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Lenacapavir

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ACTIVE PHARMA INGREDIENTS

2 NDC API

2 NDC API

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

10 Intermediates Suppliers

10 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 37 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
37 NEWS #PharmaBuzz

PATENTS & EXCLUSIVITIES

10 US Patents, 2 US Exclusivities

patents
10 US Patents
2 US Exclusivities

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

JDMF

EU WC

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NDC API

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API REF. PRICE (USD/KG)

$ 0

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FDA Orange Book

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REF. STANDARDS OR IMPURITIES

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PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

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US Medicaid (USD)

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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 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 Formula	C₃₉H₃₂ClF₁₀N₇O₅S₂
Molecular Weight	968.3 g/mol
XLogP3	6.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	19
Rotatable Bond Count	13
Exact Mass	967.1435188 g/mol
Monoisotopic Mass	967.1435188 g/mol
Topological Polar Surface Area	175 Å²
Heavy Atom Count	64
Formal Charge	0
Complexity	2040
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
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

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

01

Gilead Alberta ULC

U.S.A

SupplySide West 2024

Not Confirmed

02

Yuhan Chemical Inc

South Korea

SupplySide West 2024

Not Confirmed

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Drugs in Development

01 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

02 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

03 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

04 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

05 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

06 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

07 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

08 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

09 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

10 Gilead Sciences

U.S.A

SupplySide West 2024

Not Confirmed

Only 10 entries up to this point, click to access all

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INTERMEDIATES SUPPLIERS

01

Shanghai Minbiotech

China

SupplySide West 2024

Not Confirmed

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

2-((3bS,4aR)-5,5-Difluoro-3-(trifluoromethyl)-3b,4...

CAS Number : 1620056-83-8

End Use API : Lenacapavir

Product Web Link

Corporate PDF

02

Shanghai Minbiotech

China

SupplySide West 2024

Not Confirmed

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

3-Methyl-3-(methylsulfonyl)but-1-yne

CAS Number : 2109226-54-0

End Use API : Lenacapavir

Product Web Link

Corporate PDF

03

Shanghai Minbiotech

China

SupplySide West 2024

Not Confirmed

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

tert-butylN-[(1S)-1-(3,6-dibromopyridin-2-yl)-2-(3...

CAS Number : 1620056-47-4

End Use API : Lenacapavir

Product Web Link

Corporate PDF

04

Shanghai Minbiotech

China

SupplySide West 2024

Not Confirmed

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

Carbamic acid, N-[(1S)-1-[3-bromo-6-[3-methyl-3-(...

CAS Number : 2189684-54-4

End Use API : Lenacapavir

Product Web Link

Corporate PDF

05

Shanghai Minbiotech

China

SupplySide West 2024

Not Confirmed

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

4-Chloro-7-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan...

CAS Number : 2189684-53-3

End Use API : Lenacapavir

Product Web Link

Corporate PDF

06

Porton Pharma Solutions

China

SupplySide West 2024

Not Confirmed

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

2-((3bS,4aR)-5,5-difluoro-3- (trifluoromethyl)-3b,...

CAS Number : 1620056-83-8

End Use API : Lenacapavir

Product Web Link

07

SCI Pharmtech

Taiwan

SupplySide West 2024

Not Confirmed

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

Benzhydrylamine

CAS Number : 91-00-9

End Use API : Lenacapavir

Product Web Link

08

SCI Pharmtech

Taiwan

SupplySide West 2024

Not Confirmed

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

Benzhydrylamine

CAS Number : 91-00-9

End Use API : Lenacapavir

GILEAD SCIENCES INC

U.S.A

SupplySide West 2024

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content

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DATA COMPILATION #PharmaFlow

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.