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    Also known as: Actinomycin d, Actinomycin c1, Actinomycin iv, Cosmegen, Meractinomycin, 50-76-0
    Molecular Formula
    C62H86N12O16
    Molecular Weight
    1255.4  g/mol
    InChI Key
    RJURFGZVJUQBHK-IIXSONLDSA-N
    FDA UNII
    1CC1JFE158
    Dactinomycin
    A compound composed of a two CYCLIC PEPTIDES attached to a phenoxazine that is derived from STREPTOMYCES parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015)
    Dactinomycin is an Actinomycin. The mechanism of action of dactinomycin is as a Nucleic Acid Synthesis Inhibitor, and Protein Synthesis Inhibitor.
    1 2D Structure

    Dactinomycin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-amino-4,6-dimethyl-3-oxo-1-N,9-N-bis[(3R,6S,7R,10S,16S)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide
    2.1.2 InChI
    InChI=1S/C62H86N12O16/c1-27(2)42-59(84)73-23-17-19-36(73)57(82)69(13)25-38(75)71(15)48(29(5)6)61(86)88-33(11)44(55(80)65-42)67-53(78)35-22-21-31(9)51-46(35)64-47-40(41(63)50(77)32(10)52(47)90-51)54(79)68-45-34(12)89-62(87)49(30(7)8)72(16)39(76)26-70(14)58(83)37-20-18-24-74(37)60(85)43(28(3)4)66-56(45)81/h21-22,27-30,33-34,36-37,42-45,48-49H,17-20,23-26,63H2,1-16H3,(H,65,80)(H,66,81)(H,67,78)(H,68,79)/t33-,34-,36+,37+,42-,43-,44+,45+,48+,49+/m1/s1
    2.1.3 InChI Key
    RJURFGZVJUQBHK-IIXSONLDSA-N
    2.1.4 Canonical SMILES
    CC1C(C(=O)NC(C(=O)N2CCCC2C(=O)N(CC(=O)N(C(C(=O)O1)C(C)C)C)C)C(C)C)NC(=O)C3=C4C(=C(C=C3)C)OC5=C(C(=O)C(=C(C5=N4)C(=O)NC6C(OC(=O)C(N(C(=O)CN(C(=O)C7CCCN7C(=O)C(NC6=O)C(C)C)C)C)C(C)C)C)N)C
    2.1.5 Isomeric SMILES
    C[C@@H]1[C@@H](C(=O)N[C@@H](C(=O)N2CCC[C@H]2C(=O)N(CC(=O)N([C@H](C(=O)O1)C(C)C)C)C)C(C)C)NC(=O)C3=C4C(=C(C=C3)C)OC5=C(C(=O)C(=C(C5=N4)C(=O)N[C@H]6[C@H](OC(=O)[C@@H](N(C(=O)CN(C(=O)[C@@H]7CCCN7C(=O)[C@H](NC6=O)C(C)C)C)C)C(C)C)C)N)C
    2.2 Other Identifiers
    2.2.1 UNII
    1CC1JFE158
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Actinomycin

    2. Actinomycin D

    3. Cosmegen

    4. Cosmegen Lyovac

    5. Lyovac Cosmegen

    6. Lyovac, Cosmegen

    7. Lyovac-cosmegen

    8. Lyovaccosmegen

    9. Meractinomycin

    2.3.2 Depositor-Supplied Synonyms

    1. Actinomycin D

    2. Actinomycin C1

    3. Actinomycin Iv

    4. Cosmegen

    5. Meractinomycin

    6. 50-76-0

    7. Actinomycin I1

    8. Dactinomycinum

    9. Dilactone Actinomycin D Acid

    10. Actd

    11. Actinomycin X1

    12. Oncostatin K

    13. Actinomycin-d

    14. Act D

    15. Nci-c04682

    16. Dactinomycine [inn-french]

    17. Dactinomycinum [inn-latin]

    18. Dactinomicina [inn-spanish]

    19. Lyovac Cosmegen

    20. Gnf-pf-2290

    21. Dactinomycin D

    22. Chounghwamycin B

    23. Actinomycin 7

    24. Actinomycin Aiv

    25. Actinomycin I

    26. Mls001424196

    27. 1cc1jfe158

    28. Chebi:27666

    29. Actinomycin X 1

    30. Actinomycin A Iv

    31. Acto-d

    32. Nsc-3053

    33. Actinomycin C(sub1)

    34. Dilactone Actinomycindioic D Acid

    35. Ncgc00161622-02

    36. Actinomycin I(sub 1)

    37. Smr000469227

    38. Dsstox_cid_31

    39. Actinomycin 11 Cosmegen

    40. Cosmegen Lyovac

    41. Lyovac-cosmegen

    42. Ccris 9

    43. Dsstox_rid_75330

    44. Dsstox_gsid_20031

    45. 2-amino-4,6-dimethyl-3-oxo-1-n,9-n-bis[(3r,6s,7r,10s,16s)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide

    46. Hsdb 3220

    47. Dactinomicina

    48. Dactinomycine

    49. Actinomycindioic D Acid, Dilactone

    50. Antibiotic From Streptomyces Parvullus

    51. Actinomycin-(threo-val-pro-sar-meval)

    52. Cas-50-76-0

    53. Act [antibiotic]

    54. X 97

    55. 2-amino-n,n'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1h-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-dicarboxamide

    56. Mfcd00005033

    57. Ad (van)

    58. Gnf-pf-1977

    59. Nsc3053

    60. Unii-1cc1jfe158

    61. Dtxsid9020031

    62. Glycopeptide, 4a

    63. 2-amino-4,6-dimethyl-3-oxo-n,n'-bis[(6s,9r,10s,13r,18as)-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxohexadecahydro-1h-pyrrolo[2,1-i][1,4,7,10,13]oxatetraazacyclohexadecin-10-yl]-3h-phenoxazine-1,9-dicarboxamide

    64. Nsc 3053

    65. Dactinomycin [usan:usp:inn:ban]

    66. Einecs 200-063-6

    67. Ai3-26374

    68. Dactinomycin [mi]

    69. Dactinomycin [inn]

    70. Upcmld-dp055

    71. Dactinomycin [hsdb]

    72. Dactinomycin [usan]

    73. Schembl3844

    74. Actinomycin D [jan]

    75. Chembl1554

    76. Dactinomycin [vandf]

    77. Actinomycin D [iarc]

    78. Dactinomycin [mart.]

    79. Dactinomycin [usp-rs]

    80. Dactinomycin [who-dd]

    81. Dactinomycin [who-ip]

    82. Cid_457193

    83. Actinomycin D [who-ip]

    84. Upcmld-dp055:001

    85. Upcmld-dp055:002

    86. Bdbm43866

    87. Dactinomycin [orange Book]

    88. Hms2052o17

    89. Dactinomycin [usp Monograph]

    90. Tox21_111997

    91. Tox21_202482

    92. Bdbm50089528

    93. S8964

    94. Dactinomycinum [who-ip Latin]

    95. Akos030228553

    96. Tox21_111997_1

    97. Ccg-101134

    98. Db00970

    99. Nc00384

    100. Ncgc00090796-01

    101. Ncgc00161622-01

    102. Ncgc00260031-01

    103. Ncgc00271789-02

    104. 3h-phenoxazine-1,9-dicarboxamide, 2-amino-n,n'-bis(hexadecahydro-2,5,9-trimethyl-6,13-bis(1-methylethyl)-1,4,7,11,14-pentaoxo-1h-pyrrolo(2,1-i)(1,4,7,10,13)oxatetra-azacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-

    105. Bp-25384

    106. Specific Stereoisomer Of N,n'-((2-amino-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-diyl)-bis(carbonylimino(2-hydroxypropylidene)carbonyliminoisobutylidenecarbonyl-1,2-pyrrolidinediylcarbonyl(methylimino)methylenecarbonyl))bis(n-methyl-l-valine) Dilactone

    107. Stereoisomer Of N,n'-((2-amino-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-diyl)bis(carbonylimino(2-(1-hydroxyethyl)-1-oxo-2,1-ethanediyl)imino(2-(1-methylethyl)-1-oxo-2,1-ethanediyl)-1,2-pyrrolidinediylcarbonyl(methylimino) (1-oxo-2,1-ethanediyl)))bis(n-methyl-l-valine)di-xi-lactone

    108. Ab00514445-05

    109. 050a760

    110. Q186127

    111. Sr-01000763161

    112. Sr-01000763161-4

    113. Actinomycin D, From Streptomyces Sp., >=95% (hplc)

    114. Actinomycin D, From Streptomyces Sp., ~98% (hplc)

    115. Brd-k70578146-001-01-8

    116. Brd-k70578146-001-04-2

    117. Dactinomycin, United States Pharmacopeia (usp) Reference Standard

    118. Actinomycin D, For Fluorescence, >=90% (hplc), From Streptomyces Sp.

    119. Actinomycin D, From Streptomyces Sp., Suitable For Cell Culture, >=95%

    120. 1-n,9-n-bis[(6s,9r,10s,13r,18as)-2,5,9-trimethyl-1,4,7,11,14-pentaoxo-6,13-bis(propan-2-yl)-hexadecahydro-1h-pyrrolo[2,1-i]1-oxa-4,7,10,13-tetraazacyclohexadecan-10-yl]-2-amino-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-dicarboxamide

    121. 2-amino-4,6-dimethyl-3-oxo-1-n,9-n-bis-[(18as)-10c,14,17-trimethyl-5,8,12,15,18-pentaoxo-6c,13t-di(propan-2-yl)-18ar-hexadecahydro-1h-pyrrolo[2,1-i][1,4,7,10,13]oxatetraazacyclohexadecin-9c-yl]-3h-phenoxazine-1,9-dicarboxamide

    122. 2-amino-4,6-dimethyl-3-oxo-n1,n9-bis[(3r,6s,7r,10s,16s)-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide

    123. 2-amino-n,n''''''''-bis[(3r,6s,7r,10s,16s)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide

    124. 2-amino-n,n''''-bis[(3r,6s,7r,10s,16s)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide

    125. 2-amino-n,n''-bis[(3r,6s,7r,10s,16s)-3,10-diisopropyl-2,5,9,12,15-pentaketo-7,11,14-trimethyl-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-3-keto-4,6-dimethyl-phenoxazine-1,9-dicarboxamide

    126. 2-amino-n1,n9-bis[(3r,6s,7r,10s,16s)-3,10-diisopropyl-7,11,14-trimethyl-2,5,9,12,15-pentaoxo-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]-4,6-dimethyl-3-oxo-phenoxazine-1,9-dicarboxamide

    127. 2-azanyl-4,6-dimethyl-3-oxidanylidene-n1,n9-bis[(3r,6s,7r,10s,16s)-7,11,14-trimethyl-2,5,9,12,15-pentakis(oxidanylidene)-3,10-di(propan-2-yl)-8-oxa-1,4,11,14-tetrazabicyclo[14.3.0]nonadecan-6-yl]phenoxazine-1,9-dicarboxamide

    128. 3h-phenoxazine-1,9-dicarboxamide, 2-amino-n,n'-bis(hexadecahydro-6,13-diisopropyl-2,5,9-trimethyl-1,4,7,11,14-pentaoxo-1h-pyrrolo(2,1-i)(1,4,7,10,13)oxatetraazacyclohexadecin-10-yl)-4,6-dimethyl-3-oxo-

    129. N,n'-((2-amino-4,6-dimethyl-3-oxo-3h-phenoxazine-1,9-diyl)-bis(carbonylimino(2-hydroxypropylidene)carbonyliminoisobutylidenecarbonyl-1,2-pyrrolidinediylcarbonyl(methylimino)methylenecarbonyl))bis(n-methyl-l-valine) Dilactone

    2.4 Create Date
    2005-08-01
    3 Chemical and Physical Properties
    Molecular Weight 1255.4 g/mol
    Molecular Formula C62H86N12O16
    XLogP33.8
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count18
    Rotatable Bond Count8
    Exact Mass1254.62847470 g/mol
    Monoisotopic Mass1254.62847470 g/mol
    Topological Polar Surface Area356 Ų
    Heavy Atom Count90
    Formal Charge0
    Complexity3030
    Isotope Atom Count0
    Defined Atom Stereocenter Count10
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCosmegen
    PubMed HealthDactinomycin (Injection)
    Drug ClassesAntibiotic
    Drug LabelDactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyc...
    Active IngredientDactinomycin
    Dosage FormInjectable
    RouteInjection
    Strength0.5mg/vial
    Market StatusPrescription
    CompanyRecordati Rare

    2 of 4  
    Drug NameDactinomycin
    PubMed HealthDactinomycin (Injection)
    Drug ClassesAntibiotic
    Drug LabelDactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyc...
    Active IngredientDactinomycin
    Dosage FormInjectable
    RouteInjection
    Strength0.5mg/vial
    Market StatusPrescription
    CompanyLuitpold; Eurohlth Intl

    3 of 4  
    Drug NameCosmegen
    PubMed HealthDactinomycin (Injection)
    Drug ClassesAntibiotic
    Drug LabelDactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyc...
    Active IngredientDactinomycin
    Dosage FormInjectable
    RouteInjection
    Strength0.5mg/vial
    Market StatusPrescription
    CompanyRecordati Rare

    4 of 4  
    Drug NameDactinomycin
    PubMed HealthDactinomycin (Injection)
    Drug ClassesAntibiotic
    Drug LabelDactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyc...
    Active IngredientDactinomycin
    Dosage FormInjectable
    RouteInjection
    Strength0.5mg/vial
    Market StatusPrescription
    CompanyLuitpold; Eurohlth Intl

    4.2 Therapeutic Uses

    Antineoplastic; Anti-Bacterial Agents; Nucleic Acid Synthesis Inhibitors; Protein Synthesis Inhibitors

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

    Dactinomycin, as part of a combination chemotherapy and/or multi-modality treatment regimen, is indicated for the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer. /Included in US Product label/

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    Dactinomycin is indicated as a single agent, or as part of a combination chemotherapy regimen, for the treatment of gestational trophoblastic neoplasia. /Included in US Product label/

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    Dactinomycin, as a component of regional perfusion, is indicated for the palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies. /Included in US Product label/

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    For more Therapeutic Uses (Complete) data for DACTINOMYCIN (7 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ COSMEGEN (Dactinomycin for Injection) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (Updated: February 2013). Available from, as of April 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9914e793-a49c-eb00-1ab7-f606c786fe25

    /BOXED WARNING/ This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (eg, corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms.

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (Updated: February 2013). Available from, as of April 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9914e793-a49c-eb00-1ab7-f606c786fe25

    COSMEGEN is a toxic drug and very careful and frequent observation of the patient for adverse reactions is necessary. These reactions may involve any tissue of the body, most commonly the hematopoietic system resulting in myelosuppression. As such, live virus vaccines should not be administered during therapy with COSMEGEN. The possibility of an anaphylactoid reaction should be borne in mind.

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    Pt may ... become more susceptible to infections due to suppression of normal immune mechanisms. If dactinomycin is given at or about time of infection with chickenpox, severe generalized disease, which is sometimes fatal, may occur.

    American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 1130

    For more Drug Warnings (Complete) data for DACTINOMYCIN (24 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer as part of a combination chemotherapy and/or multi-modality treatment regimen

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Generally, the actinomycins exert an inhibitory effect on gram-positive and gram-negative bacteria and on some fungi. However, the toxic properties of the actinomycins (including dactinomycin) in relation to antibacterial activity are such as to preclude their use as antibiotics in the treatment of infectious diseases. Because the actinomycins are cytotoxic, they have an antineoplastic effect which has been demonstrated in experimental animals with various types of tumor implant. This cytotoxic action is the basis for their use in the treatment of certain types of cancer. Dactinomycin is believed to produce its cytotoxic effects by binding DNA and inhibiting RNA synthesis.

    5.2 MeSH Pharmacological Classification

    Antibiotics, Antineoplastic

    Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)

    Nucleic Acid Synthesis Inhibitors

    Compounds that inhibit cell production of DNA or RNA. (See all compounds classified as Nucleic Acid Synthesis Inhibitors.)

    Protein Synthesis Inhibitors

    Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DACTINOMYCIN
    5.3.2 FDA UNII
    1CC1JFE158
    5.3.3 Pharmacological Classes
    Nucleic Acid Synthesis Inhibitors [MoA]; Protein Synthesis Inhibitors [MoA]; Actinomycin [EPC]
    5.4 ATC Code

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01D - Cytotoxic antibiotics and related substances

    L01DA - Actinomycines

    L01DA01 - Dactinomycin

    5.5 Absorption, Distribution and Excretion

    Absorption

    poorly absorbed from gastrointestinal tract

    Dactinomycin is poorly absorbed from the GI tract. The drug is extremely irritating to tissues and, therefore, must be administered iv.

    American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1025

    Dactinomycin is rapidly distributed into tissues, with high concentrations in bone marrow and nucleated cells, including granulocytes and lymphocytes. The drug appears to cross the blood-brain barrier poorly, if at all.

    American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1025

    Plasma protein binding /of dactinomycin/ is 5%.

    Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 494

    Dactinomycin apparently crosses the placenta. It is not known if dactinomycin is distributed into milk.

    American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1025

    For more Absorption, Distribution and Excretion (Complete) data for DACTINOMYCIN (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    hepatic

    Dactinomycin appears to be only slightly metabolized; small amounts of monolactones of the drug have been detected in the urine.

    American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1025

    5.7 Biological Half-Life

    36 hours

    The terminal plasma half-life for radioactivity was approximately 36 hours.

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    The terminal elimination half life of actinomycin D is 36 to 48 hours.

    Dart, R.C. (ed). Medical Toxicology. Third Edition, Lippincott Williams & Wilkins. Philadelphia, PA. 2004., p. 494

    5.8 Mechanism of Action

    Good evidence exists that this drug bind strongly, but reversibly, to DNA, interfering with synthesis of RNA (prevention of RNA polymerase elongation) and, consequently, with protein synthesis.

    The capacity of actinomycins to bind with double-helical DNA is responsible for their biological activity and cytotoxicity. X-ray studies of a crystalline complex between dactinomycin and deoxyguanosine permitted formulation of a model that appears to explain the binding of the drug to DNA. The planar phenoxazone ring intercalates between adjacent guanine-cytosine base pairs of DNA, while the polypeptide chains extend along the minor groove of the helix. The summation of these interactions provides great stability to the dactinomycin-DNA complex, and as a result of the binding of dactinomycin, the transcription of DNA by RNA polymerase is blocked. The DNA-dependent RNA polymerases are much more sensitive to the effects of dactinomycin than are the DNA polymerases. In addition, dactinomycin causes single-strand breaks in DNA, possibly through a free-radical intermediate or as a result of the action of topoisomerase II

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 11th ed. New York, NY: McGraw-Hill, 2006., p. 1357

    Dactinomycin is an antineoplastic antibiotic. The drug has bacteriostatic activity, particularly against gram-positive organisms, but its cytotoxicity precludes its use as an anti-infective agent. Although the exact mechanism(s) of action has not been fully elucidated, the drug appears to inhibit DNA-dependent RNA synthesis by forming a complex with DNA by intercalating with guanine residues and impairing the template activity of DNA. Protein and DNA synthesis are also inhibited but less extensively and at higher concentrations of dactinomycin than are needed to inhibit RNA synthesis. Dactinomycin is immunosuppressive and also possesses some hypocalcemic activity similar to plicamycin.

    American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 1025

    Generally, the actinomycins exert an inhibitory effect on gram-positive and gram-negative bacteria and on some fungi. However, the toxic properties of the actinomycins (including dactinomycin) in relation to antibacterial activity are such as to preclude their use as antibiotics in the treatment of infectious diseases.

    US Natl Inst Health; DailyMed. Current Medication Information for COSMEGEN (dactinomycin) injection, powder, lyophilized, for solution (March 2009). Available from, as of October 14, 2009 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=10007

    Dactinomycin acts by forming stable complexes with double-helical DNA that inhibit DNA-directed RNA synthesis (interfere with RNA polymerase) more than DNA synthesis. The drug is cell-cycle active.

    Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 793

    The effect of dactinomycin on cellular respiration and accompanying ATP formation was investigated in Jurkat and HL-60 cells. Cellular mitochondrial oxygen consumption (measured by a homemade phosphorescence analyzer) and ATP content (measured by the luciferin-luciferase bioluminescence system) were determined as functions of time t during continuous exposure to the drug. The rate of respiration, k, was the negative of the slope of [O2] versus t. Oxygen consumption and ATP content were diminished by cyanide, confirming that both processes involved oxidations in the mitochondrial respiratory chain. In the presence of dactinomycin, k decreased gradually with t, the decrease being more pronounced at higher drug concentrations. Cellular ATP remained constant for 5 h in untreated cells, but in the presence of 20 microM dactinomycin it decreased gradually (to one-tenth the value at 5 h for untreated cells). The drug-induced inhibition of respiration and decrease in ATP were blocked by the pancaspase inhibitor benzyloxycarbonyl-Val-Ala-DL-Asp-fluoromethyl ketone (zVAD-fmk). A rapid but temporary decrease in cellular ATP observed on the addition of zVAD-fmk was shown to be due to DMSO (added with zVAD-fmk). The effect of dactinomycin on respiration differed from that of doxorubicin. Plots of [O2] versus t were curved for dactinomycin so that k decreased gradually with t. The corresponding plots for doxorubicin were well fit by two straight lines; so k was constant for approximately 150 min, at which time k decreased, remaining constant at a lower level thereafter. The results for cells treated with mixtures of the two drugs indicated that the drugs acted synergistically. These results show the onset and severity of mitochondrial dysfunction in cells undergoing apoptosis induced by dactinomycin.

    PMID:17140264 Tao Z et al; Mol Pharm 3 (6): 762-72 (2006).

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    Submission : 2019-11-06

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    Date of Issue : 2019-09-23

    Valid Till : 2022-07-02

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    Start Marketing Date : 2016-05-16

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    Registrant Name : Korea United Pharmaceutical Co., Ltd.

    Registration Date : 2020-07-14

    Registration Number : 20200714-210-J-490

    Manufacturer Name : Zhejiang Hisun Pharmaceutical. Co., Ltd.

    Manufacturer Address : No. 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang China

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"DACTINOMYCIN","year":"2021","qtr":"Q1","strtotime":1609785000,"product":"DACTINOMYCIN USP BNO. DDP480076170 MFGDT : DEC 2020 RETEST DT: NOV 2023","address":"302, SAKAR - III, NR. OLD HIGHCOURTOFF. INCOME TAX OFFICE,","city":"AHMEDABAD ,GUJARAT","supplier":"CONCORD BIOTECH","supplierCountry":"INDIA","foreign_port":"TEHRAN","customer":"NANO FANAVARAN DAROUEI ","customerCountry":"IRAN","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"9915516.5","totalValueFC":"100393.2","currency":"USD","unitRateINR":734244000,"date":"05-Jan-2021","totalValueINR":"7342440","totalValueInUsd":"100393.2","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"7680501","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"IRAN","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"302, SAKAR - III, NR. OLD HIGHCOURTOFF. 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BATCH#1044-B200801 (QTY 15 GRMS)","address":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD","city":"SECUNDERABAD, ANDHRA PRADESH","supplier":"APC PHARMACEUTICALS & CHEMICALS LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"VIATRIS","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.015","unit":"KGS","unitRateFc":"17900000","totalValueFC":"271646.1","currency":"USD","unitRateINR":"1349660000","date":"16-Jul-2021","totalValueINR":"20244900","totalValueInUsd":"271646.1","indian_port":"BANGALORE AIR","hs_no":"29419090","bill_no":"4702201","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"1-1-151\/1, SAIRAM TOWERS, 4TH FLOORALEXANDER ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1637260200,"product":"DACTINOMYCIN (QTY: 7.8GMS)(BCD: LIST 3, SL NO: 13, IGST: LIST 1, SL NO 13)","address":"PLOT NO.2, MAITHRIVIHAR AMEERPET,","city":"HYDERABAD","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.0078","unit":"KGS","unitRateFc":"20000000","totalValueFC":"157317.1","currency":"USD","unitRateINR":"1502000000","date":"19-Nov-2021","totalValueINR":"11715600","totalValueInUsd":"157317.1","indian_port":"HYDERABAD AIR","hs_no":"29419090","bill_no":"6318262","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.2, MAITHRIVIHAR AMEERPET,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"DACTINOMYCIN USP (QTY:10 GRAMS)","address":"PLOT NO.2, MAITHRIVIHAR,","city":"HYDERABAD, AP.","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"EUGIA PHARMA SPECIALITIES ","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"16000000","totalValueFC":"161823.6","currency":"USD","unitRateINR":"1365600000","date":"28-Nov-2024","totalValueINR":"13656000","totalValueInUsd":"161823.6","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"6926639","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.46 WAISHA ROAD JIAOJIANG TAIZHOU ZHEJIANG P.R. CHINA SDNF China","customerAddress":"PLOT NO.2, MAITHRIVIHAR,"}]
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    ABOUT THIS PAGE

    Dactinomycin Manufacturers

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

    Dactinomycin Suppliers

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

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

    Dactinomycin USDMF

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

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

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

    Dactinomycin JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Dactinomycin Drug Master File in Japan (Dactinomycin JDMF) empowers Dactinomycin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Dactinomycin JDMF during the approval evaluation for pharmaceutical products. At the time of Dactinomycin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Dactinomycin suppliers with JDMF on PharmaCompass.

    Dactinomycin KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Dactinomycin Drug Master File in Korea (Dactinomycin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dactinomycin. The MFDS reviews the Dactinomycin KDMF as part of the drug registration process and uses the information provided in the Dactinomycin KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Dactinomycin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dactinomycin API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Dactinomycin suppliers with KDMF on PharmaCompass.

    Dactinomycin WC

    A Dactinomycin written confirmation (Dactinomycin WC) is an official document issued by a regulatory agency to a Dactinomycin manufacturer, verifying that the manufacturing facility of a Dactinomycin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dactinomycin APIs or Dactinomycin finished pharmaceutical products to another nation, regulatory agencies frequently require a Dactinomycin WC (written confirmation) as part of the regulatory process.

    click here to find a list of Dactinomycin suppliers with Written Confirmation (WC) on PharmaCompass.

    Dactinomycin 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 Dactinomycin as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Dactinomycin 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 Dactinomycin 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 Dactinomycin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dactinomycin NDC to their finished compounded human drug products, they may choose to do so.

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

    Dactinomycin GMP

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

    Dactinomycin CoA

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

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

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