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Chemistry

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Also known as: 917389-32-3, Aic246, Prevymis, Aic-246, Aic 246, Mk-8228
Molecular Formula
C29H28F4N4O4
Molecular Weight
572.5  g/mol
InChI Key
FWYSMLBETOMXAG-QHCPKHFHSA-N
FDA UNII
1H09Y5WO1F

Letermovir
Letermovir is an orally bioavailable, non-nucleoside, 3,4-dihydroquinazolinyl acetic acid and inhibitor of the pUL56 subunit of the viral terminase complex of cytomegalovirus (CMV), with potential CMV-specific antiviral activity. Upon oral administration, letermovir binds to the pUL56 subunit of the viral terminase complex of CMV and prevents the cleavage of concatemeric DNA into monomeric genome length DNA. As this agent interferes with viral DNA processing and subsequent viral DNA packaging into procapsids, CMV replication is blocked and CMV infection is prevented.
Letermovir is a Cytomegalovirus DNA Terminase Complex Inhibitor. The mechanism of action of letermovir is as a DNA Terminase Complex Inhibitor, and Cytochrome P450 3A Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Cytochrome P450 2C8 Inhibitor, and Cytochrome P450 2C9 Inducer, and Cytochrome P450 2C19 Inducer.
1 2D Structure

Letermovir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(4S)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4H-quinazolin-4-yl]acetic acid
2.1.2 InChI
InChI=1S/C29H28F4N4O4/c1-40-20-6-3-5-19(16-20)35-11-13-36(14-12-35)28-34-27-21(7-4-8-22(27)30)23(17-26(38)39)37(28)24-15-18(29(31,32)33)9-10-25(24)41-2/h3-10,15-16,23H,11-14,17H2,1-2H3,(H,38,39)/t23-/m0/s1
2.1.3 InChI Key
FWYSMLBETOMXAG-QHCPKHFHSA-N
2.1.4 Canonical SMILES
COC1=C(C=C(C=C1)C(F)(F)F)N2C(C3=C(C(=CC=C3)F)N=C2N4CCN(CC4)C5=CC(=CC=C5)OC)CC(=O)O
2.1.5 Isomeric SMILES
COC1=C(C=C(C=C1)C(F)(F)F)N2[C@H](C3=C(C(=CC=C3)F)N=C2N4CCN(CC4)C5=CC(=CC=C5)OC)CC(=O)O
2.2 Other Identifiers
2.2.1 UNII
1H09Y5WO1F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Aic246

2. Prevymis

2.3.2 Depositor-Supplied Synonyms

1. 917389-32-3

2. Aic246

3. Prevymis

4. Aic-246

5. Aic 246

6. Mk-8228

7. 1h09y5wo1f

8. 2-[(4s)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4h-quinazolin-4-yl]acetic Acid

9. 2-((4s)-8-fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-4h-quinazolin-4-yl)acetic Acid

10. 4-quinazolineacetic Acid, 8-fluoro-3,4-dihydro-2-(4-(3-methoxyphenyl)-1-piperazinyl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-, (4s)-

11. Letermovir [inn]

12. Letermovir [usan:inn]

13. Unii-1h09y5wo1f

14. Prevymis (tn)

15. (s)-[8-fluoro-2-[4-(3-methoxyphenyl)piperazine-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazoline-4-yl]acetic Acid

16. (s)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazine-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazoline-4-yl}acetic Acid

17. Mk-8828

18. Letermovir(aic246)

19. Letermovir [mi]

20. Letermovir [jan]

21. Letermovir [usan]

22. Letermovir [who-dd]

23. Letermovir (jan/usan/inn)

24. Schembl379403

25. Chembl1241951

26. Letermovir [orange Book]

27. Dtxsid40238683

28. Ex-a1871

29. S8873

30. Zinc100369359

31. Cs-1571

32. Db12070

33. Aic246;aic 246;aic-246

34. Ncgc00378936-01

35. Ncgc00378936-02

36. Ac-35698

37. As-56206

38. Hy-15233

39. J3.556.145e

40. D10801

41. D71052

42. A902281

43. Q15409407

44. (4s)-2-(8-fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-3,4-dihydroquinazolin-4-yl)acetic Acid

45. (4s)-8-fluoro-3,4-dihydro-2-[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4-quinazolineacetic Acid

46. (s)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydro-quinazolin-4-yl}acetic Acid

47. (s)-{8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-(2-methoxy-5-trifluoromethylphenyl)-3,4-dihydroquinazolin-4-yl}acetic Acid

48. (s)-2-(8-fluoro-3-(2-methoxy-5-(trifluoromethyl)phenyl)-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3,4-dihydroquinazolin-4-yl)acetic Acid

2.4 Create Date
2010-04-26
3 Chemical and Physical Properties
Molecular Weight 572.5 g/mol
Molecular Formula C29H28F4N4O4
XLogP34.6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass572.20466804 g/mol
Monoisotopic Mass572.20466804 g/mol
Topological Polar Surface Area77.8 Ų
Heavy Atom Count41
Formal Charge0
Complexity931
Isotope Atom Count0
Defined Atom Stereocenter Count1
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

For use in prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).


FDA Label


Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

Consideration should be given to official guidance on the appropriate use of antiviral agents.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Letermovir inhibits the activity of the DNA terminase complex of CMV thereby preventing the cutting of viral DNA into mature length genomes for packaging into viral particles. Letemovir inhibits the DNA terminase complex with an EC50 of 2.1nM.


5.2 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.)


Poly(ADP-ribose) Polymerase Inhibitors

Chemicals and drugs that inhibit the action of POLY(ADP-RIBOSE)POLYMERASES. (See all compounds classified as Poly(ADP-ribose) Polymerase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LETERMOVIR
5.3.2 FDA UNII
1H09Y5WO1F
5.3.3 Pharmacological Classes
Cytochrome P450 2C8 Inhibitors [MoA]; Cytochrome P450 2C9 Inducers [MoA]; Cytochrome P450 3A Inhibitors [MoA]; Cytomegalovirus DNA Terminase Complex Inhibitor [EPC]; DNA Terminase Complex Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]; Cytochrome P450 2C19 Inducers [MoA]
5.4 ATC Code

J05


J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AX - Other antivirals

J05AX18 - Letermovir


5.5 Absorption, Distribution and Excretion

Absorption

Letermovir has a bioavailability of 94% in healthy subjects when administered without cyclosporin, 35% in HSCT recipients when administered without cyclosporin, and 85% in HSCT recipients when administered with cyclosporin. Letermovir's Tmax is 45 min to 2.25 h. Time to steady state has been observed to be 9-10 days. Taking Letermovir with food increases Cmax by an average of 129.82% (range of 104.35%-161.50%). No significant effect on AUC has been observed .


Route of Elimination

Letemovir is taken up by the liver through OATP1B1/3 transporters. 93% is excreted in the feces with 70% as the parent drug. <2% is excreted in the urine.


Volume of Distribution

The mean steady state volume of distrubution is 45.5L


Clearance

The mean clearance is 11.25 L/h in healthy subjects


5.6 Metabolism/Metabolites

Letermovir undergoes a minor degree of metabolism through UGT1A1/1A3.


5.7 Biological Half-Life

The mean terminal half-life was observed to be 12 hours following administration of Letemovir 480 mg IV once daily.


5.8 Mechanism of Action

CMV relies on a DNA terminase complex consisting of multiple subunits (pUL51, pUL56, and pUL89) for processing of viral DNA. Viral DNA is produced in a single repeating strand which is then cut by the DNA terminase complex into individual viral genomes which can then be packaged into mature viral particles. Letemovir inhibits the activity of this complex to prevent production of mature viral genomes and the production of viable viral particles. The exact nature of Letemovir's binding to this complex is not currently known. Initially, the observation of resistance-causing mutations in pUL56 suggested this subunit was the location of Letemovir binding. However, resistance mutations have now been observed in pUL51, pUL56, and pUL89. It is possible that changes in amino acid sequence in one subunit could result in conformational changes to interacting subunits affecting Letemovir binding or that Letemovir interacts with multiple subunits of the complex but evidence towards either of these distinctions has not yet been seen. pUL89 is known to contain the endonuclease activity of the complex but because all members of the complex are necessary for targeting as well as protection from proteosomal degradation, it is difficult to discern if Letemovir inhibits pUL89's activity directly.


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Date of Issue : 2024-08-28

Valid Till : 2027-08-27

Written Confirmation Number : SD240048

Address of the Firm : Economic Development Zone, Pingyuan County, Dezhou City, Shandong

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About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...

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Honour Lab

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Lupin Ltd

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About the Company : Lupin Limited is a global pharmaceutical leader, based in Mumbai, India, with a strong presence in over 100 markets. It specializes in branded and generic formulations, complex gen...

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About the Company : Nantong Jinghua Pharmaceutical is a public pharmaceutical company that was established in 1957, owns about 302 staff, located in No. 20, 3 Haibin Road, Yanhai Economic Development ...

Nantong Jinghua Pharmaceutical is a public pharmaceutical company that was established in 1957, owns about 302 staff, located in No. 20, 3 Haibin Road, Yanhai Economic Development Zone, Rudong, Nantong, Jiangsu, China. They are appointed as a high-new-technical enterprise by Jiangsu Scientific Technological Bureau. As a comprehensive, advanced, and innovative GMP company, they focus on the manufacture, R&D, and sales of APIs and pharmaceutical intermediates. The Company produces Phenobarbital, Primidone, Fluorouracil, Phenylbutazone, Flucytosine, Piroxicam, Propylthiouracil, etc., in which the first five products have CEP certificates.
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CORP.LTDRM 1002, BLD,A,NO1230,ZHONG SHAN(NORTH 1)RDS HANGHAI CHINA","customerAddress":"ALEMBIC ROAD"}]
21-Jul-2022
22-Feb-2025
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ABOUT THIS PAGE

Looking for 917389-32-3 / Letermovir API manufacturers, exporters & distributors?

Letermovir manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Letermovir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Letermovir manufacturer or Letermovir supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Letermovir manufacturer or Letermovir supplier.

PharmaCompass also assists you with knowing the Letermovir API Price utilized in the formulation of products. Letermovir API Price is not always fixed or binding as the Letermovir Price is obtained through a variety of data sources. The Letermovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Letermovir

Synonyms

917389-32-3, Aic246, Prevymis, Aic-246, Aic 246, Mk-8228

Cas Number

917389-32-3

Unique Ingredient Identifier (UNII)

1H09Y5WO1F

About Letermovir

Letermovir is an orally bioavailable, non-nucleoside, 3,4-dihydroquinazolinyl acetic acid and inhibitor of the pUL56 subunit of the viral terminase complex of cytomegalovirus (CMV), with potential CMV-specific antiviral activity. Upon oral administration, letermovir binds to the pUL56 subunit of the viral terminase complex of CMV and prevents the cleavage of concatemeric DNA into monomeric genome length DNA. As this agent interferes with viral DNA processing and subsequent viral DNA packaging into procapsids, CMV replication is blocked and CMV infection is prevented.

Letermovir Manufacturers

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

Letermovir Suppliers

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

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

Letermovir USDMF

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

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

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

Letermovir KDMF

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

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

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

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

Letermovir WC

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

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

Letermovir 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 Letermovir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Letermovir GMP

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

Letermovir CoA

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

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

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