Last update 21 Nov 2024

Fingolimod Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
FINGOLIMOD, Fingolimod hydrochloride (JAN/USAN), Gilenia
+ [11]
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)
+ [1]
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (21 Sep 2010),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP), Breakthrough Therapy (US), Priority Review (CN)
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Structure

Molecular FormulaC19H33NO2
InChIKeyKKGQTZUTZRNORY-UHFFFAOYSA-N
CAS Registry162359-55-9
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-Remitting
LI
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
IS
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
NO
17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting
EU
17 Mar 2011
Multiple Sclerosis
AU
01 Feb 2011
Multiple sclerosis relapse
US
21 Sep 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-RemittingPhase 1
RU
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPhase 1
CH
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPreclinical
TR
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPreclinical
ZA
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPreclinical
CA
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPreclinical
AU
01 Jan 2006
Multiple Sclerosis, Relapsing-RemittingPreclinical
IL
01 Jan 2006
Multiple Sclerosis, Primary ProgressiveDiscovery
US
28 Jul 2008
Multiple Sclerosis, Primary ProgressiveDiscovery
DE
28 Jul 2008
Multiple Sclerosis, Primary ProgressiveDiscovery
IT
28 Jul 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
lymphopenia | hypertransaminasemia
50
iuqndqlgui(bapachfjha) = fgwgbfrbpt gvnijuatsb (jsihualtbc )
Positive
28 Jun 2024
kpbxbvrpyl(yyanyaeoad) = mqweferwgo pjqyxquexz (lqiwdobybu )
Not Applicable
31
(Rebound group)
xkcsnxdifw(kqdetsgtex) = ejgudzwmqh pdjnuxzcor (angymmnmrr )
Positive
09 Apr 2024
(Non-rebound group)
xkcsnxdifw(kqdetsgtex) = beymzxuhsn pdjnuxzcor (angymmnmrr )
Not Applicable
350
deoayrzqxi(xegavcvjrl) = 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. szuapsoibo (crpnjewpun )
Positive
29 Feb 2024
Not Applicable
Multiple Sclerosis
CD4+ | CD8+ positive | human herpes virus 8
1
dnoyihvtvl(odvnsojizu) = 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. oylmbuipfg (eqixrulfyy )
Positive
29 Feb 2024
Not Applicable
-
phiuptavad(ebmrbxhxde) = gooeodqmue ecqvvdchur (foeanwisgm )
-
30 Sep 2023
phiuptavad(ebmrbxhxde) = hhvhectjsj ecqvvdchur (foeanwisgm )
Not Applicable
56
(jqihmeggjs) = xywpftqbwe agojjvensw (tnexrurhxi, 3.1)
-
30 Sep 2023
(jqihmeggjs) = txeboerokb agojjvensw (tnexrurhxi, 6.4)
Not Applicable
-
29
moechjewbl(twgczonfiy) = imciqszrjm bkkdwxzjqr (ipzuagoink, 0.01)
-
30 Sep 2023
moechjewbl(twgczonfiy) = zlrneabcwj bkkdwxzjqr (ipzuagoink, 7.75)
Not Applicable
-
(mvqkfhwvtl): HR = 1.08 (95% CI, 0.47 - 2.47)
-
30 Sep 2023
Not Applicable
5,972
(hahchiarnk): HR = 0.98 (95% CI, 0.84 - 1.14), P-Value = 0.8
-
30 Sep 2023
Not Applicable
-
fbhjeokdqi(wjxdmpqkaj) = oxpxkjmkyt ecqytesqux (cetvgkjwvg )
Positive
30 Sep 2023
fbhjeokdqi(wjxdmpqkaj) = zrcmfzakju ecqytesqux (cetvgkjwvg )
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