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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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LABORATORIES","customerCountry":"INDIA","quantity":"15.23","actualQuantity":"15.23","unit":"KGS","unitRateFc":"23806.5","totalValueFC":"365664.7","currency":"USD","unitRateINR":"2066400","date":"25-Jul-2025","totalValueINR":"31471272","totalValueInUsd":"365664.7","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"3475748","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"LTD,,N.NARASAPURAM VILLAGE NAKKAPALLI (MANDAL),ANAKAPALLI DIST SDNF India","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753727400,"product":"LENACAPAVIR SPRAY DRIED DISPERSION IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO LABS LTD UNIT IXHETERO INFRASTRUCTURE SEZ","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO LABS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"29953.9","totalValueFC":"60418.8","currency":"USD","unitRateINR":"2600000","date":"29-Jul-2025","totalValueINR":"5200000","totalValueInUsd":"60418.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29339990","bill_no":"3550884","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"LTD,,N.NARASAPURAM VILLAGE NAKKAPALLI (MANDAL),ANAKAPALLI DIST SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756837800,"product":"LENACAPAVIR SPRAY DRIED DISPERSION IH","address":"T-184, MIDC, BHOSARI,","city":"PUNE-MAHARASHTRA","supplier":"HETERO LABS LTD UNIT IX PLOT NO2NAKKAPALLI M","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"EMCURE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"17.00","actualQuantity":"17","unit":"KGS","unitRateFc":"24462","totalValueFC":"414115.6","currency":"USD","unitRateINR":"2150211","date":"03-Sep-2025","totalValueINR":"36553587","totalValueInUsd":"414115.6","indian_port":"Vizag-HIPL SEZ","hs_no":"29349990","bill_no":"4265135","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"ANAKAPALLI DISTRICT,HETERO INFRASTR UCTURE SEZ LTD,,N.NARASAPUR(V) -A.P SDNF India","customerAddress":"T-184, MIDC, BHOSARI,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1757615400,"product":"LENACAPAVIR CONDENSED AMINO COMPOUND LENACAPAVIR CONDENSED AMINO COMPOUND","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"ZHEJIANG MEDICINE HEALTH PRODUCTS","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"13000","totalValueFC":"26215.3","currency":"USD","unitRateINR":"1157000","date":"12-Sep-2025","totalValueINR":"2314000","totalValueInUsd":"26215.3","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4463315","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"IMPORT & EXPORT CO., LTD. 6-7\/F, 310 NORTH ZHONGSHAN ROAD, HANGZOU, 310003, CHINA CHINA","customerAddress":"304,ATLANTA ARCADE,"}]
23-Nov-2022
17-Oct-2025
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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

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...

Shanghai Minbiotech CB

02

  • fda
  • EDQM
  • WHO-GMP

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...

Shanghai Minbiotech CB

03

  • fda
  • EDQM
  • WHO-GMP

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...

Shanghai Minbiotech CB

04

  • fda
  • EDQM
  • WHO-GMP

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...

Shanghai Minbiotech CB

05

  • fda
  • EDQM
  • WHO-GMP

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

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

06

SCI Pharmtech

Taiwan
  • fda
  • EDQM
  • WHO-GMP

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...

SCI Company Banner

07

SCI Pharmtech

Taiwan
  • fda
  • EDQM
  • WHO-GMP

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...

SCI Company Banner

08

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 1620056-47-4

End Use API : Lenacapavir

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

09

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 2109226-54-0

End Use API : Lenacapavir

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

Company Banner

10

ChemExpress

China
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 2189684-54-4

End Use API : Lenacapavir

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

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Pipeline Prospector June 2025: Sanofi, AbbVie, Eli Lilly, BioNTech lead pharma M&A spree; BMS, Astra ink major collaborations
In June, the pharmaceutical industry continued to witness more merger and acquisitions, deals, and groundbreaking approvals by the US Food and Drug Administration (FDA).Several major players forged strategic deals, including Sanofi, Eli Lilly, BioNTech, AbbVie, and BMS, while players like AstraZeneca, Daiichi Sankyo, CSL, and Merck clinched key drug approvals.The month witnessed some of the largest deals in recent pharmaceutical history, with companies positioning themselves strategically across emerging therapeutic areas including rare diseases, oncology, and metabolic disorders. Biotech indices rebounded with the Nasdaq Biotechnology Index (NBI) gaining 3.22 percent from 4,095.80 to 4,227.68. The SPDR S&P Biotech ETF (XBI) rose 3.4 percent from 80.20 to 82.93, and the S&P Biotechnology Select Industry Index (SPSIBI) surged 4.68 percent from 6,170.44 to 6,459.28. Access the Pipeline Prospector Dashboard for June 2025 Newsmakers (Free Excel)Sanofi buys Blueprint for up to US$ 9.5 bn; BMS signs US$ 11.1 bn deal with BioNTechIn M&As, Sanofi agreed to acquire US-based biopharmaceutical company Blueprint Medicines in a deal valued at up to US$ 9.5 billion. This acquisition significantly bolsters Sanofi’s portfolio in rare immunological diseases.Eli Lilly continued to diversify its pipeline — it plans to acquire Verve Therapeutics, a Boston-based gene-editing company specializing in cardiovascular treatments, for up to US$ 1.3 billion. Lilly also entered into a strategic partnership with Swedish biotech firm Camurus, committing up to US$ 870 million to develop long-acting treatments for obesity and diabetes. In Germany, BioNTech agreed to acquire fellow German mRNA vaccine developer CureVac in an all-stock transaction valued at approximately US$ 1.25 billion. This acquisition strengthens BioNTech’s position in mRNA-based cancer immunotherapy research, development, manufacturing, and commercialization. And, as the month drew to a close, AbbVie announced the acquisition of privately held cell therapy developer Capstan Therapeutics in a deal worth up to US$ 2.1 billion. This buyout will give AbbVie access to experimental treatments for autoimmune diseases.Bristol Myers Squibb (BMS) emerged as a major deal-maker in June — it signed a landmark partnership with BioNTech, valued at up to US$ 11.1 billion. This is one of the largest deals to date for the German biotech firm. The collaboration focuses on co-developing and commercializing BNT327, a promising antibody capable of targeting two cancer cell receptors simultaneously, with potential to outperform Merck’s blockbuster Keytruda (pembrolizumab).BMS’ subsidiary RayzeBio secured exclusive worldwide rights to OncoACP3, a radiopharmaceutical agent targeting prostate cancer, from Philochem in a potential US$ 1.35 billion deal.AstraZeneca strengthened its position in China, its second-largest market, through a significant research collaboration with CSPC Pharmaceutical Group, valued at up to US$ 5.3 billion. This partnership focuses on developing therapies for chronic diseases using artificial intelligence, with CSPC conducting AI-driven research at its Shijiazhuang City facility.In other deals, Vor Bio licensed telitacicept from RemeGen for generalized myasthenia gravis in a deal potentially worth US$ 4 billion. Royalty Pharma committed up to US$ 2 billion to fund the development of Revolution Medicines’ daraxonrasib, an experimental drug to treat pancreatic cancer and non-small cell lung cancer (NSCLC).Regeneron struck a US$ 2 billion licensing deal with Hansoh Pharmaceutical for obesity drug olatorepatide. Access the Pipeline Prospector Dashboard for June 2025 Newsmakers (Free Excel) Astra-Daiichi’s Datroway okayed for lung cancer; Merck, Moderna win FDA nods for RSV productsThe FDA granted accelerated approval to Datroway (datopotamab deruxtecan), a precision cancer therapy developed by AstraZeneca and Daiichi Sankyo, for treating adults with locally advanced or metastatic EGFR-mutated NSCLC who have previously received EGFR-directed therapy and platinum-based chemotherapy.CSL secured FDA approval for Andembry (garadacimab-gxii), a groundbreaking monoclonal antibody for preventing hereditary angioedema in patients aged 12 and older.Merck’s long-acting monoclonal antibody Enflonsia (clesrovimab) received FDA approval for preventing respiratory syncytial virus (RSV) illness in newborns and full-term or pre-term infants entering their first RSV season. Moderna bagged FDA approval for its mRNA-based RSV vaccine, mRESVIA, for adults aged 18 to 59 years who are at increased risk of severe RSV disease. This represents a marked expansion from the prior over-60 age group approval.Bayer’s Nubeqa (darolutamide) won an expanded US approval and can be used to treat all patients with metastatic castration-sensitive prostate cancer. Gilead Sciences won FDA approval for lenacapavir (Yeztugo), a twice-yearly HIV prevention injection showing nearly 100 percent efficacy in trials. Nuvation Bio’s Ibtrozi (taletrectinib) received FDA approval for ROS1-positive NSCLC.FDA also granted approval to UroGen Pharma’s Zusduri (mitomycin intravesical gel), marking the first-ever non-surgical therapy for adults with recurrent low‑grade intermediate‑risk non‑muscle invasive bladder cancer.Meanwhile, AbbVie’s Mavyret (glecaprevir/pibrentasvir) expanded its hepatitis C label to include pediatric patients aged three and above without or with compensated cirrhosis. And, Sanofi-Regeneron’s Dupixent (dupilumab) received its eighth FDA approval for bullous pemphigoid, becoming the first targeted biologic for this autoimmune skin disorder. Access the Pipeline Prospector Dashboard for June 2025 Newsmakers (Free Excel) Compass’ depression therapy scores late-stage win; Sarepta suspends shipment of DMD med after second deathAmong noteworthy clinical trials, Compass Pathways achieved a historic milestone as COMP360 became the first synthetic psilocybin to meet primary endpoints in a phase 3 trial for treatment-resistant depression. Eli Lilly’s experimental oral GLP-1 receptor agonist, orforglipron, delivered compelling late-stage results in adults with type 2 diabetes. Merck’s oral PCSK9 inhibitor enlicitide successfully hit primary and secondary endpoints in two phase 3 hyperlipidemia trials, showing significant LDL cholesterol reductions and representing a potential multi-billion-dollar opportunity. Roche reported positive late-stage results for subcutaneous Lunsumio plus IV Polivy in relapsed/refractory large B-cell lymphoma.In a phase 3 trial, Otsuka Pharmaceutical’s investigational therapy — sibeprenlimab — cut severe levels of protein in the urine by 51 percent in patients with life-threatening kidney disease (known as IgAN).In negative news from trials, FDA placed five trials on Gilead's experimental HIV drugs combo on clinical hold, due to safety concerns. And Sarepta Therapeutics reported a second case of acute liver failure resulting in death after a patient (another teenaged boy) received gene therapy Elevidys (delandistrogene moxeparvovec-rokl) for treating Duchenne muscular dystrophy (DMD). The company has paused a clinical trial and suspended shipments of the therapy for non-ambulatory patients. Moreover, an FDA investigation is underway, which will look into acute liver failure due to Elevidys. Access the Pipeline Prospector Dashboard for June 2025 Newsmakers (Free Excel) Our viewThe industry continues to face challenges posed by the geopolitical volatility and pricing pressures, particularly in the US. Given these challenges, the industry has shown considerable resilience and courage to acquire companies and forge strategic partnerships. Coupled with innovation, these factors should help the industry post modest growth this year. Access the Pipeline Prospector Dashboard for June 2025 Newsmakers (Free Excel) 

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03 Jul 2025

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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.

click here to find a list of Lenacapavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

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.

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

Lenacapavir USDMF

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

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

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

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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