duvakitug (SAR447189) / Teva, Sanofi - LARVOL DELTA

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

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

AURALIGHT: A Study to Investigate Efficacy and Safety of Duvakitug in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

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

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH CROHN'S DISEASE (CD): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY (UEGW 2026) - No abstract available

Clinical • P2b data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

EFFICACY AND SAFETY OF DUVAKITUG MAINTENANCE THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UC): RESULTS FROM THE PHASE 2B RELIEVE UCCD LONG-TERM EXTENSION STUDY (UEGW 2026) - No abstract available

Clinical • P2b data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EARLY MODULATION OF TISSUE REMODELLING AND TH17-DRIVEN INFLAMMATION OBSERVED WITH DUVAKITUG INDUCTION TREATMENT IN A PLACEBO-CONTROLLED TRIAL IN MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE (UEGW 2026) - No abstract available

Clinical • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

EFFECTS OF DUVAKITUG INDUCTION TREATMENT ON BIOMARKERS OF INFLAMMATION AND GRANULOCYTIC TISSUE INFILTRATION IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (UEGW 2026) - No abstract available

Biomarker • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

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

SUNSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi

Trial initiation date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Relieving IBD with duvakitug. (PubMed, Nat Rev Gastroenterol Hepatol) - No abstract available

Journal

Innovative late-stage pipeline progressing at speed, addressing high unmet need (The Manila Times) - "duvakitug (anti-TL1A, developed in collaboration with Sanofi): announced plans to initiate studies in two additional indications - hidradenitis suppurativa (HS) and fibrostenotic Crohn’s Disease (FSCD) - demonstrating its pipeline-in-a-product potential. Recruitment is on track for our Phase 3 studies for duvakitug in ulcerative colitis (UC) and Crohn’s disease (CD)."

New trial • Trial status • Crohn's disease • Hidradenitis Suppurativa • Ulcerative Colitis

Efficacy and safety of duvakitug in patients with ulcerative colitis (RELIEVE UCCD): a phase 2b, randomised, placebo-controlled trial. (PubMed, Lancet Gastroenterol Hepatol) - P2 | "Duvakitug showed significant evidence for clinical remission versus placebo, with no safety concerns identified, in patients with moderately to severely active ulcerative colitis."

Journal • P2b data • Cerebral Hemorrhage • Colorectal Cancer • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Respiratory Diseases • Ulcerative Colitis

PKM23567: A study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants (clinicaltrialsregister.eu) - P1 | N=50 | Active, not recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement | Recruiting ➔ Active, not recruiting

Enrollment closed

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

STARSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

STARSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=671 | Recruiting | Sponsor: Sanofi

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Duvakitug: Regulatory submission for inflammatory bowel disease in 2029 or later (Teva) - Q1 2026 Results

Filing • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Duvakitug: “Duvakitug showed robust phase 2 maintenance efficacy”; Inflammatory bowel disease - Q1 2026 Results

P2b data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

STARSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

PKM23567: A study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants (clinicaltrialsregister.eu) - P1 | N=50 | Recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement | Not yet recruiting ➔ Recruiting

Enrollment open

STARSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=671 | Recruiting | Sponsor: Sanofi | N=204 ➔ 671

Enrollment change • Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

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

STARSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi

Trial initiation date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease