Seliforant

Seliforant

Clinical data
Other names	SENS-111; SENS111; UR-63325; UR63325
Routes of administration	Oral [1]
Drug class	Histamine H4 receptor antagonist
Legal status
Legal status	Investigational
Identifiers
CAS Number	1164115-89-2
PubChem CID	44126305
UNII	B61N8R7TDH
Chemical and physical data
Formula	C12H21N5
Molar mass	235.335 g·mol−1
3D model (JSmol)	Interactive image
SMILES CC(C)CC1=NC(=CC(=N1)N2CC(C2)NC)N

Seliforant (also known as SENS-111 or UR-63325) is an investigational small-molecule drug developed by Sensorion (originally by Palau Pharma) for inner-ear/vestibular disorders, particularly vertigo and vestibular neuritis, and has also been cited as having potential for tinnitus and hearing loss indications. ^[2]

Background and development

Seliforant was first developed as a first-in-class antagonist of the histamine H4 receptor (H4R), a receptor subtype implicated in immune modulation and potentially neurosensory signalling. ^[1]

The drug was granted its International Non-Proprietary Name (INN) "seliforant" by the World Health Organization in 2018. ^[2]

Mechanism of action

Seliforant functions by antagonising the histamine H₄ receptor (H4R). ^[1] H4 receptors are expressed in several tissues including immune cells and may play roles in neurosensory signalling. The rationale for vestibular/ear indications is based on modulation of aberrant vestibular/inner-ear neuronal activity rather than conventional antihistamine pathways. ^[3]

Clinical trials and status

Vestibular disorders

• A Phase 2 proof-of-concept trial (NCT03110458 / EudraCT 2016–003927–45) of seliforant in acute unilateral vestibulopathy was completed, but seliforant did not meet its primary efficacy endpoint. ^[4]

• Earlier Phase 2a trials in healthy volunteers assessing tolerability and pharmacodynamics reported that seliforant met tolerability endpoints (no sedation from anticholinergic effects) but efficacy in patients remains unsupported. ^[5]

Safety

In human Phase 1/2 volunteer studies, seliforant was reported to be well tolerated, with mild to moderate events and no sedation reported. ^[5]

See also

• List of investigational tinnitus drugs

References

1. "Seliforant (SENS-111) – Sensorion". AdisInsight / Springer. Retrieved 2025-11-13.
2. "World Health Organization Grants Name 'Seliforant' to Sensorion's SENS-111 Treatment". Santé Log. 2018-05-03. Retrieved 2025-11-13.
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. Retrieved 2025-11-13.
5. Venail 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.