Drugs / BEFIRADOL
last change Mar 2025 re-read 3 minutes ago

BEFIRADOL

also known as F-13640 · NLX-112

Small molecule targets HTR1A via activation

Developed for
drug-induced dyskinesia
Investigated by
CTC Clinical Trial Consultants AB · Michael J. Fox Foundation for Parkinson's Research · Neurolixis SAS · Parkinson's UK

Trials 1

20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05148884 Nov 2021 → Jan 2023 drug-induced dyskinesia Neurolixis SAS Completed Met primary

News releases announcing trial results or a regulatory action · 15

DateIssuerRelease
2025-03-18 Neurolixis SAS Results 18 March 2025 - Neurolixis Publishes Positive Phase 2A Trial Results for NLX-112 in Parkinson’s Disease neurolixis.com ↗
Neurolixis today announced the publication of the results from its successful Phase 2A proof-of-concept clinical trial of NLX-112 (befiradol) in Parkinson’s disease.
2024-09-25 Neurolixis SAS Regulatory 25 September 2024 - Neurolixis granted Orphan Medicinal Product Designation for NLX-112 as a Treatment for Spinocerebellar Ataxia neurolixis.com ↗
NLX-112 , a highly selective serotonin 5-HT1A receptor agonist, has been granted Orphan Medicinal Product (OMP) Designation by the European Commission for the treatment of Spinocerebellar Ataxia (SCA; approval #EU/3/24/2951).
2024-01-15 Neurolixis SAS Results 15 January 2024 - Successful NLX-112 clinical results discussed in interview with Parkinson's UK foundation neurolixis.com ↗
NLX-112 is a first-in-kind non-dopaminergic drug for treatment of dyskinesia and other symptoms of Parkinson's disease and exhibited positive effects against dyskinesia and parkinsonism in a recent study supported by The Michael J. Fox Foundation for Parkinson's Research and Parkinson's UK research foundations.
2023-08-25 Neurolixis SAS Results 25 August 2023 - Dual Clinical Efficacy of NLX-112 in Parkinson's Disease to be Presented at Movement Disorders Society Congress neurolixis.com ↗
NLX-112 , a ground-breaking, non-dopaminergic drug, exhibited both anti-dyskinetic and anti-parkinsonian properties in a proof-of-concept Phase 2A clinical trial.
2023-03-20 Neurolixis SAS Results 20 March 2023 - Neurolixis Announces Positive Ph2A Proof-of-Concept on NLX-112 in Levodopa-Induced Dyskinesia in Parkinson’s Disease neurolixis.com ↗
Neurolixis, Inc. today announced the positive results of its Phase 2A clinical trial with NLX-112 (befiradol), for treatment of levodopa-induced dyskinesias (LID) in Parkinson’s disease (PD).
2021-02-15 Neurolixis SAS Results 15 February 2021 - NLX-112 Restores Motor Function in a Transgenic Model of Spinocerebellar Ataxia neurolixis.com ↗
NLX-112 , a serotonin 5-HT 1A receptor agonist developed by Neurolixis, reversed motor deficits in a transgenic model of Spinocerebellar ataxia3 (SCA3), a rare genetic orphan disease.
2020-08-24 Neurolixis SAS Results 24 August 2020 - Antidyskinetic activity of NLX-112 in an additional non-human primate species neurolixis.com ↗
When the macaques received NLX-112, their dyskinesia symptoms were strongly reduced, confirming a previous study carried out in parkinsonian marmosets.
2020-03-02 Neurolixis SAS Results 2 March 2020 - NLX-112 shows antidyskinetic and antiparkinsonian activity in non-human primate study neurolixis.com ↗
The results showed that NLX-112 successfully reduced dyskinesia and, crucially, did not significantly reduce the effectiveness of L-DOPA, which many other similar drugs do.
2019-08-20 Neurolixis SAS Results 20 August 2019 - First human brain imaging of serotonin 5-HT1A receptors using 18F-NLX-112 as agonist PET tracer neurolixis.com ↗
The study shows that, unlike previous radiotracers, 18F-labeled NLX-112 binds to 5-HT1A receptors which are functionally-responsive, and shows accentuated labeling in specific cortical brain regions.
2019-03-12 Neurolixis SAS Regulatory 12 March 2019 - FDA approves Neurolixis IND application for clinical trial with NLX-112 neurolixis.com ↗
2018-07-25 Neurolixis SAS Results 25 July 2018 - Just Published: PET and fMRI imaging on NLX-112 and NLX-101 neurolixis.com ↗
2017-08-07 Neurolixis SAS Results 7 August 2017 - Just Published: article on NLX-112 analgesic activity in mouse neurolixis.com ↗
It exhibited potent analgesic activity in the mouse formalin test, a model of tonic pain, possibly through activation of spinal cord serotonin 5-HT1A receptors.

All press releases naming this drug 23 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as BEFIRADOL ChEMBL registry synonym — accepted as the source's own label CHEMBL45305 ↗
Known as F-13640 ChEMBL registry synonym — accepted as the source's own label CHEMBL45305 ↗
Known as NLX-112 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05148884 ↗
Action Activate “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL45305 ↗
1

“5-HT1A receptor agonist” NCT05148884 ↗

Modality Small molecule — CHEMBL45305 ↗
Target HTR1A “Serotonin 1a (5-HT1a) receptor agonist” CHEMBL45305 ↗