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Clevudine

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Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Clevudine, 163252-36-6, L-fmau, Levovir, Clevudine (levovir), In51mvp5f1

Molecular Formula

C₁₀H₁₃FN₂O₅

Molecular Weight

260.22 g/mol

InChI Key

GBBJCSTXCAQSSJ-XQXXSGGOSA-N

FDA UNII

IN51MVP5F1

Clevudine is a synthetic pyrimidine analogue with activity against hepatitis B virus (HBV). Intracellularly, clevudine is phosphorylated to its active metabolites, clevudine monophosphate and triphosphate. The triphosphate metabolite competes with thymidine for incorporation into viral DNA, thereby causing DNA chain termination and inhibiting the function of HBV DNA polymerase (reverse transcriptase). Clevudine has a long half-life and shows significant reduction of covalently closed circular DNA (cccDNA), therefore the patient is less likely to have a relapse after treatment is discontinued.

1 2D Structure

Clevudine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-[(2S,3R,4S,5S)-3-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione

2.1.2 InChI

InChI=1S/C10H13FN2O5/c1-4-2-13(10(17)12-8(4)16)9-6(11)7(15)5(3-14)18-9/h2,5-7,9,14-15H,3H2,1H3,(H,12,16,17)/t5-,6+,7-,9-/m0/s1

2.1.3 InChI Key

GBBJCSTXCAQSSJ-XQXXSGGOSA-N

2.1.4 Canonical SMILES

CC1=CN(C(=O)NC1=O)C2C(C(C(O2)CO)O)F

2.1.5 Isomeric SMILES

CC1=CN(C(=O)NC1=O)[C@@H]2[C@@H]([C@H]([C@@H](O2)CO)O)F

2.2 Other Identifiers

2.2.1 UNII

IN51MVP5F1

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 1-(2-deoxy-2-fluoro-beta-d-arabinofuranosyl)-5-methyl-2,4(1h,3h)-pyrimidinedione,

2. 1-(2-deoxy-2-fluoro-beta-l-arabinofuranosyl)-5-methyl-2,4(1h,3h)-pyrimidinedione

3. 1-(2-fluoro-2-deoxy-beta-arabinofuranosyl)thymine

4. 1-(2-fluoro-2-deoxy-beta-d-arabinofuranosyl)thymine

5. 1-(2-fluoro-5-methyl-beta,l-arabinofuranosyl)uracil

6. 1-(2-fluoro-beta-l-arabinofuranosyl)thymine

7. 2'-deoxy-2'-fluoroarabinofuranosylthymine

8. 2'-fluoro-5-methyl-1-beta-d-arabinofuranosyluracil

9. 2'-fluoro-5-methylarabinosyluracil

10. 2'-fluoro-5-methylarabinosyluracil, 2-(14)c-labeled

11. 5-methyl-2'-fluoroarauracil

12. Clevudine

13. D-fmau

14. Fmau

15. L-fmau

2.3.2 Depositor-Supplied Synonyms

1. Clevudine

2. 163252-36-6

3. L-fmau

4. Levovir

5. Clevudine (levovir)

6. In51mvp5f1

7. 1-(2-deoxy-2-fluoro-beta-l-arabinofuranosyl)thymine

8. 2'-fluoro-5-methyl-beta-l-arabinofuranosyluracil

9. Clevudine (usan)

10. Clevudine [usan]

11. 2,4(1h,3h)-pyrimidinedione, 1-(2-deoxy-2-fluoro-.beta.-l-arabinofuranosyl)-5-methyl-

12. Clevudine [usan:inn]

13. Unii-in51mvp5f1

14. Revovir

15. Mfcd00935785

16. Clevudine (form 2)

17. 1-(2-deoxy-2-fluoro-ss-l-arabinofuranosyl)-5-methyl-2,4-(1h,3h)-pyrimidinedione

18. Clevudine [inn]

19. Clevudine [mi]

20. Clevudine [who-dd]

21. 1-[(2s,3r,4s,5s)-3-fluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-methylpyrimidine-2,4-dione

22. Mls006011168

23. Schembl233494

24. Chembl458875

25. Zinc1484

26. Dtxsid2057659

27. Chebi:135964

28. S3001

29. Akos015951181

30. Ac-1177

31. Ccg-267053

32. Db06683

33. Ds-3428

34. 1-(2-deoxy-2-fluoro-beta-l-arabinofuranosyl)-5-methyl-2,4(1h,3h)-pyrimidinedione

35. Ncgc00371259-05

36. 1-[(2s,3r,4s,5s)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-5-methyl-pyrimidine-2,4-dione

37. Am807730

38. Smr004702937

39. D03537

40. A855725

41. 2'-fluoro-5-methyl-.beta.-l-arabinofuranosyluracil

42. Q1100864

43. 1-(2-deoxy-2-fluoro-beta-l-arabinofuranosyl) Thymine

44. 1-(2-deoxy-2-fluoro-.beta.-l-arabinofuranosyl)thymine

45. 2,4(1h,3h)-pyrimidinedione, 1-(2-deoxy-2-fluoro-

46. A-l-arabinofuranosyl)-5-methyl-

47. 1-[(2s,3r,4s,5s)-3-fluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]-4-hydroxy-5-methyl-pyrimidin-2-one

2.4 Create Date

2005-08-01

3 Chemical and Physical Properties

Molecular Formula	C₁₀H₁₃FN₂O₅
Molecular Weight	260.22 g/mol
XLogP3	-0.9
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	2
Exact Mass	260.08084968 g/mol
Monoisotopic Mass	260.08084968 g/mol
Topological Polar Surface Area	99.1 Å²
Heavy Atom Count	18
Formal Charge	0
Complexity	413
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Investigated for use/treatment in hepatitis (viral, B).

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antiviral Agents

Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

5.2 ATC Code

J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors

J05AF12 - Clevudine

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ABOUT THIS PAGE

Clevudine Manufacturers

A Clevudine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clevudine, including repackagers and relabelers. The FDA regulates Clevudine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clevudine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Clevudine Suppliers

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

Clevudine KDMF

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

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

After submitting a Clevudine 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 Clevudine API can apply through the Korea Drug Master File (KDMF).

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

Clevudine GMP

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

Clevudine CoA

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

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

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