Evidence map›Paper›PMID 40159671›Full record

Trial reportClinical pharmacology and therapeutics2025

First-in-Human Single and Multiple Ascending Dose Studies of Balinatunfib, a Small Molecule Inhibitor of TNFR1 Signaling in Healthy Participants.

Nassr Nassr, Faiza Rharbaoui, Dietmar Weitz, Johann Gassenhuber, Markus Rehberg, Markus Kohlmann, Fabienne Schumacher, Amel Lahmar, Andreas Kovar, Laurent Perrin and 3 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Phase 1 study of balinatunfib, an oral inhibitor of TNFR1 signal in mild-to-moderate psoriasis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Nassr NassrSanofi, Frankfurt, Germany.ORCID 0009-0008-2485-4293
Faiza RharbaouiSanofi, Frankfurt, Germany.ORCID 0009-0008-7574-457X
Dietmar WeitzSanofi, Frankfurt, Germany.ORCID 0009-0003-4810-3076
Johann GassenhuberSanofi, Frankfurt, Germany.ORCID 0000-0001-5338-8238
Markus RehbergSanofi, Frankfurt, Germany.ORCID 0000-0003-0223-0398
Markus KohlmannSanofi, Frankfurt, Germany.ORCID 0009-0001-4053-1637
Fabienne SchumacherSanofi, Frankfurt, Germany.ORCID 0009-0005-5454-1616
Amel LahmarSanofi, Bridgewater, New Jersey, USA.ORCID 0009-0002-7437-2176
Andreas KovarSanofi, Frankfurt, Germany.ORCID 0000-0002-1681-8312
Laurent PerrinSanofi, Montpellier, France.ORCID 0000-0002-1916-6639
Frank-Dietrich WagnerCharité Research Organization, Berlin, Germany.ORCID 0000-0002-0527-2166
Maria WiekowskiSanofi, Bridgewater, New Jersey, USA.ORCID 0009-0001-2922-3051
Mai Anh NguyenSanofi, Frankfurt, Germany.ORCID 0000-0001-9901-2500

Funding

Sanofi
6 · The paper itself

Abstract

Oral small molecule inhibitors of tumor necrosis factor alpha (TNFα) are emerging as attractive therapeutic agents for the treatment of various autoimmune diseases. Balinatunfib (SAR441566), a novel oral inhibitor of tumor necrosis factor receptor 1 (TNFR1) signaling, changes the configuration of the soluble TNFα (sTNFα) trimer and prevents its heterotrimerization with TNFR1 but not TNFR2, thereby blocking TNFR1 signaling. Herein, we report the results from a first-in-human (FIH) study that evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) following single ascending doses (SAD) and multiple ascending doses (MAD) of balinatunfib in healthy male participants. Single (5-600 mg) and multiple (100-600 mg total daily dose for up to 14 days) oral doses of balinatunfib were well-tolerated in all participants. Consistent PK data were obtained across the studies, with a median t

Indexed as

Receptors, Tumor Necrosis Factor, Type ISignal TransductionAdministration, OralAdultDose-Response Relationship, DrugDouble-Blind MethodHalf-LifeHealthy VolunteersHumansMaleMiddle AgedTumor Necrosis Factor-alphaYoung AdultReceptors, Tumor Necrosis Factor, Type ITNFRSF1A protein, humanTumor Necrosis Factor-alpha

Identifiers

PMID40159671
PMCPMC12166256

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.