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Chemistry

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Also known as: 1051375-10-0, Gsk1265744, Gsk744, Gsk-1265744, Gsk1265744a, S-265744
Molecular Formula
C19H17F2N3O5
Molecular Weight
405.4  g/mol
InChI Key
WCWSTNLSLKSJPK-LKFCYVNXSA-N
FDA UNII
HMH0132Z1Q

Cabotegravir
Cabotegravir, or GSK1265744, is an HIV-1 integrase inhibitor that is prescribed with the non-nucleoside reverse transcriptase inhibitor, [rilpivirine]. Early research into cabotegravir showed it had lower oral bioavailability than [dolutegravir]. The devlopment of cabotegravir was later developed to create a long acting monthly intramuscular injection. Cabotegravir was granted FDA approval on 21 January 2021.
Cabotegravir is a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. The mechanism of action of cabotegravir is as a HIV Integrase Inhibitor, and Organic Anion Transporter 1 Inhibitor, and Organic Anion Transporter 3 Inhibitor.
1 2D Structure

Cabotegravir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(3R,6S)-N-[(2,4-difluorophenyl)methyl]-10-hydroxy-6-methyl-8,11-dioxo-4-oxa-1,7-diazatricyclo[7.4.0.03,7]trideca-9,12-diene-12-carboxamide
2.1.2 InChI
InChI=1S/C19H17F2N3O5/c1-9-8-29-14-7-23-6-12(16(25)17(26)15(23)19(28)24(9)14)18(27)22-5-10-2-3-11(20)4-13(10)21/h2-4,6,9,14,26H,5,7-8H2,1H3,(H,22,27)/t9-,14+/m0/s1
2.1.3 InChI Key
WCWSTNLSLKSJPK-LKFCYVNXSA-N
2.1.4 Canonical SMILES
CC1COC2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
2.1.5 Isomeric SMILES
C[C@H]1CO[C@H]2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
2.2 Other Identifiers
2.2.1 UNII
HMH0132Z1Q
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (3s,11ar)-n-((2,6-difluoropyridin-3-yl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide

2. Apretude

3. Cabotegravir Extended-release Injectable Suspension

4. Cabotegravir Sodium

5. Gsk-1265744

6. Gsk-1265744a

7. Gsk-1265744b

8. Gsk1265744

9. Gsk1265744a

10. Gsk1265744b

11. Gsk744

12. N-((2,4-difluorophenyl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide

13. S-265744

14. S-265744b

15. Sodium (3s,11ar)-8-(((2,4-difluorophenyl)methyl)carbamoyl)-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydrooxazolo(3,2-a)pyrido(1,2-d)pyrazin-6-olate

16. Vocabria

2.3.2 Depositor-Supplied Synonyms

1. 1051375-10-0

2. Gsk1265744

3. Gsk744

4. Gsk-1265744

5. Gsk1265744a

6. S-265744

7. Gsk744 Lap

8. Gsk-1265744a

9. Gsk744 La

10. Gsk 744

11. S/gsk1265744

12. Gsk 1265744

13. Cabotegravir (gsk744, Gsk1265744)

14. Gsk744 (s/gsk1265744)

15. Hmh0132z1q

16. (3s,11ar)-n-(2,4-difluorobenzyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydrooxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide

17. Cab

18. (3s,11ar)-n-((2,4-difluorophenyl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydrooxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide

19. Unii-hmh0132z1q

20. Cabotegravir [usan:inn]

21. Cabotegravirum

22. 744 La

23. Cabotegravir [inn]

24. Cabotegravir [jan]

25. Cabotegravir [usan]

26. Schembl82803

27. Cabotegravir [who-dd]

28. Cabotegravir (jan/usan/inn)

29. Cabotegravir; Gsk1265744

30. Chembl2403238

31. Gtpl11386

32. Dtxsid50146982

33. Chebi:172944

34. Cabotegravir [orange Book]

35. Amy27899

36. Bcp08631

37. Ex-a2330

38. Bdbm50492496

39. Mfcd25976748

40. S7766

41. Zinc96927633

42. Cabenuva Component Cabotegravir

43. S/gsk-1265744

44. Cabenuva (cabotegravir + Rilpivirine)

45. Ccg-268708

46. Cs-5078

47. Db11751

48. Cabotegravir Component Of Cabenuva

49. Ncgc00386434-02

50. Ac-30895

51. As-61279

52. Hy-15592

53. S/gsk1265744; Gsk744

54. D10548

55. P14046

56. A902375

57. Q15411012

58. (3r,6s)-n-[(2,4-difluorophenyl)methyl]-10-hydroxy-6-methyl-8,11-dioxo-4-oxa-1,7-diazatricyclo[7.4.0.0?,?]trideca-9,12-diene-12-carboxamide

59. (3r,6s)-n-[(2,4-difluorophenyl)methyl]-10-hydroxy-6-methyl-8,11-dioxo-4-oxa-1,7-diazatricyclo[7.4.0.03,7]trideca-9,12-diene-12-carboxamide

60. (3s,11ar)-n-((2,6-difluoropyridin-3-yl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide

61. (3s,11ar)-n-(2,4-difluorobenzyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide

62. (3s,11ar)-n-[(2,4-difluorophenyl)methyl]-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide

63. (3s,11ar)-n-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,11,11a-tetrahydrooxazolo[[?]]pyrido[[?]]pyrazine-8-carboxamide

64. (3s,11ar)-n-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide

65. 1264720-72-0

66. N-((2,4-difluorophenyl)methyl)-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-hexahydro(1,3)oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide

67. Oxazolo(3,2-a)pyrido(1,2-d)pyrazine-8-carboxamide, N-((2,4-difluorophenyl)methyl)-2,3,5,7,11,11a-hexahydro-6-hydroxy-3-methyl-5,7-dioxo-, (3s,11ar)-

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 405.4 g/mol
Molecular Formula C19H17F2N3O5
XLogP32.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count8
Rotatable Bond Count3
Exact Mass405.11362698 g/mol
Monoisotopic Mass405.11362698 g/mol
Topological Polar Surface Area99.2 Ų
Heavy Atom Count29
Formal Charge0
Complexity814
Isotope Atom Count0
Defined Atom Stereocenter Count2
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

Oral cabotegravir is indicated in combination with rilpivirine for the short term treatment of HIV-1 in virologically suppressed adults with no history of treatment failure to assess tolerability of cabotegravir or who have missed an injected dose of cabotegravir. Intramuscular extended-release cabotegravir is indicated in combination with rilpivirine as a complete regimen for virologically suppressed adults with no history of treatment failure. The intramuscular form is meant to replace their current antiretroviral treatment.


Treatment of human immunodeficiency virus (HIV-1) infection


Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:

- oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection.

- oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.

Vocabria injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class.


Treatment of human immunodeficiency virus (HIV-1) infection


Prevention of human immunodeficiency virus (HIV-1) infection


5 Pharmacology and Biochemistry
5.1 Pharmacology

Cabotegravir is an inhibitor of HIV integrase, which reduces viral replication. It has a long duration of action as the oral tablet is given daily and the intramuscular suspension is given monthly. Patients should be counselled regarding the risk of hypersensitivity, hepatotoxicity, and depression.


5.2 MeSH Pharmacological Classification

HIV Integrase Inhibitors

Inhibitors of HIV INTEGRASE, an enzyme required for integration of viral DNA into cellular DNA. (See all compounds classified as HIV Integrase Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
CABOTEGRAVIR
5.3.2 FDA UNII
HMH0132Z1Q
5.3.3 Pharmacological Classes
Mechanisms of Action [MoA] - Organic Anion Transporter 3 Inhibitors
5.4 ATC Code

J05AX


J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AJ - Integrase inhibitors

J05AJ04 - Cabotegravir


5.5 Absorption, Distribution and Excretion

Absorption

Oral cabotegravir has a Tmax of 3 hours, reaches a Cmax of 8.0 g/mL, and has an AUC of 145 g\*h/mL. Intramuscular extended-release cabotegravir has a Tmax of 7 days, reaches a Cmax of 8.0 g/mL, and has an AUC of 1591 g\*h/mL.


Route of Elimination

An oral radiolabelled dose of cabotegravir is 58.5% recovered in the feces and 26.8% recovered in the urine.


Volume of Distribution

Data regarding the volume of distribution of cabotegravir is not readily available.


Clearance

Data regarding the clearance of cabotegravir is not readily available. Clearance in dogs was 0.34 mL/min/kg and in cynomolgus monkeys was 0.32 mL/min/kg.


5.6 Metabolism/Metabolites

Cabotegravir is O-glucuronidated to the M1 and M2 metabolites, with 67% of glucuronidation performed by UGT1A1, and 33% by UGT1A9.


5.7 Biological Half-Life

The mean half life of oral cabotegravir is 41 hours. The mean half life of intramuscular extended-release cabotegravir is 5.6-11.5 weeks.


5.8 Mechanism of Action

Cabotegravir binds to the active site of HIV integrase, preventing strand transfer of the viral genome into the host genome, and preventing replication of the virus.


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20-Mar-2025
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CABOTEGRAVIR; RILPIVIRINE

Brand Name : CABENUVA KIT

Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage Strength : 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)

Approval Date : 2021-01-21

Application Number : 212888

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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CABOTEGRAVIR; RILPIVIRINE

Brand Name : CABENUVA KIT

Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage Strength : 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)

Approval Date : 2021-01-21

Application Number : 212888

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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CABOTEGRAVIR

Brand Name : APRETUDE

Dosage Form : SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage Strength : 600MG/3ML (200MG/ML)

Approval Date : 2021-12-20

Application Number : 215499

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Dosage Strength : 200MG/ML

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Brand Name : CABENUVA

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Dosage Strength : 200MG/ML

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Pharmathen SA

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Cabotegravir; Rilpivirine

Dosage : Long Acting Injectable

Dosage Strength : 400MG/ML; 600MG/ML

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Pharmathen SA

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Cabotegravir; Rilpivirine

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Pharmathen SA

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Packaging :

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Cabotegravir; Rilpivirine

Dosage : Long Acting Injectable

Dosage Strength : 600MG; 900MG

Brand Name :

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Registration Country : Greece

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Pharmathen SA

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Cabotegravir; Rilpivirine

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Dosage Form : Long Acting Injectable

Dosage Strength : 600MG/ML; 900MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

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Pharmathen SA

Greece
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Packaging :

Regulatory Info : USA

Cabotegravir; Rilpivirine

Dosage : Long Acting Injectable

Dosage Strength : 600MG/ML; 900MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen
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DATA COMPILATION #PharmaFlow

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FDA approvals rise 49% in 2023; CRISPR’s gene editing therapy sees light of day
In 2022, when the US Food and Drug Administration (FDA) was reeling under the impact of the pandemic, new drug approvals by the agency dropped by 26 percent. But last year, FDA’s new drug approvals rebounded by an impressive 49 percent, with the Center for Drug Evaluation and Research (CDER) approving 55 new drugs in 2023. Of them, 36 percent were considered first-in-class, while small molecules made up for 62 percent of the total drugs approved (i.e. 34). FDA’s Center for Biologics Evaluation and Research (CBER) okayed 19 biologics in 2023 compared to eight in the previous year.The first half of 2023 saw the debut of vaccines for the all-too-common respiratory syncytial virus (RSV). Among the other notable approvals in H1 was Biogen and Eisai’s Alzheimer’s drug Leqembi (lecanemab). Out of the total 55 drug approvals, 29 came in H2 2023. This includes Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy that relies on the Nobel Prize-winning CRISPR gene-editing technology. Casgevy has been approved as a treatment for sickle-cell disease (SCD) and β-thalassemia.While FDA witnessed a sharp rise in approvals in 2023, many other drug regulators didn’t. The European Medicines Agency (EMA) granted marketing authorization to 32 novel drugs in 2023, a fall from 33 in 2022. Similarly, Health Canada’s approvals in 2023 decreased to 38, compared to 45 in the previous year.As usual, oncology topped the list of drug approvals by therapeutic area, at 39 (as opposed to 35 in 2022). Rare diseases was the second most popular therapeutic area for drug approvals. With drugmakers clearly paying heed to the unmet needs of patients suffering from rare diseases, this therapeutic area sprinted from a 9 percent share and the fourth position among new approvals in 2022 to an impressive 34 percent share in 2023. A quarter of the new drug approvals were in infectious diseases, followed by immunology (19 percent) and neurology (7 percent).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Casgevy, postpartum depression drug Zurzuvae emerge as potential blockbustersGene therapy Casgevy, postpartum depression (PPD) med Zurzuvae, blood cancer med Elrexfio and ulcerative colitis drug Velsipity were some of the prominent approvals of 2023.Britain’s Medicines and Healthcare products Regulatory Agency was the first to okay Casgevy in November as a cure for SCD and β-thalassemia. Soon, the FDA approved it for SCD. In January this year, the American agency also approved it for transfusion-dependent β-thalassemia (TDT). Analysts estimate Casgevy to generate US$ 2.6 billion in peak sales, says Nature. Biogen and Sage’s PPD therapy Zurzuvae became the first and only FDA-approved pill for the condition that can be life-threatening for both the mother and the child. Global sales of Zurzuvae are forecast to hit US$ 1.28 billion by 2028.In August, Pfizer’s Elrexfio (elranatamab) became the first “off-the-shelf” (ready-to-use) therapy in the US for multiple myeloma. The drug provides an option for patients with hard to treat or relapsed blood cancer and is estimated to bring in US$ 861 million in peak sales by 2028, says Nature.Pfizer also bagged another significant approval in October — its drug Velsipity (etrasimod) was greenlit by the FDA to treat adults with ulcerative colitis, an inflammatory bowel disease. Peak revenue for Velsipity is expected to come in at US$ 825 million, as per Evaluate.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Astra’s Truqap, GSK’s Ojjaara among top cancer therapies given FDA nod in H2In November, FDA approved AstraZeneca’s Truqap (capivasertib) in combination with the Anglo-Swedish drugmaker’s Faslodex (fulvestrant) for treating adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations. Evaluate Pharma forecasts peak Truqap sales to come in at about US$ 690 million.In September, FDA approved GSK’s Ojjaara (momelotinib) as the first and only treatment for myelofibrosis with anemia. Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease. Ojjaara is taken orally once a day.Other notable oncology treatments okayed by FDA in H2 2023 include Daiichi’s Vanflyta (quizartinib) in July to treat an aggressive blood cancer known as acute myeloid leukemia (AML). In August, FDA approved Janssen’s bispecific antibody Talvey (talquetamab-tgvs) for difficult-to-treat blood cancer. The agency approved two cancer therapies in November — BMS’ Augtyro (repotrectinib) for ROS1-positive non-small cell lung cancer (NSCLC) and Takeda’s targeted oral therapy Fruzaqla (fruquintinib) for adult patients with metastatic colorectal cancer (mCRC).View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Rare disease drugs Santhera-Catalyst’s Agamree, Novo’s Rivfloza bag approval in H2In October, FDA approved Santhera Pharmaceuticals and Catalyst Pharma’s Agamree (vamorolone), an oral suspension treatment for Duchenne muscular dystrophy (DMD) in patients two years of age and older. This makes it the first drug fully approved in both the US and Europe for the muscle degeneration disorder. Agamree acts in a manner similar to other steroids, which are the standard of care for the inherited rare disease. However, it causes fewer side effects.FDA also okayed Novo Nordisk’s once-a-month injection Rivfloza (nedosiran) in October to treat a rare genetic condition — primary hyperoxaluria type 1 (PH1) — that causes recurring kidney stones.In November, the agency approved Takeda’s Adzynma (ADAMTS13, recombinant-krhn) as the first treatment for both adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare genetic blood disorder. Other noteworthy FDA approvals in H2 2023 for rare blood diseases include Novartis’ Fabhalta and bluebird bio's Lyfgenia. Fabhalta is the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria, a rare disease that causes symptoms such as hemolytic anemia, hemoglobinuria (excretion of hemoglobin in the urine), fatigue, shortness of breath etc. Lyfgenia is the first cell-based gene therapy for the treatment of SCD in patients 12 years and older. Similarly, another rare disease drug — Regeneron’s Veopoz —  bagged FDA approval in August last. Veopoz treats CHAPLE disease, an ultra-rare disease in which patients have severe gastrointestinal problems.View New Drug Approvals in 2023 with Estimated Sales (Free Excel Available) Our viewAfter a lull in 2022, new drug approvals have finally gathered momentum. The good news is that this year, several pathbreaking drugs are coming up for approval, such as Madrigal Pharmaceuticals’ resmetirom (the first treatment for NASH with liver fibrosis), Merck’s sotatercept (a treatment for pulmonary arterial hypertension), Lilly’s donanemab for Alzheimer’s disease and Karuna Therapeutics’ drug to treat schizophrenia. Let’s hope 2024 turns out to be an even bigger year for new drug approvals.

Impressions: 3799

https://www.pharmacompass.com/radio-compass-blog/fda-approvals-rise-49-in-2023-crispr-s-gene-editing-therapy-sees-light-of-day

#PharmaFlow by PHARMACOMPASS
01 Feb 2024

NEWS #PharmaBuzz

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https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/march/investigational-broadly-neutralising-antibody/

PRESS RELEASE
13 Mar 2025

https://www.fiercepharma.com/pharma/gilead-coming-fast-gsk-bolsters-case-long-acting-hiv-prep-drug-apretude

FIERCE PHARMA
16 Oct 2024

https://www.businesswire.com/news/home/20241006078203/en

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https://www.businesswire.com/news/home/20240712714679/en

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15 Jul 2024

https://www.pharmabiz.com/NewsDetails.aspx?aid=168917&sid=2

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04 May 2024

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06 Mar 2024

Global Sales Information

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Regulatory FDF Prices

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01

Brand Name : Vocabria

United Kingdom
arrow
Iran Expo
Not Confirmed

Brand Name : Vocabria

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Dosage Form : Filmtabl

Dosage Strength : 30mg

Price Per Pack (Euro) : 599.8

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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02

Brand Name : Vocabria Depot

United Kingdom
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Iran Expo
Not Confirmed

Brand Name : Vocabria Depot

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Dosage Form : Inj Susp

Dosage Strength : 600mg/3ml

Price Per Pack (Euro) : 1248.14

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Annual Reports

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01

Brand Name : Cabenuva

Cabotegravir

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Iran Expo
Not Confirmed

Brand Name : Cabenuva

United Kingdom
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Iran Expo
Not Confirmed

Cabotegravir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2021 Revenue in Millions : 51

2020 Revenue in Millions : 0

Growth (%) : New Launch in 2021

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02

Brand Name : Cabenuva

Cabotegravir

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Iran Expo
Not Confirmed

Brand Name : Cabenuva

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2022 Revenue in Millions : 419

2021 Revenue in Millions : 51

Growth (%) : 715

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03

Brand Name : Apretude

Cabotegravir

arrow
Iran Expo
Not Confirmed

Brand Name : Apretude

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2022 Revenue in Millions : 51

2021 Revenue in Millions : 0

Growth (%) : New Launch in 2022

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04

Brand Name : Cabenuva

Cabotegravir

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Iran Expo
Not Confirmed

Brand Name : Cabenuva

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2023 Revenue in Millions : 764

2022 Revenue in Millions : 419

Growth (%) : 108

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05

Brand Name : Apretude

Cabotegravir

arrow
Iran Expo
Not Confirmed

Brand Name : Apretude

United Kingdom
arrow
Iran Expo
Not Confirmed

Cabotegravir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2023 Revenue in Millions : 161

2022 Revenue in Millions : 51

Growth (%) : 263

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Patents & EXCLUSIVITIES

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ABOUT THIS PAGE

Looking for 1264720-72-0 / Cabotegravir API manufacturers, exporters & distributors?

Cabotegravir manufacturers, exporters & distributors 1

12

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

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

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

API | Excipient name

Cabotegravir

Synonyms

1051375-10-0, Gsk1265744, Gsk744, Gsk-1265744, Gsk1265744a, S-265744

Cas Number

1264720-72-0

Unique Ingredient Identifier (UNII)

HMH0132Z1Q

About Cabotegravir

Cabotegravir, or GSK1265744, is an HIV-1 integrase inhibitor that is prescribed with the non-nucleoside reverse transcriptase inhibitor, [rilpivirine]. Early research into cabotegravir showed it had lower oral bioavailability than [dolutegravir]. The devlopment of cabotegravir was later developed to create a long acting monthly intramuscular injection. Cabotegravir was granted FDA approval on 21 January 2021.

Cabotegravir Manufacturers

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

Cabotegravir Suppliers

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

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

Cabotegravir USDMF

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

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

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

Cabotegravir KDMF

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

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

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

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

Cabotegravir 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 Cabotegravir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Cabotegravir GMP

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

Cabotegravir CoA

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

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

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