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    Chemistry

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    Also known as: 1577222-14-0, 2-(2,5-dioxopyrrolidin-1-yl)ethyl methyl fumarate, Alks-8700, Vumerity, Diroximel fumarete, Rdc-5108
    Molecular Formula
    C11H13NO6
    Molecular Weight
    255.22  g/mol
    InChI Key
    YIMYDTCOUQIDMT-SNAWJCMRSA-N
    FDA UNII
    K0N0Z40J3W
    Diroximel fumarate
    Multiple Sclerosis (MS) is a chronic, debilitating neurological disease that can lead to profound cognitive and physical symptoms, severely affecting quality of life. It is the main cause of neurological disability not caused by trauma in the young adult population of both North America and Europe. Relapsing-remitting forms of MS lead to neurological symptoms that resolve and recur periodically. More than 80% of patients suffering from this disease have relapsing-remitting MS. Diroximel fumarate is a new drug from the fumarate class formulated to treat various relapsing forms of MS. This drug is bioequivalent to [Dimethyl fumarate](initially manufactured in 2013), but is less likely to cause gastrointestinal side effects, owing to its unique chemical structure. Diroximel fumarate was formulated by Alkermes in collaboration with Biogen, and was approved by the FDA in October 2019 and by the EMA in November 2021.
    1 2D Structure

    Diroximel fumarate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-O-[2-(2,5-dioxopyrrolidin-1-yl)ethyl] 1-O-methyl (E)-but-2-enedioate
    2.1.2 InChI
    InChI=1S/C11H13NO6/c1-17-10(15)4-5-11(16)18-7-6-12-8(13)2-3-9(12)14/h4-5H,2-3,6-7H2,1H3/b5-4+
    2.1.3 InChI Key
    YIMYDTCOUQIDMT-SNAWJCMRSA-N
    2.1.4 Canonical SMILES
    COC(=O)C=CC(=O)OCCN1C(=O)CCC1=O
    2.1.5 Isomeric SMILES
    COC(=O)/C=C/C(=O)OCCN1C(=O)CCC1=O
    2.2 Other Identifiers
    2.2.1 UNII
    K0N0Z40J3W
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Vumerity

    2.3.2 Depositor-Supplied Synonyms

    1. 1577222-14-0

    2. 2-(2,5-dioxopyrrolidin-1-yl)ethyl Methyl Fumarate

    3. Alks-8700

    4. Vumerity

    5. Diroximel Fumarete

    6. Rdc-5108

    7. Biib098

    8. Alks8700

    9. Alks 8700

    10. Diroximel Fumarate [inn]

    11. Biib-098

    12. K0n0z40j3w

    13. Rdc5108

    14. 4-o-[2-(2,5-dioxopyrrolidin-1-yl)ethyl] 1-o-methyl (e)-but-2-enedioate

    15. (2e)-2-butenedioic Acid 1-[2-(2,5-dioxo-1-pyrrolidinyl)ethyl] 4-methyl Ester

    16. 2-butenedioic Acid (2e)-, 1-(2-(2,5-dioxo-1-pyrrolidinyl)ethyl) 4-methyl Ester

    17. Diroximel-fumarate

    18. Vumerity (tn)

    19. Unii-k0n0z40j3w

    20. Diroximel Fumarate [mi]

    21. Chembl3989944

    22. Diroximel Fumarate (usan/inn)

    23. Diroximel Fumarate [usan:inn]

    24. Schembl15499960

    25. Schembl15511916

    26. Gtpl10525

    27. Diroximel Fumarate [usan]

    28. Diroximel Fumarete(alks-8700)

    29. Dtxsid101026181

    30. Bcp20867

    31. Cnc22214

    32. Diroximel Fumarate [who-dd]

    33. Ex-a2876

    34. Mfcd28502263

    35. S6421

    36. Zinc215286156

    37. Db14783

    38. Diroximel Fumarate [orange Book]

    39. As-55046

    40. Hy-100375

    41. Cs-0018703

    42. Diroximel Fumarate; Alks8700; Alks 8700

    43. D11154

    44. W12859

    45. 2-(2,5-dioxopyrrolidin-1-yl)ethylmethylfumarate

    46. Q27281786

    47. 1-(2-(2,5-dioxopyrrolidin-1-yl)ethyl) 4-methyl But-2-enedioate

    48. 2-(2,5-dioxopyrrolidin-1-yl)ethyl Methyl (2e)-but- 2-enedioate

    49. 2-(2,5-dioxopyrrolidin-1-yl)ethyl Methyl (2e)-but-2-enedioate

    2.4 Create Date
    2014-03-31
    3 Chemical and Physical Properties
    Molecular Weight 255.22 g/mol
    Molecular Formula C11H13NO6
    XLogP3-0.9
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count7
    Exact Mass255.07428713 g/mol
    Monoisotopic Mass255.07428713 g/mol
    Topological Polar Surface Area90 Ų
    Heavy Atom Count18
    Formal Charge0
    Complexity384
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Diroximel fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in adults; specifically active secondary progressive disease and clinically isolated syndrome, as well as relapsing-remitting MS.

    Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see Section 5. 1 for important information on the populations for which efficacy has been established).

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Diroximel fumarate relieves the neurological symptoms of relapsing MS with less gastrointestinal effects than its bioequivalent counterpart, dimethyl fumarate. It is important to note that diroximel fumarate can cause angioedema, anaphylaxis, hepatotoxicity, flushing, lymphopenia, and Progressive Multifocal Leukoencephalopathy (PML). Discontinue diroximel fumarate immediately if PML is suspected or if anaphylaxis or angioedema occur. Liver function and total bilirubin should be tested prior to initiating diroximel fumarate and during treatment. A complete blood count (CBC) should be obtained prior to starting diroximel fumarate, after the first 6 months of administration, and at subsequent intervals of 6 to 12 months following this period. Suspend treatment if lymphocyte counts are measured to be less than 0.5 109/L for more than 6 months.

    5.2 ATC Code

    L04AX07

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AX - Other immunosuppressants

    L04AX09 - Diroximel fumarate

    5.3 Absorption, Distribution and Excretion

    Absorption

    Diroximel fumarate is rapidly absorbed in the gastrointestinal tract following administration, like its bioequivalent drug, dimethyl fumarate. The median Tmax of monomethyl fumarate (MMF) after oral administration ranges from 2.5-3 hours with a mean Cmax of 2.11 mg/L. The bioequivalent drug, dimethyl fumarate, administered to healthy volunteers also shows a similar mean Tmax and Cmax. The average steady state concentration of this metabolite is estimated at 8.32 mg.hr/L after it is administered twice a day in patients with MS. The mean AUC0 of the active metabolite is 88mg min L1. Food appears to significantly reduce the Cmax of diroximel fumarate's active metabolite, MMF, when compared to administration in the fasted state.

    Route of Elimination

    Monomethyl fumarate is eliminated as carbon dioxide through expired breath. Negligible amounts, under 0.3% of the ingested dose, are measured in urine. The inactive metabolite, 2-hydroxyethyl succinimide (HES), representing 58-63% of the ingested dose, is excreted in urine.

    Volume of Distribution

    The apparent volume of distribution ranges from 72L to 83L. Monomethyl fumarate (MMF), the active metabolite of diroximel fumarate, crosses the blood brain barrier.

    Clearance

    No clearance information is available on the FDA label for diroximel fumarate, however, clinical study results for its active metabolite, monomethyl fumarate show a mean apparent total clearance from the plasma after oral administration of 1.54 mgL1.

    5.4 Metabolism/Metabolites

    Esterases heavily metabolize diroximel fumarate, as well as its bioequivalent drug, dimethyl fumarate, in the liver. These enzymes are present in high quantities in the gastrointestinal tract, tissues, and blood. Esterase metabolism of this drug produces the active metabolite, mono methyl fumarate (MMF), before it moves to the systemic circulation. In addition, the major inactive metabolite, 2-hydroxyethyl succinimide (HES) is produced along with small amounts of methanol, and another inactive metabolite, RDC-8439. Following esterase metabolism, the tricarboxylic acid (TCA)cycle further metabolizes MMF. The major metabolites of MMF in plasma include fumaric acid, citric acid, and glucose. It is important that methanol is a major metabolite of dimethyl fumarate metabolism, but a minor metabolite of diroximel fumarate metabolism, conferring its lower risk of gastrointestinal effects.

    5.5 Biological Half-Life

    The terminal half-life of monomethyl fumarate (MMF), diroximel fumarate's active metabolite, is estimated to be 1 hour.

    5.6 Mechanism of Action

    Currently, the mechanism of action of this drug in MS is not fully understood. Diroximel fumarate is hypothesized to regulate cell signaling pathways, causing beneficial immune and neuroprotective effects. Monomethyl fumarate (MMF) is the active metabolite of diroximel fumarate, and activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in humans. This pathway occurs as a response to oxidative stress in cells. In addition to the above, MMF is a nicotinic acid receptor agonist in the laboratory setting. The relevance of this finding to the treatment of MS is unknown at this time. The mechanism by which this drug leads to less gastrointestinal effects is purported to be due to its lack of a methanol leaving group in its chemical structure, and substitution with inert 2-hydroxyethyl succinimide.

    API Reference Price

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    08-Aug-2022
    08-Aug-2022
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    ABOUT THIS PAGE

    Diroximel fumarate Manufacturers

    A Diroximel fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diroximel fumarate, including repackagers and relabelers. The FDA regulates Diroximel fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diroximel fumarate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Diroximel fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Diroximel fumarate Suppliers

    A Diroximel fumarate supplier is an individual or a company that provides Diroximel fumarate active pharmaceutical ingredient (API) or Diroximel fumarate finished formulations upon request. The Diroximel fumarate suppliers may include Diroximel fumarate API manufacturers, exporters, distributors and traders.

    click here to find a list of Diroximel fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Diroximel fumarate USDMF

    A Diroximel fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Diroximel fumarate active pharmaceutical ingredient (API) in detail. Different forms of Diroximel fumarate DMFs exist exist since differing nations have different regulations, such as Diroximel fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Diroximel fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Diroximel fumarate USDMF includes data on Diroximel fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diroximel fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Diroximel fumarate suppliers with USDMF on PharmaCompass.

    Diroximel fumarate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Diroximel fumarate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Diroximel fumarate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Diroximel fumarate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Diroximel fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diroximel fumarate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Diroximel fumarate suppliers with NDC on PharmaCompass.

    Diroximel fumarate GMP

    Diroximel fumarate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Diroximel fumarate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Diroximel fumarate GMP manufacturer or Diroximel fumarate GMP API supplier for your needs.

    Diroximel fumarate CoA

    A Diroximel fumarate CoA (Certificate of Analysis) is a formal document that attests to Diroximel fumarate's compliance with Diroximel fumarate specifications and serves as a tool for batch-level quality control.

    Diroximel fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Diroximel fumarate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Diroximel fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Diroximel fumarate EP), Diroximel fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diroximel fumarate USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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