Delving into the Latest Updates on Fingolimod Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

FINGOLIMOD, Fingolimod hydrochloride (JAN/USAN), Gilenia

+ [11]

Target

S1PR1 x S1PR3 x S1PR4 x S1PR5

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)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases+ [2]

Active Indication

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisMultiple sclerosis relapse+ [1]

Inactive Indication

AsthmaHepatitis C, ChronicInfluenza, Human+ [7]

Originator Organization

Novartis Pharma AG

Active Organization

Accord Healthcare SLNovartis Pharma Schweiz AG

Novartis Pharmaceuticals Corp.

+ [6]

Inactive Organization

Novartis Farmacéutica SANovartis Pharma Services AG

Novartis Pharmaceuticals Canada, Inc.

License Organization

Novartis AG

Tanabe Pharma Corp.

Drug Highest PhaseApproved

First Approval Date

United States (21 Sep 2010),

Multiple sclerosis relapse

RegulationBreakthrough Therapy (United States), Orphan 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)

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Structure/Sequence

Molecular FormulaC19H34ClNO2

InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N

CAS Registry162359-56-0

In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
Participants will be divided into 2 groups based on their weight:
* Group A will include children who weigh 40 kilograms (kg) or less. They will receive DRF in both Part 1 and Part 2 of the study.
* Group B will include children who weigh more than 40 kg. They will be randomly assigned to receive DRF, DMF, or fingolimod. Fingolimod is a drug already used to treat MS in adults. In Part 2, they will receive DRF.
This is a 2-part study. Part 1 treatment will last 96 weeks. Participants who complete Part 1 may move to Part 2. Part 2 is an extension period. Treatment will last another 96 weeks and will help researchers learn about the long-term safety and effects of treatment.
The main goal of the study is to learn about the safety of DRF and DMF and compare their effect on relapses and brain lesions with fingolimod.
The main questions researchers want to answer are:
* How many participants have adverse events and serious adverse events?
* How often do participants relapse after treatment with DRF and DMF compared to fingolimod?
Researchers will take brain imaging scans to check for any new areas of brain inflammation and compare the brain lesions before and after treatment.
Researchers will also measure the amount of drug in the blood to understand how the body processes it. To check safety, they will monitor participants' growth and development, and compare changes in heart tests, vital signs, and lab tests. They will also use rating scales to monitor depression symptoms.
The study will be done as follows:
Part 1 (Treatment Period)
* After screening, participants will join Part 1 and be divided into 2 groups based on their weight.
* Participants in Group A will receive DRF.
* Participants in Group B will be randomly assigned to receive either DRF, DMF, or fingolimod.
* Neither the researchers nor the participants will know which drug or dose the participants will receive in Group B. Participants in Group B will also receive a placebo so they do not know which drug is being given. A placebo looks like a study drug but contains no real medicine.
* All study drugs will be taken by mouth, once or twice a day. Participants who take DRF or DMF will start with a lower dose during the 1st week, then move to a standard dose.
* Treatment in Part 1 will last for 96 weeks. Participants will have up to 11 study visits and 7 phone calls.
* Participants who do not move onto Part 2 will also have a safety follow-up period of 4 to 8 weeks. This will include 1 study visit and 1 phone call.
* The total length of Part 1, including the screening, treatment, and follow-up, will be up to 108 weeks.
Part 2 (Extension Period)
* Participants who complete Part 1 can move on to Part 2 of the study.
* All participants in Part 2 will receive DRF by mouth for 96 weeks.
* Participants will have up to 10 more study visits and 1 telephone call during treatment.
* They will also have a 4-week safety follow-up, including 1 study visit and 1 phone call.
* The total length of Part 2 will be up to 100 weeks.

Start Date16 Nov 2026

Sponsor / Collaborator

Biogen, Inc.

NCT07220252

/ RecruitingPhase 2/3

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

Start Date01 Jul 2026

Sponsor / Collaborator

TG Therapeutics, Inc.

ChiCTR2600129021

/ Not yet recruitingPhase 4IIT

Efficacy and Safety of Fingolimod Adjunctive to Endovascular Treatment for Large Vessel Occlusion Stroke (FATE-ET Study)

Start Date16 May 2026

Sponsor / Collaborator

Xinqiao Hospital

[+1]

100 Clinical Results associated with Fingolimod Hydrochloride

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100 Translational Medicine associated with Fingolimod Hydrochloride

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100 Patents (Medical) associated with Fingolimod Hydrochloride

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4,224

Literatures (Medical) associated with Fingolimod Hydrochloride

31 Dec 2026·Gut Microbes

A commensal protozoan exacerbates acetaminophen-induced liver injury by producing free sphingosine

Article

Author: Cheng, Wanpeng ; Yan, Xiaoqing ; Sun, Qian ; Wei, Yanxia ; Shen, Yusi ; Kou, Yanbo ; Chen, Qiuchong ; Liu, Xiangye ; Shi, Zhen ; Wang, Yugang ; Zhu, Xiuwen ; Liao, Longxiang ; Zhou, Yuan ; Liu, Zhuanzhuan

The mechanisms by which the gut microbiota influence host disease outcomes remain poorly understood. As an integral yet overlooked component of this microbial community, the role of gut commensal protists in host physiology and pathology is even more ambiguous. Here, we show that the protozoan Tritrichomonas musculis (T. mu) remotely increases host sensitivity to drug-induced liver injury via the production of free sphingosine. Inhibiting sphingosine kinases (SPHKs) with PF543 or K145, or antagonizing sphingosine 1-phosphate receptor (S1PR) with FTY720, abolished the effect of T. mu-mediated exacerbation of acetaminophen (APAP)-induced liver injury (AILI), pointing to a sphingosine-SPHK1/2-S1P-S1PR axis underlying T. mu's remote modulation of hepatic drug sensitivity. Moreover, using U-¹³C‑palmitic acid and U-¹³C‑glucose metabolic flux tracing, we propose a novel model for sphingosine synthesis in T. mu. In this model, T. mu synthesizes sphingosine by using oxaloacetate, likely generated via the glyoxylate cycle, as a two‑carbon unit donor, rather than directly employing intact palmitic acid to supply the long‑chain carbon skeleton. Collectively, these findings not only deepen our understanding of how the gut microbiota, particularly the underappreciated gut protists, influence extra-intestinal disease outcomes via the gut-distal organ axis, but also reveal the tip of the iceberg regarding the unique metabolic pathways of gut commensal protists.

01 Nov 2026·Bioactive Materials

A closed-loop myocardial infarction theranostic platform activated by macrophage-derived nitric oxide and acidic microenvironment

Article

Author: Yang, Fang ; Chen, Yan ; Li, Mingxi ; Li, Runqian ; Lu, Hui ; Tong, Jiayi ; Li, Shengnan ; Xu, Xuan

Precise management of the inflammatory response after myocardial infarction necessitates targeted engagement of cellular drivers. Here, we report a pathophysiology-guided theranostic platform that exploits two defining features of pro-inflammatory macrophages, their high-output nitric oxide (NO) production and localized acidic microenvironment, to enable concurrent sensing, quantification, and modulation of post-infarction inflammation. The platform, PM720@NRP, is engineered from platelet membranes encapsulating an NO-responsive NIR-II fluorophore and the immunomodulator FTY720. It delivers three integrated functions: (i) specific, NO-activated NIR-II imaging of inflammatory foci; (ii) machine learning-powered translation of imaging signals into quantitative maps of pro-inflammatory macrophage activity; (iii) acid-triggered release of FTY720 to reprogram macrophages toward a reparative phenotype, synergizing with platelet-derived factors to stimulate angiogenesis. This strategy provided real-time visualization and non-invasive quantification of inflammation, while improving cardiac function and repair. By repurposing pathological biomarkers as intrinsic triggers for diagnosis and treatment, this work establishes a closed-loop, biology-inspired paradigm that autonomously adapts to dynamic disease activity.

01 Oct 2026·Biomaterials advances

Investigating FTY720-NF immunomodulation of key lipid, gene, and protein mediators to enhance oral tissue regeneration

Article

Author: Cha, Tim ; Botchwey, Edward A ; Chinniampalayam Sekar, Keerthi P ; Shah, Daniel C ; Toma, Afra I ; Wood, Levi B ; Kamalakar, Archana ; Chiappa, Nathan F ; Goudy, Steven L ; Willett, Nick J ; Duke, Victoria R

Oronasal fistula (ONF) formation following cleft palate repair remains a significant clinical challenge, often driven by persistent inflammation, fibrotic remodeling, and insufficient mucosal regeneration. Effective oral wound healing depends on precise immune regulation, particularly by macrophages that coordinate both inflammation resolution and tissue repair. The sphingosine-1-phosphate (S1P) pathway is a key regulator of immune cell function and trafficking, and its modulation through the S1P receptor agonist FTY720 (Fingolimod) offers a promising multifaceted strategy for tissue regeneration. In this study, we investigated the therapeutic effect of FTY720 delivered via nanofibers (FTY720-NF) on macrophage-mediated wound repair using multi-omics profiling and translational in vivo models. Treatment of human macrophages with phosphorylated FTY720 (FTY720P) in vitro induced a shift in cytokine and chemokine secretion toward a pro-regenerative phenotype. Integrated lipidomic and transcriptomic analyses revealed significant remodeling of sphingolipid metabolism and gene expression networks associated with pro-regenerative macrophage phenotypes and inflammation resolution. In a porcine model of oral injury, FTY720-NF treatment accelerated re-epithelialization and improved wound healing outcomes compared to injury-only and platelet-rich plasma (PRP) controls. Together, these findings highlight FTY720-NF as a potential immunotherapeutic approach that possibly reprograms cellular responses and tissue environments to promote oral wound healing.

102

News (Medical) associated with Fingolimod Hydrochloride

12 Jun 2026

·www.prnewswire.com

Harbour BioMed Appoints Dr. Dhavalkumar Patel as Scientific Advisor

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 11, 2026 /PRNewswire/ -- Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other disease areas, today announced the appointment of Dr. Dhavalkumar Patel as Scientific Advisor. Dr. Patel brings an outstanding track record of therapeutic innovation spanning over two decades in industry and academia. He is currently Executive Vice President and Chief Scientific Officer of Sana Biotechnology. Prior to joining Sana Biotechnology in 2024, Dr. Patel served as Executive Vice President and Chief Scientific Officer of UCB, where he and his teams contributed to the registration of bimekizumab (Bimzelx®), rozanolixizumab (Rystiggo®) and zilucoplan (Zilbrysq®). Prior to UCB, he spent 10 years at Novartis, most recently as the Head of Research of the Novartis Institutes for BioMedical Research (NIBR) Europe. During his tenure, he led research in the autoimmune, transplantation, and inflammation disease areas, contributing to the registration of secukinumab (Cosentyx®), fingolimod (Gilenya®), siponimod (Mayzent®), canakinumab (Ilaris®), everolimus (Zortress®/Certican®, Afinitor®), leniolisib (Joenja®), and iptacopan (Fabhalta®) in multiple indications. He was also an Entrepreneur in Residence at the Novartis Venture Fund. Dr. Patel served as a member of the Board of Directors of Inflazome prior to its acquisition by Roche in 2020. He currently serves on the Boards of Directors for Priothera, Quell Therapeutics, and RE-AIM Therapeutics, and serves as Chair of the Board of Directors for Mimetas BV. Prior to joining industry in 2006, Dr. Patel was an Eminent Professor of Medicine, Chief of Rheumatology, Allergy and Clinical Immunology, and Director of the Thurston Arthritis Research Center at the University of North Carolina in Chapel Hill. He also spent nine years at the Duke University School of Medicine, culminating in his position as the Chief of the Division of Allergy and Immunology. Dr. Patel received his B.S., M.D., and Ph.D. in Microbiology and Immunology from Duke University, and is board certified in internal medicine, rheumatology, and allergy & immunology. "We are thrilled to welcome Dr. Patel to our Scientific Advisory Board," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "His outstanding combination of deep immunological science, proven drug development success, and board-level strategic insight will be a tremendous asset to us. We look forward to his guidance as we continue to build a leading immunology pipeline." "I am honored to join Harbour BioMed as a Scientific Advisor," said Dr. Dhavalkumar Patel. "Harbour BioMed has built a compelling portfolio of novel antibody candidates targeting key immune pathways, and I believe the company is well-positioned to make meaningful progress in areas of high unmet medical need. I look forward to working closely with the team to help advance these programs from discovery through development and ultimately to patients." About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology, oncology and other areas. The Company is building a robust portfolio and differentiated pipeline through internal R&D capability, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Our proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. The HCAb-based Antibody Plus technology (HCAb PLUSTM) provides comprehensive modality solutions for the development of innovative multi-specific medicines in different disease areas. Additionally, building upon the Harbour Mice® platform, Harbour BioMed launched its first fully human Generative AI HCAb Model powered by its Hu-mAtrIxTM AI platform, accelerating the development of innovative therapies. By integrating Harbour Mice®, HBICE®, HCAb PLUSTM, a single B-cell cloning platform and AI technologies, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit . SOURCE Harbour BioMed 21% more press release views with Request a Demo

Executive Change

01 Jun 2026

·www.globenewswire.com

Mapi Pharma to Participate in the ASCO Annual Meeting and ADA 2026 Scientific Sessions

Company is seeking partnerships for the most advanced long-acting depot injections in its pipeline, including Anastrozole Depot and Semaglutide DepotNESS ZIONA, Israel, June 01, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd. (“Mapi” or the “Company”), a late-stage clinical biopharmaceutical company specializing in long-acting injectable therapies, today announced that management will participate in the Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place in May 29 - June 2, 2026, in Chicago, Illinois and in the American Diabetes Association (ADA) 2026 Scientific Sessions, to take place in June 5-8, 2026, in New Orleans, Louisiana. Long-acting injectable (LAI) therapies are increasingly recognized as a critical treatment option across multiple indications, offering improved patient adherence, consistent drug delivery, and reduced dosing frequency. Mapi utilizes extended-release depot technologies protected by strong IP to develop lifecycle management products for innovative and existing commercially successful pharmaceuticals across multiple therapeutic areas. Mapi is fully integrated in the development of depot pharmaceuticals and offers partners unique IP with leading R&D and clinical teams, dedicated depot labs and an aseptic GMP approved manufacturing facility for Depot products, collectively significantly improving time to market. The Company is actively seeking new R&D and marketing partnerships for several of its proprietary Depot products. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We are seeking ideal partners for long-acting depot formulations of semaglutide (Ozempic®) for diabetes, tirzepatide (Mounjaro®/Zepbound®) for chronic weight management, and anastrozole (Arimidex®), an adjuvant endocrine therapy for the prevention of recurrence in breast cancer. Anastrozole is currently available as an oral treatment and Mapi has developed a long-acting depot formulation of the product with unique IP and PK modeling.” The Company’s development pipeline includes an injectable version of semaglutide, developed using Mapi’s depot technology, which has demonstrated a long-acting release profile, for one monthly injection. Mapi will begin to enroll patients in a Phase I/II study this month (ClinicalTrials.gov ID NCT07563699). Company management will be available for one-on-one meetings during the conferences to discuss potential joint development collaborations. Interested parties should contact Mapi directly. About Mapi PharmaMapi Pharma is a clinical-stage pharmaceutical company focused on the development of high-value, complex injectable therapies with significant barriers to entry. The Company’s portfolio includes long-acting depot formulations targeting large and growing markets, including central nervous system disorders and metabolic diseases. Key pipeline programs include long-acting formulations of Cariprazine, as well as GLP-1 therapies such as Semaglutide and Tirzepatide for diabetes and weight management. Mapi is also developing an AB-rated generic version of Naltrexone (Vivitrol®) and markets generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in select regions. Mapi combines deep expertise in chemistry, pharmaceutical development, and clinical execution with a strong intellectual property portfolio, including numerous granted patents primarily focused on formulations. The Company operates dedicated R&D and aseptic manufacturing facilities for long-acting injectable dosage forms. For more information, please visit www.mapi-pharma.com Contacts:Alex MogleVice President, Corporate DevelopmentMapi Pharma+972 52 6080297alex@mapi-pharma.com Brian RitchieManaging DirectorLifeSci Advisors, LLCbritchie@lifesciadvisors.com

Phase 1

04 May 2026

·www.biospace.com

Mapi Pharma Explores U.S. Aseptic Manufacturing Facility to Support Growing Demand for Aseptic and Long-Acting Generic and innovative Injectables

Company to present investment opportunity at SelectUSA Summit NESS ZIONA, Israel, May 04, 2026 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd. (“Mapi” or the “Company”), a late-stage clinical biopharmaceutical company specializing in long-acting injectable therapies, today announced that it is exploring the establishment of a U.S.-based aseptic manufacturing facility to support its expanding pipeline and growing global demand for aseptic and long-acting injectables. Mapi will present this initiative as part of a corporate overview at the SelectUSA Investment Summit, to take place May 3–6, 2026, in National Harbor, Maryland, where the Company will also meet with potential partners and investors. Long-acting injectable (LAI) therapies are increasingly recognized as a critical treatment option across multiple indications, offering improved patient adherence, consistent drug delivery, and reduced dosing frequency. However, these products are complex to develop and manufacture, requiring specialized expertise and infrastructure that are often not available through traditional contract manufacturing sources. Mapi has built advanced R&D and GMP-compliant manufacturing capabilities in Israel, approved by the Israeli Ministry of Health and recognized by European regulatory authorities for global supply. Building on this foundation, the Company is evaluating the establishment of a U.S. aseptic manufacturing facility to serve both domestic and international markets. The Company is exploring a partnership-based structure for the project, which may include the formation of a new entity supported by strategic and financial investors. Mapi will use its expertise and previous investment and will look for partner(s) for capital investment and potential commercial capabilities. “The United States represents the largest and most important market for aseptic and long-acting injectables, including GLP-1 and CNS therapies,” said Ehud Marom, Chairman and Chief Executive Officer of Mapi Pharma. “Expanding our manufacturing footprint into the U.S. would position us to better support future commercialization and ensure reliable product supply for patients worldwide.” Marom added, “Recent pharmacokinetic results from our ongoing long-acting Cariprazine Depot program mark an important milestone. The positive data aligns with our predictive models and support our planned Phase III initiation in 2027. We believe a long-acting formulation of Cariprazine Depot could address significant unmet needs in schizophrenia and bipolar disorder.” The SelectUSA Investment Summit brings together representatives from U.S. states and territories, global companies, and government leaders to facilitate investment opportunities. Mapi’s management team will be available for one-on-one meetings to discuss strategic partnerships, including joint development opportunities and participation in the planned U.S. manufacturing initiative. About Mapi Pharma Mapi Pharma is a clinical-stage pharmaceutical company focused on the development of high-value, complex injectable therapies with significant barriers to entry. The Company’s portfolio includes long-acting depot formulations targeting large and growing markets, including central nervous system disorders and metabolic diseases. Key pipeline programs include long-acting formulations of Cariprazine, as well as GLP-1 therapies such as Semaglutide and Tirzepatide for diabetes and weight management. Mapi is also developing an AB-rated generic version of Naltrexone (Vivitrol ® ) and markets generic versions of Fingolimod (Gilenya ® ) and Apremilast (Otezla ® ) in select regions. Mapi combines deep expertise in chemistry, pharmaceutical development, and clinical execution with a strong intellectual property portfolio, including numerous granted patents primarily focused on formulations. The Company operates dedicated R&D and aseptic manufacturing facilities for long-acting injectable dosage forms. For more information, please visit . Contacts: Alex Mogle Vice President, Corporate Development Mapi Pharma +972 52 6080297 alex@mapi-pharma.com Brian Ritchie Managing Director LifeSci Advisors, LLC britchie@lifesciadvisors.com

100 Deals associated with Fingolimod Hydrochloride

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External Link

KEGG	Wiki	ATC	Drug Bank
D04187	Fingolimod Hydrochloride	L04AA27	DB08868

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	European Union	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Iceland	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Norway	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis	Australia	Novartis AG	01 Feb 2011
Multiple sclerosis relapse	United States	Novartis Pharmaceuticals Corp.	21 Sep 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Dec 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04088630 (FITCH, CTgov)	Early Phase 1	Cerebral Hemorrhage \| Brain Edema \| Hemorrhagic stroke	28	Fingolimod (Fingolimod)	lkortebehq = qvezfpdesx biezfjjmge (amjajisbep, xnznejqcsb - tfhmokfwec) View more	-	14 Jan 2025
				Fingolimod (Open-label Fingolimod)	lkortebehq = jyaogmnlrm biezfjjmge (amjajisbep, mrommyqovq - cnozartosw) View more
EAN2024	Not Applicable	lymphopenia \| hypertransaminasemia	50	Fingolimod	snjmewrtru(ppygfqrjvt) = twleccoctu oezawgzuuv (ienbmfivin ) View more	Positive	28 Jun 2024
				Ozanimod	hzzririkxk(pzjkswuwop) = yprioxbbig aabspvweld (cgaufvojum ) View more
S31.010 (AAN2024)	Not Applicable	Multiple Sclerosis	930	Fingolimod	zqnzmnzytj(mmynoojyey) = mlfqratfqz afuqotysww (anbdpyoihq )	Negative	09 Apr 2024
				Natalizumab	zqnzmnzytj(mmynoojyey) = suwnawdett afuqotysww (anbdpyoihq )
ACTRIMS2024	Not Applicable	Drug-Related Side Effects and Adverse Reactions	350	Fingolimod	sspevdctpz(lwlcsyjvjn) = 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. hbxlktbkil (kswyvtzgff )	Positive	29 Feb 2024
NCT00731692 (INFORMS, Pubmed \| Eur J Neurol)	Phase 3	Multiple Sclerosis	324	Fingolimod	cvxcgoyumq(rgqqwrvimc) = qibugajzsy oufbkjttjr (hpmxqhsjrx )	Positive	01 Jan 2024
				Placebo	cvxcgoyumq(rgqqwrvimc) = msxgxoywmi oufbkjttjr (hpmxqhsjrx )
NCT00355134 (FREEDOMS II, Pubmed)	Phase 3	Multiple Sclerosis, Chronic Progressive retinal nerve fiber layer thickness	885	Fingolimod 0.5 mg	umlkbhysgi(cvmnmveqrr) = dsjncovtww tjmhqtmibq (uxtchryqwh )	-	01 Feb 2023
				Fingolimod 1.25 mg	umlkbhysgi(cvmnmveqrr) = xaxqxbodqt tjmhqtmibq (uxtchryqwh )
ECTRIMS2022	Not Applicable	-	3,840	fingolimod (Patients with FTY rebound)	llhdawmkfw(jekvtncuzx) = iqmzvicknn cglhizufav (gwxfcivjdh )	-	12 Oct 2022
ECTRIMS2022	Not Applicable	COVID-19	-	Fingolimod	szsraronqb(bsizhrhzuo) = penelmuiuf mmlttetqay (mlzxjwoprd ) View more	-	12 Oct 2022
				Siponimod	szsraronqb(bsizhrhzuo) = tklhdcopct mmlttetqay (mlzxjwoprd ) View more
NCT01665144 \| NCT00731692 (Pubmed \| Neurology)	Phase 3	Multiple Sclerosis, Chronic Progressive plasma neurofilament light	-	Siponimod	gkwbfoxscg(yrypijtsnp) = xsgkrbqcbf dhyxtcdrra (tapyulamuk ) View more	Positive	24 May 2022
				Fingolimod	-
CLARION (ECTRIMS2021)	Not Applicable	Multiple Sclerosis First line	1,597	Cladribine tablets (CladT)	hvffhknrzw(xarblogzze) = yfuoqwumtt shrlvkpdte (ajeqytxbgv )	-	12 Oct 2021
				Fingolimod	hvffhknrzw(xarblogzze) = zibywjqmry shrlvkpdte (ajeqytxbgv )