{"id":34990,"date":"2026-04-13T17:56:00","date_gmt":"2026-04-13T12:26:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=34990"},"modified":"2026-04-13T14:17:07","modified_gmt":"2026-04-13T08:47:07","slug":"novartis-in-radioligand-therapies","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/novartis-in-radioligand-therapies","title":{"rendered":"Novartis Bets Big on Radioligand Therapy with Multiple Pipeline Candidates and Expanding Trials"},"content":{"rendered":"\n<p><strong><em>Summary&nbsp;<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>With FDA-approved products LUTATHERA and PLUVICTO, both beta-emitters, Novartis has established itself as an industry frontrunner.<\/em><\/li>\n\n\n\n<li><em>Over 15 ongoing or planned trials and several next-generation candidates in development in Novartis RLT pipeline.<\/em><\/li>\n\n\n\n<li><em>Rivals include AstraZeneca, Bayer, Eli Lilly, Curium Pharma, ITM Isotope Technologies, and others.<\/em><\/li>\n<\/ul>\n\n\n\n<p>As radioligand therapy rapidly advances as a promising therapeutic option, <strong>Novartis <\/strong>is already demonstrating clear leadership in the field with its approved products, <strong>LUTATHERA <\/strong>and <strong>PLUVICTO, <\/strong>both of which are beta emitters. LUTATHERA became the first <a href=\"https:\/\/www.delveinsight.com\/blog\/radioligand-therapies-in-cancer-treatment\">FDA-approved radioligand therapy<\/a> for adult GEP-NET patients and was recently approved for pediatric patients as well. According to Novartis&#8217; 2025 annual report, LUTATHERA sales increased primarily in the US, Europe, and Japan, driven by rising demand and use in earlier treatment lines (within the approved indication) in the US and Japan. LUTATHERA generated approximately <strong>USD 816 million<\/strong> in sales in 2024. In 2022, the FDA approved PLUVICTO, establishing it as the first targeted <a href=\"https:\/\/www.delveinsight.com\/report-store\/metastatic-castration-resistant-prostate-cancer-mcrpc-market\">radioligand therapy for patients with mCRPC<\/a>. Despite supply limitations and its third-line positioning, the therapy generated nearly <strong>USD<\/strong> <strong>980<\/strong> <strong>million<\/strong> in revenue in 2023 within 18 months of launch, while its prospects in the earlier pre-taxane setting continue to attract significant attention. Last year, PLUVICTO generated <strong>USD 1.9 billion <\/strong>in sales.<\/p>\n\n\n\n<p><em>Sadaf Javed, Manager of Forecasting and Analytics at DelveInsight, noted that the pharmaceutical industry is increasingly interested in targeted radiation therapy as a novel, promising cancer treatment option following the success of LUTATHERA.<\/em> <em>Javed added, Novartis is a large-scale buyer procuring Lu-177, securing the isotope to support its radioligand therapy portfolio. The company, Javed said, currently markets two approved radioligand therapies worldwide. It continues to expand its presence in this space, with multiple additional RLT candidates in development and more than <\/em><strong><em>15 clinical trials<\/em><\/strong><em> either ongoing or planned to advance its pipeline, as per Javed.<\/em><\/p>\n\n\n\n<p>Novartis is developing multiple <a href=\"https:\/\/www.delveinsight.com\/blog\/emerging-radioligand-therapies-in-clinical-trials\">radioligand candidates<\/a>, including <strong>177Lu\u2011NeoB<\/strong> (solid tumors, including breast and glioblastoma), <strong>AAA614<\/strong> (solid tumors), <strong>177Lu-NNS309<\/strong> (solid tumors), and <strong>ESP359<\/strong> (solid tumors), as well as several actinium\u2011225 PSMA constructs, such as <strong>225Ac\u2011PSMA\u2011617<\/strong>.<\/p>\n\n\n\n<p><strong>PLUVICTO (177Lu-PSMA-617)<\/strong> is already redefining outcomes for patients with mCRPC. This smart therapy combines the beta-emitting isotope lutetium-177 with a PSMA-targeting ligand, homing in on tumor cells that overexpress PSMA and precisely destroying them from within. In the landmark <strong>VISION trial<\/strong>, PLUVICTO cut the risk of death by <strong>38% <\/strong>and reduced the chance of disease progression or death by <strong>60% <\/strong>versus standard care.<\/p>\n\n\n\n<p>Building on that success, the <strong>PSMAfore and PSMAddition trials <\/strong>are exploring its use in earlier-stage and hormone-sensitive prostate cancers, showing promising improvements in radiographic progression-free survival (rPFS). With FDA approvals and <strong>Breakthrough Therapy Designation<\/strong>, PLUVICTO is expanding into new indications, including neuroendocrine and oligometastatic prostate cancer.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"394\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-1024x394.webp\" alt=\"Emerging-Radioligand-Therapies-in-Novartis-Pipeline\" class=\"wp-image-34992\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-1024x394.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-300x115.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-150x58.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-768x295.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline-1536x590.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/04\/Emerging-Radioligand-Therapies-in-Novartis-Pipeline.webp 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p>To overcome resistance and improve potency, Novartis is developing <strong>225Ac-PSMA-617<\/strong>, an alpha-emitting RLT that uses actinium-225 instead of lutetium-177. Alpha particles deliver intense, short-range radiation that causes dense DNA damage, potentially eliminating even resistant tumor cells with remarkable precision.<\/p>\n\n\n\n<p>Currently in <strong>Phase 1<\/strong>, this next-generation therapy is showing high tumor uptake and early antitumor activity, despite challenges like salivary gland toxicity. The company is also advancing related candidates such as 225Ac-PSMA-R2 to strengthen its radioligand arsenal.<\/p>\n\n\n\n<p>Beyond PSMA, Novartis is expanding into novel targets across the tumor microenvironment. <strong>177Lu-NNS309<\/strong> focuses on <a href=\"https:\/\/www.delveinsight.com\/report-store\/fap-inhibitor-market-forecast\">fibroblast activation protein (FAP)<\/a>, a stromal marker expressed in over 90% of solid tumors, including pancreatic, lung, breast, and colorectal cancers. By targeting the tumor-supporting stroma rather than cancer cells alone, this approach introduces a new therapeutic dimension, with <strong>Phase 1 trials<\/strong> showing encouraging early safety, dosimetry, and efficacy signals.<\/p>\n\n\n\n<p>Similarly, <strong>177Lu-NeoB<\/strong> targets the gastrin-releasing peptide receptor (GRPR), which is implicated in several difficult-to-treat cancers such as glioblastoma, breast, and prostate cancer. When paired with the diagnostic imaging agent 68Ga-NeoB, it enables a theranostic strategy, combining diagnosis and treatment using the same molecular target. Early clinical studies have demonstrated favorable biodistribution and tolerability, and combination approaches with chemotherapies like Capecitabine are already being explored.<\/p>\n\n\n\n<p>Further strengthening its pipeline, Novartis is developing <strong>AAA614<\/strong>, a <strong>Phase 2 program<\/strong> built on proprietary PurAffin technology designed for precise stromal targeting across major solid tumor types, to disrupt tumor-supportive tissue directly. Meanwhile, <strong>ESP359 <\/strong>is emerging as a promising early-stage candidate targeting <a href=\"https:\/\/www.delveinsight.com\/report-store\/delta-like-ligand-3-targeted-therapies-market-forecast\">DLL3<\/a>, a neuroendocrine biomarker highly expressed in small cell lung cancer and other aggressive malignancies. Together, these innovations highlight Novartis\u2019 ambition to expand the frontiers of radioligand therapy by unlocking new biological targets and transforming treatment paradigms across a wide spectrum of cancers.<\/p>\n\n\n\n<p>Driven by deep expertise in molecular targeting and radiochemistry, Novartis is positioning itself at the forefront of a new therapeutic era, where radioligand therapies bring precision, potency, and personalized care to patients facing some of the toughest cancers.<\/p>\n\n\n\n<p>However, Novartis may face challenges from both new rivals and expected generic entrants; therefore, the company must accelerate its strategy. Recently, <strong>Lantheus <\/strong>has secured tentative FDA approval for its Abbreviated New Drug Application (ANDA) for <strong>Lutetium<\/strong> <strong>Lu<\/strong> <strong>177<\/strong> <strong>Dotatate<\/strong> <strong>(PNT2003)<\/strong>, a radioequivalent of LUTATHERA.<\/p>\n\n\n\n<p>Companies such as <strong>AstraZeneca, Eli Lilly, Curium Pharma, Novartis, Bayer, and ITM Isotope Technologies<\/strong> are actively developing radioligand therapies. In addition, <strong>ARTBIO <\/strong>is advancing early-stage clinical candidates such as <strong>AB001 <\/strong>for prostate cancer, with three other targets (ABA, ABB, and ABC) yet to be disclosed. <strong>Johnson &amp; Johnson<\/strong> is also investigating <strong>JNJ-69086420<\/strong> in a Phase I trial for mCRPC.<\/p>\n\n\n\n<p><strong>Curium Pharma<\/strong> is collaborating closely with the FDA and anticipates potential approval of its <strong>Lutetium Lu-177-PSMA-I&amp;T<\/strong>, which could expand access for patients with mCRPC. Meanwhile, <strong>BAMF Health<\/strong> is conducting clinical trials in partnership with various companies, contributing significantly to the <a href=\"https:\/\/www.delveinsight.com\/blog\/radioligand-therapies-reshaping-the-neuroendocrine-tumors-treatment\">radioligand therapy pipeline<\/a>. These studies include candidates such as <strong>177Lu-PSMA-617<\/strong> for mHSPC, <strong>64Cu-SAR-BBN and 67Cu SAR-BBN<\/strong> targeting Gastrin-Releasing Peptide Receptor (GRPR)-positive mCRPC in patients not eligible for <strong>177Lu-PSMA-617 therapy, <\/strong>and <strong>FPI-2265<\/strong> for PSMA-expressing prostate cancer, among others.<\/p>\n\n\n\n<p>In addition, companies such as <strong>Convergent<\/strong> <strong>Therapeutics<\/strong> (CONV01-\u03b1), <strong>Perspective<\/strong> <strong>Therapeutics<\/strong> (VMT-\u03b1-NET, VMT01, and PSV359), <strong>PRECIRIX<\/strong> (CAM-FAP-Ac-225), <strong>Ariceum<\/strong> <strong>Therapeutics<\/strong> (225Ac-SSO110 and ATT001), and <strong>Nuclidium<\/strong> (NU101 and NU201) are investigating radioligand therapies at various stages of development.&nbsp;<\/p>\n\n\n\n<p>As the RLT landscape evolves, Novartis stands at a pivotal point, leveraging its established market presence with LUTATHERA and PLUVICTO while betting big on innovative next-generation candidates. Its deep investment in targeted isotopes, novel tumor microenvironment targets, and alpha-emitting constructs underscores a long-term vision to sustain leadership amid increasing competition and patent challenges. The coming years are likely to see RLTs move beyond niche oncology indications into broader solid tumor applications, facilitated by advances in theranostic platforms, improved isotope availability, and combination therapy strategies.<\/p>\n\n\n\n<p>The future of radioligand therapy is anchored in precision and personalization, matching the right isotope to the right target for the right patient at the right time. As innovation accelerates and more players enter the space, the convergence of diagnostics and therapeutics is positioning RLTs as a cornerstone of next-generation cancer care.<\/p>\n\n\n\n<p>At the same time, the <a href=\"https:\/\/www.delveinsight.com\/blog\/ai-integration-in-radiopharmaceuticals\">integration of AI in radiopharmaceuticals<\/a> is adding a new layer of intelligence to this paradigm, enhancing target identification, optimizing radioligand design, and enabling more accurate patient selection and dosimetry. AI-driven insights are helping translate complex imaging and molecular data into actionable treatment decisions, further refining the precision medicine approach.<\/p>\n\n\n\n<p>By continuing to innovate and scale, and by leveraging AI to streamline development and personalize therapy pathways, Novartis has the potential not only to shape this emerging market but also to redefine how cancer is treated at the molecular level, ushering in a more adaptive and data-driven era of oncology.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/radioligand-therapies-market-forecast\"><img decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-1024x194.webp\" alt=\"Radioligand Therapies Market Outlook\" class=\"wp-image-34670\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-1024x194.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-300x57.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-150x28.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-768x145.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook-1536x291.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/03\/Radioligand-Therapies-Market-Outlook.webp 1584w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Summary&nbsp; As radioligand therapy rapidly advances as a promising therapeutic option, Novartis is already demonstrating clear leadership in the field with its approved products, LUTATHERA and PLUVICTO, both of which are beta emitters. LUTATHERA became the first FDA-approved radioligand therapy for adult GEP-NET patients and was recently approved for pediatric patients as well. According to [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":34993,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[22929,18415,22916,22073,22915,22917],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-34990","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-emerging-radioligand-therapies","tag-lutathera","tag-pluvicto","tag-radioligand-therapies","tag-radioligand-therapies-treatment","tag-rlts","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) 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