Last update 27 Jan 2026

Fingolimod Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FINGOLIMOD, Fingolimod hydrochloride (JAN/USAN), Gilenia
+ [11]
Action
modulators
Mechanism
EDG6 modulators(Sphingosine 1-phosphate receptor Edg-6 modulators), S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR3 modulators(Sphingosine 1-phosphate receptor Edg-3 modulators)
Originator Organization
License Organization
Drug Highest PhaseApproved
First Approval Date
United States (21 Sep 2010),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC19H34ClNO2
InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N
CAS Registry162359-56-0

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-Remitting
European Union
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
Iceland
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
Norway
17 Mar 2011
Multiple Sclerosis
Australia
01 Feb 2011
Multiple sclerosis relapse
United States
21 Sep 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
United States
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
United States
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Japan
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Japan
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Australia
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Australia
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Belgium
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Belgium
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Canada
22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathyPhase 3
Canada
22 Dec 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Early Phase 1
28
(Fingolimod)
dekfrkntzo = tmvpflpmiv qfschvldsb (gpilyxzqyp, vcthllewzt - jgdqcvjtyl)
-
14 Jan 2025
(Open-label Fingolimod)
dekfrkntzo = kqigtmwqdi qfschvldsb (gpilyxzqyp, vqqjcmwfsf - zofzdhdvkr)
Not Applicable
lymphopenia | hypertransaminasemia
50
memgpzdhva(uzufjwkjkw) = bcbnlyaxxz gtozburveu (xnmtaphuar )
Positive
28 Jun 2024
qdhbpipuoh(cygctlebil) = usdtopprpq bsuieciacj (njlpatozlf )
Not Applicable
930
ioyhhsuaah(zitylyeeko) = odepjbwwrh rcvcgiurne (qhbfseypuf )
Negative
09 Apr 2024
ioyhhsuaah(zitylyeeko) = crnlhpwlof rcvcgiurne (qhbfseypuf )
Not Applicable
350
bsmnevpffg(hmkxdgouce) = A 39-year-old woman with RRMS since 2003 presented changes in a nevus on her right foot sole in July 2018. It was excised in November 2018, with a report indicating melanocytic proliferation with atypia. Fingolimod was discontinued, and an autologous bone marrow transplant was performed in 2019. She is currently free of disease activity and skin lesions. A 32-year-old man with RRMS since 2010 reported heartburn and regurgitation in November 2018. Laboratory tests showed aspartate aminotransferase at 19, alanine aminotransferase at 42, and gamma-glutamyl transferase at 97, with no other abnormalities. An endoscopy and biopsy revealed a 2.8 cm subepithelial lesion in the cardia, consistent with leiomyoma. He is currently asymptomatic and continues fingolimod therapy. A 35-year-old woman with Diabetes Mellitus and RRMS since 2015, treated with fingolimod since 2018, developed a skin lesion in 2022. Histopathological examination confirmed cutaneous tuberculosis. Antimicrobial management was initiated without discontinuing fingolimod. The skin lesion has resolved, and there is no RRMS activity. A 38-year-old woman with RRMS since 2016, treated with fingolimod since 2018, developed an axillary lymph node in 2022, which was diagnosed as breast cancer. She is currently undergoing chemotherapy for oncology, with no RRMS activity. zcswsgczxf (tvyanhbkww )
Positive
29 Feb 2024
Phase 3
324
exsbrdlkpp(mmgpwkekfz) = ivsajmjnql tsteabxaqm (payynaakon )
Positive
01 Jan 2024
Placebo
exsbrdlkpp(mmgpwkekfz) = gjxnhucbhg tsteabxaqm (payynaakon )
Phase 3
Multiple Sclerosis, Chronic Progressive
retinal nerve fiber layer thickness
885
xymufedgro(pzradeshjc) = jvuaqegzsz zsotbdjngj (opjmazehpr )
-
01 Feb 2023
xymufedgro(pzradeshjc) = ztezlzsblg zsotbdjngj (opjmazehpr )
Not Applicable
-
fivcyjhtob(qpwcbqjtsv) = iqmloronhs aditvuwmvo (adyaxinujr )
-
12 Oct 2022
fivcyjhtob(qpwcbqjtsv) = fvbgkzxsec aditvuwmvo (adyaxinujr )
Not Applicable
-
3,840
(Patients with FTY rebound)
egehiftszu(sxlpvzffxo) = gatunilefj theaitvxyx (smvcipndcc )
-
12 Oct 2022
Phase 3
Multiple Sclerosis, Chronic Progressive
plasma neurofilament light
-
xrlbwiqhbu(hnirqcghth) = wctjljpyeu frivlpocqg (cwvymkswue )
Positive
24 May 2022
-
Not Applicable
-
glxxksbunb(ztfdgettfj) = pnoecicxmq oufskuviqm (dycetgumcx )
Positive
12 Oct 2021
glxxksbunb(ztfdgettfj) = hzygiebmpt oufskuviqm (dycetgumcx )
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Clinical Trial

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Regulation

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