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    Chemistry

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    Also known as: 497871-47-3, Pm01183, Tryptamicidin, Zepzelca, Pm-01183, Pm-1183
    Molecular Formula
    C41H44N4O10S
    Molecular Weight
    784.9  g/mol
    InChI Key
    YDDMIZRDDREKEP-HWTBNCOESA-N
    FDA UNII
    2CN60TN6ZS
    Lurbinectedin
    Lurbinectedin is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death.
    Lurbinectedin is an Alkylating Drug. The mechanism of action of lurbinectedin is as an Alkylating Activity.
    1 2D Structure

    Lurbinectedin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(1R,2R,3R,11S,12S,14R,26R)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22-yl] acetate
    2.1.2 InChI
    InChI=1S/C41H44N4O10S/c1-17-11-20-12-25-39(48)45-26-14-52-40(49)41(38-22(9-10-42-41)23-13-21(50-5)7-8-24(23)43-38)15-56-37(31(45)30(44(25)4)27(20)32(47)33(17)51-6)29-28(26)36-35(53-16-54-36)18(2)34(29)55-19(3)46/h7-8,11,13,25-26,30-31,37,39,42-43,47-48H,9-10,12,14-16H2,1-6H3/t25-,26-,30+,31+,37+,39-,41+/m0/s1
    2.1.3 InChI Key
    YDDMIZRDDREKEP-HWTBNCOESA-N
    2.1.4 Canonical SMILES
    CC1=CC2=C(C3C4C5C6=C(C(=C7C(=C6C(N4C(C(C2)N3C)O)COC(=O)C8(CS5)C9=C(CCN8)C2=C(N9)C=CC(=C2)OC)OCO7)C)OC(=O)C)C(=C1OC)O
    2.1.5 Isomeric SMILES
    CC1=CC2=C([C@@H]3[C@@H]4[C@H]5C6=C(C(=C7C(=C6[C@@H](N4[C@H]([C@H](C2)N3C)O)COC(=O)[C@@]8(CS5)C9=C(CCN8)C2=C(N9)C=CC(=C2)OC)OCO7)C)OC(=O)C)C(=C1OC)O
    2.2 Other Identifiers
    2.2.1 UNII
    2CN60TN6ZS
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Pm 01183

    2. Pm-01183

    3. Pm01183

    2.3.2 Depositor-Supplied Synonyms

    1. 497871-47-3

    2. Pm01183

    3. Tryptamicidin

    4. Zepzelca

    5. Pm-01183

    6. Pm-1183

    7. 2cn60tn6zs

    8. Pm 01183

    9. Pm1183

    10. [(1r,2r,3r,11s,12s,14r,26r)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22-yl] Acetate

    11. Zepsyre

    12. Lurbinectedin [inn]

    13. Unii-2cn60tn6zs

    14. Lurbinectedin [mi]

    15. Lurbinectedin [usan:inn]

    16. Lurbinectedin [usan]

    17. Lurbinectedin [who-dd]

    18. Chembl4297516

    19. Schembl16152477

    20. Gtpl10681

    21. Dtxsid30198065

    22. Lurbinectedin [orange Book]

    23. Ex-a4316

    24. Who 9397

    25. Nsc826275

    26. S9603

    27. At22223

    28. Cs-6323

    29. Db12674

    30. Nsc-826275

    31. Hy-16293

    32. J3.531.659k

    33. J3.652.626b

    34. Pm01183;pm-1183;ly-01017;ryptamicidin

    35. Q27254568

    36. (1'r,6r,6ar,7r,13s,14s,16r)-8,14-dihydroxy-6',9-dimethoxy-4,10,23-trimethyl-19-oxo-2',3',4',6,7,9',12,13,14,16-decahydro-6ahspiro(7,13-azano-6,16-(epithiopropanooxymethano)(1,3)dioxolo(7,8)isoquinolino(3,2-b)(3)benzazocine-20,1'-pyrido(3,4-b)indol)-5-yl Acetate

    37. [(1r,2r,3r,11s,12s,14r,26r)-5,12-dihydroxy-6,6'-dimethoxy-7,21,30-trimethyl-27-oxospiro[17,19,28-trioxa-24-thia-13,30-diazaheptacyclo[12.9.6.13,11.02,13.04,9.015,23.016,20]triaconta-4(9),5,7,15,20,22-hexaene-26,1'-2,3,4,9-tetrahydropyrido[3,4-b]indole]-22

    38. Spiro(6,16-(epithiopropanoxymethano)-7,13-imino-12h-1,3-dioxolo(7,8)isoquino(3,2-b)(3)benzazocine-20,1'-(1h)pyrido(3,4-b)indol)-19-one, 5-(acetyloxy)-2',3',4',6,6a,7,9',13,14,16-decahydro-8,14-dihydroxy-6',9-dimethoxy-4,10,23-trimethyl-, (1'r,6r,6ar,7r,13s,14s,16r)-

    2.4 Create Date
    2012-06-18
    3 Chemical and Physical Properties
    Molecular Weight 784.9 g/mol
    Molecular Formula C41H44N4O10S
    XLogP33.9
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count4
    Exact Mass784.27781479 g/mol
    Monoisotopic Mass784.27781479 g/mol
    Topological Polar Surface Area190 Ų
    Heavy Atom Count56
    Formal Charge0
    Complexity1530
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    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

    Lurbinectedin is indicated for the treatment of adult patients with metastatic small-cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

    Treatment of small cell lung cancer

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Lurbinectedin exerts its chemotherapeutic activity by covalently binding to DNA, resulting in double-strand DNA breaks and subsequent cell death. Lurbinectedin has been associated with myelosuppression, and patients receiving therapy with this agent should be closely monitored for evidence of cytopenias. Prior to beginning therapy, ensure baseline neutrophil counts are >1,500 cells/mm3 and platelet counts are >100,000/mm3. The supplementary use of granulocyte colony-stimulating factor (G-CSF) should be considered if the neutrophil count falls below 500 cells/mm3. Lurbinectedin has also been associated with hepatotoxicity. Monitor liver function tests at baseline and regular intervals throughout therapy, and consider holding, reducing, or permanently discontinuing therapy based on the severity of observed hepatotoxicity.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    LURBINECTEDIN
    5.2.2 FDA UNII
    2CN60TN6ZS
    5.2.3 Pharmacological Classes
    Alkylating Drug [EPC]; Alkylating Activity [MoA]
    5.3 ATC Code

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01X - Other antineoplastic agents

    L01XX - Other antineoplastic agents

    L01XX69 - Lurbinectedin

    5.4 Absorption, Distribution and Excretion

    Absorption

    Following intravenous administration, the Cmax and AUC0-inf were 107 g/L and 551 g*h/L, respectively. No accumulation between dosing intervals (every 3 weeks) has been observed. No significant differences in absorption were found between special populations (e.g. based on age, sex, ethnicity, etc.), but lurbinectedin has not been studied in the setting of severe renal impairment or moderate/severe hepatic impairment.

    Route of Elimination

    Approximately 89% of a given dose is recovered in the feces (<0.2% unchanged) and 6% in the urine (1% unchanged).

    Volume of Distribution

    The steady-state volume of distribution of lurbinectedin is 504 L.

    Clearance

    The total plasma clearance of lurbinectedin is approximately 11 L/h.

    5.5 Metabolism/Metabolites

    Lurbinectedin is metabolized primarily by CYP3A4 _in vitro_, though specific data regarding its biotransformation are lacking. An N-desmethylated metabolite has been identified in canine subjects.

    5.6 Biological Half-Life

    The terminal half-life of lurbinectedin is 51 hours.

    5.7 Mechanism of Action

    Lurbinectedin is a DNA alkylating agent. It covalently binds to guanine residues in the DNA minor groove, forming adducts that bend the DNA helix towards the major groove. This process triggers a cascade of events that affect the activity of transcription factors and impairs DNA repair pathways, ultimately leading to double-strand DNA breaks and eventual cell death. Additional mechanism(s) of action include inhibition of RNA-polymerase-II activity, inactivation of Ewing Sarcoma Oncoprotein (EWS-FL11) via nuclear redistribution, and the inhibition of human monocyte activity and macrophage infiltration into tumor tissue.

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