{"id":36048,"date":"2026-08-28T17:09:00","date_gmt":"2026-08-28T11:39:00","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=36048"},"modified":"2026-08-26T15:11:41","modified_gmt":"2026-08-26T09:41:41","slug":"ptcl-drugs-in-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/ptcl-drugs-in-clinical-trials","title":{"rendered":"The Next Wave in Peripheral T-Cell Lymphoma Treatment: 4 Late-Stage Drugs Making Their Mark"},"content":{"rendered":"\n<p><strong><em>Summary<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><em>Peripheral T-cell lymphoma (PTCL) is a rare and aggressive group of mature T-cell malignancies, representing approximately 10\u201315% of non-Hodgkin lymphomas in the US.<\/em><\/li>\n\n\n\n<li><em>CHOP remains the standard first-line treatment, but its intensive cytotoxic profile limits use in some patients.\u00a0<\/em><\/li>\n\n\n\n<li><em>ADCETRIS (brentuximab vedotin) is the only approved agent in the first-line setting, while therapies such as BELEODAQ, POTELIGEO, XALKORI, and EZHARMIA are primarily applicable to selected subtypes or treatment settings.<\/em><\/li>\n\n\n\n<li><em>The key late-stage candidates poised to drive significant changes during the upcoming forecast period include Duvelisib (COPIKTRA; Secura Bio), golidocitinib (Dizal Pharmaceutical), linperlisib (Shanghai YingLi Pharmaceutical), and Soquelitinib (Corvus Pharmaceuticals).<\/em><\/li>\n<\/ul>\n\n\n\n<p>PTCL represents a diverse group of aggressive mature <a href=\"https:\/\/www.delveinsight.com\/blog\/t-cell-malignancies-treatment-space\">T-cell lymphoid malignancies<\/a>, accounting for approximately <strong>10\u201315%<\/strong> of non-Hodgkin lymphomas in the United States, <strong>6.5%<\/strong> in Europe, and up to <strong>25%<\/strong> in Japan. Its incidence varies considerably across regions and disease subtypes, with PTCL-NOS, AITL, and ALCL among the most frequently diagnosed forms. Patients often experience poor clinical outcomes, high relapse rates, and limited access to durable treatment options, resulting in a substantial clinical and quality-of-life burden.<\/p>\n\n\n\n<p><strong>CHOP <\/strong>continues to serve as the standard first-line treatment for PTCL; however, significant unmet needs remain, particularly for patients who are unable to tolerate intensive cytotoxic chemotherapy. ADCETRIS remains the only approved agent in the first-line setting, underscoring the limited therapeutic progress in this disease. Moreover, efforts to improve outcomes through CHOP-based combinations have largely been constrained by increased toxicity and the absence of a sufficiently biomarker-driven treatment approach.<\/p>\n\n\n\n<p>Japan has emerged as a key market for PTCL therapies, with a significant proportion of treatment approvals concentrated in the country. This reflects both its evolving regulatory environment and continued focus on addressing the substantial unmet needs associated with this rare and aggressive group of lymphomas.<\/p>\n\n\n\n<p>The current <a href=\"https:\/\/www.delveinsight.com\/blog\/peripheral-t-cell-lymphoma-treatment-market\">PTCL treatment landscape<\/a> includes therapies such as <strong>ADCETRIS <\/strong>from Takeda for CD30-positive disease, along with <strong>BELEODAQ <\/strong>from Acrotech Biopharma, <strong>POTELIGEO <\/strong>from Kyowa Kirin, <strong>XALKORI <\/strong>from Pfizer, and <strong>EZHARMIA <\/strong>from Daiichi Sankyo for selected patient populations and subtypes. However, the benefits offered by these therapies are generally limited to specific disease settings or molecular subgroups.<\/p>\n\n\n\n<p>The emerging peripheral T-cell lymphoma pipeline is increasingly focused on targeted and biologically driven approaches. Key candidates include <strong>Duvelisib <\/strong>from Secura Bio targeting Phosphoinositide 3-kinase inhibitors, <strong>Golidocitinib <\/strong>from Dizal Pharmaceuticals targeting JAK1 inhibitor, <strong>linperlisib <\/strong>from Shanghai YingLi Pharmaceutical targeting PI3K\u03b4, and <strong>Soquelitinib <\/strong>from Corvus Pharmaceuticals targeting Interleukin-2 Inducible T-cell kinase inhibitor. These investigational therapies aim to address distinct biological mechanisms underlying PTCL, although their clinical profiles and potential applicability across subtypes continue to vary.<\/p>\n\n\n\n<p>Despite recent advances, outcomes remain particularly challenging for patients with high-risk subtypes such as PTCL-NOS and AITL\/TFH. The <a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-t-cell-lymphomas-ptcl-pipeline-insight\">PTCL drug market<\/a> continues to require safer, more effective, and biologically guided treatment options across both first-line and relapsed\/refractory settings, especially therapies capable of demonstrating activity across a broader range of PTCL subtypes.<\/p>\n\n\n\n<p><em>Below is a comprehensive review of four late-stage pipeline candidates expected to enter the peripheral T-cell lymphoma treatment space in the coming years.<\/em><\/p>\n\n\n\n<p><strong>Secura Bio\u2019s Duvelisib<\/strong><\/p>\n\n\n\n<p><em>Phosphoinositide 3-kinase inhibitor<\/em><\/p>\n\n\n\n<p><strong>Duvelisib (COPIKTRA)<\/strong> is an oral phosphoinositide 3-kinase (PI3K) inhibitor and the first therapy approved in the United States to selectively inhibit both PI3K\u03b4 and PI3K\u03b3. These enzymes play important roles in the growth, survival, and proliferation of malignant cells. Aberrant PI3K signaling has been linked to tumor progression and may also contribute to the development and persistence of a tumor-supportive microenvironment.<\/p>\n\n\n\n<p>In April 2026, Secura Bio, Inc. announced the publication of <strong>Phase 2 PRIMO study<\/strong> results in the <em>Journal of Clinical Oncology<\/em>, highlighting the clinical activity and tolerability of duvelisib in patients with relapsed or refractory peripheral T-cell lymphoma (R\/R PTCL). The global, open-label, multicenter, single-arm Phase 2 PRIMO trial evaluated duvelisib monotherapy in 123 adult <a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-t-cell-lymphoma-ptcl-epidemiology-forecast\">patients with R\/R PTCL<\/a> across the United States, European Union, United Kingdom, and Japan. The study consisted of a dose-optimization phase followed by a dose-expansion phase (PRIMO-EP), with the published analysis reporting outcomes from all 123 patients enrolled in the PRIMO-EP population.<\/p>\n\n\n\n<p>Results demonstrated an overall response rate (ORR) of 48.0% and a complete response rate (CRR) of 33.3%, along with a median progression-free survival (mPFS) of 3.4 months and a median overall survival (mOS) of 12.4 months. These findings compare favorably with currently available single-agent therapies, which have historically demonstrated ORRs below 30% and CRRs of less than 15%.<\/p>\n\n\n\n<p>Earlier, in December 2025, Secura Bio announced that the <strong>Phase III TERZO study<\/strong> remained on track for an interim data readout in early 2027, based on the pace of patient enrollment. The Phase III TERZO trial is a multicenter, open-label, randomized controlled study comparing duvelisib with the investigator\u2019s choice of gemcitabine or bendamustine in patients with relapsed or refractory nodal T-follicular helper lymphoma (r\/r nTFHL). Patients enrolled across the European Union (CT: 2024-516605-23-00) and the United Kingdom (NCT06522737) are randomized in a 1:1 ratio, with treatment continuing until disease progression or unacceptable toxicity.<\/p>\n\n\n\n<p>Duvelisib has also achieved several notable regulatory and clinical recognition milestones. In January 2023, Secura Bio announced that the European Commission had granted <strong>Orphan Drug Designation (ODD)<\/strong> to duvelisib for the treatment of peripheral T-cell lymphoma (PTCL). Subsequently, in December 2023, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines (Version 4.2024), moving duvelisib from the \u201cother recommended regimens\u201d category to the \u201cpreferred regimens\u201d category for angioimmunoblastic T-cell lymphoma (AITL), nodal PTCL with T-follicular helper phenotype, and follicular T-cell lymphoma (FTCL), irrespective of transplant eligibility.<\/p>\n\n\n\n<p>Earlier, the NCCN (Version 1.2022) assigned duvelisib a Category 2A recommendation across all subtypes of relapsed or refractory PTCL. The therapy had also received <strong>Orphan Drug Designation<\/strong> from the U.S. FDA in October 2019 for T-cell lymphoma, as well as <strong>Fast Track Designation<\/strong> in September 2017 for patients with PTCL who had received at least one prior line of therapy.<\/p>\n\n\n\n<p><strong>Dizal Pharmaceutical\u2019s Golidocitinib<\/strong><\/p>\n\n\n\n<p><em>JAK1 inhibitor<\/em><\/p>\n\n\n\n<p><strong>Golidocitinib <\/strong>is the first and only selective <a href=\"https:\/\/www.delveinsight.com\/report-store\/janus-kinase-jak-inhibitors-market\">Janus kinase 1 (JAK1) inhibitor<\/a> currently being evaluated for patients with relapsed\/refractory peripheral T-cell lymphoma (R\/R PTCL). Golidocitinib (DZD4205\/AZD4205) has progressed through a Phase I\/II trial, with the pivotal <strong>Phase II portion (JACKPOT8 Part B)<\/strong> supporting its development in relapsed\/refractory PTCL. Additionally, golidocitinib is being evaluated in a <strong>Phase III trial (JACKPOT19)<\/strong> versus investigator&#8217;s choice in adults with relapsed\/refractory PTCL.<\/p>\n\n\n\n<p>In June 2024, China&#8217;s National Medical Products Administration (NMPA) approved golidocitinib for the treatment of adult patients with R\/R PTCL. Data from Part A of the <strong>Phase I JACKPOT8 study<\/strong> were published in <em>Annals of Oncology<\/em>, while findings from the global pivotal JACKPOT Part B trial were reported in <em>The Lancet Oncology<\/em>. Earlier, in February 2022, the U.S. FDA granted <strong>Fast Track Designation (FTD)<\/strong> to golidocitinib for R\/R PTCL.<\/p>\n\n\n\n<p>In December 2025, Dizal Pharmaceutical presented new clinical data on golidocitinib at the 67th ASH Annual Meeting, highlighting its potential across newly diagnosed PTCL, R\/R PTCL, rare PTCL subtypes, and PTCL-associated hemophagocytic lymphohistiocytosis (HLH).<\/p>\n\n\n\n<p><em>Sadaf Javed, Functional Head of Forecasting &amp; Analytics at DelveInsight, stated that golidocitinib is anticipated to reach the market earliest, potentially by 2027 in the US. Its entry is expected to intensify competition in the R\/R setting, likely exerting downward pressure on the market share of currently approved therapies.<\/em><\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"223\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-1024x223.webp\" alt=\"Comparison-of-Emerging-PTCL-Drugs-Under-Development\" class=\"wp-image-36053\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-1024x223.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-300x65.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-150x33.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-768x167.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development-1536x334.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Comparison-of-Emerging-PTCL-Drugs-Under-Development.webp 1920w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p><strong>Shanghai YingLi Pharmaceutical\u2019s Linperlisib (YY-20394)<\/strong><\/p>\n\n\n\n<p><em>Selective PI3K\u03b4 inhibitor<\/em><\/p>\n\n\n\n<p><strong>Linperlisib <\/strong>is a highly selective and potent <a href=\"https:\/\/www.delveinsight.com\/report-store\/pi3k-market-forecast\">PI3K\u03b4 inhibitor<\/a> being developed as a once-daily oral therapy. The treatment has demonstrated encouraging antitumor activity, a favorable safety profile, and promising pharmacokinetic and pharmaceutical properties in clinical development. Linperlisib has been evaluated across three clinical studies in patients with relapsed\/refractory peripheral T-cell lymphoma (R\/R PTCL) in China, the United States, and Europe, with more than 165 patients treated to date.&nbsp;<\/p>\n\n\n\n<p>Results from these studies have consistently demonstrated high objective and complete response rates, along with encouraging progression-free survival and overall survival outcomes. The therapy has also shown a manageable safety profile across ongoing evaluations. Consistent efficacy and tolerability across Chinese, U.S., and European patient populations support the advancement of Linperlisib into a global registration trial. Its <strong>Phase II clinical study<\/strong> was conducted in collaboration with The University of Texas MD Anderson Cancer Center.<\/p>\n\n\n\n<p>In April 2025, Shanghai YingLi Pharmaceutical announced that, following a Type B End-of-Phase II meeting with the FDA, the company received clearance to advance its pivotal <strong>Phase III<\/strong> protocol for the treatment of relapsed and\/or refractory PTCL.<\/p>\n\n\n\n<p><em>Javed noted that Linperlisib is expected to enter the US PTCL treatment market by 2029 and is anticipated to experience slow-to-moderate uptake, with its adoption likely to depend on its positioning within the treatment landscape, differentiation from existing therapies, and the availability of long-term efficacy and safety data.<\/em><\/p>\n\n\n\n<p><strong>Corvus Pharmaceuticals\u2019 Soquelitinib<\/strong><\/p>\n\n\n\n<p><em>Interleukin-2 Inducible T-cell kinase inhibitor<\/em><\/p>\n\n\n\n<p><strong>Soquelitinib (formerly CPI-818)<\/strong> is an investigational oral small-molecule inhibitor that selectively targets interleukin-2-inducible T-cell kinase (ITK), an enzyme predominantly expressed in T cells and involved in regulating T-cell and natural killer (NK) cell activity. By modulating T-cell differentiation, soquelitinib promotes the development of Th1 helper T cells while inhibiting Th2 and Th17 differentiation and reducing the production of their associated cytokines. Th1 cells play an important role in immune responses against tumors, viral infections, and other pathogens, whereas Th2 and Th17 cells have been associated with various autoimmune and allergic conditions.<\/p>\n\n\n\n<p>In August 2024, Corvus Pharmaceuticals announced that the U.S. FDA had granted <strong>Fast Track Designation (FTD)<\/strong> to soquelitinib for the treatment of adults with relapsed or refractory peripheral T-cell lymphoma (R\/R PTCL) who had received at least two prior lines of systemic therapy. This followed the FDA\u2019s <strong>Orphan Drug Designation (ODD) <\/strong>for soquelitinib in February 2024 for the <a href=\"https:\/\/www.delveinsight.com\/report-store\/t-cell-malignancies-market\">treatment of patients with T-cell lymphoma<\/a>.<\/p>\n\n\n\n<p>In December 2025, Corvus Pharmaceuticals presented final results from its Phase I\/Ib study of soquelitinib in patients with T-cell lymphoma at the ASH 2025 meeting. The findings provided clinical support for the continued development of soquelitinib and served as the basis for the ongoing registration-enabling <strong>Phase III trial<\/strong> in R\/R PTCL.<\/p>\n\n\n\n<p>The anticipated launch of these emerging peripheral T-cell lymphoma therapies are poised to transform the market landscape in the coming years. As these cutting-edge PTCL therapies continue to mature and gain regulatory approval, they are expected to reshape the peripheral T-cell lymphoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.<\/p>\n\n\n\n<p>Beyond the aforementioned PTCL therapies, several other investigational treatments including&nbsp; <strong>Lacutamab <\/strong>(Innate Pharma), <strong>KEYTRUDA <\/strong>(pembrolizumab; Merck Sharp &amp; Dohme, <strong>OPDIVO <\/strong>(nivolumab; Bristol\u2013Myers Squibb), <strong>BR101801 <\/strong>(Boryung Pharmaceutical), <strong>TOLINAPANT <\/strong>(ASTX660; Otsuka Pharmaceutical\/Astex Pharmaceuticals), <strong>AUTO4 <\/strong>(Autolus Therapeutics), <strong>HH2853 <\/strong>(Haihe Biopharma), Dibotatug (DR-01; Dren Bio), BMS-986369 (Bristol-Myers Squibb), ONO-4685 (Ono Pharmaceutical), <strong>KK2223 <\/strong>(Kyowa Kirin), <strong>KT-333<\/strong> (Kymera Therapeutics), <strong>BP1002 <\/strong>(Bio-Path Holdings), <strong>Fenretinide <\/strong>(ST-001; SciTech Development), <strong>Tinostamustine <\/strong>(Mundipharma), <strong>INCA036873 <\/strong>(Incyte Corporation), <strong>LIS22 <\/strong>(XENOTHERA), <strong>PF-08046044\/SGN-35C<\/strong> (Pfizer), and others are currently in development. These emerging therapies could potentially reshape the <a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-t-cell-lymphoma-ptcl-market\">PTCL market landscape<\/a> and influence market dynamics upon successful approval.<\/p>\n\n\n\n<p>In summary, with growing insights into the biology and heterogeneity of PTCL, future treatment strategies should prioritize subtype-specific clinical trials and the investigation of novel combination therapies in the frontline setting.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><a href=\"https:\/\/www.delveinsight.com\/report-store\/peripheral-t-cell-lymphoma-ptcl-market\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"194\" src=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-1024x194.webp\" alt=\"Peripheral T-cell Lymphoma Market Outlook\" class=\"wp-image-36050\" srcset=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-1024x194.webp 1024w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-300x57.webp 300w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-150x28.webp 150w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-768x145.webp 768w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook-1536x291.webp 1536w, https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/08\/Peripheral-T-cell-Lymphoma-Market-Outlook.webp 1584w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/a><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Summary PTCL represents a diverse group of aggressive mature T-cell lymphoid malignancies, accounting for approximately 10\u201315% of non-Hodgkin lymphomas in the United States, 6.5% in Europe, and up to 25% in Japan. Its incidence varies considerably across regions and disease subtypes, with PTCL-NOS, AITL, and ALCL among the most frequently diagnosed forms. Patients often experience [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":36051,"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":[17510,19014,21283,23085,23084,23077],"industry":[17225],"therapeutic_areas":[17228],"class_list":["post-36048","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-jak-inhibitor","tag-peripheral-t-cell-lymphoma","tag-ptcl","tag-ptcl-drugs","tag-ptcl-treatment","tag-t-cell-malignancies","industry-pharmaceutical","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>4 Late-Stage Drugs Redefining PTCL Treatment<\/title>\n<meta name=\"description\" content=\"Key late-stage PTCL treatment drugs include Duvelisib (Secura Bio), golidocitinib (Dizal Pharmaceutical), and others.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/ptcl-drugs-in-clinical-trials\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"4 Late-Stage Drugs Redefining PTCL Treatment\" \/>\n<meta property=\"og:description\" content=\"Key late-stage PTCL treatment drugs include Duvelisib (Secura Bio), golidocitinib (Dizal Pharmaceutical), and others.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/ptcl-drugs-in-clinical-trials\" \/>\n<meta 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content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"4 Late-Stage Drugs Redefining PTCL Treatment","description":"Key late-stage PTCL treatment drugs include Duvelisib (Secura Bio), golidocitinib (Dizal Pharmaceutical), and others.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/ptcl-drugs-in-clinical-trials","og_locale":"en_US","og_type":"article","og_title":"4 Late-Stage Drugs Redefining PTCL Treatment","og_description":"Key late-stage PTCL treatment drugs include Duvelisib (Secura Bio), golidocitinib (Dizal Pharmaceutical), and others.","og_url":"https:\/\/www.delveinsight.com\/blog\/ptcl-drugs-in-clinical-trials","og_site_name":"DelveInsight Business 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