argenx, Tourmaline Bio, Hoffmann-La Roche, and Sling Therapeutics spearheading the development of targeted therapies for thyroid disorders. Promising candidates in the late stages of Graves\u2019 disease treatment include veligrotug (VRDN-001), VRDN-003, batoclimab, Efgartigimod PH20 SC, ENSPRYNG (satralizumab, 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disorders.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/graves-disease-drugs-in-late-stage-development#faq-question-1757480455320","position":2,"url":"https:\/\/www.delveinsight.com\/blog\/graves-disease-drugs-in-late-stage-development#faq-question-1757480455320","name":"What does Graves\u2019 disease late-stage pipeline look like?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"Promising candidates in the late stages of Graves\u2019 disease treatment include <strong>veligrotug (VRDN-001), VRDN-003, batoclimab, Efgartigimod PH20 SC, ENSPRYNG (satralizumab, RG6168), and IMVT-1402<\/strong>.","inLanguage":"en-US"},"inLanguage":"en-US"},{"@type":"Question","@id":"https:\/\/www.delveinsight.com\/blog\/graves-disease-drugs-in-late-stage-development#faq-question-1757480469466","position":3,"url":"https:\/\/www.delveinsight.com\/blog\/graves-disease-drugs-in-late-stage-development#faq-question-1757480469466","name":"Where is the Graves\u2019 disease market headed?","answerCount":1,"acceptedAnswer":{"@type":"Answer","text":"As per DelveInsight analysis, the Graves\u2019 disease market size in the 7MM was around <strong>USD 4.4 billion<\/strong> in 2023 and is expected to increase with a significant CAGR during the forecast period. Among the 7MM, the United States accounted for the largest market size, i.e., approximately <strong>72%<\/strong> of the overall market in 2023.","inLanguage":"en-US"},"inLanguage":"en-US"}]}},"author_meta":{"display_name":"Sandeep Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2025\/01\/24134158\/graves-disease-drugs-in-late-stage-development-300x183.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Articles<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Articles<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Graves' Disease Drugs<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Graves\u2019 Disease Treatment<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/articles\/\" class=\"advgb-post-tax-term\">Thyroid eye disease<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Graves' Disease Drugs<\/span>","<span class=\"advgb-post-tax-term\">Graves\u2019 Disease Treatment<\/span>","<span class=\"advgb-post-tax-term\">Thyroid eye disease<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 1 year ago","modified":"Updated 8 months ago"},"absolute_dates":{"created":"Posted on Jan 24, 2025","modified":"Updated on Sep 10, 2025"},"absolute_dates_time":{"created":"Posted on Jan 24, 2025 5:43 pm","modified":"Updated on Sep 10, 2025 10:31 am"},"featured_img_caption":"","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30871","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=30871"}],"version-history":[{"count":4,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30871\/revisions"}],"predecessor-version":[{"id":33308,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30871\/revisions\/33308"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/30873"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=30871"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=30871"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=30871"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=30871"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=30871"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}