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

Mylan Pharmaceuticals Ltd.

Novartis Pharmaceuticals Corp.Novartis Europharm Ltd.

+ [6]

Inactive Organization

Novartis Pharma Services AGNovartis Farmacéutica SA

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), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Molecular FormulaC19H34ClNO2

InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N

CAS Registry162359-56-0

135

Clinical Trials associated with Fingolimod Hydrochloride

NCT07483632

/ Not yet recruitingPhase 3

A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis

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

/ SuspendedPhase 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

100 Translational Medicine associated with Fingolimod Hydrochloride

100 Patents (Medical) associated with Fingolimod Hydrochloride

3,732

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 Dec 2026·CLINICAL IMMUNOLOGY

Comparative multi-analyte serum protein differences between generic and brand-name dimethyl fumarate, fingolimod, and teriflunomide in multiple sclerosis

Article

Author: Moog, Tatum M ; Stüve, Olaf ; Anderson, Benjamin J ; Taylor, Sophia M ; Sguigna, Peter V ; Burgess, Katy W ; Light, David Y ; Santoyo, Jose R ; Tran, Diem H ; Punnen, Tom G ; Okuda, Darin T ; Jones-McCreary, Morgan C ; Wright, Crystal M

Multiple sclerosis (MS) is treated with branded or generic disease-modifying therapies (DMTs), with increasing concern for the composition and quality of off-patent products. Our objective was to evaluate differences in disease-specific biomarkers, a potential indicator of suboptimal therapeutic exposure, between individuals treated with branded and generic DMTs. We compared biomarker variability in MS individuals (n=1,124) treated with generic or brand-name fumarates (diroximel fumarate, dimethyl fumarate (DMF)), fingolimod, and teriflunomide. In the generic DMF group, higher coefficients of variation (COV) for CXCL9, CCL20, and TNFSF13B were observed, with a paradoxically lower variability for CXCL13. Higher COVs for CXCL9 were observed with generic fingolimod and for CXCL9 and CXCL13 with generic teriflunomide when compared to brand. Additionally, all generic DMTs demonstrated higher multi-variable variability index values across 18 proteins associated with MS disease activity. Greater biomarker variability with generic formulations may reflect differences in therapeutic exposure and less consistent disease control.

01 Dec 2026·JOURNAL OF THEORETICAL BIOLOGY

A stochastic agent-based model for naive CD8+ T cell recirculation dynamics in mice

Article

Author: Elrefaei, Nagat ; Christian, David A ; Adams, Thomas A

Understanding the dynamics of T cell recirculation is vital for predicting immune responses and providing mechanistic insights into T cell migration. In this work we present a stochastic agent-based mathematical model for naive CD8⁺ T cell dynamics and recirculation patterns in mice. This work includes the ability to interrogate the earliest stages of T cell trafficking using a dataset with uniquely dense temporal sampling. Measurements beginning at 10 min post-transfer enabled characterization of the rapid redistribution phase that is often missed in studies with coarser sampling intervals. The model structure includes the bloodstream, lymph nodes, spleen, and other parts of the body where naive T cells recirculate. The model is governed by migration parameters designed according to the physiological nature of the system components. A parameter estimation technique was used to fit the model to experimental data while maintaining a reasonable level of stochasticity. The results show that the simulated naive CD8⁺ T cell counts in the different tissues matched the experimental data up to 47 h post T cell transfer. The model incorporates lymph node size heterogeneity and distinct splenic red and white pulp compartments to better capture naive CD8⁺ T cell recirculation dynamics. The robustness of the model was demonstrated by simulating the effect of FTY720 drug on T cell counts in the bloodstream at two different drug doses and over the span of one week, which is much longer than the original training period. This work offers a novel tool for quantifying T cell recirculation parameters and enables predictive capabilities for T cell dynamics.

107

News (Medical) associated with Fingolimod Hydrochloride

18 Sep 2026

·www.biospace.com

CHMP recommends EU approval of Roche’s Ocrevus for children and adolescents with relapsing multiple sclerosis

Ocrevus addresses a critical need in paediatric neurology as the first high- efficacy anti-CD20 treatment option for people with MS as young as 10 years old In the Phase III OPERETTA 2 study, Ocrevus demonstrated non-inferiority in relapse control and superiority over fingolimod in suppressing brain lesions 1 Safety in children and adolescents was aligned with the established safety pro Ocrevus across more than 525,000 adult patients globally 1 Basel, 18 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS). The U.S. FDA approved Ocrevus for paediatric RMS patients in May 2026. A final decision from the European Commission is expected in the near future. “Children and teens living with multiple sclerosis experience more frequent and severe relapses than adults, yet their treatment options have lagged behind,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The positive CHMP opinion brings us closer to bridging a longstanding gap in Europe, offering young people with MS a high-efficacy therapy backed by a decade of adult experience.” "Living with a paediatric MS diagnosis means that children and adolescents must navigate a complex condition with unpredictable relapses that require hospital admission and acute therapies, lead to missed days of school and social activities, and face the potential for future disability,” said Dr. Brenda Banwell, MD, Chair of Pediatrics, Johns Hopkins Medicine, Pediatrician-in-Chief and Co-Director, Johns Hopkins Children’s Center. “Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health." The CHMP's positive opinion is based on the Phase III OPERETTA 2 study, which showed that Ocrevus was non-inferior to fingolimod (the current standard treatment in paediatric MS) at controlling relapses, reducing the risk of relapses by 48% compared with fingolimod. In OPERETTA 2, Ocrevus was superior at reducing brain inflammation, showing significant reductions in new or enlarging T2 lesions (-48%) and gadolinium-enhancing active T1 lesions (-87%). Ocrevus demonstrated a consistent safety pro children and teens similar to that seen in adults, with no patients stopping treatment due to side effects. 1 At least 40,000 children and adolescents are living with MS worldwide, with roughly one-third in Europe, emphasising the need for early high-efficacy MS treatment. 2 About Ocrevus® (ocrelizumab) Ocrevus is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. Ocrevus IV and Ocrevus subcutaneous (SC; marketed as Ocrevus Zunovo® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both Ocrevus IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. Ocrevus SC is given as a single 920 mg subcutaneous injection every six months. About multiple sclerosis Multiple sclerosis is a chronic disease that affects more than 3 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible. Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus®, there had been no FDA-approved treatments for PPMS, and Ocrevus is still the only approved treatment for PPMS. Despite the availability of high-efficacy therapies, over a third of MS patients remain on lower-efficacy therapy today. Slowing or stopping progression while simultaneously stopping relapses remains a high unmet need in MS. About Roche in Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Banwell B, et al. Efficacy and Safety of Ocrelizumab Compared With Fingolimod in Paediatric Relapsing- Remitting MS: Results of the Phase III OPERETTA 2 Study. Presented at the 2025 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); 26 September 2025; Barcelona, Spain. [2] MS International Federation. The Atlas of MS 2026: A global update on MS prevalence, incidence, and the gaps that remain. September 2026. Available from: Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75 Albert Thottiyil Phone: +41 79 775 66 12 Attachment Media Release Ocrevus Paediatric CHMP English

Phase 3Drug ApprovalClinical Result

11 Sep 2026

·www.fiercepharma.com

After FDA nod for novel Cabometyx formulation, analysts predict limited threat to Exelixis

Following formal sign-off from the FDA, Handa Pharmaceuticals’ branded drug reformulation strategy has paid off for a third time. On Friday, the U.S. and Taiwan-headquartered company announced final FDA approval for its Omcazio capsules, a laurylsulfate salt formulation of Exelixis’ cancer med Cabometyx that uses cabozantinib, the same tyrosine kinase inhibitor active ingredient. The novel formulation of Exelixis’ patent-protected med was devised by the company’s Handa Oncology subsidiary and shifts a prior tentative approval into a formal green light, clearing the way for the drug to be marketed in the United States. Omcazio now joins two other branded reformulated medicines in Handa’s portfolio, Phyrago, a modified version of Bristol Myers Squibb’s oncology medicine Sprycel (dasatinib) that can be used alongside proton pump inhibitors and H2 receptor antagonists, and Tascenso ODT, an orally disintegrating tablet formulation of Novartis’ relapsing multiple sclerosis therapy Gilenya (fingolimod). Both of those products are being commercialized in the U.S. under licensing agreements with Cycle Pharmaceuticals. As for Omcazio, Handa said Friday that it plans to provide additional information on the drug’s U.S. commercial availability in a forthcoming announcement. The capsule’s key advantage, according to a statement from Handa CEO Bill Liu, is that it can be taken with or without food, which he said gives both doctors and patients “added flexibility in treatment.” The medicine can be used in adults with advanced renal cell carcinoma and as a first-line treatment in those patients in combination with BMS’ Opdivo, as well as in hepatocellular carcinoma patients previously treated with Bayer’s Nexavar and in adults and children 12 and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors. Meanwhile, the 60-, 40- and 20-mg once-a-day doses of Cabometyx correspond to 34.5-, 23- and 11.5-mg daily doses of Omcazio, respectively, Handa noted. Cabometyx, which won its first approval more than a decade ago, is among the most commonly used oral targeted therapies in cancer treatment, per Handa. Last year, Exelixis reported a 17% sales bump for the medicine to $2.11 billion in the U.S. As for what Handa’s nod means for Exelixis, analysts at William Blair wrote to clients Friday that they don’t view the full approval of Omcazio as a threat. They cited the apparent gap between approval and commercial availability and further asserted that they believe Handa’s drug is “not equivalent to Cabometyx.” Omcazio was approved using bioavailability and bioequivalence data via the FDA’s 505(b)(2) pathway, the William Blair team pointed out. This pathway enables developers to rely in part on existing data supporting a previously approved drug, and is often used when a company is developing a new formulation or novel combination of an already-approved medicine. Nevertheless, Omcazio’s labeling specifically states that the drug is not substitutable on a milligram-to-milligram basis with other cabozantinib products. The William Blair analysts said they therefore believe Handa will “likely have to build a sales force to fully commercialize Omcazio,” adding that the lack of data also leads them to suspect “minimal” uptake of Omcazio in the U.S. The reformulation game has been picking up traction of late, as multiple developers look to retool versions of already-approved medicines in hopes of delivering a new, patent-protected product that fills some lingering unmet need. One prominent example is Veradermics, the buzzy hair-loss biotech that has continued to generate positive data —and investor excitement—around its lead candidate VDPHL01, which is an extended-release oral formulation of minoxidil. Minoxidil is likely better known by most as the topical hair loss treatment Rogaine, first approved in 1988. Meanwhile, an oral version of the drug was approved in the late 1970s as a blood pressure medicine, but it has not been approved in that format for hair loss.

Drug ApprovalLicense out/in

28 Aug 2026

·www.prnewswire.com

CivicaScript® launches 3 low-cost generics to expand its market impact

Treatments for cancer, multiple sclerosis priced up to 98% lower than average for other generic versions LEHI, Utah, Aug. 25, 2026 /PRNewswire/ -- CivicaScript, a nonprofit company dedicated to bringing low-cost generic and biosimilar medicines to U.S. patients, today announced the addition of three products to its expanding portfolio: Yulithira™ (everolimus) tablets, 2.5 mg, 5 mg, 7.5 mg and 10 mg, used to treat hormone receptor-positive, HER2-negative breast cancer; neuroendocrine tumors; renal cell carcinoma; tuberous sclerosis complex (TSC)-associated renal angiomyolipoma; and TSC-associated subependymal giant cell astrocytoma. Fingolimod capsules, 0.5 mg, used to treat relapsing forms of multiple sclerosis. Imatinib mesylate tablets, film coated, 100 mg and 400 mg, used to treat: Newly diagnosed Philadelphia positive chronic myeloid leukemia (Ph+ CML) Ph+ CML in blast crisis, accelerated phase or chronic phase after interferon-alpha therapy Adult patients with Ph+ acute lymphoblastic leukemia Pediatric patients with Ph+ acute lymphoblastic leukemia in combination with chemotherapy. Myelodysplastic/myeloproliferative diseases in adult patients. Aggressive systemic mastocytosis in adult patients. Hypereosinophilic syndrome and/or chronic eosinophilic leukemia in adult patients. Dermatofibrosarcoma protuberans in adult patients. Kit+ gastrointestinal stromal tumors (GIST) Adjuvant treatment of GIST These products have a recommended price to patients of up to 98% lower than the average price of generic versions available from other manufacturers, in keeping with CivicaScript's goal to make generic and biosimilar medicines affordable and available to everyone.[1] All three products are available nationwide. "Patients and payers deserve greater transparency and lower-cost treatment options," said CivicaScript President Brent J. Eberle. "Our model is designed to improve access to generics and biosimilars at sustainable prices." CivicaScript's maximum retail price, or MaxRP® policy, delivers significant savings to patients and payers when they switch to CivicaScript products: The MaxRP for Yulithira (everolimus) tablets, 2.5 mg is about $1,631/month less than the average 2017-22 claim cost for everolimus prescriptions filled at traditional PBM-affiliated pharmacies.[2] The MaxRP for fingolimod capsules, 0.5 mg (30 capsules) is about $1,032/month less than the equivalent Medicare unit price estimate from 2026.[3] The MaxRP for imatinib mesylate tablets, 400 mg (30 tablets) is about $5,564/month less than the average 2017-22 claim cost for imatinib prescriptions filled at traditional PBM-affiliated pharmacies.[4] The MaxRP for each product can be found here. The MaxRP allows patients and others to compare prices; they can confirm they are being charged no more than the MaxRP by scanning the QR code on the CivicaScript package. Since the launch of its first product in 2022, CivicaScript has delivered nearly $44 million in savings to patients and its payer members. CivicaScript's business model focuses on unprecedented transparency to transform the generic and biosimilars marketplace, working with like-minded healthcare stakeholders to transform the system from the inside out. The company partners with manufacturers to supply low-cost generic and biosimilar medicines, then works with payers and pharmacies across the country to pass along the cost savings to patients. Learn more about the organization and its mission here. The newly available products were chosen by CivicaScript members as priority generic medicines based on their high list price in the pharmaceutical supply chain and significant patient need for these products. About Yulithira (everolimus): For full prescribing information and patient information, including important warnings and precautions, potential adverse reactions and drug interactions, please refer to the Package Insert, available here. About fingolimod: For full prescribing information and patient information, including important warnings and precautions, potential adverse reactions and drug interactions, please refer to the Package Insert, available here. About imatinib mesylate: For full prescribing information and patient information, including important warnings and precautions, potential adverse reactions and drug interactions, please refer to the Package Insert, available here. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. [1] MaxRP® of CivicaScript imatinib mesylate tablets, 400 mg (30 film-coated tablets) compared with 2017-2022 average commercial reimbursement rate for all strengths of imatinib. See Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers, Federal Trade Commission Second Interim Staff Report, January 2025, at Fig. A1 (pg. 33), available at [2] Compared with 2017-2022 average commercial reimbursement rate for all strengths of everolimus. See Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers, Federal Trade Commission Second Interim Staff Report, January 2025, at Fig. A1 (pg. 33), available at [3] (Q1 2026) [4] Compared with 2017-2022 average commercial reimbursement rate for all strengths of imatinib. See Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers, Federal Trade Commission Second Interim Staff Report, January 2025, at Fig. A1 (pg. 33), available at SOURCE Civica Rx 21% more press release views with Request a Demo

100 Deals associated with Fingolimod Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04187	Fingolimod Hydrochloride	L04AA27	DB08868

R&D Status

Approved

10 top approved records.

to view more data

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.

to view more data

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	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	Canada	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Tanabe Pharma Corp.	22 Dec 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ACTRIMS2025	Not Applicable	Multiple Sclerosis	581	Ocrelizumab	uayfkpiwau(jbglmsvwmi) = zevcdaddrj lbrjiuuxdc (bpbdthsrun ) View more	Negative	27 Feb 2025
				Fingolimod	uayfkpiwau(jbglmsvwmi) = tezdclatjy lbrjiuuxdc (bpbdthsrun ) View more
NCT04088630 (FITCH, CTgov)	Early Phase 1	Cerebral Hemorrhage \| Brain Edema \| Hemorrhagic stroke	28	Fingolimod (Fingolimod)	etpekdspny = mubcoohgff nzwzrvgcib (utahmkodud, agiggwhocg - wlijbuqgyq) View more	-	14 Jan 2025
				Fingolimod (Open-label Fingolimod)	etpekdspny = ctffnvecwj nzwzrvgcib (utahmkodud, ywrejuociq - kalfakvoft) View more
EAN2024	Not Applicable	lymphopenia \| hypertransaminasemia	50	Fingolimod	hphqajqwim(xhbikeixem) = dbfpbvjbga bwbthicrjy (qugyazlsqm ) View more	Positive	28 Jun 2024
				Ozanimod	thbtaojrxc(lwdxihilux) = qkdljimduo jtdliurnfw (igajyiieys ) View more
S31.010 (AAN2024)	Not Applicable	Multiple Sclerosis	930	Fingolimod	zrpmymrasd(mkpisdchgi) = roclrbddhe zvjwnbnyzq (jexvokwent )	Negative	09 Apr 2024
				Natalizumab	zrpmymrasd(mkpisdchgi) = btnowvjlqd zvjwnbnyzq (jexvokwent )
ACTRIMS2024	Not Applicable	Drug-Related Side Effects and Adverse Reactions	350	Fingolimod	fppahbxnpm(wdvorxgfhf) = 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. hqnrgtdscc (uoxbaocfin )	Positive	29 Feb 2024
NCT00731692 (INFORMS, Pubmed \| Eur J Neurol)	Phase 3	Multiple Sclerosis	324	Fingolimod	ltgttmpqoi(omrpwsepyf) = dvwnmsmarc ubghmqbytt (kpjxebyxnl )	Positive	01 Jan 2024
				Placebo	ltgttmpqoi(omrpwsepyf) = sxdtbyhesx ubghmqbytt (kpjxebyxnl )
NCT00355134 (FREEDOMS II, Pubmed)	Phase 3	Multiple Sclerosis, Chronic Progressive retinal nerve fiber layer thickness	885	Fingolimod 0.5 mg	zmlwkwmixk(rlgequfwru) = qeubdnjeli lyifqnexiu (wulzbhvbwn )	-	01 Feb 2023
				Fingolimod 1.25 mg	zmlwkwmixk(rlgequfwru) = enjfulyvev lyifqnexiu (wulzbhvbwn )
ECTRIMS2022	Not Applicable	-	3,840	fingolimod (Patients with FTY rebound)	jpaaqmxzgt(xwfitchmqs) = ocavrzykhc orltwboqhr (ahfpkxszkv )	-	12 Oct 2022
ECTRIMS2022	Not Applicable	COVID-19	-	Fingolimod	vmmoupxmbv(ngrnrpnveh) = bejrhspgbb xadltnezdk (lnekqzfmph ) View more	-	12 Oct 2022
				Siponimod	vmmoupxmbv(ngrnrpnveh) = fedzptvidz xadltnezdk (lnekqzfmph ) View more
NCT01665144 \| NCT00731692 (Pubmed \| Neurology)	Phase 3	Multiple Sclerosis, Chronic Progressive plasma neurofilament light	-	Siponimod	xcbthfjywu(riheohqbzw) = jgloepzilt odrudihnll (eidyewrrln ) View more	Positive	24 May 2022
				Fingolimod	-

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