Fingolimod Hydrochloride
Established medicineAlso known as Fingolimod, Gilenya, fingolimod HCl.
Recent clinical, regulatory, research and industry developments relating to this drug.
Label change: FINGOLIMOD (ANDA208014)
Label change: FINGOLIMOD HYDROCHLORIDE (ANDA207991)
Label change: FINGOLIMOD HYDROCHLORIDE (ANDA208004)
Label change: FINGOLIMOD HYDROCHLORIDE (ANDA208004)
Label change: FINGOLIMOD HYDROCHLORIDE (ANDA207991)
Label change: FINGOLIMOD (ANDA208014)
Label change: FINGOLIMOD (ANDA208014)
Label change: FINGOLIMOD (ANDA208014)
Label change: FINGOLIMOD HYDROCHLORIDE (ANDA207991)
Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial
Treatment of Established Chemotherapy-Induced Neuropathy With Fingolimod: A Pilot Trial
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10… Show full indicationShow less
Indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Indication: Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients… Show full indicationShow less
Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1). or Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes1
Journals, researchers & institutions
- The Journal of neuroscience : the official journal of the Society for Neuroscience1
- Berg AJ1
- Cai Y1
- Cui T1
- Lok C1
- Morency DT1
- Paganelli PM1
- Vicini S1
- Wang T1
- First Affiliated Hospital1
- Georgetown University1
- Georgetown University Medical Center1
- Shanghai General Hospital1
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across the same disease area as Fingolimod Hydrochloride in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
- Europe PMC — research literature
- ClinicalTrials.gov — clinical trials
- Regulatory event sources are credited in the Regulatory Timeline above.