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ACTIVE PHARMA INGREDIENTS

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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


NDC API

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LENACAPAVIR SODIUM

NDC Package Code : 54014-6902

Start Marketing Date : 2022-12-22

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Yuhan Chemical Inc

South Korea
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Yuhan Chemical Inc

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LENACAPAVIR

NDC Package Code : 66721-830

Start Marketing Date : 2022-08-17

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (20kg/20kg)

Marketing Category : BULK INGREDIENT

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INTERMEDIATES SUPPLIERS

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 1620056-83-8

End Use API : Lenacapavir

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2109226-54-0

End Use API : Lenacapavir

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 1620056-47-4

End Use API : Lenacapavir

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

CAS Number : 2189684-54-4

End Use API : Lenacapavir

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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CAS Number : 2189684-53-3

End Use API : Lenacapavir

About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

Shanghai Minbiotech CB

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Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

CAS Number : 1620056-83-8

End Use API : Lenacapavir

About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...

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SCI Pharmtech

Taiwan
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Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

CAS Number : 91-00-9

End Use API : Lenacapavir

About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...

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SCI Pharmtech

Taiwan
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Virtual BoothSCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

CAS Number : 91-00-9

End Use API : Lenacapavir

About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...

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CAS Number : 2189684-53-3

End Use API : Lenacapavir

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

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CAS Number : 2189684-54-4

End Use API : Lenacapavir

About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...

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LENACAPAVIR SODIUM

Brand Name : SUNLENCA

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Packaging :

Approval Date : 2022-12-22

Application Number : 215973

Regulatory Info : RX

Registration Country : USA

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LENACAPAVIR SODIUM

Brand Name : SUNLENCA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Packaging :

Approval Date : 2022-12-22

Application Number : 215974

Regulatory Info : RX

Registration Country : USA

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LENACAPAVIR SODIUM

Brand Name : SUNLENCA

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)

Approval Date : 2022-12-22

Application Number : 215973

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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LENACAPAVIR SODIUM

Brand Name : SUNLENCA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 300MG BASE

Approval Date : 2022-12-22

Application Number : 215974

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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FDA’s drug approvals drop 26% due to Covid; okays three costly gene therapies in H2
The year 2022 saw the lowest number of drug approvals by the US Food and Drug Administration (FDA) since 2016. The agency’s Center for Drug Evaluation and Research (CDER) approved only 37 new drugs, a decrease of 26 percent from the 50 meds that it had approved in 2021. Of these, 21 were approved in the second half of the year (H2). Eight biologics were approved by FDA’s Center for Biologics Evaluation and Research (CBER) in 2022 (against 10 in 2021). The FDA cited the Covid-19 pandemic as one of the main reasons behind the drop in drug approvals. Among the promising drugs approved in H1 2022 were Eli Lilly’s Mounjaro (tirzepatide) for type 2 diabetes, Alnylam Pharmaceuticals’ rare disease drug Amvuttra (vutrisiran), Roche’s bispecific antibody for eye – Vabysmo (faricimab) – and Janssen Biotech and Legend Biotech's CAR-T therapy — Carvykti — to treat multiple myeloma. The second half saw some equally promising drugs bag FDA nod, such as Mirati’s Krazati (adagrasib) and Johnson and Johnson’s Tecvayli (teclistamab-cqyv), along with three of the costliest gene therapies. In 2022, 44 drugs were authorized by the European Medicines Agency (EMA), five less than the 49 authorized in 2021. Health Canada approved 20 drugs in H2, taking the total approvals to 45 in 2022. View New Drug Approvals in 2022 with Estimated Sales (Free Excel Available) Mirati’s Krazati, J&J’s Tecvayli bag approval; may clock around US$ 2 billion in peak sales  Oncology drugs continued to account for the largest number of approvals in H2 – nearly 35 percent of the drugs approved by CDER and CBER were from the therapeutic area. In H2 2022, cancer drugmaker Mirati’s Krazati became the second small molecule (KRAS) inhibitor to receive FDA approval for the treatment of advanced lung cancer. Amgen’s Lumakras was the first KRAS inhibitor to be approved in the US in May 2021. Krazati is expected to generate US$ 2 billion in peak sales by 2028. J&J’s Tecvayli was approved by the FDA as a fifth-line therapy for multiple myeloma. The drug is expected to generate peak sales of around US$ 1.7 billion. View New Drug Approvals in 2022 with Estimated Sales (Free Excel Available) FDA okays Gilead’s HIV drug, BMS’ plaque psoriasis drug, Amylyx’s ALS drug Gilead Sciences’ long-acting HIV drug Sunlenca (lenacapavir) finally bagged an FDA approval in H2, after receiving a complete response letter (CRL) in H1. The European Commission also authorized the drug to treat patients who suffer from multi-drug resistant HIV. FDA has also approved Bristol Myers Squibb’s oral drug Sotyktu (deucravacitinib) as a treatment for moderate-to-severe plaque psoriasis. It’s the only TYK2 inhibitor approved for this condition and the first oral treatment approved in almost 10 years. One of the most notable drug approvals of 2022 was Amylyx Pharmaceuticals’ Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS). During H2, Lilly’s Mounjaro, Alnylam’s Amvuttra and Roche’s Vabysmo also received marketing authorization in Europe. AstraZeneca’s Tezspire was authorized in the EU as a treatment for severe asthma. View New Drug Approvals in 2022 with Estimated Sales (Free Excel Available) CSL’s Hemgenix emerges as costliest med; Bavarian Nordic’s monkeypox jab bags EUA The second half saw several gene therapies bag an FDA nod – such as CSL’s Hemgenix (for hemophilia B) and bluebird bio’s Skysona and Zynteglo (beti-cel). Priced at US$ 3.5 million per dose, Hemgenix became the most expensive treatment in the world, snatching the title from Skysona (priced at US$ 3 million), which was approved for a rare neurological disorder – cerebral adrenoleukodystrophy (CALD). Zynteglo (to treat beta thalassemia) was approved a month prior to Skysona, and is the third most expensive drug in the US (priced at US$ 2.8 million). Ferring’s bladder cancer gene therapy, Adstiladrin, also received a regulatory nod, after getting rejected by the FDA in May 2020. With a rise in monkeypox cases, the World Health Organization declared monkeypox as a global health emergency in July. The European Commission gave marketing authorization to Bavarian Nordic’s Imvanex vaccine as a protection against monkeypox. The FDA granted emergency use authorization (EUA) to the same vaccine – branded as Jynneos – in August. View New Drug Approvals in 2022 with Estimated Sales (Free Excel Available) FDA rejects Y-mAbs’ cancer drug Omblastys, Gilead’s hepatitis med bulevirtide  One of the most noteworthy drugs that received FDA’s CRL is Y-mAbs Therapeutics’ Omblastys. The drug, meant to treat central nervous system metastasis from neuroblastoma, also received a negative recommendation from the EMA. FDA also issued a CRL to Gilead Sciences’ hepatitis delta virus drug bulevirtide, citing concerns over the manufacturing and delivery of the drug. The agency also rejected Ipsen’s palovarotene, an experimental drug to treat fibrodysplasia ossificans progressiva (a tissue disorder), requesting additional trial information. View New Drug Approvals in 2022 with Estimated Sales (Free Excel Available) Our view Though 2022 was a lackluster year for drug approvals, 2023 has got off to a good start. In the first week, Eisai and Biogen received FDA’s accelerated approval for their second Alzheimer's disease drug – Leqembi (lecanemab) – to treat patients who are in their earliest stages of the disease. Another Alzheimer’s drug – Eli Lilly’s donanemab – is up for review in February. The year should also see the approval of the first respiratory syncytial virus (RSV) vaccine in the US. GSK and Pfizer’s RSV vaccines for older adults, along with Sanofi-AstraZeneca’s therapy for infants, are up for FDA review in 2023. Moderna also plans to seek approval for its RSV vaccine for older adults in H1 this year. Moreover, hemophilia A gene therapies from Sanofi (efmoroctocog alfa) and BioMarin (valoctocogene roxaparvovec) are also up for approval. All in all, this should be an exciting year for new drug approvals.

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

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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