Seliforant
 | This article may incorporate text from a large language model. (November 2025) |
 | |
| 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 | |
| Identifiers | |
| CAS Number | |
| PubChem CID | |
| UNII | |
| Chemical and physical data | |
| Formula | C12H21N5 |
| Molar mass | 235.335 g·mol−1 |
| 3D model (JSmol) | |
| |
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
References
- ^ a b c "Seliforant (SENS-111) – Sensorion". AdisInsight / Springer. Retrieved 2025-11-13.
- ^ a b "World Health Organization Grants Name 'Seliforant' to Sensorion's SENS-111 Treatment". Santé Log. 2018-05-03. Retrieved 2025-11-13.
- ^ 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.
- ^ "Sensorion Scuttles SENS-111 Vestibulopathy Drug to Focus on Sudden Hearing Loss". The Hearing Review. 2019-12-03. Retrieved 2025-11-13.
- ^ a b 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.