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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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US DMFs Filed

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JDMF

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VMF

NDC API

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API REF. PRICE (USD/KG)

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Data Compilation #PharmaFlow

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Chemistry

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Also known as: Gs-6207, 2189684-44-2, Gs-hiv, Gs-ca2, Gs-ca-2, Lenacapavir [usan]
Molecular Formula
C39H32ClF10N7O5S2
Molecular Weight
968.3  g/mol
InChI Key
BRYXUCLEHAUSDY-WEWMWRJBSA-N
FDA UNII
A9A0O6FB4H

Lenacapavir
Lenacapavir is under investigation in clinical trial NCT04150068 (Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance).
1 2D Structure

Lenacapavir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[(1S)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)pyridin-2-yl]-2-(3,5-difluorophenyl)ethyl]-2-[(2S,4R)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetamide
2.1.2 InChI
InChI=1S/C39H32ClF10N7O5S2/c1-36(2,63(3,59)60)10-9-21-5-6-22(23-7-8-26(40)30-32(23)57(17-37(43,44)45)54-35(30)55-64(4,61)62)31(51-21)27(13-18-11-19(41)14-20(42)12-18)52-28(58)16-56-34-29(33(53-56)39(48,49)50)24-15-25(24)38(34,46)47/h5-8,11-12,14,24-25,27H,13,15-17H2,1-4H3,(H,52,58)(H,54,55)/t24-,25+,27-/m0/s1
2.1.3 InChI Key
BRYXUCLEHAUSDY-WEWMWRJBSA-N
2.1.4 Canonical SMILES
CC(C)(C#CC1=NC(=C(C=C1)C2=C3C(=C(C=C2)Cl)C(=NN3CC(F)(F)F)NS(=O)(=O)C)C(CC4=CC(=CC(=C4)F)F)NC(=O)CN5C6=C(C7CC7C6(F)F)C(=N5)C(F)(F)F)S(=O)(=O)C
2.1.5 Isomeric SMILES
CC(C)(C#CC1=NC(=C(C=C1)C2=C3C(=C(C=C2)Cl)C(=NN3CC(F)(F)F)NS(=O)(=O)C)[C@H](CC4=CC(=CC(=C4)F)F)NC(=O)CN5C6=C([C@H]7C[C@H]7C6(F)F)C(=N5)C(F)(F)F)S(=O)(=O)C
2.2 Other Identifiers
2.2.1 UNII
A9A0O6FB4H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Gs-ca1

2.3.2 Depositor-Supplied Synonyms

1. Gs-6207

2. 2189684-44-2

3. Gs-hiv

4. Gs-ca2

5. Gs-ca-2

6. Lenacapavir [usan]

7. Gs-ca1

8. A9a0o6fb4h

9. Gs-714207

10. Gs6207

11. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)pyridin-2-yl]-2-(3,5-difluorophenyl)ethyl]-2-[(2s,4r)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetamide

12. N-((s)-1-(3-(4-chloro-3-(methylsulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl)acetamide

13. N-[(1s)-1-(3-{4-chloro-3-[(methylsulfonyl)amino]-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl}-6-[3-methyl-3-(methylsulfonyl)but-1-yn-1-yl]pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl]-2-[(3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl]acetamide

14. Qng

15. Lenacapavir [inn]

16. Unii-a9a0o6fb4h

17. Lenacapavir [who-dd]

18. Chembl4594438

19. Schembl19875642

20. Gtpl11446

21. Ex-a5518

22. Who 11108

23. At20076

24. Hy-111964

25. Cs-0094695

26. 1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazole, N-((1s)-1-(3-(4-chloro-3-((methylsulfonyl)amino)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)-1-butyn-1-yl)-2-pyridinyl)-2-(3,5-difluorophenyl)ethyl)-5,5-difluoro-3b,4,4a,5-tetrahydro-3-(trifluoromethyl)-, (3bs,4ar)-

27. N-((1s)-1-(3-(4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-(methanesulfonyl)-3-methylbut-1-yn-1-yl)pyridin-2-yl)-2-(3,5- Difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazol-1-yl)acetamide

28. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonyl-but-1-ynyl)-2-pyridyl]-2-(3,5-difluorophenyl)ethyl]-2-[difluoro(trifluoromethyl)[?]yl]acetamide

2.4 Create Date
2018-05-16
3 Chemical and Physical Properties
Molecular Weight 968.3 g/mol
Molecular Formula C39H32ClF10N7O5S2
XLogP36.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count19
Rotatable Bond Count13
Exact Mass967.1435188 g/mol
Monoisotopic Mass967.1435188 g/mol
Topological Polar Surface Area175 Ų
Heavy Atom Count64
Formal Charge0
Complexity2040
Isotope Atom Count0
Defined Atom Stereocenter Count3
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

Treatment of human immunodeficiency virus (HIV-1) infection


* Sunlenca injection: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 and 5. 1).

* Sunlenca tablet: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 and 5. 1).


5 Pharmacology and Biochemistry
5.1 ATC Code

J05AX


J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AX - Other antivirals

J05AX31 - Lenacapavir


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ABOUT THIS PAGE

Looking for 2189684-44-2 / Lenacapavir API manufacturers, exporters & distributors?

Lenacapavir manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Lenacapavir 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 Lenacapavir manufacturer or Lenacapavir supplier for your needs.

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

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

API | Excipient name

Lenacapavir

Synonyms

Gs-6207, 2189684-44-2, Gs-hiv, Gs-ca2, Gs-ca-2, Lenacapavir [usan]

Cas Number

2189684-44-2

Unique Ingredient Identifier (UNII)

A9A0O6FB4H

About Lenacapavir

Lenacapavir is under investigation in clinical trial NCT04150068 (Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV-1 Infection With Multidrug Resistance).

Lenacapavir Manufacturers

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

Lenacapavir Suppliers

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

Lenacapavir 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 Lenacapavir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Lenacapavir GMP

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

Lenacapavir CoA

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

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

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