balinatunfib (SAR441566) / Sanofi - LARVOL DELTA

Characterizing the mode of action of the oral TNFR1 signal inhibitor, balinatunfib, in rheumatoid arthritis (ACR Convergence 2026) - No abstract available

Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TNFRSF1A

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS) (clinicaltrials.gov) - P2 | N=325 | Active, not recruiting | Sponsor: Sanofi | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: May 2030 ➔ Oct 2026 | Trial primary completion date: May 2030 ➔ Sep 2026

Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SPECIFI-UC: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis (clinicaltrials.gov) - P2 | N=204 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: May 2028 ➔ Oct 2026 | Trial primary completion date: Jul 2027 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL23A

SPECIFI-CD: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (clinicaltrials.gov) - P2 | N=260 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: May 2029 ➔ Oct 2026 | Trial primary completion date: Jul 2027 ➔ Jul 2026

Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Sanofi drops two more programmes in R&D clear-out (pharmaphorum) - "Regeneron-partnered itepekimab was in two phase 3 trials in chronic obstructive pulmonary disease (COPD), AERIFY 1 and 2...While the drug achieved its primary objective in AERIFY 1, achieving a statistically significant reduction in moderate or severe COPD exacerbations, that was not replicated in AERIFY 2...Oral, small-molecule TNF inhibitor balinatunfib...was in a pair of phase 2 trials in Crohn's disease and ulcerative colitis...the company has now revealed that interim results from the studies did not meet the internal efficacy expectations on clinical endpoints and/or the primary endpoint of clinical remission."

Discontinued • Chronic Obstructive Pulmonary Disease • Crohn's disease • Immunology • Ulcerative Colitis

A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion

Efficacy and Safety of the Oral TNFR1 Signal Inhibitor, Balinatunfib, in Patients With Moderate-to-Severe Rheumatoid Arthritis: Results From the SPECIFI-RA Phase 2b Study (EULAR 2026) - P2 | "Methods SPECIFI-RA (NCT06073093) is a phase 2b, 12-week, multi-centre, randomised, double-blind, placebo- controlled, dose-ranging study, with a 4- to 6-week methotrexate (MTX) run-in period. A pharmacodynamic effect was observed by peripheral blood IL-6 reduction indicating target engagement of balinatunfib. These data support further evaluation of balinatunfib in RA."

Clinical • P2b data • Immunology • Infectious Disease • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP • IL6 • TNFRSF1A

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS) (clinicaltrials.gov) - P2 | N=325 | Enrolling by invitation | Sponsor: Sanofi | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed

SPECIFI-CD: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease. (clinicaltrials.gov) - P2 | N=260 | Recruiting | Sponsor: Sanofi | N=191 ➔ 260

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

LTS19689: A study to investigate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohns disease or ulcerative colitis (clinicaltrialsregister.eu) - P1/2 | N=73 | Not yet recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement

New P1/2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

LTS19689: A study to investigate the long-term safety, tolerability and efficacy of balinatunfib in participants with Crohns disease or ulcerative colitis (clinicaltrialsregister.eu) - P1/2 | N=2 | Not yet recruiting | Sponsor: Sanofi-Aventis Recherche & Developpement

New P1/2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Phase 1 study of balinatunfib, an oral inhibitor of TNFR1 signal in mild-to-moderate psoriasis. (PubMed, J Eur Acad Dermatol Venereol) - "Patients with mild-to-moderate psoriasis treated with balinatunfib reported no severe or serious TEAEs and showed promising clinical responses, suggesting that further evaluation of TNFR1 signal inhibition in inflammatory diseases is warranted."

Clinical • Journal • P1 data • Dermatology • Immunology • Oncology • Psoriasis • IL22 • TNFRSF1A

A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS) (clinicaltrials.gov) - P2 | N=325 | Not yet recruiting | Sponsor: Sanofi | Initiation date: Dec 2025 ➔ May 2026

Trial initiation date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Sanofi

New P1 trial

A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS) (clinicaltrials.gov) - P2 | N=325 | Not yet recruiting | Sponsor: Sanofi

New P2 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Balinatunfib, the first oral selective inhibitor of TNFR1 signalling, in plaque psoriasis: A double-blind, randomized, placebo-controlled Phase 2b study (EADV 2025) - "While the highest balinatunfib dose (200 mg BID) group did not meet statistical significance vs placebo for the primary endpoint (PASI75 at W12) in the naïve population, clinically meaningful and numerically larger (nominal p< 0.05) improvements at W12 were observed with other dose groups vs placebo in both advanced therapy-naïve and experienced patients. Inhibition of TNFR1 signal by balinatunfib was associated with reduction in biomarkers of Th17/Th22-mediated inflammation."

Clinical • Late-breaking abstract • P2b data • Dermatology • Immunology • Infectious Disease • Musculoskeletal Pain • Psoriasis • IL17A • IL22 • TNFA • TNFRSF1A

At the 2025 European Academy of Dermatology and Venereology (EADV) Congress, a late-breaking session led by Fernando Valenzuela, MD, highlighted new clinical trial data for balinatunfib... (DermatologyTimes) - "While the 200 mg twice-daily dose did not achieve statistical significance for the primary endpoint in the naïve cohort, encouraging signals emerged across other groups....Responses were observed as early as week 4, with improvements continuing through week 12. Patients on active treatment also achieved higher rates of PASI 90 compared to placebo."

Late-breaking abstract • P2b data • Psoriasis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=264 | Completed | Sponsor: Sanofi | Active, not recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Balinatunfib: A Clinical Oral Small Molecule TNFα Inhibitor. (PubMed, ChemMedChem) - "The oral route of administration confers practical advantages in terms of patient compliance and could facilitate drug access to sites traditionally less amenable to biologics, such as the central nervous system. By demonstrating that small molecules can achieve high-affinity, conformation-based inhibition of TNFα, balinatunfib, and related compounds may result in a new area of orally administered therapies that advance the management of TNFα-mediated diseases."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Rheumatoid Arthritis • Rheumatology

Selective inhibition of TNFR1 signal by balinatunfib in vitro does not inhibit Treg expansion in contrast to anti-TNF biologics inhibiting TNFR1 and TNFR2 signaling (EULAR 2025) - "Treatment with balinatunfib that selectively binds to sTNF and inhibits TNFR1 signal does not inhibit the mTNF–TNFR2 mediated induction of T reg cells, confirming TNFR2 signal sparing by balinatunfib. Induction of CD45 + CD4 + CD25 + FoxP3 + T reg cells in co-culture with memTNF-CHO cells for 48h in the presence or absence of TNFR1 signalling inhibitor balinatunfib, or the TNF blocking biologics etanercept and adalimumab. Triplicate measurements were performed from five donors."

Preclinical • Dermatology • Immunology • Oncology • Psoriasis • ADAM17 • FOXP3 • IL2 • IL2RA • PTPRC • TNFRSF1A

Sanofi axes development of oral TNF inhibitor as monotherapy following Phase II fail (Clinical Trials Arena) - P2 | N=221 | SPECIFI-PSO (NCT06073119) | Sponsor: Sanofi | "Sanofi will halt the development of its oral tumour necrosis factor (TNF) inhibitor balinatunfib as a monotherapy after it failed to reach the primary endpoint in a Phase II trial. Preliminary results from the SPECIFIC-PSO Phase II study (NCT06073119) in patients with psoriasis showed that balinatunfib achieved clinically relevant changes in the primary endpoint – the PASI-75 response – with efficacy levels comparable to other oral medicines in psoriasis. However, it did not reach statistical significance. Sanofi said this miss was due to 'the nature of this limited Phase II study. PASI-75 is a commonly used metric which measures whether a patient has benefited from a 75% reduction in symptoms compared to baseline....The company plans to present full data at an upcoming medical meeting."

Discontinued • P2 data • Psoriasis

Balinatunfib: Data from P2 SPECIFI-RA trial (NCT06073093) for rheumatoid arthritis in H2 2025 (Sanofi) - Q1 2025 Results

P2 data • Rheumatoid Arthritis

SPECIFI-RA: A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis (clinicaltrials.gov) - P2 | N=264 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP