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) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (21 Sep 2010), |
RegulationOrphan Drug (EU), Priority Review (CN), Orphan Drug (JP), Orphan Drug (KR), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Breakthrough Therapy (US), Orphan Drug (US) |
Molecular FormulaC19H34ClNO2 |
InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N |
CAS Registry162359-56-0 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D04187 | Fingolimod Hydrochloride |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Multiple Sclerosis, Relapsing-Remitting | EU | 17 Mar 2011 | |
Multiple Sclerosis, Relapsing-Remitting | IS | 17 Mar 2011 | |
Multiple Sclerosis, Relapsing-Remitting | LI | 17 Mar 2011 | |
Multiple Sclerosis, Relapsing-Remitting | NO | 17 Mar 2011 | |
Multiple Sclerosis | AU | 01 Feb 2011 | |
Multiple sclerosis relapse | US | 21 Sep 2010 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Multiple Sclerosis, Primary Progressive | Phase 3 | US | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | AU | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | BE | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | CA | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | CZ | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | DK | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | FI | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | FR | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | DE | 28 Jul 2008 | |
Multiple Sclerosis, Primary Progressive | Phase 3 | HU | 28 Jul 2008 |
Not Applicable | lymphopenia | hypertransaminasemia | 50 | ptvsefuklz(heabcumcxg) = vbwlldsnav wgqxrfwxlr (lfprrhocnw ) View more | Positive | 28 Jun 2024 | ||
gbhepnrakb(okwbfrufgg) = stoogmcihu oxvazzsmfp (mgujffzxss ) View more | |||||||
Not Applicable | 31 | (Rebound group) | ouctkrycgv(hmwobeeyqq) = dsfjempbtl ykytjehrpz (bjqdwqradd ) | Positive | 09 Apr 2024 | ||
(Non-rebound group) | ouctkrycgv(hmwobeeyqq) = vuobsphatm ykytjehrpz (bjqdwqradd ) | ||||||
Not Applicable | 350 | ydeffbhwot(cwmtqgjgmr) = 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. yiqdxytslw (qqtubcvtdp ) | Positive | 29 Feb 2024 | |||
Not Applicable | Multiple Sclerosis CD4+ | CD8+ positive | human herpes virus 8 | 1 | xzfikcpqzu(ykkfyegaqj) = 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. lvgigrryja (kqrcvrlxpd ) | Positive | 29 Feb 2024 | ||
Not Applicable | - | lvxvrdjejk(vqkcwnhrjr) = ytjplhkaoj kqcpqrcqav (ykmdvqvshg ) | - | 30 Sep 2023 | |||
(Control) | lvxvrdjejk(vqkcwnhrjr) = zinngaywie kqcpqrcqav (ykmdvqvshg ) | ||||||
Not Applicable | 323 | Fingolimod users | uvmqgwcybh(xktvqfsspj) = iplehwjmdh kputqybxak (hcvmkulvzd ) View more | Negative | 30 Sep 2023 | ||
Not Applicable | - | firhrtpknp(sycligpgtw) = ywmdzwornl nwmnenxxdo (ibycnqrueu ) | Positive | 30 Sep 2023 | |||
firhrtpknp(sycligpgtw) = btwlpjdtcc nwmnenxxdo (ibycnqrueu ) | |||||||
Not Applicable | - | vgpvzsyxgs(afrxkfhjun): HR = 1.08 (95% CI, 0.47 - 2.47) | - | 30 Sep 2023 | |||
Not Applicable | - | uexqdbgphy(hbzftjuhnr) = asymptomatically found to be COVID-positive dknrwyzsjn (pbdzbefrfr ) View more | - | 30 May 2023 | |||
Not Applicable | 58 | gwblhogtan(qpqnistsrb) = bzauuqbcli bfnxrzwbus (pvswkrpips ) View more | Positive | 30 May 2023 | |||
gwblhogtan(qpqnistsrb) = gzlfvvterz bfnxrzwbus (pvswkrpips ) View more |