tulisokibart (MK-7240) / Merck (MSD) - LARVOL DELTA

Novel Agents on the Therapeutic Horizon For Paediatric Inflammatory Bowel Diseases: An Analysis of Clinical Trials Registries. (PubMed, Paediatr Drugs) - "Efforts to expedite approval of new agents in pIBD are warranted to ensure timely access to effective medications. Consideration for novel trial designs alongside continued engagement with regulatory bodies, sponsors, and the academic pIBD community is essential to advance drug approvals for pIBD."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Pediatrics

Tumor necrosis factor-like cytokine 1 A antagonists for inflammatory bowel disease: A systematic review and meta-analysis. (PubMed, Indian J Gastroenterol) - "Anti-TL1A agents appear to be a promising therapeutic option in patients with IBD. Overall, anti-TL1A demonstrated an acceptable short-term safety profile, although mild adverse events were reported in almost half of treated patients."

Journal • Retrospective data • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

Targeting the TL1A pathway in inflammatory bowel disease: mechanistic insights and emerging therapeutic pipeline. (PubMed, Inflamm Bowel Dis) - "Three anti-TL1A monoclonal antibodies (tulisokibart, afimkibart, and duvakitug) have advanced to phase 3 trials across multiple global programs, with phase 2 clinical remission rates of 26%-48% in ulcerative colitis (placebo-adjusted differences 15-26 percentage points) and endoscopic response rates of 26%-48% in Crohn's disease, alongside favorable safety profiles...The pipeline has expanded to at least 19 development programs, including extended half-life antibodies (XmAb942, SPY002, and BCD-261), bispecifics combining TL1A with IL-23 or α4β7 (RO7837195, XmAb412, LQ080, and ALX001), a first-in-class oral anti-TL1A nanobody, and a first-in-class DR3 receptor antagonist (SL-325). We discuss therapeutic positioning and timing, the opportunity in acute severe UC, and the unusual standing of IBD as the lead indication for this mechanism class."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CD40LG • IL23A • TNFA • TNFRSF25 • TNFSF15

TL1A-Targeted Therapy in Ulcerative Colitis: A Meta-Analysis of Randomized Placebo-Controlled Induction Trial (ACG 2026) - "Three induction trials met inclusion criteria; ARTEMIS-UC evaluating Tulisokibart (Sands et al., 2024), TUSCANY-2 evaluating Afimkibart (Danese et al., 2025), and RELIEVE UCCD-UC evaluating Duvakitug (Reinisch et al., 2025). Three randomized controlled trials were included. For clinical remission, Sands et al., 2024 (ARTEMIS-UC) contributed 18/68 TL1A-treated versus 1/67 placebo-treated patients, Danese et al., 2025 (TUSCANY-2) contributed 63/195 versus 5/43, and Reinisch et al., 2025 (RELIEVE UCCD-UC) contributed 39/93 versus 9/44. The pooled analysis showed significantly higher clinical remission with TL1A inhibition versus placebo (RR 3.09, 95% CI 1.36-6.99; I²=52%)."

Retrospective data • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

Functional Advantage of the Preference of Afimkibart for Trimeric Tumor Necrosis Factor-Like Ligand 1A in Blocking Active TL1A Signaling (ACG 2026) - "In contrast to monomeric rhTL1A, trimeric rhTL1A robustly induced NF-κB activation in peripheral T lymphocytes and peripheral blood mononuclear cells (PBMCs). Afimkibart potently inhibited this NF-κB signaling, with PRA023 inhibiting to a lesser extent. With IL-12 and IL-18 co-stimulation, trimeric rhTL1A also significantly enhanced IFN-γ production in human PBMCs; monomeric rhTL1A elicited only a marginal response, even at high concentrations."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • IFNG • IL12A • IL18 • TNFA • TNFRSF25

Are TL1A Inhibitors Safe and Effective in Inflammatory Bowel Disease? A Systematic Review (ACG 2026) - "Our search yielded 240 articles, of which, three articles met the inclusion criteria. In the randomized ARTEMIS-UC trial, Tulisokibart achieved a 26% clinical remission rate at week 12 compared to 1% for placebo. Remission was even higher (32%) in patients with positive genetic testing."

Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • IL12A

TULISOKIBART'S BIOCHEMICAL MECHANISM OF ACTION: EVIDENCE FOR TL1A TRIMER NEUTRALIZATION AND DISRUPTION (UEGW 2026) - No abstract available

Inflammatory Bowel Disease

Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012) (clinicaltrials.gov) - P2 | N=149 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Jan 2029 ➔ Jun 2028 | Trial primary completion date: Nov 2026 ➔ Apr 2026

Trial completion date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

TL1A-DR3 Signaling in Inflammatory Bowel Disease: From Pathogenesis to Therapeutic Targeting. (PubMed, Kurume Med J) - "Recent clinical trials of TL1A-neutralizing antibodies, including afimkibart, tulisokibart, and duvakitug, have demonstrated encouraging efficacy and safety in moderate-to-severe IBD, with emerging biomarker strategies suggesting potential for personalized treatment. Collectively, current evidence highlights TL1A blockade as a promising dual-pathway therapeutic approach targeting inflammation and fibrotic remodeling, with ongoing studies expected to define its long-term impact on disease modification."

Journal • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • CD40LG • TNFSF15

A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013) (clinicaltrials.gov) - P2 | N=315 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Initiation date: Feb 2026 ➔ Sep 2025

Trial initiation date • Ankylosing Spondylitis • Immunology • Inflammatory Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Spondylarthritis

Symptomatic relief and disease clearance with 50 weeks tulisokibart treatment in moderate to severe ulcerative colitis in phase 2 ARTEMIS-UC (BSG 2026) - P2 | "Among week 12 responders treated with tulisokibart 250 mg, symptomatic remission and disease clearance were achieved in 68% and 44% of participants, respectively, by 1 year. A phase 3 trial to confirm these findings is ongoing."

P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

Tulisokibart in Patients with Moderately to Severely Active Crohn's Disease: Efficacy and Safety Through Week 146 from the Phase 2 APOLLO-CD Study (AOCC-IMKASID 2026) - P2 | "Tulisokibart, particularly the 250-mg dose, maintained efficacy and was well tolerated with no new safety signals identified through 3 years of treatment. Larger phase 3 trials are ongoing to confirm these findings. Keywords: Tulisokibart, TL1a, Crohn's Disease, Phase 2, Long-term Extension"

Clinical • P2 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Infectious Disease • Inflammatory Bowel Disease • Respiratory Diseases • Skin Cancer • Solid Tumor • Suicidal Ideation • Thrombosis

Relationship Between Clinical and Histologic Findings with Tulisokibart Induction at Week 12 and Maintenance Dosing at Week 50 in the Randomized Controlled ARTEMIS-UC Study in Participants with Ulcerative Colitis (AOCC-IMKASID 2026) - "Strong correlations were demonstrated among clinical, endoscopic, and histologic endpoints after 12 weeks of tulisokibart induction therapy, followed by 38 weeks of maintenance therapy in induction responders. These findings indicate the potential of tulisokibart in achieving deep remission in patients with UC. Keywords: Tulisokibart, TL1a, Ulcerative Colitis, Phase 2, Histologic Endpoints"

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy and Safety of Tulisokibart Maintenance Treatment in Induction Responders vs Reinduction and Delayed Induction Responders: Results from the Phase 2 ARTEMIS-UC Trial Open-Label Extension in Participants with Ulcerative Colitis (AOCC-IMKASID 2026) - "Tulisokibart maintenance treatment was effective and well tolerated in participants with moderate to severe UC. The effect was generally similar across tulisokibart induction responders, rein-duction responders, and delayed induction responders. Altogether, this suggests that a second induction regimen in tulisokibart nonresponders may result in a long-term efficacy benefit without increased safety risk."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Sustained Symptomatic Relief and Disease Clearance Through 50 Weeks of Treatment with Tulisokibart in Participants with Moderately to Severely Active Ulcerative Colitis in the Phase 2 ARTEMIS-UC Study (AOCC-IMKASID 2026) - P2 | "Participants receiving tulisokibart achieved higher rates of SF normalization, resolution of RB, symptomatic remission, and disease clearance vs placebo at week 12; these response rates were sustained or increased through week 50. A phase 3 trial to confirm these findings is ongoing. Keywords: Tulisokibart, TL1a, Ulcerative Colitis, Phase 2, Patient Reported Outcomes"

P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFA

Merck’s Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC) (Businesswire) - "Consistent with previously reported Phase 2 studies, no safety concerns were identified...Results from the ATLAS-UC Study 2 will be presented with the results from the ongoing induction and maintenance study (Study 1) at an upcoming scientific congress and will be shared with regulatory authorities."

P3 data: top line • Ulcerative Colitis

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) (clinicaltrials.gov) - P2 | N=182 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2029 ➔ Mar 2029 | Trial primary completion date: Mar 2027 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Study of MK-7240 in Healthy Participants (MK-7240-009) (clinicaltrials.gov) - P1 | N=330 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

TL1A and TL1A-driven Inflammatory Pathways are Upregulated in RA, PsA and axSpA (EULAR 2026) - "Tulisokibart, a monoclonal TL1A blocking antibody, has shown efficacy in ulcerative colitis and Crohn’s disease and reduces Th1, Th17 and activated fibroblast pathways in intestinal tissue...In a skin psoriasis model, imiquimod (IMQ) was applied topically for 5 days...Anti-TL1A prevented inflammation in an arthritis model and skin inflammation in a psoriatic mouse model. Data supports targeting TL1A as a potential effective therapy in RA, PsA and axSpA."

Ankylosing Spondylitis • Crohn's disease • Dermatitis • Gastroenterology • Gastrointestinal Disorder • Inflammatory Arthritis • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Seronegative Spondyloarthropathies • Spondylarthritis • Ulcerative Colitis • CD40 • CD40LG • IFNG • IL17A • IL6 • TNFRSF25 • TNFSF15

TL1A as a therapeutic renaissance in inflammatory bowel disease: a systematic review from molecular mechanisms to clinical translation. (PubMed, J Crohns Colitis) - "TL1A inhibitors represent a promising novel therapeutic class with dual anti-inflammatory and anti-fibrotic properties, addressing critical unmet clinical needs in IBD. These agents hold the potential to become cornerstone therapies in the evolving landscape of precision medicine for IBD care."

Journal • Review • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • TNFA • TNFRSF25

Unravelling the TL1A-DR3 axis in Hidradenitis suppurativa. (PubMed, Front Immunol) - P2 | "Participant recruitment for the phase 2b trial (NCT06956235) assessing the efficacy of anti-TL1A therapy tulisokibart in moderate-to severe HS was reported on 1 December, 2025 to be completed. This review aims to explore the potential links between the TL1A and HS by synthesizing immune mechanisms of HS pathogenesis with existing data of the TL1A/DR3 axis in immune pathways. A discussion highlighting the potential for anti-TL1A therapies as a class that simultaneously addresses fibrosis and comorbidities of HS is also presented, and future directions to address knowledge gaps are also proposed."

Journal • Review • Dermatology • Fibrosis • Hidradenitis Suppurativa • Immunology • Inflammation

A clinical study of tulisokibart in people with psoriatic arthritis (MK-7240-015) (clinicaltrialsregister.eu) - P1/2 | N=37 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1/2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015) (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Review Article: TL1A Inhibitors in IBD - Mechanistic Rationale and Clinical Evidence. (PubMed, Aliment Pharmacol Ther) - "TL1A-DR3 integrates mucosal immunity with stromal injury, positioning inhibitors as a novel class to overcome IBD therapeutic ceilings by targeting the inflammation-fibrosis continuum."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis

Therapeutic Potential of Tulisokibart and Anti-TL1A Therapy in Inflammatory Disorders: Current Insights and Future Directions. (PubMed, Clin Rev Allergy Immunol) - No abstract available

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease