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Seliforant

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Pharmaceutical compound
Seliforant
Clinical data
Other namesSENS-111; SENS111; UR-63325; UR63325
Routes of
administration
Oral[1]
Drug classHistamineH4 receptorantagonist
Legal status
Legal status
Identifiers
CAS Number
PubChemCID
UNII
Chemical and physical data
FormulaC12H21N5
Molar mass235.335 g·mol−1
3D model (JSmol)
  • CC(C)CC1=NC(=CC(=N1)N2CC(C2)NC)N

Seliforant (also known asSENS-111 orUR-63325) is aninvestigationalsmall-moleculedrug developed by Sensorion (originally by Palau Pharma) forinner-ear/vestibular disorders, particularlyvertigo andvestibular neuritis, and has also been cited as having potential fortinnitus andhearing loss indications.[2]

Background and development

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Seliforant was first developed as a first-in-classantagonist of thehistamine H4 receptor (H4R), areceptor subtype implicated in immune modulation and potentially neurosensory signalling.[1]

The drug was granted itsInternational Non-Proprietary Name (INN) "seliforant" by theWorld Health Organization in 2018.[2]

Mechanism of action

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Seliforant functions byantagonising thehistamineH4 receptor (H4R).[1] H4 receptors are expressed in severaltissues includingimmune cells and may play roles inneurosensory signalling. The rationale for vestibular/ear indications is based on modulation of aberrant vestibular/inner-ear neuronal activity rather than conventionalantihistamine pathways.[3]

Clinical trials and status

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Vestibular disorders

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  • A Phase 2 proof-of-concept trial (NCT03110458 / EudraCT 2016–003927–45) of seliforant in acute unilateralvestibulopathy was completed, but seliforant did not meet its primary efficacy endpoint.[4]
  • Earlier Phase 2a trials in healthy volunteers assessingtolerability andpharmacodynamics reported that seliforant met tolerability endpoints (no sedation fromanticholinergic effects) but efficacy in patients remains unsupported.[5]

Safety

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In human Phase 1/2 volunteer studies, seliforant was reported to be well tolerated, with mild to moderate events and nosedation reported.[5]

See also

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References

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  1. ^abc"Seliforant (SENS-111) – Sensorion".AdisInsight / Springer. Retrieved2025-11-13.
  2. ^ab"World Health Organization Grants Name 'Seliforant' to Sensorion's SENS-111 Treatment".Santé Log. 2018-05-03. Retrieved2025-11-13.
  3. ^Petremann M, Gueguen C, Delgado Betancourt V, Wersinger E, Dyhrfjeld-Johnsen J (February 2020)."Effect of the novel histamine H4 receptor antagonist SENS-111 on spontaneous nystagmus in a rat model of acute unilateral vestibular loss".British Journal of Pharmacology.177 (3):623–633.doi:10.1111/bph.14803.PMC 7012942.PMID 31347148.
  4. ^"Sensorion Scuttles SENS-111 Vestibulopathy Drug to Focus on Sudden Hearing Loss".The Hearing Review. 2019-12-03. Retrieved2025-11-13.
  5. ^abVenail F, Attali P, Wersinger E, Gomeni R, Poli S, Schmerber S (December 2018)."Safety, tolerability, pharmacokinetics and pharmacokinetic-pharmacodynamic modelling of the novel H4 receptor inhibitor SENS-111 using a modified caloric test in healthy subjects".British Journal of Clinical Pharmacology.84 (12):2836–2848.doi:10.1111/bcp.13744.PMC 6255991.PMID 30152527.
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