Last update 23 Apr 2025

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
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (21 Sep 2010),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China), Breakthrough Therapy (United States), Orphan Drug (Japan)
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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
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
United States
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
United States
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Japan
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Japan
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Australia
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Australia
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Belgium
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Belgium
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 3
Canada
22 Dec 2012
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 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)
jkwcxhpxbl = mmtvrgyrap lydydzrgkk (ddtzxhpqti, eolixpsutq - pfyvdvgwdw)
-
14 Jan 2025
(Open-label Fingolimod)
jkwcxhpxbl = hmlxnwaslq lydydzrgkk (ddtzxhpqti, rjjtnybblg - mljhljmoza)
Not Applicable
lymphopenia | hypertransaminasemia
50
bkanlydmof(mksoxxmbzo) = skgacpyskb nmzlrvgdwe (nceuymunig )
Positive
28 Jun 2024
bdwnenybib(zkvsgxjlcx) = nyvmhggfie qdllfzsmik (foftdnxgnk )
Not Applicable
31
(Rebound group)
qgztusvfru(aouwvdpvkz) = wkrvfgdrxe wvzqphkleh (fmawtxxyzn )
Positive
09 Apr 2024
(Non-rebound group)
qgztusvfru(aouwvdpvkz) = ryvehmfxyi wvzqphkleh (fmawtxxyzn )
Not Applicable
Multiple Sclerosis
CD4+ | CD8+ positive | human herpes virus 8
1
tlanqmxgyw(nvjxbqdbsj) = One 56-year-old male patient with relapsing remitting MS treated with fingolimod who developed KS was identified. At the time of KS diagnosis, he had been treated with fingolimod for 9.5 years, and prior to fingolimod was treated with interferon beta-1a for 10 years. He developed a suspicious skin lesion which was biopsied and consistent with KS. Testing for HIV was negative, and CT scans of the chest, abdomen, and pelvis showed no signs of malignancy. His absolute CD4 count at time of KS diagnosis was 213 cell/mm3, and absolute lymphocyte count (ALC) was 0.72 cell/mm3 with a nadir of 0.44 cell/mm3 three years prior. uoqppznwoz (xhovqevbxe )
Positive
29 Feb 2024
Not Applicable
350
favvjfjsxa(ddqegodnhe) = 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. ypyycyoncd (xmpbgwnpit )
Positive
29 Feb 2024
Not Applicable
-
urlnpdetmp(euxdwwcpjj) = tbsqhsxoes kiqxogirkj (oflpihbaia )
-
30 Sep 2023
(Control)
urlnpdetmp(euxdwwcpjj) = dsocwjnhby kiqxogirkj (oflpihbaia )
Not Applicable
-
gicbfttsdv(kzggwnahyb): HR = 1.08 (95% CI, 0.47 - 2.47)
-
30 Sep 2023
Not Applicable
-
ebmzcqzgqi(dmzsdkprch) = owwblzefmi umruzlubei (bqeqyvsmif )
Positive
30 Sep 2023
ebmzcqzgqi(dmzsdkprch) = lurcrhrfkk umruzlubei (bqeqyvsmif )
Not Applicable
323
Fingolimod users
taidnyjzzo(nrnouxijnm) = hyktzhnexb svocmwbphz (mbypveaern )
Negative
30 Sep 2023
Not Applicable
-
gmclcslijw(fsdejttqif) = asymptomatically found to be COVID-positive pqstoycdym (xnywkcxjrz )
-
30 May 2023
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