How many clinical trials are studying Fingolimod?

4 recruiting trials in our tracked data involve Fingolimod.

What conditions is Fingolimod being studied for?

In our tracked recruiting trials, Fingolimod is being studied in trials for Multiple Sclerosis, Diabetes Mellitus, Type 2, Multiple Sclerosis, Relapsing-Remitting.

Fingolimod: clinical trials recruiting now

Q: Is Fingolimod FDA-approved?

Yes. According to the FDA drug label available through openFDA, Fingolimod is an FDA-approved drug.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Fingolimod appears in the FDA drug-label database. Marketed as FINGOLIMOD.
Drug class: Sphingosine 1-phosphate Receptor Modulator (FDA established pharmacologic class)
Mechanism of action: Sphingosine 1-Phosphate Receptor Modulators (as stated on the FDA label)

FDA-approved use

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Failed Dissolution Specifications — Ascend Laboratories, LLC	Class II (FDA: may cause temporary or reversible harm)	Ongoing	2023-07-11

FDA label via openFDA

Phase breakdown

Phase 2 1 Phase 3 2 Phase 4 2

Conditions being studied

Condition	Trials
Multiple Sclerosis · Fingolimod for Multiple Sclerosis	3
Diabetes Mellitus, Type 2	1
Multiple Sclerosis, Relapsing-Remitting	1
Relapsing Multiple Sclerosis	1
Type 2 diabetes	1

Recruiting trials involving Fingolimod

Fingolimod for Type 2 Diabetes Mellitus
NCT05307731 · Phase: Phase 4 · Ages: 18 Years to 70 Years · Sex: All (male and female) · 1 location
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
NCT04480853 · Phase: Phase 4 · Ages: 20 Years to 100 Years · Sex: All (male and female) · 6 locations
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis
NCT07220252 · Phase: Phase 2, Phase 3 · Ages: 10 Years to 17 Years · Sex: All (male and female) · 2 locations
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
NCT06408259 · Phase: Phase 3 · Ages: 10 Years to 17 Years · Sex: All (male and female) · 33 locations

Common questions

Is Fingolimod FDA-approved?

Yes, marketed as FINGOLIMOD.

How many recruiting trials involve Fingolimod?

4 recruiting trials across 5 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.