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Chemistry

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Also known as: Romidepsin, Depsipeptide, Fk228, Chromadax, 128517-07-7, Antibiotic fr 901228
Molecular Formula
C24H36N4O6S2
Molecular Weight
540.7  g/mol
InChI Key
OHRURASPPZQGQM-GCCNXGTGSA-N
FDA UNII
CX3T89XQBK

Romidepsin
romidepsin is a natural product found in Chromobacterium violaceum with data available.
Romidepsin is a Histone Deacetylase Inhibitor. The mechanism of action of romidepsin is as a Histone Deacetylase Inhibitor, and Bile Salt Export Pump Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Organic Anion Transporter 1 Inhibitor, and Organic Cation Transporter 2 Inhibitor.
1 2D Structure

Romidepsin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
2.1.2 InChI
InChI=1S/C24H36N4O6S2/c1-6-16-21(30)28-20(14(4)5)24(33)34-15-9-7-8-10-35-36-12-17(22(31)25-16)26-23(32)19(13(2)3)27-18(29)11-15/h6-7,9,13-15,17,19-20H,8,10-12H2,1-5H3,(H,25,31)(H,26,32)(H,27,29)(H,28,30)/b9-7+,16-6-/t15-,17-,19-,20+/m1/s1
2.1.3 InChI Key
OHRURASPPZQGQM-GCCNXGTGSA-N
2.1.4 Canonical SMILES
CC=C1C(=O)NC(C(=O)OC2CC(=O)NC(C(=O)NC(CSSCCC=C2)C(=O)N1)C(C)C)C(C)C
2.1.5 Isomeric SMILES
C/C=C\1/C(=O)N[C@H](C(=O)O[C@H]\2CC(=O)N[C@@H](C(=O)N[C@H](CSSCC/C=C2)C(=O)N1)C(C)C)C(C)C
2.2 Other Identifiers
2.2.1 UNII
CX3T89XQBK
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fk228

2. Fr 901228

3. Fr-901228

4. Fr901228

5. L-valine, N-(3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-d-valyl-d-cysteinyl-(z)-2,3-didehydro-2-aminobutanoyl-, Xi-lactone, Cyclic (1-2)-disulfide, (s-(e))-

6. Romidepsin

2.3.2 Depositor-Supplied Synonyms

1. Romidepsin

2. Depsipeptide

3. Fk228

4. Chromadax

5. 128517-07-7

6. Antibiotic Fr 901228

7. Fr901228

8. Fk 228

9. Fk-228

10. Fr 901228

11. Fr-901228

12. Nsc-630176

13. Chembl343448

14. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

15. Chebi:61080

16. Nsc 630176

17. Nsc630176

18. Nsc754143

19. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

20. C24h36n4o6s2

21. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

22. Istodax (tn)

23. Romidepsin [usan]

24. Cx3t89xqbk

25. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo(8.7.6)tricos-16-ene-3,6,9,19,22-pentone

26. Hdinhib_000006

27. Romidepsina

28. Romidepsine

29. Romidepsinum

30. Oxa-12,8,20,23-tetrazabicyclo[8.7.6]tricosane, Cyclic Peptide Deriv.

31. Romidepsin (fk228)

32. Romidepsin; Fk-228

33. Romidepsin [mi]

34. Fk-901228

35. Romidepsin [inn]

36. Romidepsin [jan]

37. Romidepsin [vandf]

38. Probes1_000153

39. Probes2_000337

40. Romidepsin [mart.]

41. Romidepsin [who-dd]

42. Depsipeptide [who-dd]

43. Romidepsin (jan/usan/inn)

44. Schembl677497

45. Gtpl7006

46. Romidepsin [orange Book]

47. Romidepsin, >=98% (hplc)

48. Bdbm19151

49. Romidepsin (fk228 ,depsipeptide)

50. Cyclo((2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl), Cyclic (3->5)-disulfide

51. Zinc3935130

52. Mfcd18433404

53. S3020

54. Api0005301

55. Cs-0985

56. Db06176

57. Nsc-754143

58. Hy-15149

59. D06637

60. Ab01273968-01

61. Sr-01000941579

62. Q7363205

63. Sr-01000941579-1

64. L-valine,3-didehydro-2- Aminobutanoyl-,.xi.-lactone, Cyclic (1.fwdarw.2)-disulfide

65. L-valine,3-didehydro-2-aminobutanoyl-,.xi.-lactone, Cyclic (1.fwdarw.2)-disulfide

66. (1s,4s,7z,10s,16e,21r)-7- Ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23- Tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

67. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(1methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16ene-3,6,9,19,22-pentone

68. (e)-(1s,10s,21r)-7-[(z)-ethylidene]-4,21-diisopropyl-2- Oxa-12,13-dithia-5,8,20,23- Tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

69. (e)-(1s,10s,21r)-7-[(z)-ethylidene]-4,21-diisopropyl-2- Oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone

70. Cyclo((2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl), Cyclic (3->5)-disulphide

71. Cyclo[(2z)-2-amino-2-butenoyl-l-val Yl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valy L-d-cysteinyl], Cyclic (3-5) Disulfide

72. Cyclo[(2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl], Cyclic (3-5) Disulfide

2.4 Create Date
2006-02-02
3 Chemical and Physical Properties
Molecular Weight 540.7 g/mol
Molecular Formula C24H36N4O6S2
XLogP32.2
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count8
Rotatable Bond Count2
Exact Mass540.20762723 g/mol
Monoisotopic Mass540.20762723 g/mol
Topological Polar Surface Area193 Ų
Heavy Atom Count36
Formal Charge0
Complexity905
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

For the treatment of cutaneous T-cell lymphoma (CTCL) or/and peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.


FDA Label


treatment of peripheral T-cell lymphoma (PTCL),


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antibiotics, Antineoplastic

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


Histone Deacetylase Inhibitors

Compounds that inhibit HISTONE DEACETYLASES. This class of drugs may influence gene expression by increasing the level of acetylated HISTONES in specific CHROMATIN domains. (See all compounds classified as Histone Deacetylase Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
ROMIDEPSIN
5.2.2 FDA UNII
CX3T89XQBK
5.2.3 Pharmacological Classes
Histone Deacetylase Inhibitor [EPC]; Histone Deacetylase Inhibitors [MoA]; Organic Anion Transporter 1 Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]; Organic Cation Transporter 2 Inhibitors [MoA]; Bile Salt Export Pump Inhibitors [MoA]
5.3 ATC Code

L01XX39


L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

L01XH - Histone deacetylase (hdac) inhibitors

L01XH02 - Romidepsin


5.4 Absorption, Distribution and Excretion

Absorption

Romidepsin exhibited linear pharmacokinetics at standard doses.


Volume of Distribution

44.5L


Clearance

8.4L/h


5.5 Metabolism/Metabolites

Romidepsin undergoes extensive hepatic metabolism in vitro primarily by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6 and CYP2C19.


5.6 Biological Half-Life

Approximately 3 hours


5.7 Mechanism of Action

Romidepsin is a prodrug, where it becomes active once taken up into the cell. The active metabolite has a free thiol group, which interacts with zinc ions in the active site of class 1 and 2 HDAC enzymes, resulting in inhibition of its enzymatic activity. Certain tumors have over expressed HDACs and downregulated/mutated histone acetyltransferases. This imbalance of HDAC relative to histone acetyltransferase can lead to a decrease in regulatory genes, ensuing tumorigenesis. Inhibition of HDAC may restore normal gene expression in cancer cells and result in cell cycle arrest and apoptosis.


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ABOUT THIS PAGE

Romidepsin Manufacturers

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

Romidepsin Suppliers

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

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

Romidepsin USDMF

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

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

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

Romidepsin WC

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

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

Romidepsin 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 Romidepsin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Romidepsin GMP

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

Romidepsin CoA

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

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

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