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    Also known as: 1825352-65-5, Rg7916, Evrysdi, Ro7034067, Risdiplam [inn], Risdiplam [usan]
    Molecular Formula
    C22H23N7O
    Molecular Weight
    401.5  g/mol
    InChI Key
    ASKZRYGFUPSJPN-UHFFFAOYSA-N
    FDA UNII
    76RS4S2ET1
    Risdiplam
    Risdiplam is an orally bioavailable mRNA splicing modifier used for the treatment of spinal muscular atrophy (SMA). It increases systemic SMN protein concentrations by improving the efficiency of SMN2 gene transcription. This mechanism of action is similar to its predecessor [nusinersen], the biggest difference being their route of administration: nusinersen requires intrathecal administration, as does the one-time gene therapy [onasemnogene abeparvovec], whereas risdiplam offers the ease of oral bioavailability. Risdiplam was approved by the FDA in August 2020 for use in patients 2 months of age or older in the treatment of spinal muscular atrophy (SMA). Set to be substantially cheaper than other available SMA therapies, risdiplam appears to provide a novel and relatively accessible treatment option for patients with SMA regardless of severity or type.
    1 2D Structure

    Risdiplam

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one
    2.1.2 InChI
    InChI=1S/C22H23N7O/c1-14-9-18(26-29-11-15(2)24-21(14)29)17-10-20(30)28-12-16(3-4-19(28)25-17)27-8-7-23-22(13-27)5-6-22/h3-4,9-12,23H,5-8,13H2,1-2H3
    2.1.3 InChI Key
    ASKZRYGFUPSJPN-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC(=NN2C1=NC(=C2)C)C3=CC(=O)N4C=C(C=CC4=N3)N5CCNC6(C5)CC6
    2.2 Other Identifiers
    2.2.1 UNII
    76RS4S2ET1
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-4h-pyrido(1,2-a)pyrimidin-4-one

    2.3.2 Depositor-Supplied Synonyms

    1. 1825352-65-5

    2. Rg7916

    3. Evrysdi

    4. Ro7034067

    5. Risdiplam [inn]

    6. Risdiplam [usan]

    7. Rg-7916

    8. 76rs4s2et1

    9. Ro-7034067

    10. 7-(4,7-diazaspiro[2.5]octan-7-yl)-2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido[1,2-a]pyrimidin-4-one

    11. 2-(2,8-dimethylimidazo[1,2-b]pyridazin-6-yl)-7-(4,7-diazaspiro[2.5]octan-7-yl)-4h-pyrido[1,2-a]pyrimidin-4-one

    12. 4h-pyrido(1,2-a)pyrimidin-4-one, 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-

    13. Evrysdi (tn)

    14. Risdiplam; Rg7916

    15. Risdiplam [jan]

    16. Risdiplam [mi]

    17. Risdiplam [usan:inn]

    18. Risdiplam [who-dd]

    19. Unii-76rs4s2et1

    20. Risdiplam (jan/usan/inn)

    21. Risdiplam [orange Book]

    22. Chembl4297528

    23. Schembl17260852

    24. Gtpl11170

    25. Dtxsid701109185

    26. Amy23728

    27. Ex-a2074

    28. Mfcd31657372

    29. Who 10614

    30. Compound 1 [pmid: 30044619]

    31. Db15305

    32. Ac-36304

    33. Br166842

    34. Rg7916;ro7034067

    35. Hy-109101

    36. Cs-0039501

    37. D11406

    38. F53623

    39. Q48969152

    40. (7-(4,7-diazaspiro(2.5)octan-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)pyrido(1,2-a)pyrimidin-4-one

    41. 7-(4,7-diazaspiro(2.5)oct-7-yl)-2-(2,8-dimethylimidazo(1,2-b)pyridazin-6-yl)-4h-pyrido(1,2-a)pyrimidin-4-one

    2.4 Create Date
    2016-02-23
    3 Chemical and Physical Properties
    Molecular Weight 401.5 g/mol
    Molecular Formula C22H23N7O
    XLogP30.5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count2
    Exact Mass401.19640838 g/mol
    Monoisotopic Mass401.19640838 g/mol
    Topological Polar Surface Area78.1 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity886
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Risdiplam is indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.

    Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Risdiplam helps to alleviate symptoms of spinal muscular atrophy by stimulating the production of a critical protein in which these patients are deficient. Early trials with risdiplam demonstrated up to a 2-fold increase in SMN protein concentration in SMA patients after 12 weeks of therapy.

    5.2 MeSH Pharmacological Classification

    Neuromuscular Agents

    Drugs used for their actions on skeletal muscle. Included are agents that act directly on skeletal muscle, those that alter neuromuscular transmission (NEUROMUSCULAR BLOCKING AGENTS), and drugs that act centrally as skeletal muscle relaxants (MUSCLE RELAXANTS, CENTRAL). Drugs used in the treatment of movement disorders are ANTI-DYSKINESIA AGENTS. (See all compounds classified as Neuromuscular Agents.)

    5.3 ATC Code

    M09AX10

    M - Musculo-skeletal system

    M09 - Other drugs for disorders of the musculo-skeletal system

    M09A - Other drugs for disorders of the musculo-skeletal system

    M09AX - Other drugs for disorders of the musculo-skeletal system

    M09AX10 - Risdiplam

    5.4 Absorption, Distribution and Excretion

    Absorption

    The Tmax following oral administration is approximately 1-4 hours. Following once-daily administration with a morning meal (or after breastfeeding), risdiplam reaches steady-state in approximately 7-14 days. The pharmacokinetics of risdiplam were found to be approximately linear between all studied dosages in patients with SMA.

    Route of Elimination

    Following the oral administration of 18mg risdiplam, approximately 53% of the dose was excreted in the feces and 28% was excreted in the urine. Unchanged parent drug comprised 14% of the dose excreted in feces and 8% of the dose excreted in urine.

    Volume of Distribution

    Following oral administration, risdiplam distributes well into the central nervous system and peripheral tissues. The apparent volume of distribution at steady-state is 6.3 L/kg.

    Clearance

    For a 14.9kg patient, the apparent clearance of risdiplam is 6.3 L/kg.

    5.5 Metabolism/Metabolites

    The metabolism of risdiplam is mediated primarily by flavin monooxygenases 1 and 3 (FMO1 and FMO3), with some involvement of CYP1A1, CYP2J2, CYP3A4, and CYP3A7. Parent drug comprises approximately 83% of circulating drug material. A pharmacologically-inactive metabolite, M1, has been identified as the major circulating metabolite - this M1 metabolite has been observed _in vitro_ to inhibit MATE1 and MATE2-K transporters, similar to the parent drug.

    5.6 Biological Half-Life

    The terminal elimination half-life of risdiplam is approximately 50 hours in healthy adults.

    5.7 Mechanism of Action

    Spinal muscular atrophy (SMA) is a severe and progressive congenital neuromuscular disease resulting from mutations in the survival of motor neuron 1 (_SMN1_) gene responsible for making SMN proteins. Clinical features of SMA include degeneration of motor neurons in the spinal cord which ultimately leads to muscular atrophy and, in some cases, loss of physical strength. SMN proteins are expressed ubiquitously throughout the body and are thought to hold diverse intracellular roles in DNA repair, cell signaling, endocytosis, and autophagy. A secondary _SMN_ gene (_SMN2_) can also produce SMN proteins, but a small nucleotide substitution in its sequence results in the exclusion of exon 7 during splicing in approximately 85% of the transcripts - this means that only ~15% of the SMN proteins produced by _SMN2_ are functional, which is insufficient to compensate for the deficits caused by _SMN1_ mutations. Emerging evidence suggests that many cells and tissues are selectively vulnerable to reduced SMN concentrations, making this protein a desirable target in the treatment of SMA. Risdiplam is an mRNA splicing modifier for _SMN2_ that increases the inclusion of exon 7 during splicing, which ultimately increases the amount of functional SMN protein produced by _SMN2_. It does so by binding to two sites in _SMN2_ pre-mRNA: the 5' splice site (5'ss) of intron 7 and the exonic splicing enhancer 2 (ESE2) of exon 7.

    API Reference Price

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    28-Oct-2024
    28-Oct-2024
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    ABOUT THIS PAGE

    Risdiplam Manufacturers

    A Risdiplam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risdiplam, including repackagers and relabelers. The FDA regulates Risdiplam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risdiplam 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 Risdiplam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Risdiplam Suppliers

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

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

    Risdiplam USDMF

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

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

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

    Risdiplam GMP

    Risdiplam 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 Risdiplam 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 Risdiplam GMP manufacturer or Risdiplam GMP API supplier for your needs.

    Risdiplam CoA

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

    Risdiplam CoA mostly includes findings from lab analyses of a specific batch. For each Risdiplam 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.

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