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    Chemistry

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    Also known as: 1374248-77-7, Ubrelvy, Mk-1602, Ubrogepant anhydrous, Ad0o8x2qjr, (3's)-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro(cyclopenta(b)pyridine-6,3'-pyrrolo(2,3-b)pyridine)-3-carboxamide
    Molecular Formula
    C29H26F3N5O3
    Molecular Weight
    549.5  g/mol
    InChI Key
    DDOOFTLHJSMHLN-ZQHRPCGSSA-N
    FDA UNII
    AD0O8X2QJR
    Ubrogepant
    Ubrogepant is indicated for the acute treatment of migraine headaches with or without aura in adults. It was approved by the FDA on December 23, 2019, and is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine. Several oral small molecule CGRP receptor antagonists, belonging to a class of medications referred to as "gepants", have been investigated for migraines, but only ubrogepant and [rimegepant] remain in clinical development. Previous agents within this class were efficacious but limited by liver toxicity - this led to the development of ubrogepant, which was designed to be a hepatoxicity-free alternative to its predecessors. Several parenteral monoclonal antibodies acting against the CGRP pathway (e.g. [erenumab], [fremanezumab], [galcanezumab]) have also been approved in recent years. Compared to the current standard of therapy for migraine treatment, namely triptans such as [sumatriptan] and [almotriptan], CGRP antagonists present several advantages. They appear to be better tolerated, do not contribute to medication overuse headaches, and carry no apparent cardiovascular risk, making them suitable for use in patients with cardiovascular disease. The development of oral gepants, including ubrogepant, may therefore constitute a significant advance in migraine headache treatment and may become the new standard of therapy in the treatment of this debilitating condition.
    Ubrogepant is a Calcitonin Gene-related Peptide Receptor Antagonist. The mechanism of action of ubrogepant is as a Calcitonin Gene-related Peptide Receptor Antagonist.
    1 2D Structure

    Ubrogepant

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S)-N-[(3S,5S,6R)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl]-2-oxospiro[1H-pyrrolo[2,3-b]pyridine-3,6'-5,7-dihydrocyclopenta[b]pyridine]-3'-carboxamide
    2.1.2 InChI
    InChI=1S/C29H26F3N5O3/c1-16-20(17-6-3-2-4-7-17)11-22(26(39)37(16)15-29(30,31)32)35-25(38)19-10-18-12-28(13-23(18)34-14-19)21-8-5-9-33-24(21)36-27(28)40/h2-10,14,16,20,22H,11-13,15H2,1H3,(H,35,38)(H,33,36,40)/t16-,20-,22+,28+/m1/s1
    2.1.3 InChI Key
    DDOOFTLHJSMHLN-ZQHRPCGSSA-N
    2.1.4 Canonical SMILES
    CC1C(CC(C(=O)N1CC(F)(F)F)NC(=O)C2=CC3=C(CC4(C3)C5=C(NC4=O)N=CC=C5)N=C2)C6=CC=CC=C6
    2.1.5 Isomeric SMILES
    C[C@@H]1[C@@H](C[C@@H](C(=O)N1CC(F)(F)F)NC(=O)C2=CC3=C(C[C@@]4(C3)C5=C(NC4=O)N=CC=C5)N=C2)C6=CC=CC=C6
    2.2 Other Identifiers
    2.2.1 UNII
    AD0O8X2QJR
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 1',2',5,7-tetrahydro-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)-3-piperidinyl)-2'-oxo-, (6s)- Spiro(6h-cyclopenta(b)pyridine-6,3'-(3h)pyrrolo(2,3-b)pyridine)-3-carboxamide

    2. Mk-1602

    3. Ubrelvy

    2.3.2 Depositor-Supplied Synonyms

    1. 1374248-77-7

    2. Ubrelvy

    3. Mk-1602

    4. Ubrogepant Anhydrous

    5. Ad0o8x2qjr

    6. (3's)-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro(cyclopenta(b)pyridine-6,3'-pyrrolo(2,3-b)pyridine)-3-carboxamide

    7. (3s)-n-[(3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl]-2-oxospiro[1h-pyrrolo[2,3-b]pyridine-3,6'-5,7-dihydrocyclopenta[b]pyridine]-3'-carboxamide

    8. Spiro(6h-cyclopenta(b)pyridine-6,3'-(3h)pyrrolo(2,3-b)pyridine)-3-carboxamide, 1',2',5,7-tetrahydro-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)-3-piperidinyl)-2'-oxo-, (3's)-

    9. Ubrogepant [usan]

    10. Ubrogepant [usan:inn]

    11. Unii-ad0o8x2qjr

    12. Ubrelvy (tn)

    13. Ubrogepant [mi]

    14. Ubrogepant [inn]

    15. Ubrogepant (usan/inn)

    16. Ubrogepant [who-dd]

    17. Schembl3698428

    18. Chembl2364638

    19. Ubrogepant [orange Book]

    20. Gtpl10176

    21. Dtxsid00160178

    22. Ex-a3049

    23. Mfcd28386182

    24. Mk1602

    25. Zinc95598454

    26. At16059

    27. Db15328

    28. Ac-31965

    29. Hy-12366

    30. Cs-0011109

    31. D10673

    32. A934103

    33. Q27273878

    34. S-1374248-77-7

    35. (6s)-n-[(3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl]-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide

    36. (s)-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 549.5 g/mol
    Molecular Formula C29H26F3N5O3
    XLogP33.1
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass549.19877419 g/mol
    Monoisotopic Mass549.19877419 g/mol
    Topological Polar Surface Area104 Ų
    Heavy Atom Count40
    Formal Charge0
    Complexity1000
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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

    Ubrogepant is indicated for the acute treatment of migraine with or without aura in adults.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Ubrogepant acutely treats migraine headache pain by blocking the activity of a key transmitter involved in migraine pathogenesis. Exposure to ubrogepant can be significantly increased in patients with severe hepatic or renal insufficiency - dose adjustments are required for these patients in order to avoid excessive exposure, and ubrogepant is not recommended in patients with end-stage renal disease.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    UBROGEPANT
    5.2.2 FDA UNII
    AD0O8X2QJR
    5.2.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Calcitonin Gene-related Peptide Receptor Antagonists
    5.3 ATC Code

    N - Nervous system

    N02 - Analgesics

    N02C - Antimigraine preparations

    N02CD - Calcitonin gene-related peptide (cgrp) antagonists

    N02CD04 - Ubrogepant

    5.4 Absorption, Distribution and Excretion

    Absorption

    Following oral administration, Tmax occurs between 0.7 and 1.5 h. When administered with a high-fat meal, Tmax is delayed by approximately 2 hours and Cmax was reduced by 22% with no significant changes to the AUC. Ubrogepant exhibits dose-proportional pharmacokinetics throughout the entirety of its recommended dosing range.

    Route of Elimination

    The main route of elimination is fecal/biliary, while renal excretion is comparatively minor - following administration of a single oral dose to healthy subjects, approximately 42% of the dose was recovered unchanged in the feces and 6% was recovered unchanged in the urine.

    Volume of Distribution

    The apparent central volume of distribution following oral administration is approximately 350 L.

    Clearance

    The apparent oral clearance of ubrogepant is approximately 87 L/h.

    5.5 Metabolism/Metabolites

    Ubrogepant is eliminated primarily via metabolism, the majority of which is mediated by CYP3A4. Two circulating glucuronide conjugates, along with unchanged parent drug, were found to be the most abundant circulating components in human plasma. The glucuronide metabolites reportedly carry 6000-fold less activity at CGRP receptors and are therefore considered to be pharmacologically inert.

    5.6 Biological Half-Life

    Ubrogepant has an elimination half-life of 5-7 hours.

    5.7 Mechanism of Action

    The currently accepted theory of migraine pathophysiology considers dysfunction of the central nervous system, in particular the trigeminal ganglion, to be the root cause behind the condition. Activation of the trigeminal ganglion triggers the stimulation of trigeminal afferents that project to the spinal cord and synapse on various pain-sensing intra- and extracranial structures, such as the dura mater. Pain signals are then further transmitted via second-order ascending neurons to the brainstem, hypothalamus, and thalamic nuclei, and from there to several cortical regions (e.g. auditory, visual, motor cortices). The trigeminal ganglion appears to amplify and perpetuate the migraine headache pain through the activation of perivascular fibers and the release of molecules involved in pain generation, such as calcitonin gene-related peptide (CGRP). The -isoform of CGRP, expressed in primary sensory neurons, is a potent vasodilator and has been implicated in migraine pathogenesis - CGRP levels are acutely elevated during migraine attacks, return to normal following treatment with triptan medications, and intravenous infusions of CGRP have been shown to trigger migraine-like headaches in migraine patients. In addition to its vasodilatory properties, CGRP appears to be a pronociceptive factor that modulates neuronal excitability to facilitate pain responses. Ubrogepant is a potent antagonist of the calcitonin gene-related peptide receptor - it competes with CGRP for occupancy at these receptors, preventing the actions of CGRP and its ability to amplify and perpetuate migraine headache pain, ultimately terminating the headache.

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